Remodulin generics — when can they launch?
Remodulin (TREPROSTINIL) · United Therap · 80 active US patents · 0 expired
Where Remodulin sits in the generic timeline
Imminent generic cliff: earliest active US patent for Remodulin expires in 2027 (~1 year from today). ANDA filers are likely already preparing Paragraph IV certifications. Expect first-filer 180-day exclusivity competition imminently.
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.
- Method of Use — 37 patents
- Composition of Matter — 32 patents
- Formulation — 11 patents
FDA U-codes carved out by Remodulin 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-1849 | (no description) |
U-1437 | (no description) |
U-3749 | (no description) |
Sample patent estate
Showing 6 of 80 active US patents. View full estate on the Remodulin drug page →
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This patent protects a method of administering the drug treprostinil using a metered dose inhaler.USPTO title: Treprostinil administration by inhalation
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This patent protects a method of administering the drug treprostinil using a metered dose inhaler.USPTO title: Treprostinil administration by inhalation
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This patent protects a method of administering the drug treprostinil using a metered dose inhaler.USPTO title: Treprostinil administration by inhalation
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This patent protects a method of administering the drug treprostinil using a metered dose inhaler.USPTO title: Treprostinil administration by inhalation
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This patent protects a method of administering the drug treprostinil using a metered dose inhaler.USPTO title: Treprostinil administration by inhalation
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This patent protects a method of administering the drug treprostinil using a metered dose inhaler.USPTO title: Treprostinil administration by inhalation
Sources
- FDA Orange Book — patents listed against Remodulin (NDA filed 2002)
- Remodulin drug profile — full patent estate, indications, clinical trials, pricing
- United Therap patent portfolio
- Patent cliff 2027 — 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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