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Belbuca patents expiration

Can you believe BELBUCA received compensation for the extended wait time during the regulatory approval process?
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6159498 BDSI Bioerodable film for delivery of pharmaceutical compounds of mucosal surfaces
Oct, 2016

(7 years ago)

US7579019 BDSI Pharmaceutical carrier device suitable for delivery of pharmaceutical compounds to mucosal surfaces
Jan, 2020

(4 years ago)

US8147866 BDSI Transmucosal delivery devices with enhanced uptake
Jul, 2027

(3 years from now)

US9655843 BDSI Transmucosal delivery devices with enhanced uptake
Jul, 2027

(3 years from now)

US9901539 BDSI Transmucosal drug delivery devices for use in chronic pain relief
Dec, 2032

(8 years from now)

Belbuca is owned by Bdsi.

Belbuca contains Buprenorphine Hydrochloride.

Belbuca has a total of 5 drug patents out of which 2 drug patents have expired.

Expired drug patents of Belbuca are:

  • US6159498
  • US7579019

Belbuca was authorised for market use on 23 October, 2015.

Belbuca is available in film;buccal dosage forms.

Belbuca can be used as treatment of pain by transmucosal delivery of buprenorphine, management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

The generics of Belbuca are possible to be released after 21 December, 2032.

Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Oct 23, 2018

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Drugs and Companies using BUPRENORPHINE HYDROCHLORIDE ingredient

Market Authorisation Date: 23 October, 2015

Treatment: Treatment of pain by transmucosal delivery of buprenorphine; Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options...

Dosage: FILM;BUCCAL

How can I launch a generic of BELBUCA before it's drug patent expiration?
More Information on Dosage

BELBUCA family patents

Family Patents