Opsumit generics — when can they launch?
Opsumit (MACITENTAN) · AstraZeneca · 19 active US patents · 3 expired
Where Opsumit sits in the generic timeline
All listed Orange Book patents for Opsumit have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.
Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.
Patent estate by type — active patents
Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.
- Other — 11 patents
- Method of Use — 8 patents
FDA U-codes carved out by Opsumit patents
Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.
| U-code | Description |
|---|---|
U-3881 | (no description) |
U-1445 | (no description) |
U-1820 | (no description) |
U-1446 | (no description) |
U-3882 | (no description) |
Sample patent estate
Showing 6 of 19 active US patents. View full estate on the Opsumit drug page →
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This patent protects novel sulfamides and their use as active ingredients in pharmaceutical compositions, particularly as endothelin receptor antagonists.USPTO title: Sulfamides and their use as endothelin receptor antagonists
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This patent protects novel sulfamides and their use as active ingredients in pharmaceutical compositions, particularly as endothelin receptor antagonists.USPTO title: Sulfamides and their use as endothelin receptor antagonists
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This patent protects novel sulfamides and their use as active ingredients in pharmaceutical compositions, particularly as endothelin receptor antagonists.USPTO title: Sulfamides and their use as endothelin receptor antagonists
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This patent protects stable pharmaceutical compositions containing a specific compound or its acceptable forms, used in a certain concentration in a pharmaceutical composition.USPTO title: Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
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This patent protects stable pharmaceutical compositions containing a specific compound or its acceptable forms, used in a certain concentration in a pharmaceutical composition.USPTO title: Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
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This patent protects stable pharmaceutical compositions containing a specific compound or its acceptable forms, used in a certain concentration in a pharmaceutical composition.USPTO title: Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
Sources
- FDA Orange Book — patents listed against Opsumit (NDA filed 2013)
- Opsumit drug profile — full patent estate, indications, clinical trials, pricing
- AstraZeneca patent portfolio
- Patent cliff 2026 — every drug losing US exclusivity that year
Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.
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