BUPRENORPHINE HYDROCHLORIDE Drug Patent Profile
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When do Buprenorphine Hydrochloride patents expire, and what generic alternatives are available?
Buprenorphine Hydrochloride is a drug marketed by Alvogen, Am Regent, Endo Operations, Hikma, Hospira, Actavis Elizabeth, Barr, Ethypharm, Mylan, Rhodes Pharms, Rubicon, Sun Pharm, Aveva, Dr Reddys Labs Sa, Mylan Technologies, Alkem Labs Ltd, Amneal Pharms, Ethypharm Usa Corp, Lannett Co Inc, Specgx Llc, Teva Pharms Usa, and Wes Pharma Inc. and is included in thirty-one NDAs.
The generic ingredient in BUPRENORPHINE HYDROCHLORIDE 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 Buprenorphine Hydrochloride
A generic version of BUPRENORPHINE HYDROCHLORIDE was approved as buprenorphine hydrochloride; naloxone hydrochloride by ACTAVIS ELIZABETH on February 22nd, 2013.
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Summary for BUPRENORPHINE HYDROCHLORIDE
![BUPRENORPHINE HYDROCHLORIDE drug patent expirations Drug patent expirations by year for BUPRENORPHINE HYDROCHLORIDE](/p/graph/s/t/BUPRENORPHINE_HYDROCHLORIDE-patent-expirations.png)
Recent Clinical Trials for BUPRENORPHINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Brigham and Women's Hospital | Phase 1 |
Cure Addiction Now | Phase 3 |
Gangnam Severance Hospital | N/A |
Pharmacology for BUPRENORPHINE HYDROCHLORIDE
Drug Class | Partial Opioid Agonist |
Mechanism of Action | Partial Opioid Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for BUPRENORPHINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for BUPRENORPHINE HYDROCHLORIDE
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 BUPRENORPHINE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan Technologies | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 207607-002 | Jun 14, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Aveva | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 212756-001 | Jun 2, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Dr Reddys Labs Sa | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 206953-002 | Jul 17, 2020 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |