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NUCYNTA Drug Profile

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Which patents cover Nucynta, and when can generic versions of Nucynta launch?

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

This drug has seventy-nine patent family members in thirty-three countries.

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

Summary for NUCYNTA

International Patents:	79
US Patents:	2
Applicants:	2
NDAs:	3
Suppliers / Packagers:	5
Bulk Api Vendors:	63
Clinical Trials:	6
Patent Applications:	984
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

See drug prices for NUCYNTA

Recent Clinical Trials for NUCYNTA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Grünenthal GmbH	Phase 4
Ortho-McNeil Janssen Scientific Affairs, LLC	Phase 3
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 3

See all NUCYNTA clinical trials

Recent Litigation for NUCYNTA

Identify potential future generic entrants

District Court Litigation

Case Name	Date
GRUNENTHAL GMBH v. ROXANE LABORATIORES, INC.	2014-06-19
Celltrion Healthcare Co., Ltd. v. Janssen Biotech, Inc.	2014-03-31
GRUNENTHAL GMBH v. ALKEM LABORATORIES LIMITED	2013-12-23

See all NUCYNTA litigation

PTAB Litigation

Petitioner	Date
Rosellini Scientific, LLC	2016-01-15

See all NUCYNTA litigation

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 hydrochloride

(-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride

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

(R,R)-Tapentadol

175591-09-0

175591-23-8

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

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

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

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

3-(1-DIMETHYLAMINO-2-METHYL-PENTAN-3-YL)PHENOL

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

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

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

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

4084AH

591T238

71204KII53

AB1008538

AB1008539

ACN-050883

AJ-08434

AK-43468

AKOS015951190

AN-3500

AX8210956

B-1798

BCP9000118

BDBM50386381

BN 200

BN 200 (BASE)

BN-200

CG 5503

CG-5503

CG5503

CG5503 (BASE)

CHEBI:135935

CHEMBL1201776

CHEMBL1201777

CS-0879

CS-M0020

D06007

D10199

DB06204

DEA No. 9780

DTXSID30170003

EBD2202137

FT-0674809

FT-0699883

GTPL7477

H8A007M585

HSDB 8309

HY-70042A

JNS-024 ER

KB-79930

KB-80810

KS-00000OJT

KWTWDQCKEHXFFR-SMDDNHRTSA-N

MFCD00944992

Nucynta (TN)

Nucynta ER

Palexia

Palexia retard

Palexia SR

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]-, hydrochloride

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

QC-1146

R-331333

RL02248

SB17333

SB17334

SCHEMBL116924

SCHEMBL238138

ST24049325

Tapentadol

Tapentadol (hydrochloride)

Tapentadol (USAN/INN)

Tapentadol [USAN:INN]

Tapentadol HCl

Tapentadol hydrochloride

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

UNII-H8A007M585

W-5241

X4992

ZELFLGGRLLOERW-YECZQDJWSA-N

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	200533-003	Aug 25, 2011		RX	Yes	No
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	200533-005	Aug 25, 2011		RX	Yes	Yes			Y

Expired US Patents for NUCYNTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Depo Nf	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-002	Nov 20, 2008
Assertio	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	022304-003	Nov 20, 2008

Paragraph IV (Patent) Challenges for NUCYNTA

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

International Patents for NUCYNTA

Country	Patent Number	Estimated Expiration
South Africa	200700774
Russian Federation	95113154
New Zealand	551605
Canada	2154424

Supplementary Protection Certificates for NUCYNTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	CR 2010 00036	Denmark		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	CA 2010 00036	Denmark
0693475	PA2011007	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