SovereignNinja5
7時間前
Contact IR directly as well as Sarissa and Torok. Torok has zero experience and shouldn’t even be on the BOD. All he did was send a letter as a CSG and put an add in an online publication and that failure Denner Capitulated and gave him a seat on the BOD. Torok is not qualified to flip burgers.
Subject: Request for Immediate Action on Strategic Review and Capital Allocation – Retail Shareholder Communication
Dear Amarin Investor Relations Team and Members of the Board of Directors,
I am a long-term retail shareholder of Amarin Corporation. I am writing to express serious concern regarding the company’s priorities and execution under the current board’s leadership since March 2023.
Following the May 13, 2026 Annual General Meeting, retail shareholders rejected the new share issuance authority, the amendment to the 2020 Stock Incentive Plan, pre-emption rights, and several director re-elections for the second consecutive year. Despite clear opposition stacking up in real time, the Board chose not to adjourn the meeting. After the results were finalized, the Board issued only one brief, defensive comment with no meaningful acknowledgment of the scale of retail dissatisfaction or commitment to improved transparency.
The Board’s response to this clear shareholder message has been to shift a significant portion of executive and director compensation from equity to all-cash payments. This change will create a new, recurring cash outflow of approximately $5 million per year beginning in the second half of 2026.
Amarin is expected to report positive operating cash flow in 2026. The first meaningful deployment of that cash should not be increased compensation to the same executives and directors whose dilution proposals shareholders just rejected. Retail shareholders approved a $50 million share repurchase program. Zero shares have been repurchased.
During the Q1 2026 earnings conference call, analysts directly asked management about plans for share buybacks or a special dividend. The responses were vague and non-committal.
Barclays was engaged as exclusive financial advisor in June 2025. Eleven months later, retail investors have received no meaningful updates on the status or timeline of the strategic review. The Board also remained silent following the unanimous Supreme Court decision in Hikma v. Amarin on June 4, 2026.
Derisking of the asset is now substantially complete. The operational reset has been executed, positive cash flow has been achieved, the Recordati royalty partnership is in place, and the major legal overhang from the Supreme Court has been resolved. There is no longer a credible reason for further delay.
We respectfully request the following:
1. Accelerate the Barclays-led strategic review with the explicit objective of completing a value-maximizing transaction in 2026.
2. Provide greater transparency on commercial priorities and the post-FDC lifecycle management strategy.
3. Offer clear, substantive updates on the status and expected timing of the LREtEPA patent application and related 505(b)(2) regulatory pathway.
4. Provide a concrete timeline and commitment regarding the execution of the previously approved $50 million share repurchase program or the consideration of a special dividend.
Retail shareholders expect the board to fulfill its fiduciary duty by maximizing value now that the operational reset is complete. Continued silence or defensive prioritization over commercial execution and shareholder returns is no longer acceptable.
I look forward to your prompt response and to concrete actions demonstrating alignment with shareholder interests.
Sincerely,
[Your Full Name]
Long-term Retail Shareholder
[Approximate shares held or years invested, if comfortable]
rosemountbomber
1日前
Shadolane, when you and Lizzy muse about whether you will still be around, I am wondering if you guys are referring to age or whether you will stay invested here?
I have been here a long time and often think of some posters that were here a decade ago. Most are gone, at least from posting, so hard to know if they still hold shares. When a stock loses so much it seems almost pointless to liquidate (although I realized I needed to liquidate some of my highest cost basis shares in case one of us dies and the basis gets reset), so I hold. It is definitely (at this moment anyway) not growth investing but at least Amarin is currently not losing money, has cash in the bank, and most of the bad news has been digested.
Anyway, in case you guys were referring to age, I am in the same boat, so wishing everyone continued good health so that we can be around to see the developments here.
SovereignNinja5
1日前
LMAO ok Beer, I know where you get your info. Send my regards. PBM decisions are not what you think.
This is cute.
