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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Johnson and Johnson
Federal Trade Commission
US Department of Justice
Daiichi Sankyo
Fish and Richardson
Cipla
QuintilesIMS
McKesson

Generated: August 20, 2018

DrugPatentWatch Database Preview

Tapentadol hydrochloride - Generic Drug Details

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What are the generic sources for tapentadol hydrochloride and what is the scope of tapentadol hydrochloride patent protection?

Tapentadol hydrochloride is the generic ingredient in two branded drugs marketed by Depomed Inc and is included in three NDAs. There are seven patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tapentadol hydrochloride has two hundred and fifty-five patent family members in thirty-seven countries.

There are five drug master file entries for tapentadol hydrochloride. Four suppliers are listed for this compound.

Pharmacology for tapentadol hydrochloride
Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists
Synonyms for tapentadol hydrochloride
(-)-(1r,2r)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol hydrochloride
(-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride
175591-09-0
3-((1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl) phenol hydrochloride
3-((1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl)-phenol hydrochloride
3-((1R,2R)-3-(Dimethylamino)-1-ethyl-2-methylpropyl)phenol hydrochloride
3-((2R,3R)-1-(dimethylamino)-2-methylpentan-3-yl)phenol hydrochloride
3-[(1R,2R)-3-(Dimethylamino)-1-ethyl-2-methylpropyl]phenol hdrochloride
3-[(1R,2R)-3-(Dimethylamino)-1-ethyl-2-methylpropyl]phenol Hydrochloride
3-[(1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride
591T238
71204KII53
AB1008539
AK-43468
AX8210956
CHEMBL1201777
CS-0879
D10199
EBD2202137
FT-0674809
HY-70042A
JNS-024 ER
KB-80810
KS-00000OJT
MFCD00944992
Nucynta (TN)
Nucynta ER
Palexia retard
Palexia SR
Phenol, 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]-, hydrochloride
R-331333
SCHEMBL238138
ST24049325
Tapentadol (hydrochloride)
Tapentadol HCl
Tapentadol HCl (1.0 mg/mL in Methanol)
Tapentadol hydrochloride (JAN)
Tapentadol hydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material
Tydol|||Zyntap|||3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]-phenol hydrochloride
UNII-71204KII53
W-5241
X4992
ZELFLGGRLLOERW-YECZQDJWSA-N

US Patents and Regulatory Information for tapentadol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-001 Aug 25, 2011 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-002 Aug 25, 2011 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-004 Aug 25, 2011 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Depomed Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-003 Nov 20, 2008 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-003 Aug 25, 2011 RX Yes No ➤ Sign Up ➤ Sign Up Y 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 tapentadol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-003 Aug 25, 2011 ➤ Sign Up ➤ Sign Up
Depomed Inc NUCYNTA tapentadol hydrochloride SOLUTION;ORAL 203794-001 Oct 15, 2012 ➤ Sign Up ➤ Sign Up
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-004 Aug 25, 2011 ➤ Sign Up ➤ Sign Up
Depomed Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-001 Nov 20, 2008 ➤ Sign Up ➤ Sign Up
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-001 Aug 25, 2011 ➤ Sign Up ➤ Sign Up
Depomed Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-003 Nov 20, 2008 ➤ 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 tapentadol 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
6,248,737 1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects ➤ Sign Up
6,344,558 1-phenyl-3-dimethylaminopropane compounds with a pharmacological effect ➤ Sign Up
8,114,384 Process for the production of an abuse-proofed solid dosage form ➤ Sign Up
8,192,722 Abuse-proof dosage form ➤ Sign Up
8,323,889 Process for the production of an abuse-proofed solid dosage form ➤ Sign Up
9,629,807 Abuse-proofed dosage form ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for tapentadol hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2010 00036 Denmark ➤ Sign Up PRODUCT NAME: TAPENTADOL ((1R-2R)-3-(3-DIMETHYLAMINO-1-ETHYL-2-METHYL-PROPYL)-PHENOL), HERUNDER HYDROCHLORIDET; NAT. REG. NO/DATE: 45151-45158, 45162-45169 20100830; FIRST REG. NO/DATE: EU 75043.00.00-75048.00.00, 75261.00.00-75270.00.00 20100819
0693475/01 Switzerland ➤ Sign Up PRODUCT NAME: TAPENTADOL; REGISTRATION NO/DATE: SWISSMEDIC 60530 20110222
11/010 Ireland ➤ Sign Up PRODUCT NAME: TAPENTADOL IN BASIC FORM OR IN THE FORM OF A SALT OF A PHYSIOLOGICALLY COMPATIBLE ACID, ESPECIALLY TAPENTADOL HYDROCHLORIDE; NAT REGISTRATION NO/DATE: PA1189/007/001-008 20101221; FIRST REGISTRATION NO/DATE: PA1189/008/001-008 21/12/2010 GERMANY 75043.00.00 75044.00.00 75045.00.00 19/08/2010 GERMANY 76261.00.00 76262.00.00 76263.00.00 76264.00.00 76265.00.00 19/08/2010 GERMANY 75046.00.00 75047.00.00 75048.00.00 19/08/2010 GERMANY 76266.00.00 76267.00.00 76268.00.0076269.00.00 76270.00.00 20100819
793 Luxembourg ➤ Sign Up 91793, EXPIRES: 20200712
C/GB11/031 United Kingdom ➤ Sign Up PRODUCT NAME: TAPENTADOL IN THE FORM OF ITS BASE OR A SALT OF A PHYSIOLOGICALLY COMPATIBLE ACID, ESPECIALLY THE HYDROCHLORIDE SALT.; REGISTERED: DE 75043 20100819; UK PL 21727/0032 - 0050 20110204
2011007 Lithuania ➤ Sign Up PRODUCT NAME: TAPENTADOLUM; NAT. REGISTRATION NO/DATE: LT/1/10/2341/001 - LT/1/10/2341/66, 2011 02 19; LT/1/10/2342/001 - LT/1/10/2342/110 20110219; FIRST REGISTRATION: 75043.00.00 - 75048.00.00, 2010 08 19; 76261.00.00 - 76270.00.00 20100819
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Express Scripts
Julphar
Johnson and Johnson
Daiichi Sankyo
Harvard Business School
Teva
Dow
Chubb

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.