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Last Updated: June 25, 2021

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ZUBSOLV Drug 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 seven patents protecting this drug and four Paragraph IV challenges.

This drug has forty-eight patent family members in twenty-eight 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 NDA Submissiondate
ZUBSOLV TABLET;SUBLINGUAL buprenorphine hydrochloride; naloxone hydrochloride 204242 2017-05-04
ZUBSOLV TABLET;SUBLINGUAL buprenorphine hydrochloride; naloxone hydrochloride 204242 2015-12-21
ZUBSOLV TABLET;SUBLINGUAL buprenorphine hydrochloride; naloxone hydrochloride 204242 2015-07-24
ZUBSOLV TABLET;SUBLINGUAL buprenorphine hydrochloride; naloxone hydrochloride 204242 2013-10-22

US Patents and Regulatory Information for ZUBSOLV

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   Get Started Free   Get Started Free Y   Get Started Free
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-003 Dec 11, 2014 RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-004 Dec 11, 2014 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-003 Dec 11, 2014 RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-006 Oct 4, 2016 RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-005 Jun 4, 2015 RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-002 Jul 3, 2013 RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
>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

Supplementary Protection Certificates for ZUBSOLV

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2236132 CA 2015 00004 Denmark   Get Started Free 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 484 Finland   Get Started Free
2236132 92636 Luxembourg   Get Started Free PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2236132 122015000006 Germany   Get Started Free 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   Get Started Free PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
2236132 300714 Netherlands   Get Started Free PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson

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