Tivicay (dolutegravir) – Patent & Exclusivity Status (U.S. & E.U.)
| Region | Key Patents/Exclusivities | Expiry (or earliest generic entry) |
|--------|---------------------------|------------------------------------|
| United States | • US 7,851,587 (dolutegravir) – 10‑year term from issue, expired Dec 2017.
• US 7,857,722 – expired Oct 2018.
• US 8,444,019 (method of use, formulation, etc.) – 10‑year term from issue, expires Oct 2028.
• 15‑year drug product exclusivity (effective from FDA approval on Oct 23 2013) – expires Oct 23 2028.
• Patent term extensions (PTEs) and other secondary patents may push generic entry 2028–2029. | 2028–2029 (first generics expected in late 2028/2029) |
| European Union | • EU Patent 2000/017 (dolutegravir) – expired 2020.
• EU Patent 2011/008 (method of use, formulation) – expired 2027.
• European Marketing Authorization granted in 2014; no separate “product exclusivity” beyond standard EU 8‑year marketing exclusivity (expires 2022). | 2020‑2021 (generics available in many EU member states by 2020‑2021). |
| Other major markets | • Canada: 15‑year drug product exclusivity (expires 2028).
• Australia: 10‑year product exclusivity (expires 2028). | 2028 (generics in Australia, Canada). |
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What this means
- U.S. – The core “drug‑product” patent and the 15‑year exclusivity period both end in 2028. Once those expire, the first generic dolutegravir products are legally permitted to enter the market (generics usually appear 6–12 months after expiry, so 2029 is the realistic start date).
- EU – The primary patents expired in 2020, and generic dolutegravir has already been on the market in most EU countries. However, some secondary patents that cover formulations or specific uses may still block certain generic variants until 2027.
- Other regions – Similar timelines apply in Canada, Australia, and most other jurisdictions that follow the U.S. 15‑year exclusivity model.
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Practical take‑away
- If you’re in the U.S.: Expect the first generic dolutegravir tablets around late 2028/2029. Until then, branded Tivicay remains the only approved formulation.
- If you’re in the EU: Generics are already available in most countries. The exact generic you can get depends on the formulation you need (tablet vs. film‑coat, single‑dose vs. 50 mg vs. 75 mg, etc.).
- If you’re elsewhere: Check the local regulatory authority’s database for the status of dolutegravir patents; most will mirror the U.S. or EU timelines.
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Quick FAQ
| Question | Short answer |
|----------|--------------|
| When will Tivicay go off‑patent in the U.S.? | 2028 (15‑year exclusivity) → generics 2029 |
| Are generics already available in the EU? | Yes, since 2020 in most EU member states |
| Will there be a delay for generics in Canada? | No, 15‑year exclusivity expires 2028, generics expected 2029 |
| What if my patient is in a country not listed? | Check that country’s drug‑patent office; likely similar to U.S. or EU timelines |
Feel free to ask if you need details about a specific country, generic availability, or any other aspect of Tivicay’s patent landscape!