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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.

Summary for tapentadol hydrochloride

International Patents:	263
US Patents:	7
Tradenames:	2
Applicants:	2
NDAs:	3
Drug Master File Entries:	5
Suppliers / Packagers:	5
Bulk Api Vendors:	34
Clinical Trials:	66
Patent Applications:	275
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for tapentadol hydrochloride
DailyMed Link:	tapentadol hydrochloride at DailyMed

Pharmacology for tapentadol hydrochloride

Drug Class	Opioid Agonist
Mechanism of Action	Opioid 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			Y	Y
Depo Nf	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-004	Aug 25, 2011		RX	Yes	No			Y		Y
Depo Nf	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-001	Aug 25, 2011		RX	Yes	No			Y	Y
Depo Nf	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-002	Aug 25, 2011		RX	Yes	No			Y	Y
Depo Nf	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-005	Aug 25, 2011		RX	Yes	Yes			Y		Y
Depo Nf	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-003	Aug 25, 2011		RX	Yes	No			Y
Depo Nf	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-004	Aug 25, 2011		RX	Yes	No			Y

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
Depo Nf	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-003	Nov 20, 2008
Depo Nf	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-005	Aug 25, 2011
Assertio	NUCYNTA	tapentadol hydrochloride	SOLUTION;ORAL	203794-001	Oct 15, 2012
Depo Nf	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-003	Aug 25, 2011
Depo Nf	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-002	Aug 25, 2011
Depo Nf	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-001	Aug 25, 2011

International Patents for tapentadol hydrochloride

Country	Patent Number	Estimated Expiration
Finland	953523
Brazil	122018014454
Denmark	1612203
China	1863513
Portugal	1612203
Israel	185018
Brazil	PI0512792

Supplementary Protection Certificates for tapentadol hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0693475	C300541	Netherlands		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		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		PRODUCT NAME: TAPENTADOL; REGISTRATION NO/DATE: SWISSMEDIC 60530 20110222
0693475	CA 2010 00036	Denmark
0693475	1190004-0.L	Sweden		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		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		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