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Last Updated: March 3, 2024

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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 ten patents protecting this drug and four Paragraph IV challenges.

This drug has sixty 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-five 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 ten US patents.

Patents protecting ZUBSOLV

Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE

Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE

Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE

Non-abusable pharmaceutical composition comprising opioids
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE

Non-abusable pharmaceutical composition comprising opioids
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  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
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
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 204242-004 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 204242-004 Dec 11, 2014 RX Yes Yes ⤷  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 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: ⤷  Try a Trial

Denmark

Patent: 01740
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 01740
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 84062
Estimated Expiration: ⤷  Try a Trial

Patent: 10511683
Estimated Expiration: ⤷  Try a Trial

Patent: 13249312
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 01740
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 01740
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 01740
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 39581
Estimated Expiration: ⤷  Try a Trial

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
Japan 2010511683 ⤷  Try a Trial
Czech Republic 20011029 ⤷  Try a Trial
Slovakia 283302 ⤷  Try a Trial
Israel 142135 ⤷  Try a Trial
Brazil 112014006356 nova composição farmacêutica resistente ao abuso para o tratamento de dependência de opioide ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZUBSOLV

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2236132 300714 Netherlands ⤷  Try a Trial PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
2236132 CA 2015 00004 Denmark ⤷  Try a Trial 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 122015000006 Germany ⤷  Try a Trial 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 C300714 Netherlands ⤷  Try a Trial PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
2236132 484 Finland ⤷  Try a Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.