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Buprenorphine hydrochlorideis 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
|Drug Master File Entries:||29|
|Suppliers / Packagers:||18|
|Bulk Api Vendors:||20|
|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
|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
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
|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|
|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|
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