“Amarin's benefit from the science will come from Europe and ROW, and Guideline upgrades in those regions.”
The OUS Revenue Reality Check
Looking at the Q1 2026 10-Q and earnings release, the OUS business remains very small in absolute terms:
• Europe (Recordati): $4.9 million (mostly initial supply shipments)
• Rest of World product sales: $2.8 million
• Total licensing & royalties across all international partners: $1.8 million
Management noted they are seeing “good growth” from partners outside Europe. While technically true on a percentage basis, this growth is coming from a very low base. Quarter-to-quarter comparable European royalty economics under the Recordati model will not be visible until Q3 2026.
China has also been taken off the table as a near-term growth driver. Aaron Berg has publicly stated that Edding is focusing on private/self-pay sales rather than pursuing broad NRDL reimbursement. This is a deliberate strategic choice that significantly limits the addressable market in what is otherwise a massive potential territory.
HLS in Canada remains the most mature and credible of the non-European partnerships, but it is still relatively small in the overall picture. The other partners (Lotus, Israel, MENA, etc.) are early-stage or minor contributors.
Bottom line: The current OUS revenue does not yet reflect a strong or proven growth story. The shift to an asset-light model has stabilized the P&L, but the recurring royalty economics that would support a higher valuation are not yet visible in the reported numbers. Clean, comparable data from Recordati only begins in Q3 2026.
The longer the company waits, the more retail shareholders continue to bear the opportunity cost while the OUS story remains unproven in the financials.
Thank you for your attention to this matter.
TalShu
2日前
CaptainBeer,
LR-EtEPA patent, if granted, could extend Amarin’s EPA exclusivity to 2043 in the U.S. and worldwide.
LR-EtEPA is designed to cover not just the active ingredient (icosepentethyl) but also the novel formulation and uses: “lymph-releasing composition” comprising EPA ethyl ester with a phospholipid emulsifier (e.g. lecithin), and optionally other emulsifiers, to enhance lymphatic absorption, thereby increasing EPA uptake in tissues. The claims extend to treat a broad range of diseases – cardiopulmonary, renal, neurological diseases, and cancer – using this formulation. In practical terms, the patent would protect any extended-release or self-emulsifying EPA formulations similar to MND-2119 in the U.S., and key global markets. This broad scope helps insulate Amarin from would-be generic competitors trying to introduce improved EPA products. Generic drug could still sell regular icosepoentethyl capsules, but they could not copy the LR-EtEPA formulation (EPA + specific phospholipid/emulsifier system) without infringing. Thus, if Amarin can convert patients to the new formulation, generics of old Vascepa would be less threatening.
The LR-EtEPA patent is designed to be a life-cycle managenet tool to fend off generic competition. With Vascepa, Amarin’s patents were method-of-use focused (for triglyceride reduction and CV risk reduction) and proved vulnerable to attack and to “skinny labeling” workaround by generics. In contrast, the LR-EtEPA patent focuses on the drug formulation itself, making it harder for generics to circumvent. A generic manufacturer cannot omit an indication to avoid infringing – they would have to either wait until patent expiry or engineer a non-infringing formulation (which is challenging if the patent claims are broad). This positions LR-EtEPA as a branded alternative that physicians could prescribe to regain the benefits of a protected product. Notably, Amarins U.S. patent application claims priority from nine provisional filings in early 2022 signaling that Amarin moved swiftly to stake out this intellectual property. By being first to file, Amarin has the earliest priority date on this invention, which is critical to establishing dominance if other companies were exploring similar enhanced EPA delivery technologies.
Still, legal challenges could threaten its duration or scope. One vulnerability is prior art in the form of Mochida’s own self-emulsifying EPA. Mochida’s patent (now granted as US10,786,575 B2 and related family) discloses a very similar formulation that closely mirrors the LR-EtEPA formulation. Because Mochida’s patent was filed in 2019-2020 and published by 2021 it predates Amarin’s January 2022 priority date – meaning it could be cited against Amarin’s claims. There is a risk that patent examiners or generic challengers argue Amarin’s LR-EtEPA invention is not sufficiently novel or obvious in light of Mochida’s work. Amarin will need to distinguish its claims (perhaps on specific usage methods, unique ratios, or new therapeutic applications not covered by Mochida).
