BICTEGRAVIR SODIUM generics — when can they launch?
BICTEGRAVIR SODIUM (BICTEGRAVIR SODIUM) · · 18 active US patents · 0 expired
Where BICTEGRAVIR SODIUM sits in the generic timeline
Mid-term cliff: earliest active US patent for BICTEGRAVIR SODIUM expires in 2032 (~6 years). Generic developers typically begin ANDA bioequivalence studies 3-4 years ahead of this date. Paragraph IV filings + Hatch-Waxman 30-month stays may shift the effective entry by another 18-36 months.
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 — 6 patents
- Other — 4 patents
- Formulation — 2 patents
FDA U-codes carved out by BICTEGRAVIR SODIUM 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-257 | (no description) |
Sample patent estate
Showing 6 of 18 active US patents. View full estate on the BICTEGRAVIR SODIUM drug page →
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This patent protects a hemifumarate form of tenofovir alafenamide, used in antiviral therapy.USPTO title: Tenofovir alafenamide hemifumarate
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This patent protects a hemifumarate form of tenofovir alafenamide, used in antiviral therapy.USPTO title: Tenofovir alafenamide hemifumarate
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This patent protects a hemifumarate form of tenofovir alafenamide, used in antiviral therapy.USPTO title: Tenofovir alafenamide hemifumarate
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This patent protects a hemifumarate form of tenofovir alafenamide, used in antiviral therapy.USPTO title: Tenofovir alafenamide hemifumarate
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This patent protects a hemifumarate form of tenofovir alafenamide, used in antiviral therapies.USPTO title: Tenofovir alafenamide hemifumarate
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This patent protects a hemifumarate form of tenofovir alafenamide, used in antiviral therapies.USPTO title: Tenofovir alafenamide hemifumarate
Sources
- FDA Orange Book — patents listed against BICTEGRAVIR SODIUM (NDA filed 2018)
- BICTEGRAVIR SODIUM drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2032 — 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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