BUNAVAIL Drug Patent Profile
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When do Bunavail patents expire, and what generic alternatives are available?
Bunavail is a drug marketed by Bdsi and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges.
This drug has eighty-three patent family members in twenty-six countries.
The generic ingredient in BUNAVAIL is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Bunavail
A generic version of BUNAVAIL was approved as buprenorphine hydrochloride; naloxone hydrochloride by ACTAVIS ELIZABETH on February 22nd, 2013.
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Questions you can ask:
- What is the 5 year forecast for BUNAVAIL?
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- What is Average Wholesale Price for BUNAVAIL?
Summary for BUNAVAIL
International Patents: | 83 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 4 |
Clinical Trials: | 2 |
Patent Applications: | 279 |
Drug Prices: | Drug price information for BUNAVAIL |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BUNAVAIL |
What excipients (inactive ingredients) are in BUNAVAIL? | BUNAVAIL excipients list |
DailyMed Link: | BUNAVAIL at DailyMed |


Recent Clinical Trials for BUNAVAIL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Indivior Inc. | Phase 4 |
BioDelivery Sciences International | Phase 3 |
Paragraph IV (Patent) Challenges for BUNAVAIL
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
BUNAVAIL | Buccal Film | buprenorphine hydrochloride; naloxone hydrochloride | 2.1 mg/0.3 mg and 4.2 mg/0.7 mg | 205637 | 1 | 2016-11-23 |
BUNAVAIL | Buccal Film | buprenorphine hydrochloride; naloxone hydrochloride | 6.3 mg/1 mg | 205637 | 1 | 2015-12-21 |
US Patents and Regulatory Information for BUNAVAIL
BUNAVAIL is protected by four US patents.
Expired US Patents for BUNAVAIL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-001 | Jun 6, 2014 | ⤷ Try for Free | ⤷ Try for Free |
Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-003 | Jun 6, 2014 | ⤷ Try for Free | ⤷ Try for Free |
Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-003 | Jun 6, 2014 | ⤷ Try for Free | ⤷ Try for Free |
Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-002 | Jun 6, 2014 | ⤷ Try for Free | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BUNAVAIL
When does loss-of-exclusivity occur for BUNAVAIL?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 06326377
Patent: Abuse resistant transmucosal drug delivery device
Estimated Expiration: ⤷ Try for Free
Brazil
Patent: 0619806
Patent: dispositivo para fornecimento de fármacos transmucosal resistente ao abuso
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 29046
Patent: DISPOSITIF RESISTANT AUX ABUS POUR L'ADMINISTRATION TRANSMUCOSALE DE MEDICAMENTS (ABUSE RESISTANT TRANSMUCOSAL DRUG DELIVERY DEVICE)
Estimated Expiration: ⤷ Try for Free
China
Patent: 1330903
Patent: Abuse resistant transmucosal drug delivery device
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 68539
Patent: DISPOSITIF RESISTANT AUX ABUS POUR L'ADMINISTRATION TRANSMUCOSALE DE MEDICAMENTS (ABUSE RESISTANT TRANSMUCOSAL DRUG DELIVERY DEVICE)
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 86151
Estimated Expiration: ⤷ Try for Free
Patent: 09519347
Estimated Expiration: ⤷ Try for Free
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering BUNAVAIL around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Poland | 2054031 | ⤷ Try for Free | |
Japan | 2010270153 | PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR TRANSMITTING PHARMACEUTICAL COMPOUND TO MUCOSA SURFACE | ⤷ Try for Free |
Serbia | 54764 | SREDSTVO ZA TRANSMUKOZALNU ISPORUKU SA POVEĆANIM NAKUPLJANJEM (TRANSMUCOSAL DELIVERY DEVICES WITH ENHANCED UPTAKE) | ⤷ Try for Free |
Japan | 2005281322 | PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF PHARMACEUTICAL COMPOUND TO MUCOSAL SURFACE | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory for BUNAVAIL
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