Friday, April 29, 2022 9:51:37 PM
Question regarding authorized generic
If Amarin did issue an AG, would it be authorized only for the Marine very high triglycerides indication that current Generics have ANDA for selling without infringement, and not authorized for the Reduce-it CVD indication. That is, prescriptions for the patented method of use for CVD that Amarin spent millions to demonstrate and subsequently received the FDA-approved label for would still be for brand Vascepa at a higher cost, and any prescriptions filled for this indication with the Amarin generic would still be subject to infringement by the insurers? Is this not a solution to preserve the higher margin Reduce-it indication CVD label market while also competing against and undercutting obvious infringement now crazily allowed by Hatch Waxman skinny label with prescriptions auto-switched to DRL, Himka, Apotex? Then in parallel continue to tackle the infringement the autoswitching and formulary issues are inducing?
If Amarin did issue an AG, would it be authorized only for the Marine very high triglycerides indication that current Generics have ANDA for selling without infringement, and not authorized for the Reduce-it CVD indication. That is, prescriptions for the patented method of use for CVD that Amarin spent millions to demonstrate and subsequently received the FDA-approved label for would still be for brand Vascepa at a higher cost, and any prescriptions filled for this indication with the Amarin generic would still be subject to infringement by the insurers? Is this not a solution to preserve the higher margin Reduce-it indication CVD label market while also competing against and undercutting obvious infringement now crazily allowed by Hatch Waxman skinny label with prescriptions auto-switched to DRL, Himka, Apotex? Then in parallel continue to tackle the infringement the autoswitching and formulary issues are inducing?
Recent AMRN News
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- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 03/02/2026 10:31:01 PM
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/04/2026 12:00:09 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/04/2026 12:00:07 AM
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/04/2026 12:00:05 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/04/2026 12:00:04 AM
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- Form 8-K - Current report • Edgar (US Regulatory) • 01/08/2026 12:05:27 PM
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/06/2026 10:00:21 PM
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