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Buprenorphine hydrochloride; naloxone hydrochloride - Generic Drug Details
What are the generic sources for buprenorphine hydrochloride; naloxone hydrochloride and what is the scope of freedom to operate?
Buprenorphine hydrochloride; naloxone hydrochloride
is the generic ingredient in five branded drugs marketed by Bdsi, Alvogen Pine Brook, Dr Reddys Labs Sa, Mylan Technologies, Indivior Inc, Teva Pharms Usa, Actavis Elizabeth, Amneal Pharms, Ethypharm Usa Corp, Hikma, Lannett Co Inc, Rhodes Pharms, Specgx Llc, Sun Pharm, and Orexo Us Inc, and is included in nineteen NDAs. There are seventeen patents protecting this compound and nine Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Buprenorphine hydrochloride; naloxone hydrochloride has three hundred and forty-seven patent family members in thirty-seven countries.
There are twenty-nine drug master file entries for buprenorphine hydrochloride; naloxone hydrochloride. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for buprenorphine hydrochloride; naloxone hydrochloride
| International Patents: | 347 |
| US Patents: | 17 |
| Tradenames: | 5 |
| Applicants: | 15 |
| NDAs: | 19 |
| Drug Master File Entries: | 29 |
| Suppliers / Packagers: | 18 |
| Clinical Trials: | 107 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for buprenorphine hydrochloride; naloxone hydrochloride |
| DailyMed Link: | buprenorphine hydrochloride; naloxone hydrochloride at DailyMed |
Recent Clinical Trials for buprenorphine hydrochloride; naloxone hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| NYU Langone Health | Phase 4 |
| Emergency Medicine Foundation | Phase 4 |
| Ohio State University | Phase 4 |
See all buprenorphine hydrochloride; naloxone hydrochloride clinical trials
Generic filers with tentative approvals for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | EQ 8MG BASE;EQ 2MG BASE | FILM;BUCCAL, SUBLINGUAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for buprenorphine hydrochloride; naloxone hydrochloride
| Drug Class | Partial Opioid Agonist Opioid Antagonist |
| Mechanism of Action | Partial Opioid Agonists Opioid Antagonists |
Paragraph IV (Patent) Challenges for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
US Patents and Regulatory Information for buprenorphine hydrochloride; naloxone hydrochloride
Expired US Patents for buprenorphine hydrochloride; naloxone hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-003 | Jun 6, 2014 | Start Trial | Start Trial |
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-001 | Jun 6, 2014 | Start Trial | Start Trial |
| Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-001 | Jul 3, 2013 | Start Trial | Start Trial |
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-003 | Jun 6, 2014 | Start Trial | Start Trial |
| Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-004 | Dec 11, 2014 | Start Trial | Start Trial |
| Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-006 | Oct 4, 2016 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for buprenorphine hydrochloride; naloxone hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2461795 | Start Trial |
| Japan | 4879458 | Start Trial |
| Australia | 2006329819 | Start Trial |
| World Intellectual Property Organization (WIPO) | 03030881 | Start Trial |
| China | 1764443 | Start Trial |
| Eurasian Patent Organization | 201991223 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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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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