ZUBSOLV Drug Patent Profile
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Which patents cover Zubsolv, 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-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.
Summary for ZUBSOLV
International Patents: | 60 |
US Patents: | 10 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 5 |
Clinical Trials: | 6 |
Patent Applications: | 279 |
Formulation / Manufacturing: | see details |
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 |
Orexo AB | Phase 4 |
Pharmacology for ZUBSOLV
Drug Class | Opioid Antagonist Partial Opioid Agonist |
Mechanism of Action | Opioid Antagonists Partial Opioid Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for ZUBSOLV
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 | |||
Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-002 | Jul 3, 2013 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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
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 a Trial | ⤷ Try a Trial |
Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-005 | Jun 4, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-006 | Oct 4, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-002 | Jul 3, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-001 | Jul 3, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-003 | Dec 11, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 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 |
---|---|---|---|
Hungary | 0800435 | ⤷ Try a Trial | |
Japan | 6210988 | ⤷ Try a Trial | |
Singapore | 2014009401 | NEW ABUSE-RESISTANT PHARMACEUTICAL COMPOSITION FOR THE TREATMENT OF OPIOID DEPENDENCE | ⤷ Try a Trial |
Bulgaria | 65502 | ⤷ Try a Trial | |
Lithuania | 2915525 | ⤷ Try a Trial | |
Portugal | 2805716 | ⤷ 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 | 484 | Finland | ⤷ Try a Trial | |
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 | 92636 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES |
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 | 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 | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |