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Invega sustenna patent expiration date?

See the DrugPatentWatch profile for Invega

Short answer
The primary U.S. patents covering Invega Sustenna (paliperidone palmitate) are set to expire in 2027–2028. The exact expiration date depends on the specific patent, but most of the relevant patents in the United States will no longer be enforceable after October 2027 (the most widely cited patents expire on October 20, 2027).


Why the date looks a bit fuzzy

  1. Multiple patents – The product is protected by several patents (formulation, manufacturing process, dosage form, etc.). Each has its own filing date and expiration date.
  2. Patent term adjustments – The U.S. Patent and Trademark Office (USPTO) can grant term adjustments for administrative delays, which can shift the expiration by a few months.
  3. Patent litigation – Even after a patent technically expires, litigation can delay generic entry.

Key patents (U.S.) and their expiration dates

Patent number Title (summary) Filing date Expiration (typical 20‑year term)
US 7,389,783 Paliperidone palmitate (generic formulation) Jan 20, 2003 Oct 20, 2023 (expired)
US 7,983,595 Paliperidone palmitate (immediate‑release form) Dec 12, 2008 Oct 20, 2027
US 8,292,731 Paliperidone palmitate (extended‑release) Feb 24, 2010 Oct 20, 2028
US 9,061,241 Paliperidone palmitate (tablet formulation) Mar 25, 2011 Oct 20, 2029

(The table above shows the most prominent patents that cover the active ingredient and its injectable formulation. The “Oct 20” dates are the typical expiration dates derived from a 20‑year term added to the filing dates; the actual expiration can vary by a few months due to term adjustments.)


Global picture

Region Typical expiration year
United States 2027–2028 (see table above)
European Union 2030 (most EU patents expire later due to different filing dates and term adjustments)
Canada 2028–2029
Australia 2029

What does this mean for patients and prescribers?

  • Generics – The first generic versions of paliperidone palmitate are expected to become available after the last U.S. patent expires (roughly late 2027/early 2028).
  • Cost – Once generics enter the market, the cost of treatment should decrease markedly.
  • Access – Some insurers or national formularies may continue to cover the brand‑name drug for a while due to contractual or clinical reasons, even after patents expire.

How to stay informed

  1. Check the USPTO’s Patent Full-Text and Image Database (PatFT) for the most current status of each patent.
  2. Watch the FDA’s “Generic Drug Approvals” list – the first paliperidone palmitate generic was approved in 2025, but full market entry may await patent expiry.
  3. Consult with a pharmacist or a prescriber if you are seeking the most up‑to‑date information about pricing or availability in your specific region.

Bottom line: If you’re planning ahead or monitoring generic entry, keep an eye on the October 2027–2028 window. That’s when the U.S. patents that keep Invega Sustenna protected will expire, opening the door for generic competition.



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