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Generated: September 18, 2019

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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 Assertio and Depo Nf, 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 sixty-three patent family members in thirty-seven countries.

There are five drug master file entries for tapentadol hydrochloride. Five 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
Nucynta (TN)
Nucynta ER
Palexia retard
Palexia SR
Phenol, 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]-, hydrochloride
R-331333
SB17334
SCHEMBL238138
ST24049325
Tapentadol (hydrochloride)
Tapentadol HCl
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
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-002 Aug 25, 2011 RX Yes No   Try a Free Trial   Try a Free Trial Y Y   Try a Free Trial
Depo Nf 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 Y   Try a Free Trial
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-001 Aug 25, 2011 RX Yes No   Try a Free Trial   Try a Free Trial Y Y   Try a Free Trial
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-002 Aug 25, 2011 RX Yes No   Try a Free Trial   Try a Free Trial Y Y   Try a Free Trial
Depo Nf 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
Depo Nf 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
Depo Nf 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
>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
Depo Nf NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-001 Nov 20, 2008   Try a Free Trial   Try a Free Trial
Depo Nf NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-003 Nov 20, 2008   Try a Free Trial   Try a Free Trial
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011   Try a Free Trial   Try a Free Trial
Assertio NUCYNTA tapentadol hydrochloride SOLUTION;ORAL 203794-001 Oct 15, 2012   Try a Free Trial   Try a Free Trial
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-003 Aug 25, 2011   Try a Free Trial   Try a Free Trial
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-002 Aug 25, 2011   Try a Free Trial   Try a Free Trial
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-001 Aug 25, 2011   Try a Free Trial   Try a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Supplementary Protection Certificates for tapentadol hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0693475 C300541 Netherlands   Try a Free Trial PRODUCT NAME: TAPENTADOL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TAPENTADOL HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 110721-110724 RVG 110728-110731 20120316; FIRST REGISTRATION: DE 75043.00.00 - 75045.00.00, 75046.00.00, 76261.00.00 - 76270.00.00 20120819
0693475 12C0016 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
0693475 C00693475/01 Switzerland   Try a Free Trial PRODUCT NAME: TAPENTADOL; REGISTRATION NO/DATE: SWISSMEDIC 60530 20110222
0693475 CA 2010 00036 Denmark   Try a Free Trial
0693475 1190004-0.L Sweden   Try a Free Trial PRODUCT NAME: TAPENTADOL; NAT. REG. NO/DATE: 42622-42628 20100910; FIRST REG.: DE 7543-7548,7661-76270" EESGODKLANDKOD="DE" EESGODKDATUM="2010-08-19" SEGODKNR="42622-42628 20100819
0693475 SPC/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
0693475 PA2011007,C0693475 Lithuania   Try a Free Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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