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Buprenorphine hydrochloride - Generic Drug Details
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What are the generic drug sources for buprenorphine hydrochloride and what is the scope of patent protection?
Buprenorphine hydrochloride
is the generic ingredient in ten branded drugs marketed by Bdsi, Titan Pharms, Indivior Inc, Am Regent, Hospira, Par Sterile Products, West-ward Pharms Int, Actavis Elizabeth, Barr, Casi Pharms Inc, Ethypharm, Mylan, Rhodes Pharms, Sun Pharm, 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 twenty 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 nine patent family members in thirty countries.
There are twenty-nine drug master file entries for buprenorphine hydrochloride. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for buprenorphine hydrochloride
| International Patents: | 109 |
| US Patents: | 20 |
| Tradenames: | 10 |
| Applicants: | 23 |
| NDAs: | 33 |
| Drug Master File Entries: | 29 |
| Suppliers / Packagers: | 18 |
| Bulk Api Vendors: | 29 |
| Clinical Trials: | 400 |
| Patent Applications: | 1,215 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for buprenorphine hydrochloride |
| DailyMed Link: | buprenorphine hydrochloride at DailyMed |
Recent Clinical Trials for buprenorphine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Centre Hospitalier Universitaire de Nīmes | Phase 3 |
| Heffter Research Institute | Phase 1 |
| University of Wisconsin, Madison | Phase 1 |
Recent Litigation for buprenorphine hydrochloride
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| BIODELIVERY SCIENCES INTERNATIONAL, INC. v. CHEMO RESEARCH, S.L. | 2019-03-15 |
| BioDelivery Sciences International, Inc. v. Chemo Research, S.L. | 2019-03-01 |
| BioDelivery Sciences International, Inc. v. Alvogen Pb Research & Development LLC | 2018-09-07 |
See all buprenorphine hydrochloride litigation
PTAB Litigation
| Petitioner | Date |
|---|---|
| MONOSOL RX, LLC | 2014-01-22 |
Generic filers with tentative approvals for BUPRENORPHINE 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
| 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 |
Paragraph IV (Patent) Challenges for BUPRENORPHINE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| BELBUCA | FILM;BUCCAL | buprenorphine hydrochloride | 207932 | 2016-10-24 |
| BELBUCA | FILM;BUCCAL | buprenorphine hydrochloride | 207932 | 2016-10-04 |
US Patents and Regulatory Information for buprenorphine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-003 | Oct 23, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Orexo Us Inc | ZUBSOLV | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 204242-001 | Jul 3, 2013 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Indivior Inc | SUBOXONE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410-003 | Aug 10, 2012 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start 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 buprenorphine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-005 | Oct 23, 2015 | Start Trial | Start Trial |
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-006 | Oct 23, 2015 | Start Trial | Start Trial |
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-001 | Oct 23, 2015 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for buprenorphine hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2015500886 | Start Trial |
| Japan | 5689144 | Start Trial |
| South Korea | 101230804 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.