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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Fish and Richardson
Citi
UBS
Healthtrust
Farmers Insurance
US Department of Justice
Merck
McKesson

Generated: July 15, 2018

DrugPatentWatch Database Preview

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
is the generic ingredient in nine 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, Amneal Pharms, Ethypharm Usa Corp, Lannett Co Inc, Specgx Llc, Teva Pharms Usa, and Orexo Us Inc, and is included in thirty-one 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 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.
Pharmacology for buprenorphine hydrochloride
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

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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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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Federal Trade Commission
Healthtrust
Chinese Patent Office
Mallinckrodt
QuintilesIMS
Boehringer Ingelheim
Deloitte
Dow

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.