It is worthwhile recalling here that a secret June 2018 collaboration agreement with Mochida, the originator of MND-2119 in Japan, still obtains. All that is publicly known about this agreement is that it gives Amarin “an exclusive license to certain Mochida intellectual property to advance our interests in the United States and certain other territories” (see Amarin annual reports). For its part the Mochida Annual Review 2018 stated: “In June 2018, Mochida also entered an agreement with Amarin Corporation Plc Group to develop and commercialize high-purity EPA products in the US and certain other countries under Mochida’s intellectual properties, including new EPA formulation.”
Accordingly, among the pending worldwide patent applications for LR-etEPA (Israel, Japan, Europe, Australia, Morocco, Mexico, Canada, Korea, U.S.) the absence of an application in China is salient.
So far, there is no public legal conflict between the two companies; rather, Mochida simply no longer references Amarin in its communications post-2020 as a "strategic partner” while Amarin continues to make annual milestone payment to Mochida. This might reflect a double entente by both partners to :
1) avoid direct litigation and possibly cross-licensing IP, and
2) engage in a division of labor regarding:
- geographies whereby Mochida focuses on Asia and Amarin on Western markets,
- market segments as Mochida has never claimed pursuing CVD therapies;
- API supplies.
Another legal challenge could be patent invalidation attempts (post-grant review or future litigation). Given the high stakes – lR-EtEPA is essentially Amarin’s strategy to reclaim the U.S. market – generic manufacturers have incentive to challenge the patent early. If the U.S. patent is granted, a post-grant review in the PTAB within the first 9 months is a possible avenue for opponents. They might argue obviousness by combining prior knowledge of fish-oil emulsification techniques. Additionally, because Amarin’s patent extends to broad disease treatment claims (including areas like cancer or neurology), it could be vulnerable if those claims are not fully supported by data. Patents must indeed enable and support the scope of claims. Competitors might also watch for any procedural missteps (errors in inventorship or priority) to exploit.
In summary, the LR-EtEPA patent, if granted and maintained, would be stronger and longer-lasting than the original Vascepa patents - covering the product itself in addition to uses, and extending into the 2040s. It offers Amarin a renewed defensive moat in the U.S. and globally. Nonetheless, patent strength will ultimately depend on surviving challenges from prior-art (e.g. Mochida’s inventions) and competitors. Amarin’s multi-filing strategy and 2023 win in Europe show a concerted effort to build a fortress of IP around EPA worldwide. If successful, this will keep generic competition at bay in the cardiovascular space for many years and markedly enhance Amarin’s valuation of the Vascepa franchise.
SovereignNinja5
2日前
Thanks to DMC for providing a link to an Amarin funded study that says Sarissa/Torok/Berg are failures. The sales Rep on linked in confirms they intentionally don’t sell the drug is just the icing on the cake. Keep contacting IR for the share buybacks and having them explain themselves. The hypocrisy is astounding.
Public Health Rhetoric vs. Commercial Reality: A Clear Disconnect
Fellow shareholders,
Amarin has been vocal in supporting the FDA’s October 2025 decision to revise fenofibrate labeling. In their press release, the company applauded the FDA for adding language stating that fenofibrates “did not reduce cardiovascular disease morbidity or mortality” in large trials. They called for a “long-overdue shift in clinical practice” away from therapies without proven cardiovascular benefit and toward treatments like Vascepa that have demonstrated outcomes.
These are strong public statements about protecting patients and promoting evidence-based care.
However, the company’s actions tell a different story.
