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-one 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-four suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Zubsolv
A generic version of ZUBSOLV was approved as buprenorphine hydrochloride; naloxone hydrochloride by ACTAVIS ELIZABETH on February 22nd, 2013.
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Questions you can ask:
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Summary for ZUBSOLV
International Patents: | 61 |
US Patents: | 10 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 5 |
Clinical Trials: | 6 |
Patent Applications: | 279 |
Drug Prices: | Drug price information for ZUBSOLV |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ZUBSOLV |
What excipients (inactive ingredients) are in ZUBSOLV? | ZUBSOLV excipients list |
DailyMed Link: | ZUBSOLV at DailyMed |


Recent Clinical Trials for ZUBSOLV
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Johns Hopkins University | Phase 2 |
Indivior Inc. | Phase 4 |
Worldwide Clinical Trials | Phase 4 |
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.
Expired US Patents for ZUBSOLV
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-004 | Dec 11, 2014 | ⤷ Try for Free | ⤷ Try for Free |
Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-005 | Jun 4, 2015 | ⤷ Try for Free | ⤷ Try for Free |
Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-006 | Oct 4, 2016 | ⤷ Try for Free | ⤷ Try for Free |
Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-002 | Jul 3, 2013 | ⤷ Try for Free | ⤷ Try for Free |
Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-003 | Dec 11, 2014 | ⤷ Try for Free | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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 for Free
Denmark
Patent: 01740
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 01740
Patent: NOUVELLE COMPOSITION PHARMACEUTIQUE NON SUSCEPTIBLE D'ABUS COMPRENANT DES OPIOÏDES (NEW NON-ABUSABLE PHARMACEUTICAL COMPOSITION COMPRISING OPIOIDS)
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 84062
Estimated Expiration: ⤷ Try for Free
Patent: 10511683
Estimated Expiration: ⤷ Try for Free
Patent: 13249312
Patent: NEW NON-ABUSE PHARMACEUTICAL COMPOSITION CONTAINING OPIOID
Estimated Expiration: ⤷ Try for Free
Poland
Patent: 01740
Estimated Expiration: ⤷ Try for Free
Portugal
Patent: 01740
Estimated Expiration: ⤷ Try for Free
Slovenia
Patent: 01740
Estimated Expiration: ⤷ Try for Free
Spain
Patent: 39581
Estimated Expiration: ⤷ Try for Free
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 |
---|---|---|---|
Poland | 2101740 | ⤷ Try for Free | |
Australia | 2012311293 | New abuse-resistant pharmaceutical composition for the treatment of opioid dependence | ⤷ Try for Free |
European Patent Office | 2915525 | Comprimés résistant aux abus à administration sublinguale contenant de buprénorphine et de naloxone (Sublingual abuse-resistant tablets comprising buprenorphine and naloxone) | ⤷ Try for Free |
Chile | 2014000575 | ⤷ Try for Free | |
Singapore | 2014009401 | NEW ABUSE-RESISTANT PHARMACEUTICAL COMPOSITION FOR THE TREATMENT OF OPIOID DEPENDENCE | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZUBSOLV
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2236132 | 92636 | Luxembourg | ⤷ Try for Free | PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES |
2236132 | 484 | Finland | ⤷ Try for Free | |
2236132 | C300714 | Netherlands | ⤷ Try for Free | PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718 |
2236132 | 122015000006 | Germany | ⤷ Try for 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 | 300714 | Netherlands | ⤷ Try for 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 |
Market Dynamics and Financial Trajectory for Zubsolv
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