ABACAVIR SULFATE generics — when can they launch?
ABACAVIR SULFATE (ABACAVIR SULFATE) · · 8 active US patents · 0 expired
Where ABACAVIR SULFATE sits in the generic timeline
Imminent generic cliff: earliest active US patent for ABACAVIR SULFATE 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.
- Composition of Matter — 4 patents
- Other — 4 patents
Sample patent estate
Showing 6 of 8 active US patents. View full estate on the ABACAVIR SULFATE drug page →
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This patent protects a class of substituted 5-hydroxy-3,4,6,9,9a,10-hexahydro-2H-1-oxa-4a,8a-diaza-anthracene-6,10-diones useful as anti-HIV agents.USPTO title: Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness
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This patent protects a class of substituted 5-hydroxy-3,4,6,9,9a,10-hexahydro-2H-1-oxa-4a,8a-diaza-anthracene-6,10-diones useful as anti-HIV agents.USPTO title: Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness
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This patent protects a class of compounds useful as anti-HIV agents, specifically substituted 5-hydroxy-3,4,6,9,9a,10-hexahydro-2H-1-oxa-4a,8a-diaza-anthracene-6,10-diones.USPTO title: Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness
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This patent protects a class of compounds useful as anti-HIV agents, specifically substituted 5-hydroxy-3,4,6,9,9a,10-hexahydro-2H-1-oxa-4a,8a-diaza-anthracene-6,10-diones.USPTO title: Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness
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This patent protects a synthesis approach for carbamoylpyridone HIV integrase inhibitors and their intermediates.USPTO title: Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
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This patent protects a synthesis approach for carbamoylpyridone HIV integrase inhibitors and their intermediates.USPTO title: Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Sources
- FDA Orange Book — patents listed against ABACAVIR SULFATE (NDA filed 1998)
- ABACAVIR SULFATE drug profile — full patent estate, indications, clinical trials, pricing
- 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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