Amarin currently has no dedicated sales force and no meaningful PBM or payer management infrastructure. Despite publicly advocating for reduced inappropriate use of fibrates and greater use of proven therapies, the company eliminated the commercial resources required to actually drive that change.
A recent study published in the Journal of Clinical Lipidology (2026) highlights the real-world consequences: despite REDUCE-IT outcomes data, EVAPORATE plaque regression evidence, and support in the 2026 ACC/AHA Dyslipidemia Guideline and AHA CABG Scientific Statement, icosapent ethyl remains significantly underutilized in eligible high-risk patients. This underutilization is particularly evident in concentrated, high-yield populations such as patients in cardiac rehabilitation and those who have undergone CABG.
Further compounding this picture, Amarin’s SEC filings show elevated inventory levels across multiple stages — including raw materials (API), work-in-process, and finished goods — along with long-term supplier commitments that required amendments after generic entry. This reflects a heavy focus on supply-side management and defensive positioning rather than building commercial execution to increase appropriate use of the product.
The scientific differentiation of Vascepa is real. The opportunity to better serve appropriate patients while displacing therapies without proven cardiovascular benefit also remains real. What has been missing is the commercial execution required to turn that evidence into broader patient access.
This gap between public statements and operational decisions raises legitimate questions about priorities and capability. A company that publicly calls for better prescribing for patients should have the commercial tools in place to support it.
Retail shareholders who would like more clarity on how Amarin plans to address real-world underutilization of icosapent ethyl and align its commercial efforts with its public statements on evidence-based care are encouraged to contact the company’s Investor Relations team directly.
Civil discussion welcome.
Thank you for your attention to this matter.
https://www.sciencedirect.com/science/article/abs/pii/S1933287426002540
marzan
3日前
DAR, excellent reminder. A lot of people seem to forget that Judge Andrews’ original dismissal was not the type of ruling that slammed every door shut forever and a death sentence. It was ‘Without Prejudice’. The alleged deficiencies were in the pleadings, and Amarin was effectively given an opportunity to come back with a stronger factual record if one existed.
What stands out to me is that during Supreme Court oral argument, Amarin’s counsel specifically asked that, at a minimum, the case be remanded so the company could pursue that path. The Supreme Court reversed the Federal Circuit’s legal theory, but it did not simply terminate the litigation and walk away. It sent the case back to the lower court. That matters.
Now Amarin has the benefit of years of additional information, discovery efforts, market data, and evidence that did not exist when the original complaint was filed. None of us knows exactly what Amarin will do next, but if management and counsel believe they have stronger inducement evidence, repleading seems like the logical next step. The silence since the decision may simply reflect careful legal planning rather than surrender.
Thanks for bringing the history back into the discussion. The 9-0 remand keeps the door open, and until Amarin announces its next move, I wouldn’t assume Hikma is completely out of the woods.
DAR53
3日前
marzan, if everyone would remember the original suit that landed in Judge Andrew's District Court, she dismissed the suit against Hikma. However she did that "without prejudice" to allow Amarin to stregthen their case and replead. Judge Andrews gave Amarin an out.
District Court (January 2022): Judge Andrews granted Hikma's motion to dismiss, finding that neither Hikma's "skinny label" nor its generic marketing statements constituted active steps to encourage infringement. Under federal procedure, a dismissal for failure to state a claim upon which relief can be granted is typically without prejudice, allowing the plaintiff the opportunity to amend their complaint to cure the defects if they can.
As Huston requested at oral arguments to the SC, he asked for at a inimum to be remanded back to the lower courts. Hopefully she will be open to listening to the facts uncovered through discovery.
I am not suggesting this is an end all choice for Amarin, but I personnally would like this to proceed at the DC.
marzan
3日前
Monk, thanks for speaking up. It takes some courage to challenge the same small group that seems to patrol the AMRN board around the clock.
They often present themselves as guardians of retail investors, but somehow the message is almost always the same: doubt, pessimism, and reasons why nothing can work. Healthy skepticism is one thing; constant negativity is another.
