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Express Scripts
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Cipla
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Medtronic
Daiichi Sankyo
Fish and Richardson
Boehringer Ingelheim

Generated: April 19, 2018

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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. Six suppliers are listed for this compound.
Summary for tapentadol hydrochloride
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 200533-004 Aug 25, 2011 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-004 Aug 25, 2011 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-003 Aug 25, 2011 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 tapentadol hydrochloride TABLET;ORAL 022304-001 Nov 20, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-001 Aug 25, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Depomed Inc NUCYNTA tapentadol hydrochloride SOLUTION;ORAL 203794-001 Oct 15, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Depomed Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-002 Nov 20, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
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
8,114,384 Process for the production of an abuse-proofed solid dosage form ➤ Try a Free Trial
8,192,722 Abuse-proof dosage form ➤ Try a Free Trial
8,323,889 Process for the production of an abuse-proofed solid dosage form ➤ Try a Free Trial
6,248,737 1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects ➤ Try a Free Trial
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
0693475/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: TAPENTADOL; REGISTRATION NO/DATE: SWISSMEDIC 60530 20110222
2010 00036 Denmark ➤ Try a Free Trial
C0016 France ➤ Try a Free Trial PRODUCT NAME: TAPENTADOL SOUS FORME DE SA BASE LIBRE OU SOUS FORME D'UN DE SES SELS D'ACIDES ACCEPTABLES DU POINT DE VUE PHYSIOLOGIQUE; NAT. REGISTRATION NO/DATE: NL40884 20111003; FIRST REGISTRATION: DE - 76261.00.00 20100819
C/GB11/031 United Kingdom ➤ Try a Free Trial 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Accenture
Baxter
UBS
Fuji
US Department of Justice
Moodys
Express Scripts
Chubb

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