Tivicay (ViiV Healthcare / GSK)

Dolutegravir

A real, completed two-patent family triage. The composition-of-matter patent is not the one that actually controls generic entry timing here -- a separate, later-expiring crystal-form patent is, which is exactly the kind of family-level nuance a Paragraph IV screen exists to surface.

Patent family

Composition-of-matter patent (unpublished number, per GSK FY2025 investor materials)

Composition of matter — expires 2027-10-05

Covers the dolutegravir molecule itself. Also the basis for a separate $1.25B settlement requiring Gilead to pay ViiV a 3% royalty on Biktarvy sales until this same date -- evidence the composition claim is broad enough to reach a structurally different rival integrase inhibitor.

US 9,242,986Controlling

Crystal form (Orange Book-listed) — expires 2029-12-08

This is the patent every real Paragraph IV challenge on record actually targeted (Cipla, Dr. Reddy's Laboratories, Lupin, Apotex, Mylan/Viatris, Sandoz, 2017) -- confirming it, not the composition patent, is the practically-controlling barrier to US generic entry.

Generic status

No FDA-final-approved generic dolutegravir tablet exists in the US as of this research pass. Aurobindo Pharma (tentative approval, Sept 2016) and Strides Pharma (tentative approval, Sept 2023) hold approvals under the FDA's PEPFAR pathway only -- these permit supply to PEPFAR-designated countries, not US commercial sale, until the crystal-form patent expires.

Paragraph IV litigation history

All identified Paragraph IV litigation against the crystal-form patent has settled, not gone to trial -- including the ViiV Healthcare v. Hetero USA/Hetero Labs consent judgment, closed December 2024. The legal path is clear; the calendar (Dec 8, 2029) is the only thing still standing between the settled litigation and actual US market entry.