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Buprenorphine hydrochloride - Generic Drug Details
What are the generic drug sources for buprenorphine hydrochloride and what is the scope of buprenorphine hydrochloride patent protection?
Buprenorphine hydrochloride
is the generic ingredient in ten branded drugs marketed by Bdsi, Titan Pharms, Indivior Inc, Hospira, Luitpold, Par Sterile Products, West-ward Pharms Int, Actavis Elizabeth, Barr, Casi Pharms Inc, Ethypharm, Mylan Pharms Inc, Rhodes Pharms, Sun Pharm Inds Ltd, Alvogen Pine Brook, Dr Reddys Labs Sa, Mylan Technologies, Teva Pharms Usa, Amneal Pharms, Ethypharm Usa Corp, Lannett Co Inc, Specgx Llc, and Orexo Us Inc, and is included in thirty-three NDAs. There are nineteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Buprenorphine hydrochloride has one hundred and three patent family members in thirty countries.
There are twenty-nine drug master file entries for buprenorphine hydrochloride. Twenty-two suppliers are listed for this compound.
Summary for buprenorphine hydrochloride
| International Patents: | 103 |
| US Patents: | 19 |
| Tradenames: | 10 |
| Applicants: | 23 |
| NDAs: | 33 |
| Drug Master File Entries: | 29 |
| Suppliers / Packagers: | 22 |
| Bulk Api Vendors: | 30 |
| Clinical Trials: | 390 |
| Patent Applications: | 1,170 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for buprenorphine hydrochloride |
| DailyMed Link: | buprenorphine hydrochloride at DailyMed |
Pharmacology for buprenorphine hydrochloride
| Drug Class | Partial Opioid Agonist |
| Mechanism of Action | Partial Opioid Agonists |
Synonyms for buprenorphine hydrochloride
| (2S)-2-[17-(Cyclopropylmethyl)-4,5a-epoxy-3-hydroxy-6-methoxy-6a,14-ethano-14a-morphinan-7a-yl]-3,3-dimethylbutan-2-ol hydrochloride |
| (5alpha,7alpha(S))-alpha-tert-Butyl-17-(cyclopropylmethyl)-4,5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-alpha-methyl-6,14-ethenomorphinan-7-methanol hydrochloride |
| [5?,7?(S)]-17-(Cyclopropylmethyl)-?-(1,1-dimethylethyl)-4,5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-?-methyl-6,14-ethenomorphinan-7-methanol hydrochloride |
| [5|A,7|A(S)]-17-(Cyclopropylmethyl)-|A-(1,1-dimethylethyl)-4,5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-|A-methyl-6,14-ethenomorphinan-7-methanol Hydrochloride |
| [5|A,7|A(S)]-17-(Cyclopropylmethyl)-|A-(1,1-dimethylethyl)4,5-epoxy-18,19-dihydo-3-hydroxy-6-methoxy-|A-methyl-6,14-ethenomorphinan-7-methanol hydrochloride |
| 21-Cyclopropyl-7alpha-((S)-1-hydroxy-1,2,2-trimethylpropyl)-6,14-endo-ethano-6,7,8,14-tetrahydrooripavine hydrochloride |
| 52485-79-7 |
| 52485-79-7 (Parent) |
| 53152-21-9 |
| 53187-13-6 |
| 55327-62-3 |
| 56W8MW3EN1 |
| 6,14-Ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)-alpha-(1,1-dimethylethyl)-4,5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-alpha-methyl-, hydrochloride, (5-alpha,7-alpha(S))- |
| 6,14-Ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)-alpha-(1,1-dimethylethyl)-4,5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-alpha-methyl-, hydrochloride, (5alpha,7alpha(S))- |
| 64425-21-4 |
| AC1L9B1P |
| AC1MHV55 |
| AKOS024457300 |
| BCP16140 |
| Belbuca |
| BEMA LA |
| BEMA long acting analgesic |
| BEMA-buprenorphine |
| Buprenex (TN) |
| buprenorphine |
| Buprenorphine (hydrochloride) |
| Buprenorphine Depot |
| Buprenorphine Hcl |
| Buprenorphine hydrochloride (JP17/USP) |
| Buprenorphine hydrochloride [USAN:JAN] |
| Buprenorphine hydrochloride [USAN:USP:JAN] |
| Buprenorphine hydrochloride solution |
| Buprenorphine hydrochloride solution, analytical standard, for drug analysis |
| Buprenorphine hydrochloride, British Pharmacopoeia (BP) Reference Standard |
| Buprenorphine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material |
| Buprenorphine hydrochloride, United States Pharmacopeia (USP) Reference Standard |
| Buprex |
| Butrans |
| C29H41NO4.HCl |
| CAS-53152-21-9 |
| CHEBI:652822 |
| CHEMBL1200401 |
| CHEMBL1894325 |
| CHEMBL2368861 |
| CL 112,302 |
| CL 112302 |
| CL-112302 |
| CL112302 |
| CS-2940 |
| D00836 |
| DEA No. 9064 |
| DSSTox_CID_28831 |
| DSSTox_GSID_48905 |
| DSSTox_RID_83100 |
| DTXSID2048905 |
| EINECS 258-396-8 |
| ETI-311 |
| Finibron |
| FTB-8127 |
| HY-B0701 |
| IX-1003 |
| IX-1004 |
| IX-1005 |
| Lepetan |
| LS-67683 |
| MLS002320704 |
| MR 56 |
| NCGC00247733-01 |
| NIH 8805 |
| NIH-8805 |
| NIH8805 |
| Norspan |
| RX 6029-M |
| RX 6029-M HCl |
| RX-6029-M |
| RX-6029M HCL |
| SCHEMBL17220698 |
| SCHEMBL17220699 |
| SCHEMBL42107 |
| SMR001338850 |
| Subutex |
| Temgesic |
| Tox21_112899 |
| Transtec |
| TSN-09 |
| U- 952 |
| UAIXRPCCYXNJMQ-HPRIMLMLSA-N |
| UM 952 |
| UM-952 |
| UNII-56W8MW3EN1 |
| V-1003 |
| V-1004 |
| V-1005 |
US Patents and Regulatory Information for buprenorphine hydrochloride
Expired US Patents for buprenorphine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-006 | Oct 23, 2015 | ➤ Sign Up | ➤ Sign Up |
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-001 | Oct 23, 2015 | ➤ Sign Up | ➤ Sign Up |
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-002 | Oct 23, 2015 | ➤ Sign Up | ➤ Sign Up |
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-003 | Oct 23, 2015 | ➤ Sign Up | ➤ Sign Up |
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-004 | Oct 23, 2015 | ➤ Sign Up | ➤ Sign Up |
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-005 | Oct 23, 2015 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for buprenorphine hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 1193566 | ➤ Sign Up |
| Croatia | P20160405 | ➤ Sign Up |
| Germany | 69923675 | ➤ Sign Up |
| European Patent Office | 3067044 | ➤ Sign Up |
| Hungary | E027395 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 9955312 | ➤ Sign Up |
| 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 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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Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.