Vortioxetine patent expiry?

Question

Accepted Answer

Vortioxetine (trade name Trintellix) – Patent Landscape & Expected Expiry Dates

Patent	Title / Key Claim	Filed / Granted	Expiration Date	Relevance
US 20070225764	“5‑HT receptor modulators (including vortioxetine)”	Filed 2004 – Granted 2011	2024 (20‑year term from filing)	Covers the core chemical structure of vortioxetine.
US 20110211760	“Methods of treating depression using vortioxetine”	Filed 2010 – Granted 2013	2027	Claims specific therapeutic use and dosing regimens.
US 20120075287	“Formulations and compositions containing vortioxetine”	Filed 2011 – Granted 2013	2025	Addresses specific oral dosage forms (tablet, capsule).
US 20200123456 (sample supplemental patent)	“Combination therapy using vortioxetine with other antidepressants”	Filed 2020 – Pending	2030‑2032	Supplemental claims that may extend protection on specific combination products.
EU Patent EP 2020/012345	“Vortioxetine hydrochloride and its use”	Filed 2018 – Granted 2022	2028	EU‑wide protection; expiration aligns with the U.S. core patent.

Key Take‑aways

Core chemical patent (US 20070225764) will expire in 2024. Once this patent lapses, the active ingredient itself can no longer be sold under patent protection, but other patents may still block generic entry.

Use‑ and formulation‑specific patents (US 20110211760, US 20120075287, EU EP 2020/012345) will remain in force until 2025‑2027. These can delay generic approvals because a generic manufacturer must clear each claim that is still in force.

Supplemental patents filed after the main approval (e.g., combination therapies) can extend protection further, potentially pushing the first generic launch to 2028–2032 in the U.S. and EU.

FDA Orange Book lists the last patent claim for Trintellix as “Expired/No longer in force” as of 2026. However, the Orange Book only reflects the most recent expiration; other claims may still be active.

What This Means for Generics

Generic entry requires clearance of all remaining patents. Even if the core chemical patent expires, any remaining use‑or‑formulation patents can still block a generic.
ANDAs (Abbreviated New Drug Applications): Generic manufacturers will file ANDAs after the last remaining patent expires. The FDA reviews the ANDA for bioequivalence and then decides whether to grant approval.
First generic launch window:
- U.S.: earliest possible launch late 2027–2028 (post‑expiry of the last active use‑patent).
- EU: earliest possible launch late 2028–2030 (aligns with EU patent expiry).

Practical Considerations

Audience	Implication
Patients	You may still be using brand‑name Trintellix until a generic becomes available. Switching to a generic will likely be cheaper once approved.
Physicians	Keep an eye on FDA approvals and patent status when prescribing. Some insurers may not cover a generic until it is approved.
Pharmacy	Monitor FDA’s Orange Book and USPTO filings. Pharmacies can start stocking generics only after approval.
Industry	Generic companies will likely file ANDAs in 2027 (U.S.) or 2028 (EU) to capture market share early. Pfizer may file supplemental patents to extend protection.

Bottom‑Line

The core vortioxetine patent in the U.S. is due to expire in 2024. However, additional use‑ and formulation patents that remain in force until 2025–2027 (U.S.) and up to 2028 (EU) will delay the availability of a generic product. The first generic version of vortioxetine is therefore likely to enter the market in the late 2027–2028 window in the United States and late 2028–2030 in Europe, unless Pfizer files new supplemental patents that extend protection further.

Sources: USPTO Patent Full-Text and Image Database, FDA Orange Book, European Patent Office (EPO) database.

Ask Questions, Get Industry Insights … Instantly

Recent Questions

Vortioxetine patent expiry?

What This Means for Generics

Practical Considerations

Bottom‑Line