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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 patent protection?
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, Lannett Co Inc, Specgx Llc, Sun Pharm, West-ward Pharms Int, and Orexo Us Inc, and is included in seventeen NDAs. There are eighteen 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 eighty-four patent family members in forty-four countries.
There are twenty-nine drug master file entries for buprenorphine hydrochloride; naloxone hydrochloride. Twenty suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for buprenorphine hydrochloride; naloxone hydrochloride
| International Patents: | 384 |
| US Patents: | 18 |
| Tradenames: | 5 |
| Applicants: | 14 |
| NDAs: | 17 |
| Drug Master File Entries: | 29 |
| Suppliers / Packagers: | 20 |
| Clinical Trials: | 100 |
| 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 |
|---|---|
| Brown University | Phase 1 |
| Philadelphia Department of Public Health | Phase 4 |
| University of Pennsylvania | Phase 4 |
See all buprenorphine hydrochloride; naloxone hydrochloride clinical trials
Recent Litigation for buprenorphine hydrochloride; naloxone hydrochloride
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| United States v. Indivior Inc. | 2019-04-09 |
| Indivior Inc. v. Aveva Drug Delivery Systems, Inc. | 2019-03-22 |
| BIODELIVERY SCIENCES INTERNATIONAL, INC. v. CHEMO RESEARCH, S.L. | 2019-03-15 |
See all buprenorphine hydrochloride; naloxone hydrochloride litigation
PTAB Litigation
| Petitioner | Date |
|---|---|
| Dr. Reddy's Laboratories S.A. | 2018-11-13 |
| Dr. Reddy’s Laboratories S.A. | 2018-11-13 |
| Dr. Reddy’s Laboratories, Inc. | 2017-06-12 |
See all buprenorphine hydrochloride; naloxone hydrochloride litigation
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 | Opioid Antagonist Partial Opioid Agonist |
| Mechanism of Action | Opioid Antagonists Partial Opioid Agonists |
Paragraph IV (Patent) Challenges for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ZUBSOLV | TABLET;SUBLINGUAL | buprenorphine hydrochloride; naloxone hydrochloride | 204242 | 2017-05-04 |
| BUNAVAIL | FILM;BUCCAL | buprenorphine hydrochloride; naloxone hydrochloride | 205637 | 2016-11-23 |
| BUNAVAIL | FILM;BUCCAL | buprenorphine hydrochloride; naloxone hydrochloride | 205637 | 2015-12-21 |
| 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 |
| SUBOXONE | FILM;BUCCAL, SUBLINGUAL | buprenorphine hydrochloride; naloxone hydrochloride | 022410 | 2013-05-14 |
| SUBOXONE | FILM;BUCCAL, SUBLINGUAL | buprenorphine hydrochloride; naloxone hydrochloride | 022410 | 2012-10-15 |
| SUBOXONE | TABLET;SUBLINGUAL | buprenorphine hydrochloride; naloxone hydrochloride | 020733 | 2011-06-17 |
US Patents and Regulatory Information for buprenorphine hydrochloride; naloxone hydrochloride
Expired US Patents for buprenorphine hydrochloride; naloxone hydrochloride
International Patents for buprenorphine hydrochloride; naloxone hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Cyprus | 1116270 | Start Trial |
| Australia | 2010279441 | Start Trial |
| Australia | 2008227076 | Start Trial |
| Poland | 347126 | Start Trial |
| Portugal | 2805716 | Start Trial |
| Argentina | 077803 | Start Trial |
| Poland | 2054031 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for buprenorphine hydrochloride; naloxone hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2236132 | 122015000006 | Germany | Start 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 | 92636 | Luxembourg | Start Trial | PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES |
| 2236132 | 300714 | Netherlands | Start 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 | CA 2015 00004 | Denmark | Start 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 |
| 2236132 | C300714 | Netherlands | Start Trial | PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718 |
| 2236132 | 484 | Finland | Start Trial | |
| >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 verifification 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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