Velsipity generics — when can they launch?
Velsipity (Etrasimod Arginine) · Pfizer Inc. · 9 active US patents · 0 expired
Where Velsipity sits in the generic timeline
Imminent generic cliff: earliest active US patent for Velsipity expires in 2029 (~3 years 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 — 6 patents
- Composition of Matter — 3 patents
FDA U-codes carved out by Velsipity 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-3732 | (no description) |
U-4047 | (no description) |
U-4255 | (no description) |
U-3730 | (no description) |
U-3731 | (no description) |
Sample patent estate
Showing 6 of 9 active US patents. View full estate on the Velsipity drug page →
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This patent protects certain substituted compounds and their pharmaceutical compositions for use in treating S1P1 receptor-associated disorders such as psoriasis, rheumatoid arthritis, and transplant rejection.USPTO title: Substituted 1,2,3,4-tetrahydrocyclopenta[b]indol-3-yl)acetic acid derivatives useful in the treatment of autoimmune and inflammatory disorders
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This patent protects certain substituted 1,2,3,4-tetrahydrocyclopenta[b]indol-3-yl)acetic acid derivatives and their salts, useful as S1P1 receptor agonists.USPTO title: Substituted 1,2,3,4-tetrahydrocyclopenta[b]indol-3-yl)acetic acid derivatives useful in the treatment of autoimmune and inflammatory disorders
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This patent protects methods of treating conditions related to the S1P1 receptor by prescribing a standard dose of the compound (R)-2-(7-(4-cyclopentyl-3-(trifluoromethyl) benzyloxy)-1,2,3,4-tetrahydrocyclopenta[b]indol-3-yl)acetic acid.USPTO title: Methods of treating conditions related to the S1P1 receptor
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This patent protects methods of treating conditions related to the S1P1 receptor by prescribing a standard dose of Velsipity.USPTO title: Methods of treating conditions related to the S1P1 receptor
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This patent protects methods of treating conditions related to the S1P1 receptor by prescribing a standard dose of Velsipity.USPTO title: Methods of treating conditions related to the S1P1 receptor
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This patent protects a crystalline form of the L-arginine salt of a specific compound for use in treating S1P1 receptor-associated disorders.USPTO title: Crystalline L-arginine salt of (R)-2-(7-(4-cyclopentyl-3-(trifluoromethyl)benzyloxy)-1,2,3, 4-tetrahydrocyclo-penta [b]indol-3-yl)acetic acid(compound1) for use in S1P1 receptor-associated disorders
Sources
- FDA Orange Book — patents listed against Velsipity (NDA)
- Velsipity drug profile — full patent estate, indications, clinical trials, pricing
- Pfizer Inc. patent portfolio
- Patent cliff 2029 — 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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