Adempas generics — when can they launch?
Adempas (RIOCIGUAT) · Bayer · 20 active US patents · 0 expired
Where Adempas sits in the generic timeline
Imminent generic cliff: earliest active US patent for Adempas expires in 2026 (~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 — 15 patents
- Composition of Matter — 5 patents
FDA U-codes carved out by Adempas 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-2834 | (no description) |
U-2835 | (no description) |
Sample patent estate
Showing 6 of 20 active US patents. View full estate on the Adempas drug page →
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This patent protects compounds that stimulate soluble guanylate cyclase, which are used as medicaments for treating cardiovascular disorders and/or sexual dysfunction.USPTO title: Carbamate-substituted pyrazolopyridines
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This patent protects compounds that stimulate soluble guanylate cyclase, which are used as medicaments for treating cardiovascular disorders and/or sexual dysfunction.USPTO title: Carbamate-substituted pyrazolopyridines
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This patent protects compounds that stimulate soluble guanylate cyclase, which are used as medicaments for treating cardiovascular disorders and/or sexual dysfunction.USPTO title: Carbamate-substituted pyrazolopyridines
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This patent protects compounds that stimulate soluble guanylate cyclase, which are used as medicaments for treating cardiovascular disorders and/or sexual dysfunction.USPTO title: Carbamate-substituted pyrazolopyridines
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This patent protects compounds that stimulate soluble guanylate cyclase, which are used as medicaments for treating cardiovascular disorders and/or sexual dysfunction.USPTO title: Carbamate-substituted pyrazolopyridines
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This patent protects various forms of the drug substance methyl {4,6-diamino-2-[1(2-fluorobenzyl)-1H-pyrazolo[3-4-b]pyridino-3-yl]pyrimidino-5-yl}methyl carbamate.USPTO title: Forms of methyl {4,6-diamino-2-[1(2-fluorobenzyl)-1H-pyrazolo[3-4-b]pyridino-3-yl]pyrimidino-5-yl}methyl carbamate
Sources
- FDA Orange Book — patents listed against Adempas (NDA filed 2013)
- Adempas drug profile — full patent estate, indications, clinical trials, pricing
- Bayer 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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