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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 buprenorphine hydrochloride patent protection?
Buprenorphine hydrochloride has ninety-five 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: | 95 |
| US Patents: | 19 |
| Tradenames: | 9 |
| Applicants: | 22 |
| NDAs: | 31 |
| Drug Master File Entries: | 29 |
| Suppliers / Packagers: | 22 |
| Bulk Api Vendors: | 29 |
| Clinical Trials: | 353 |
| Patent Applications: | 6,665 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Titan Pharms | PROBUPHINE | buprenorphine hydrochloride | IMPLANT;IMPLANTATION | 204442-001 | May 26, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| West-ward Pharms Int | BUPRENORPHINE HYDROCHLORIDE | buprenorphine hydrochloride | INJECTABLE;INJECTION | 076931-001 | Mar 2, 2005 | AP | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Actavis Elizabeth | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 091422-001 | Feb 22, 2013 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-002 | Jun 6, 2014 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Expired US Patents for buprenorphine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-002 | 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 |
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-006 | Oct 23, 2015 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Non-Orange Book US Patents for buprenorphine hydrochloride
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 2,017,035,688 | ➤ Sign Up | |
| 9,597,288 | Transmucosal delivery devices with enhanced uptake | ➤ Sign Up |
| 5,800,832 | Bioerodable film for delivery of pharmaceutical compounds to mucosal surfaces | ➤ Sign Up |
| 6,159,498 | Bioerodable film for delivery of pharmaceutical compounds of mucosal surfaces | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for buprenorphine hydrochloride
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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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