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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 freedom to operate?
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, 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-two NDAs. There are nineteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.There are twenty-nine drug master file entries for buprenorphine hydrochloride. Twenty-two suppliers are listed for this compound.
Summary for buprenorphine hydrochloride
| US Patents: | 19 |
| Tradenames: | 10 |
| Applicants: | 22 |
| NDAs: | 32 |
| Drug Master File Entries: | 29 |
| Suppliers / Packagers: | 22 |
| Bulk Api Vendors: | 29 |
| Clinical Trials: | 367 |
| Patent Applications: | 6,619 |
| 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 |
| 53152-21-9 |
| 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, (5alpha,7alpha(S))- |
| AKOS024457300 |
| Belbuca |
| Buprenex (TN) |
| buprenorphine |
| Buprenorphine (hydrochloride) |
| Buprenorphine Hcl |
| Buprenorphine hydrochloride (JP17/USP) |
| 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; traceable to USP, PhEur |
| Buprenorphine hydrochloride, United States Pharmacopeia (USP) Reference Standard |
| Buprex |
| Butrans |
| CAS-53152-21-9 |
| CHEBI:652822 |
| CHEMBL1894325 |
| CHEMBL2368861 |
| CL 112,302 |
| CL 112302 |
| CL-112302 |
| CL112302 |
| CS-2940 |
| DEA No. 9064 |
| DSSTox_CID_28831 |
| DSSTox_GSID_48905 |
| DSSTox_RID_83100 |
| DTXSID2048905 |
| EINECS 258-396-8 |
| Finibron |
| FTB-8127 |
| HY-B0701 |
| Lepetan |
| 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 |
| Tox21_112899 |
| U- 952 |
| UAIXRPCCYXNJMQ-HPRIMLMLSA-N |
| UM 952 |
| UM-952 |
| UNII-56W8MW3EN1 |
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 | 207932-005 | Oct 23, 2015 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ 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 | |||
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-005 | Oct 23, 2015 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ 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 buprenorphine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-004 | 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 | 207932-007 | 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 | Document Number | Estimated Expiration |
|---|---|---|
| Spain | 2188907 | ➤ Sign Up |
| Australia | 2017258916 | ➤ Sign Up |
| Japan | 2001508037 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
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Major Patent Expirations 2018 - 2019
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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