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 eight 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. Two suppliers are 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.

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:	73
Clinical Trials:	6
Patent Applications:	1,526
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 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.

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
Grünenthal GmbH	Phase 3

See all NUCYNTA clinical trials

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	200533-002	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			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	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	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	0743853	COMPOSES AGISSANT AU NIVEAU D'UN NOUVEAU SITE SUR DES CANAUX CALCIQUES ACTIVES PAR DES RECEPTEURS, ET UTILISES DANS LE TRAITEMENT DE TROUBLES ET DE MALADIES NEUROLOGIQUES (COMPOUNDS ACTIVE AT A NOVEL SITE ON RECEPTOR-OPERATED CALCIUM CHANNELS USEFUL FOR TREATMENT OF NEUROLOGICAL DISORDERS AND DISEASES)
China	1153568
Denmark	0831799

Supplementary Protection Certificates for NUCYNTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
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