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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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 |
| Formulation / Manufacturing: | see details |
| 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.
Patents protecting BUNAVAIL
Transmucosal delivery devices with enhanced uptake
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
Abuse-resistant mucoadhesive devices for delivery of buprenorphine
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Abuse resistant transmucosal drug delivery device
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Transmucosal delivery devices with enhanced uptake
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF OPIOID DEPENDENCE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-001 | Jun 6, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-002 | Jun 6, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-001 | Jun 6, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-003 | Jun 6, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-002 | Jun 6, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 | 205637-003 | Jun 6, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-001 | Jun 6, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-003 | Jun 6, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-002 | Jun 6, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-001 | Jun 6, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| >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: ⤷ Sign Up
Brazil
Patent: 0619806
Patent: dispositivo para fornecimento de fármacos transmucosal resistente ao abuso
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 29046
Patent: DISPOSITIF RESISTANT AUX ABUS POUR L'ADMINISTRATION TRANSMUCOSALE DE MEDICAMENTS (ABUSE RESISTANT TRANSMUCOSAL DRUG DELIVERY DEVICE)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1330903
Patent: Abuse resistant transmucosal drug delivery device
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 68539
Patent: DISPOSITIF RESISTANT AUX ABUS POUR L'ADMINISTRATION TRANSMUCOSALE DE MEDICAMENTS (ABUSE RESISTANT TRANSMUCOSAL DRUG DELIVERY DEVICE)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 86151
Estimated Expiration: ⤷ Sign Up
Patent: 09519347
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Russian Federation | 2009106177 | СПОСОБ ТРАНСМУКОЗАЛЬНОЙ ДОСТАВКИ ЛЕКАРСТВ, СРЕДСТВО ДЛЯ ЕГО ОСУЩЕСТВЛЕНИЯ (ВАРИАНТЫ) И СПОСОБ ЛЕЧЕНИЯ БОЛИ | ⤷ Sign Up |
| Austria | 288743 | ⤷ Sign Up | |
| Israel | 230996 | התקנים דביקים לריר עמידים לפגיעות להעברה של בופרנורפין (Abuse - resistant mucoadhesive devices for delivery of buprenorphine) | ⤷ Sign Up |
| Portugal | 1079813 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2008011194 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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