The Supreme Court remanded the case, Amarin’s counsel specifically sought the opportunity to replead with additional evidence, and the story is clearly not over. I appreciate posters who are willing to look at all sides of the situation rather than simply declaring defeat at every turn.
10-4, Monk.
marzan
3日前
What I find interesting is that some of the loudest voices declaring Amarin "dead" seem to spend an extraordinary amount of time discussing it every single day.
If the company truly has no future, the lawsuit is over, the pipeline is worthless, management has no plan, and shareholders are doomed, then why the constant attention? Most investors move on when they conclude an investment has no value. They don't spend months or years dissecting every filing, conference call, patent application, board change, and court docket.
The reality is that Amarin still has over $300 million in cash, global partnerships, a next-generation formulation under development, and a controlling shareholder in Sarissa that continues to reshape the company. You can disagree on where that leads, but calling the company "dead" while following it 24/7 suggests even the critics know there is still a story unfolding here.
Are you still the moderator? Just asking.
JRoon71
3日前
RMB, I can't disagree. I have not spent that much time following the patent approval process, because it mostly happens "behind closed doors". But Capt's explanation is absolutely valid. I just don't know where that would leave us.
My assumption is, if we had to abandon the patent, they could still partner with someone in the US market to sell and market Vascepa.
But I have to assume Amarin has already contemplated this issue when applying for the patent. Interestingly, they have applied for the patent in Japan. My only assumption is that with Amarin and Mochida's history together, that they have worked together on this to some extent. Maybe Amarin has improved on Mochida's original work (JELIS), and now Amarin is going to share that with Mochida, allowing Mochida to use their new work in Japan.
Originally, all of the work on IPE was developed by Mochida. And they shared that with Amarin for ex-Japan markets. And they had a long-standing collaboration to "share" their research. One can only hope this continues.
They do note on their 2025 Annual Report that they are still paying Mochida under their Agreement.
rosemountbomber
3日前
JRoon, good point highlighting something that we sometimes forget or neglect to think about. Namely, that Denner first got into Amarin after the Generics had already gotten in. Of course, so far, he hasn't been able to figure out how to monetize this investment. What I am not so aware of, is where the thought, idea, process of the new formulation was when Denner came aboard? Capt Beer's post this morning offered a sobering thought. Whether the USPTO will consider that the specific ratio's of ingredients are unique and that they have shown unexpected results. I am in a holding pattern until, hopefully by the end of the year, we hear whether the patent has been granted and if so what Amarin's plans for it are.
JRoon71
3日前
I agree that the case is essentially dead. And even if they can resurrect it somehow, it will be many more years of this. So I really don't think there is any "value" in the legal case going forward.
Having said that, I don't agree that the company is dead. The trial outcome could have been some icing on the cake for us, but I find it highly improbable that Sarissa was banking their entire investment on the outcome of a shaky trial - one which still could have legally left 7 other generic manufacturers in the market. And it's not as if they lost the patent after Sarissa invested. They knew going into it that the patent was gone.
I also don't believe that Sarissa thought that (1) losing the patent, then (2) firing the entire sales & marketing department, and having the company go virtually dark from a marketing perspective, was going to bolster their investment. So it leaves you to look much deeper at what Sarissa has been trying to do. And since they don't say a damn thing about anything, all you can do is watch their actions.
So, what have they done? They have outsourced sales & marketing for the entire world, ex-US. Will the U.S. market be next? Are they morphing into a cashflow/royalty machine?
Look at their Balance Sheet. Look at Retained Earnings. Then look at Innoviva's P&L. They are absolutely smoking it right now. Trailing 12 months they have a $95M Income Tax accrual. Innoviva is a cashflow/royalty machine. And their Balance Sheet is loaded with biotech startup investments. Look at some of their "Strategic Investments"...Armata, ImaginAb, Syndeio, Beacon, etc. All have Sarissa board members or executive committee members. Innoviva's CEO (Pavel Raifeld) is a former Sarissa employee. Mark Dipaolo (our former board member), is now chairman of the board of Syndeio. Innoviva's board has multiple members that are on other Sarissa holding boards, or have been in the past. Innoviva is continuing to host and fund those investments (this goes well beyond the ISP Fund). It has become Sarissa's investment incubator.
