Belbuca Drug Patent Profile
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When do Belbuca patents expire, and what generic alternatives are available?
Belbuca is a drug marketed by Bdsi and is included in one NDA. There are three patents protecting this drug and three Paragraph IV challenges.
This drug has seventy-six patent family members in twenty-seven countries.
The generic ingredient in BELBUCA is buprenorphine hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Belbuca
A generic version of Belbuca was approved as buprenorphine hydrochloride by HOSPIRA on June 3rd, 1996.
Summary for Belbuca
International Patents: | 76 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 30 |
Clinical Trials: | 9 |
Patent Applications: | 2 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for Belbuca |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for Belbuca |
What excipients (inactive ingredients) are in Belbuca? | Belbuca excipients list |
DailyMed Link: | Belbuca at DailyMed |
Recent Clinical Trials for Belbuca
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Carolinas Pain Institute | Phase 4 |
BioDelivery Sciences International | Phase 4 |
Medical College of Wisconsin | Phase 2 |
Pharmacology for Belbuca
Drug Class | Partial Opioid Agonist |
Mechanism of Action | Partial Opioid Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for Belbuca
Paragraph IV (Patent) Challenges for BELBUCA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
BELBUCA | Buccal Film | buprenorphine hydrochloride | 75 mcg and 150 mcg | 207932 | 1 | 2016-10-24 |
BELBUCA | Buccal Film | buprenorphine hydrochloride | 300 mcg, 450 mcg, 600 mcg and 750 mcg | 207932 | 1 | 2016-10-04 |
BELBUCA | Buccal Film | buprenorphine hydrochloride | 900 mcg | 207932 | 1 | 2016-09-12 |
US Patents and Regulatory Information for Belbuca
Belbuca is protected by three US patents.
Patents protecting Belbuca
Transmucosal delivery devices with enhanced uptake
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
Transmucosal delivery devices with enhanced uptake
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Transmucosal drug delivery devices for use in chronic pain relief
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Expired US Patents for Belbuca
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-001 | Oct 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-005 | Oct 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-003 | Oct 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-004 | Oct 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-005 | Oct 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-007 | Oct 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-003 | Oct 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for Belbuca
See the table below for patents covering Belbuca around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Portugal | 1079813 | ⤷ Try a Trial | |
Japan | 6255349 | ⤷ Try a Trial | |
European Patent Office | 0973497 | DISPOSITIF DE SUPPORT POUR DIFFUSION DE COMPOSES PHARMACEUTIQUES A LA SURFACE DES MUQUEUSES (PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES) | ⤷ Try a Trial |
China | 103550136 | Transmucosal delivery devices with enhanced uptake | ⤷ Try a Trial |
Japan | 2009544619 | ⤷ Try a Trial | |
Japan | 2005281322 | PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF PHARMACEUTICAL COMPOUND TO MUCOSAL SURFACE | ⤷ Try a Trial |
Slovenia | 2054031 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |