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NUCYNTA Drug Profile

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Which patents cover Nucynta, and what generic alternatives are available?

Nucynta is a drug marketed by Depomed Inc and Depo Nf and is included in three NDAs. There are seven patents protecting this drug and four Paragraph IV challenges.

The generic ingredient in NUCYNTA is tapentadol hydrochloride. There are five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.

Summary for NUCYNTA

US Patents:	2
Applicants:	2
NDAs:	3
Suppliers / Packagers:	4
Bulk Api Vendors:	28
Clinical Trials:	6
Patent Applications:	803
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for NUCYNTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NUCYNTA
DailyMed Link:	NUCYNTA at DailyMed

Pharmacology for NUCYNTA

Drug Class	Opioid Agonist
Mechanism of Action	Opioid Agonists

Synonyms for NUCYNTA

(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol

(R,R)-Tapentadol

175591-23-8

3-((1R,2R)-3-(Dimethylamino)-1-ethyl-2-methylpropyl)phenol

3-((2R,3R)-1-(dimethylamino)-2-methylpentan-3-yl)phenol

3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methyl-propyl]phenol

3-[(2R,3R)-1-(dimethylamino)-2-methylpentan-3-yl]phenol

3-[(2R,3R)-1-dimethylamino-2-methylpentan-3-yl]phenol

4084AH

AB1008538

ACN-050883

AJ-08434

AKOS015951190

AN-3500

B-1798

BCP9000118

BDBM50386381

BN 200

BN 200 (BASE)

BN-200

CG 5503

CG-5503

CG5503

CG5503 (BASE)

CHEBI:135935

CHEMBL1201776

CS-M0020

D06007

D0K4MH

DB06204

DEA No. 9780

DTXSID30170003

FT-0699883

GTPL7477

H8A007M585

HSDB 8309

KB-79930

KWTWDQCKEHXFFR-SMDDNHRTSA-N

Nucynta ER

Palexia

Phenol, 3-((1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl)-

phenol, 3-[(1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl]-

Phenol,3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]-

QC-1146

RL02248

SCHEMBL116924

Tapentadol

Tapentadol (USAN/INN)

Tapentadol [USAN:INN]

UNII-H8A007M585

ZINC20783

US Patents and Regulatory Information for NUCYNTA

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	200533-004	Aug 25, 2011		RX	Yes	No			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	200533-004	Aug 25, 2011		RX	Yes	No
Depo Nf	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-005	Aug 25, 2011		RX	Yes	Yes

Expired US Patents for NUCYNTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Depo Nf	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-003	Nov 20, 2008
Depomed Inc	NUCYNTA	tapentadol hydrochloride	SOLUTION;ORAL	203794-001	Oct 15, 2012
Depo Nf	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-001	Nov 20, 2008
Depo Nf	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-002	Nov 20, 2008

Paragraph IV (Patent) Challenges for NUCYNTA

Drugname	Dosage	Strength	RLD	Date
	Extended-release Tablets	50 mg, 100 mg, 150 mg, 200 mg, and 250 mg
	Tablets	x50 mg, 75 mg, and 100 mg
	Oral Solution	20 mg/mL
	Oral Solution	20 mg/mL

International Patents for NUCYNTA

Country	Document Number	Estimated Expiration
Portugal	1799633
World Intellectual Property Organization (WIPO)	2006000441
Germany	4426245
Russian Federation	95113154

Supplementary Protection Certificates for NUCYNTA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0693475/01	Switzerland		PRODUCT NAME: TAPENTADOL; REGISTRATION NO/DATE: SWISSMEDIC 60530 20110222
90004-0.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
11/010	Ireland		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
C0016	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