Pifeltro generics — when can they launch?
Pifeltro (DORAVIRINE) · Merck & Co. · 4 active US patents · 0 expired
Where Pifeltro sits in the generic timeline
Mid-term cliff: earliest active US patent for Pifeltro 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 — 2 patents
- Formulation — 2 patents
FDA U-codes carved out by Pifeltro 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-2630 | (no description) |
U-2629 | (no description) |
Sample patent estate
Showing 4 of 4 active US patents. View full estate on the Pifeltro drug page →
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This patent protects a class of heteroaromatic compounds that inhibit HIV reverse transcriptase and are useful in treating or preventing HIV infection and AIDS.USPTO title: Non-nucleoside reverse transcriptase inhibitors
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This patent protects a class of heteroaromatic compounds that inhibit HIV reverse transcriptase and are useful in treating or preventing HIV infection and AIDS.USPTO title: Non-nucleoside reverse transcriptase inhibitors
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This patent protects pharmaceutical compositions containing doravirine, tenofovir disoproxil fumarate, and lamivudine for treating HIV infection.USPTO title: Pharmaceutical compositions containing doravirine, tenofovir disoproxil fumarate and lamivudine
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This patent protects pharmaceutical compositions containing doravirine, tenofovir disoproxil fumarate, and lamivudine for treating HIV infection.USPTO title: Pharmaceutical compositions containing doravirine, tenofovir disoproxil fumarate and lamivudine
Sources
- FDA Orange Book — patents listed against Pifeltro (NDA filed 2018)
- Pifeltro drug profile — full patent estate, indications, clinical trials, pricing
- Merck & Co. patent portfolio
- 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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