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Buprenorphine hydrochloride; naloxone hydrochlorideis the generic ingredient in five branded drugs marketed by Bdsi, Alvogen Pine Brook, Dr Reddys Labs Sa, Mylan Technologies, Indivior Inc, Teva Pharms Usa, Actavis Elizabeth, Amneal Pharms, Ethypharm Usa Corp, Hikma, Lannett Co Inc, Mayne Pharma Inc, Rhodes Pharms, Specgx Llc, Sun Pharm, Wes Pharma Inc, and Orexo Us Inc, and is included in twenty-one NDAs. There are eighteen patents protecting this compound and nine Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.
Buprenorphine hydrochloride; naloxone hydrochloride has three hundred and twenty patent family members in thirty-six countries.
There are twenty-nine drug master file entries for buprenorphine hydrochloride; naloxone hydrochloride. Twenty-two suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
|Drug Master File Entries:||29|
|Finished Product Suppliers / Packagers:||22|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE|
|DailyMed Link:||BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE at DailyMed|
Recent Clinical Trials for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
|Milton S. Hershey Medical Center||Early Phase 1|
|Virginia Commonwealth University||Phase 1/Phase 2|
|Ho Chi Minh City CDC||Phase 2|
Generic filers with tentative approvals for BUPRENORPHINE HYDROCHLORIDE; NALOXONE 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; NALOXONE HYDROCHLORIDE
|Drug Class||Partial Opioid Agonist |
|Mechanism of Action||Partial Opioid Agonists |
Paragraph IV (Patent) Challenges for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Indivior Inc||SUBOXONE||buprenorphine hydrochloride; naloxone hydrochloride||FILM;BUCCAL, SUBLINGUAL||022410-004||Aug 10, 2012||AB||RX||Yes||Yes||Get Started for $10||Get Started for $10||Y||Get Started for $10|
|Orexo Us Inc||ZUBSOLV||buprenorphine hydrochloride; naloxone hydrochloride||TABLET;SUBLINGUAL||204242-006||Oct 4, 2016||RX||Yes||No||Get Started for $10||Get Started for $10||Y||Get Started for $10|
|Indivior Inc||SUBOXONE||buprenorphine hydrochloride; naloxone hydrochloride||FILM;BUCCAL, SUBLINGUAL||022410-001||Aug 30, 2010||AB||RX||Yes||No||Get Started for $10||Get Started for $10||Y||Get Started for $10|
|>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|
|Orexo Us Inc||ZUBSOLV||buprenorphine hydrochloride; naloxone hydrochloride||TABLET;SUBLINGUAL||204242-006||Oct 4, 2016||Get Started for $10||Get Started for $10|
|Bdsi||BUNAVAIL||buprenorphine hydrochloride; naloxone hydrochloride||FILM;BUCCAL||205637-001||Jun 6, 2014||Get Started for $10||Get Started for $10|
|Bdsi||BUNAVAIL||buprenorphine hydrochloride; naloxone hydrochloride||FILM;BUCCAL||205637-002||Jun 6, 2014||Get Started for $10||Get Started for $10|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
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