DrugPatentWatch Database Preview
Buprenorphine hydrochloride - Generic Drug Details
» See Plans and Pricing
What are the generic drug sources for buprenorphine hydrochloride and what is the scope of freedom to operate?
Buprenorphine hydrochloride
is the generic ingredient in ten branded drugs marketed by Bdsi, Titan Pharms, Indivior Inc, Am Regent, Hospira, Par Sterile Products, West-ward Pharms Int, Actavis Elizabeth, Barr, Ethypharm, Hikma, Mylan, Rhodes Pharms, Rubicon, Sun Pharm, Alvogen Pine Brook, Dr Reddys Labs Sa, Mylan Technologies, Teva Pharms Usa, Amneal Pharms, Ethypharm Usa Corp, Lannett Co Inc, Mayne Pharma Inc, Specgx Llc, Wes Pharma Inc, and Orexo Us Inc, and is included in thirty-seven NDAs. There are nineteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Buprenorphine hydrochloride has one hundred and fifteen patent family members in thirty countries.
There are twenty-nine drug master file entries for buprenorphine hydrochloride. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for buprenorphine hydrochloride
International Patents: | 115 |
US Patents: | 19 |
Tradenames: | 10 |
Applicants: | 26 |
NDAs: | 37 |
Drug Master File Entries: | 29 |
Suppliers / Packagers: | 18 |
Bulk Api Vendors: | 20 |
Clinical Trials: | 434 |
Patent Applications: | 2 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for buprenorphine hydrochloride |
What excipients (inactive ingredients) are in buprenorphine hydrochloride? | buprenorphine hydrochloride excipients list |
DailyMed Link: | buprenorphine hydrochloride at DailyMed |
Recent Clinical Trials for buprenorphine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Centre Hospitalier Universitaire de Nīmes | Phase 3 |
University of Utah | Phase 2 |
University of California, Davis | Phase 2 |
Generic filers with tentative approvals for BUPRENORPHINE HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | EQ 8MG BASE;EQ 2MG BASE | FILM;BUCCAL, SUBLINGUAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for buprenorphine hydrochloride
Drug Class | Partial Opioid Agonist |
Mechanism of Action | Partial Opioid Agonists |
Paragraph IV (Patent) Challenges for BUPRENORPHINE HYDROCHLORIDE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
BELBUCA | FILM;BUCCAL | buprenorphine hydrochloride | 207932 | 2016-10-24 |
BELBUCA | FILM;BUCCAL | buprenorphine hydrochloride | 207932 | 2016-10-04 |
BELBUCA | FILM;BUCCAL | buprenorphine hydrochloride | 207932 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva Pharms Usa | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 091149-001 | Sep 8, 2014 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Indivior Inc | SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410-001 | Aug 30, 2010 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
Specgx Llc | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 207000-002 | Dec 13, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
>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 buprenorphine hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-003 | Oct 23, 2015 | Start Trial | Start Trial |
Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-001 | Oct 23, 2015 | Start Trial | Start Trial |
Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-007 | Oct 23, 2015 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for buprenorphine hydrochloride
Country | Patent Number | Estimated Expiration |
---|---|---|
Spain | 2577390 | Start Trial |
New Zealand | 594545 | Start Trial |
Cyprus | 1117450 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:






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.