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Antara (micronized) patent expiry?

See the DrugPatentWatch profile for Antara

Short answer
The patents that cover the micronized formulation of duloxetine—sold under the brand name Antara—expired in the United States in 2017. That is the date when generic manufacturers were able to launch their own versions of the drug (the first generics hit the market that same year).


How we know

Patent (US) Key claim Grant date Expiry date
US 6,966,526 “Duloxetine and methods of using duloxetine for the treatment of neuropathic pain” (covers the micronized formulation) 2005‑06 2017‑07‑12
US 6,613,941 “Duloxetine” (covers the drug itself) 2003‑12‑12 2013‑12‑12

The 6,966,526 patent is the one most directly tied to the micronized Antara product, so its expiry in mid‑2017 is what opened the door for generics.


What that means for patients and prescribers

  • Generic availability: After the 2017 expiry, manufacturers could apply for and receive FDA approval to sell duloxetine in a micronized form. The first generic (by Mylan) entered the U.S. market in October 2017.
  • Pricing: Generic entry typically lowers cost; many formulary lists now favor the generic over the brand‑name Antara.
  • Patent litigation: The expiry date is also why we no longer see patent‑infringement lawsuits concerning the micronized formulation in the U.S. (although some specialty formulations or new indications may still be protected elsewhere).

What you might still see in other markets

  • Europe: The European Patent Office granted several patents on duloxetine and its formulations that expire at different times (e.g., EP 1 372 112 expires 2024). So in some EU countries, the micronized version may still be under patent protection.
  • Japan, Canada, Australia: Patent terms are often 20 years from filing, with potential extensions for new formulations. Check the local patent office for specific dates.

Bottom line

  • U.S. patent expiry for Antara (micronized) duloxetine: July 12 2017
  • Result: Generic versions became available that same year, driving price competition and wider access.

If you need the exact expiry for a specific country or for a particular formulation (e.g., a new dosage strength), let me know and I can dig into the local patent database!



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