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Last Updated: July 2, 2022

Buprenorphine hydrochloride; naloxone hydrochloride - Generic Drug Details


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What are the generic 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 Inc, Teva Pharms Usa, Actavis Elizabeth, Alkem Labs Ltd, 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-three NDAs. There are twenty-one 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-five patent family members in thirty-seven countries.

Twenty-three suppliers are listed for this compound. There is one tentative approval 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
Wake Forest University Health SciencesPhase 2
Montefiore Medical CenterPhase 4
IMEA ParisPhase 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
See Plans and PricingSee Plans and PricingEQ 8MG BASE;EQ 2MG BASEFILM;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; 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
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-003 Dec 11, 2014 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-003 Dec 11, 2014 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Alvogen BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 205954-003 Jan 24, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-002 Jul 3, 2013 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-003 Aug 10, 2012 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
Canada 2658585 DISPOSITIFS D'ADMINISTRATION TRANSMUQUEUSE AVEC ABSORPTION ACCRUE (TRANSMUCOSAL DELIVERY DEVICES WITH ENHANCED UPTAKE) See Plans and Pricing
Japan 2004530928 See Plans and Pricing
Ireland 20030269 Method for testing uniformity in a film manufacturing process See Plans and Pricing
Mexico 2015013184 COMPOSICIONES DE PELICULAS SUBLINGUAL Y BUCAL. (SUBLINGUAL AND BUCCAL FILM COMPOSITIONS.) See Plans and Pricing
Australia 2012311293 New abuse-resistant pharmaceutical composition for the treatment of opioid dependence See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Merck
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Dow

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.