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-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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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 |
| 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 |
Pharmacology for ZUBSOLV
| Drug Class | Opioid Antagonist Partial Opioid Agonist |
| Mechanism of Action | Opioid Antagonists Partial Opioid Agonists |
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
Non-abusable pharmaceutical composition comprising opioids
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
Non-abusable pharmaceutical composition comprising opioids
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: SUBLINGUAL OR BUCCAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
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Patent Expiration: ⤷ Sign Up
Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
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Patent Expiration: ⤷ Sign Up
Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
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Patent Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-002 | Jul 3, 2013 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-004 | Dec 11, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-004 | Dec 11, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-004 | Dec 11, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 | 204242-005 | Jun 4, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-006 | Oct 4, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-002 | Jul 3, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-001 | Jul 3, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-003 | Dec 11, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| >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: ⤷ Sign Up
Denmark
Patent: 01740
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Japan
Patent: 84062
Estimated Expiration: ⤷ Sign Up
Patent: 10511683
Estimated Expiration: ⤷ Sign Up
Patent: 13249312
Patent: NEW NON-ABUSE PHARMACEUTICAL COMPOSITION CONTAINING OPIOID
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 01740
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 01740
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 01740
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 39581
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Australia | 764346 | ⤷ Sign Up | |
| Czech Republic | 20080315 | ⤷ Sign Up | |
| Canada | 2345121 | COMPOSITION PHARMACEUTIQUE POUR LE TRAITEMENT DES MALADIES AIGUES (PHARMACEUTICAL COMPOSITION FOR THE TREATMENT OF ACUTE DISORDERS) | ⤷ Sign Up |
| Germany | 69936393 | ⤷ Sign Up | |
| Japan | 2002526439 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZUBSOLV
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2236132 | C300714 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718 |
| 2236132 | 484 | Finland | ⤷ Sign Up | |
| 2236132 | 92636 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES |
| 2236132 | 122015000006 | Germany | ⤷ Sign Up | 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 | ⤷ Sign Up | 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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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.
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