Go to Innoviva's website. Read their "Strategy" tab. Read the "Our Business" tab. It's not a pharmaceutical company. It's an investment company with a cashflow/growth engine. It takes a page out of Warren Buffet's BH playbook (using insurance company cashflows to fund his investments). And Innoviva is 100% owned by institutional investors. Wall Street absolutely LOVES them. Amarin? Beyond Sarissa's investment, we are 15%.
Innoviva went to like 8 healthcare investor conferences in 2025. Amarin? Zero. We used to go to most of them as well. Why wouldn't Amarin/Sarissa be attending those if Sarissa has now "cleared the decks to sell the company", as so many have stated, after the lawsuit failed?
I don't think Sarissa is interested in just selling to a 3rd party like Pfizer or Recordati. I think they have larger aspirations. And I do think it starts with the new formulation. My feeling is that there is still a very bright future for Amarin, but it is likely going to be a slow grind upwards for a while.
There would be a lot of hurdles to cross to combine the companies. But Innoviva is absolutely killing it right now. And adding Amarin's potential future cashflow from their Vascepa 2.0 royalties would be a huge addition to that. This is not some "pie in the sky" concept that requires ChatGPT to write out a novel with fancy icons, trying to find the connection. Sarissa is literally doing this in front of our faces.
SovereignNinja5
3日前
Glad to see the infringement “investors” have moved on. That part of the con is almost over. I have faith in judge Andrew’s dismantling Sarissa’s game as they horde API and pretend the drug has no clinical utility. Keep reading and definitely keep contacting IR and don’t swallow the narrative sideways. We sent a strong message voting down all of the idiotic Sarissa and Torok proposals and they still don’t do share buy backs. Berg hates answering questions around returning money to shareholders and if he can keep the PBM contracts. Activism is next but first let’s talk about patents.
Do We Need a First Office Action Before the Company Can Be Sold?
A common belief on this board is that Amarin cannot be sold until the LR-EtEPA patent receives a First Office Action (FOA). This is not accurate.
In biotech and pharmaceutical M&A, it is very common for companies to be acquired while key patents are still pending or early in prosecution — often well before a First Office Action is issued.
Here are several real-world examples of large biotech acquisitions where key patents were still maturing at the time of the deal:
• Kite Pharma / Gilead (2017) — $11.9 billion
Several foundational CAR-T patents were still in active prosecution or had only recently entered examination when the deal was announced.
• AveXis / Novartis (2018) — $8.7 billion
Core AAV9 vector and manufacturing patents were still relatively early in prosecution when Novartis acquired the company.
• Forty Seven / Gilead (2020) — $4.9 billion
Key composition and method-of-use patents for magrolimab were still in prosecution at the time of the acquisition.
• Juno Therapeutics / Celgene (2018) — $9 billion
Multiple important CAR-T related patents were still pending or early in the examination process.
These deals show that sophisticated buyers do not require patents to be granted — or even to have received a First Office Action — before moving forward with an acquisition. Buyers perform detailed due diligence on pending applications and underwrite the risk accordingly.
What about the Mochida prior art risk?
Mochida is the most relevant prior art the examiner is expected to cite when examining the elected composition claims. Mochida has marketed self-emulsifying EPA formulations in Japan that use similar components (EPA combined with phospholipids and emulsifiers).
Amarin is actively prosecuting around this prior art. The company narrowed its claims to a specific phospholipid-to-EPA weight ratio (approximately 1:1 to 1:5), defined lecithin specifications, and a limited set of emulsifiers. This is a standard design-around strategy. The First Office Action is the stage where the examiner will likely issue obviousness rejections based on Mochida, and Amarin will have the opportunity to respond with arguments and amendments.
