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Last Updated: March 19, 2024

Buprenorphine hydrochloride; naloxone hydrochloride - Generic Drug Details


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What are the generic drug sources for buprenorphine hydrochloride; naloxone hydrochloride and what is the scope of freedom to operate?

Buprenorphine hydrochloride; naloxone hydrochloride is the generic ingredient in five branded drugs marketed by Bdsi, Alvogen, Aveva, Dr Reddys Labs Sa, Mylan Technologies, Indivior, Teva Pharms Usa, Actavis Elizabeth, Alkem Labs Ltd, Amneal Pharms, Ethypharm Usa Corp, Hikma, Lannett Co Inc, Rhodes Pharms, Specgx Llc, Sun Pharm, Wes Pharma Inc, and Orexo Us Inc, and is included in twenty-three 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 thirty-six patent family members in thirty-seven countries.

Twenty-five suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for buprenorphine hydrochloride; naloxone hydrochloride
Recent Clinical Trials for buprenorphine hydrochloride; naloxone hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Bicycle HealthPhase 4
Royal Victoria Hospital, CanadaPhase 4
Wake Forest University Health SciencesPhase 2

See all buprenorphine hydrochloride; naloxone hydrochloride clinical trials

Generic filers with tentative approvals for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a TrialEQ 8MG BASE;EQ 2MG BASEFILM;BUCCAL, SUBLINGUAL
⤷  Try a Trial⤷  Try a TrialEQ 1.4MG BASE;EQ 0.36MG BASETABLET;SUBLINGUAL
⤷  Try a Trial⤷  Try a TrialEQ 0.7MG BASE;EQ 0.18MG BASETABLET;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; naloxone hydrochloride
Paragraph IV (Patent) Challenges for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ZUBSOLV Sublingual Tablets buprenorphine hydrochloride; naloxone hydrochloride 0.7 mg/0.18 mg 204242 1 2017-05-04
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
ZUBSOLV Sublingual Tablets buprenorphine hydrochloride; naloxone hydrochloride 2.9 mg/7.1 mg 204242 1 2015-12-21
BUNAVAIL Buccal Film buprenorphine hydrochloride; naloxone hydrochloride 6.3 mg/1 mg 205637 1 2015-12-21
ZUBSOLV Sublingual Tablets buprenorphine hydrochloride; naloxone hydrochloride 8.6 mg/2.1 mg and 11.4 mg/2.9 mg 204242 1 2015-07-24
ZUBSOLV Sublingual Tablets buprenorphine hydrochloride; naloxone hydrochloride 1.4 mg/0.36 mg and 5.7 mg/1.4 mg 204242 1 2013-10-22
SUBOXONE Sublingual Film buprenorphine hydrochloride; naloxone hydrochloride 12 mg/3 mg 022410 1 2013-05-14
SUBOXONE Sublingual Film buprenorphine hydrochloride; naloxone hydrochloride 2 mg/0.5 mg* and 8 mg/2 mg 022410 1 2012-10-15
SUBOXONE for Injection buprenorphine hydrochloride; naloxone hydrochloride 500 mg/vial 020733 2 2009-01-26

US Patents and Regulatory Information 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
Sun Pharm BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 201633-001 Aug 5, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-002 Jul 3, 2013 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-004 Dec 11, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-002 Jul 3, 2013 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-003 Dec 11, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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; naloxone hydrochloride

International Patents for buprenorphine hydrochloride; naloxone hydrochloride

Country Patent Number Title Estimated Expiration
European Patent Office 2716284 Films à base d'oxyde de polyéthylène et systèmes d'administration de médicament fabriqués à partir de ceux-ci (Polyethylene oxide-based films and drug delivery systems made herefrom) ⤷  Try a Trial
Australia 2008216887 Polymer-based films and drug delivery systems made therefrom ⤷  Try a Trial
Japan 2005536443 ⤷  Try a Trial
Australia 2002362772 ⤷  Try a Trial
Mexico 2014001873 DISPOSITIVOS MUCOADHESIVOS RESISTENTES AL ABUSO PARA EL SUMINISTRO DE BUPRENORFINA. (ABUSE-RESISTANT MUCOADHESIVE DEVICES FOR DELIVERY OF BUPRENORPHINE.) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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