NUCYNTA Drug Patent Profile

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

Nucynta is a drug marketed by Collegium Pharm Inc and is included in three NDAs. There are nine patents protecting this drug and two Paragraph IV challenges.

This drug has eighty-three patent family members in thirty-four countries.

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

DrugPatentWatch^® Generic Entry Outlook for Nucynta

Nucynta was eligible for patent challenges on November 20, 2012.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 27, 2025. This may change due to patent challenges or generic licensing.

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are three tentative approvals for the generic drug (tapentadol hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for NUCYNTA

International Patents:	83
US Patents:	2
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	6
Patent Applications:	410
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for NUCYNTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NUCYNTA
What excipients (inactive ingredients) are in NUCYNTA?	NUCYNTA excipients list
DailyMed Link:	NUCYNTA at DailyMed

See drug prices for NUCYNTA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) 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.

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

Pharmacology for NUCYNTA

Drug Class	Opioid Agonist
Mechanism of Action	Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for NUCYNTA

N02AX	Other opioids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for NUCYNTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NUCYNTA	Oral Solution	tapentadol hydrochloride	20 mg/mL	203794	1	2013-12-20
NUCYNTA	Tablets	tapentadol hydrochloride	50 mg, 75 mg, and 100 mg	022304	4	2012-11-20

US Patents and Regulatory Information for NUCYNTA

NUCYNTA is protected by four US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting NUCYNTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-005	Aug 25, 2011		RX	Yes	Yes
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-003	Aug 25, 2011		RX	Yes	No			Y
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-003	Aug 25, 2011		RX	Yes	No			Y
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-004	Aug 25, 2011		RX	Yes	No
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-002	Aug 25, 2011		RX	Yes	No
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	SOLUTION;ORAL	203794-001	Oct 15, 2012		DISCN	Yes	No			Y	Y
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-005	Aug 25, 2011		RX	Yes	Yes			Y	Y

Expired US Patents for NUCYNTA

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

International Patents for NUCYNTA

When does loss-of-exclusivity occur for NUCYNTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Austria

Brazil

Canada

China

Croatia

Cyprus

Denmark

Ecuador

European Patent Office

Germany

Israel

Japan

Mexico

New Zealand

Norway

Peru

Poland

Portugal

Russian Federation

Slovenia

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering NUCYNTA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1612203	Formes cristallines de chlorhydrate de (-)-(1R,2R)-3-(3-diméthylamino-1-ethyl-2-méthylpropyl)-phénol (Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride)
Norway	20171103	Krystallinske former av (-)-(1R,2R)-3-(3-dimetylamino-1-etyl-2-metylpropyl)-fenol hydroklorid
Slovenia	1612203
Russian Federation	2007103297	КРИСТАЛЛИЧЕСКИЕ МОДИФИКАЦИИ ГИДРОХЛОРИДА (-)-(1R,2R)-3-(3-ДИМЕТИЛАМИНО-1-ЭТИЛ-2-МЕТИЛПРОПИЛ)ФЕНОЛА
Canada	2223978
China	1088585
New Zealand	551605	Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride

Supplementary Protection Certificates for NUCYNTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1439829	99 1-2011	Slovakia		PRODUCT NAME: TAPENTADOL; NAT. REGISTRATION NO/DATE: 65/0667-0674/10-S, 65/090-0697/10-S 20101012; FIRST REGISTRATION: DE 75043-75048.00.00, 76261-76270.00.00 20100819
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	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	C00693475/01	Switzerland		PRODUCT NAME: TAPENTADOL; REGISTRATION NO/DATE: SWISSMEDIC 60530 20110222
0693475	91793	Luxembourg		91793, EXPIRES: 20200712
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	2011/010	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