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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 Depomed Inc and is included in three NDAs. There are seven patents protecting this drug and four Paragraph IV challenges.

This drug has seventy-seven 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. Four suppliers are listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.

Summary for NUCYNTA

International Patents:	77
US Patents:	2
Applicants:	1
NDAs:	3
Suppliers / Packagers:	4
Bulk Api Vendors:	35
Clinical Trials:	6
Patent Applications:	785
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

Generic Entry Opportunity Date for NUCYNTA

NDA:

203794

Dosage:

SOLUTION;ORAL

NDA:

022304

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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
Depomed Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-004	Aug 25, 2011		RX	Yes	No			Y
Depomed Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-005	Aug 25, 2011		RX	Yes	Yes			Y	Y
Depomed Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-004	Aug 25, 2011		RX	Yes	No
Depomed Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-005	Aug 25, 2011		RX	Yes	Yes
Depomed Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-002	Aug 25, 2011		RX	Yes	No			Y
Depomed Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-003	Aug 25, 2011		RX	Yes	No			Y	Y

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Expired US Patents for NUCYNTA

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

Non-Orange Book US Patents for NUCYNTA

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
6,248,737	1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects
6,344,558	1-phenyl-3-dimethylaminopropane compounds with a pharmacological effect

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International Patents for NUCYNTA

Country	Document Number	Estimated Expiration
China	1997621
Peru	34896
Japan	H0899939
South Korea	100364465
Japan	4846552
Japan	4034366

Supplementary Protection Certificates for NUCYNTA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/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
00541	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
2010 00036	Denmark
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
2011007	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
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