Sophisticated buyers routinely diligence exactly this type of prior art risk. They assess the strength of the elected claims, the applicant’s ability to overcome rejections, and the commercial value of the resulting patent scope. Many large deals have closed with similar or greater patent uncertainty than what currently exists with LR-EtEPA.
Bottom line
The idea that Amarin must wait for a First Office Action — or a full patent grant — before a sale can happen is not supported by how these transactions actually occur in the industry. The LR-EtEPA application is still early in substantive prosecution, but that status alone does not prevent a transaction. What matters more to a potential buyer is the defensibility of the composition claims and the overall clinical and commercial story supporting the asset.
marzan
4日前
That is not necessarily how U.S. federal litigation works. A 9-0 unanimous remand does not automatically erase every deposition, document, or discovery item gathered previously. Judge Richard G. Andrews still has procedural discretion on how the case proceeds from here.
Also, remember: Amarin’s counsel specifically argued they had additional evidence and sought the opportunity to replead. If the court allows an amended complaint, prior discovery can still influence the case directly or indirectly, and the judge can also reopen or restart discovery if needed. The SCOTUS ruling clarified the pleading standard for induced infringement under 271(b); it did not say all evidence collected becomes legally radioactive or unusable forever.
Most importantly, the case was remanded, not terminated. That distinction matters.
SovereignNinja5
4日前
Turns out many of you pretended to listen to the hot wash post SCOTUS with the Goodwin law firm who successfully tried the GSK/Teva infringement case. If you actually listened and read the slides you would have learned that Amarin caused the problems by going to the FDA with a method of use patent not Judge Du. You would have learned what the 505b2 path is, you would have heard their predictions that Amarin would lose 9-0 and you would finally learn how infringement works at the state level. Good thing Sarissa didn’t hire Goodwin law and instead hired Perkins Coie, a political law firm (Russiagate) because now Judge Andrew’s who dismissed the case in 2020, sat through the recent court case and now has Amarin back in his court with a 9-0 beat down from SCOTUS gets to finally rub it in Amarin’s nose. Anyways, keep reading and see the photo. Because we move on to activism next. Sarissa and Torok are jokers in this con.
How State Pharmacy Laws (Not the FDA) Drive Generic Substitution
Fellow shareholders,
Many people are confused about how skinny-label generics have captured volume in the REDUCE-IT population. The answer lies in state law, not federal law or the FDA.
Here is the simple reality:
• When a generic is rated AB (therapeutically equivalent) in the FDA’s Orange Book, state pharmacy laws generally require or permit pharmacists to substitute it for the brand-name drug.
• This substitution happens at the pharmacy counter.
• Substitution is not limited to the indications listed on the generic’s label.
This means:
• A doctor can write a prescription intending the branded product for a patient in the 150–499 mg/dL cardiovascular risk reduction population (the carved-out indication).
• The pharmacist sees an AB-rated generic available and substitutes it anyway.
• This occurs even if the generic’s label only lists severe hypertriglyceridemia (≥500 mg/dL) and properly carves out the patented cardiovascular use.
State laws do not require the pharmacist to verify whether the prescription is for the carved-out patented indication. They substitute based on the AB rating, not the label language.
This is why skinny-label launches have been so effective at eroding branded volume. The legal protection the generic gains from using a skinny label does not prevent real-world substitution at the pharmacy level.
Prescribers can block substitution by writing “Dispense as Written” (DAW) or “Do Not Substitute,” but this requires active intervention by the physician and does not happen automatically in most cases.
This mechanism is controlled by state pharmacy statutes, which vary somewhat by state but follow the same general pattern across the country. It is a structural issue that the current Vascepa formulation cannot escape without a new, non-AB-rated formulation.
Civil discussion welcome.
Thank you for your attention to this matter.