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Last Updated: September 25, 2022

ZUBSOLV Drug Patent Profile


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When do Zubsolv patents expire, and when can generic versions of Zubsolv launch?

Zubsolv is a drug marketed by Orexo Us Inc and is included in one NDA. There are nine patents protecting this drug and four Paragraph IV challenges.

This drug has fifty-nine patent family members in thirty-one countries.

The generic ingredient in ZUBSOLV is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

Paragraph IV (Patent) Challenges for ZUBSOLV
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
ZUBSOLV Sublingual Tablets buprenorphine hydrochloride; naloxone hydrochloride 2.9 mg/7.1 mg 204242 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

US Patents and Regulatory Information for ZUBSOLV

ZUBSOLV is protected by nine US patents.

Patents protecting ZUBSOLV

Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE

Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE

Non-abusable pharmaceutical composition comprising opioids
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE

Non-abusable pharmaceutical composition comprising opioids
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: SUBLINGUAL OR BUCCAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE

Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Patent Number: See Plans and Pricing
Patent Expiration: 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
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-004 Dec 11, 2014 RX Yes Yes 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
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-004 Dec 11, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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
>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 ZUBSOLV

International Patents for ZUBSOLV

When does loss-of-exclusivity occur for ZUBSOLV?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Cyprus

Patent: 15088
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 01740
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 01740
Estimated Expiration: See Plans and Pricing

Japan

Patent: 84062
Estimated Expiration: See Plans and Pricing

Patent: 10511683
Estimated Expiration: See Plans and Pricing

Patent: 13249312
Estimated Expiration: See Plans and Pricing

Poland

Patent: 01740
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 01740
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 01740
Estimated Expiration: See Plans and Pricing

Spain

Patent: 39581
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ZUBSOLV around the world.

Country Patent Number Title Estimated Expiration
Canada 2345121 COMPOSITION PHARMACEUTIQUE POUR LE TRAITEMENT DES MALADIES AIGUES (PHARMACEUTICAL COMPOSITION FOR THE TREATMENT OF ACUTE DISORDERS) See Plans and Pricing
New Zealand 510284 A solid form dosage for sublingual administration of medicaments for treating acute disorders such as pain See Plans and Pricing
European Patent Office 2236132 Composition pharmaceutique pour le traitement de l'insomnie par la voie sub-linguale (Pharmaceutical composition for the treatment of insomnia by sublingual administration) See Plans and Pricing
Portugal 2805716 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZUBSOLV

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2236132 122015000006 Germany See Plans and Pricing PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
2236132 CA 2015 00004 Denmark See Plans and Pricing PRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
2236132 300714 Netherlands See Plans and Pricing PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
2236132 484 Finland See Plans and Pricing
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
Dow
Medtronic
Moodys
Boehringer Ingelheim
Johnson and Johnson

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.