Tapentadol hydrochloride - Generic Drug Details

What are the generic sources for tapentadol hydrochloride and what is the scope of patent protection?

Tapentadol hydrochloride is the generic ingredient in two branded drugs marketed by Collegium Pharm Inc and is included in three NDAs. There are nine patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tapentadol hydrochloride has three hundred and fifty-three patent family members in thirty-seven countries.

There are four drug master file entries for tapentadol hydrochloride. Two suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for tapentadol hydrochloride

International Patents:	353
US Patents:	9
Tradenames:	2
Applicants:	1
NDAs:	3
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	67
Patent Applications:	605
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for tapentadol hydrochloride
What excipients (inactive ingredients) are in tapentadol hydrochloride?	tapentadol hydrochloride excipients list
DailyMed Link:	tapentadol hydrochloride at DailyMed

Recent Clinical Trials for tapentadol hydrochloride

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

Sponsor	Phase
Aretaieion University Hospital	N/A
All India Institute of Medical Sciences, Bhubaneswar	Phase 4
Oslo University Hospital	Phase 4

See all tapentadol hydrochloride clinical trials

Generic filers with tentative approvals for TAPENTADOL HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 20MG BASE/ML	SOLUTION;ORAL
		100MG	TABLET;ORAL
		75MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for tapentadol hydrochloride

Drug Class	Opioid Agonist
Mechanism of Action	Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for tapentadol hydrochloride

N02AX	Other opioids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for TAPENTADOL HYDROCHLORIDE

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
NUCYNTA ER	Extended-release Tablets	tapentadol hydrochloride	50 mg, 100 mg, 150 mg, 200 mg, and 250 mg	200533	2	2012-11-20

US Patents and Regulatory Information for tapentadol hydrochloride

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			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	200533-001	Aug 25, 2011		RX	Yes	No			Y
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-002	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			Y

Expired US Patents for tapentadol hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-003	Aug 25, 2011
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-003	Aug 25, 2011
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 ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-004	Aug 25, 2011
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-005	Aug 25, 2011

International Patents for tapentadol hydrochloride

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1765298	PROCEDE DE PRODUCTION D'UNE FORME POSOLOGIQUE SOLIDE ANTI-ABUS AU MOYEN D'UNE EXTRUDEUSE A VIS PLANETAIRES (METHOD FOR PRODUCING A SOLID DOSAGE FORM, WHICH IS SAFEGUARDED AGAINST ABUSE, WHILE USING A PLANETARY GEAR EXTRUDER)
Portugal	1845956
Russian Federation	2423345	КРИСТАЛЛИЧЕСКИЕ МОДИФИКАЦИИ ГИДРОХЛОРИДА (-)-(1R,2R)-3-(3-ДИМЕТИЛАМИНО-1-ЭТИЛ-2-МЕТИЛПРОПИЛ)ФЕНОЛА (CRYSTALLINE MODIFICATIONS OF HYDROCHLORIDE (-)-(1R, 2R)-3-(3-DIMETHYLAMINO-1-ETHYL-2-METHYLPROPYL)PHENOL)
Japan	2019131598	タペンタドールの用量調節 (TITRATION OF TAPENTADOL)
Israel	173558	DOSAGE FORM THAT IS SAFEGUARDED FROM ABUSE
Germany	102005005446	Bruchfeste Darreichungsformen mit retardierter Freisetzung

Supplementary Protection Certificates for tapentadol hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1439829	C20110003 00036	Estonia		PRODUCT NAME: PALEXIA; REG NO/DATE: RR-4/42 22.10.2010
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	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	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	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