Details for New Drug Application (NDA): 022304

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NDA 022304 describes NUCYNTA, which is a drug marketed by Collegium Pharm Inc and is included in three NDAs. It is available from one supplier. There are four patents protecting this drug and four Paragraph IV challenges. Additional details are available on the NUCYNTA profile page.

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.

Summary for 022304

Tradename:	NUCYNTA
Applicant:	Collegium Pharm Inc
Ingredient:	tapentadol hydrochloride
Patents:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 022304

Generic Entry Date for 022304^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: NEW PATIENT POPULATION 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 NDA: 022304

Mechanism of Action	Opioid Agonists

Suppliers and Packaging for NDA: 022304

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304	NDA	Collegium Pharmaceutical, Inc.	24510-050	24510-050-01	10 BLISTER PACK in 1 CARTON (24510-050-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK
NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304	NDA	Collegium Pharmaceutical, Inc.	24510-050	24510-050-10	100 TABLET, FILM COATED in 1 BOTTLE (24510-050-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 50MG BASE
Approval Date:	Nov 20, 2008	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jul 3, 2026
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:	Jan 3, 2027
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Patent:	7,994,364*PED	Patent Expiration:	Dec 27, 2025	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 022304

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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	RE39593	⤷ Subscribe
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-001	Nov 20, 2008	6,071,970	⤷ Subscribe
Collegium Pharm Inc	NUCYNTA	tapentadol hydrochloride	TABLET;ORAL	022304-002	Nov 20, 2008	6,071,970	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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