Question 1

Is there a generic for Tapentadol hydrochloride?

Accepted Answer

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Tapentadol hydrochloride, referencing the brand NUCYNTA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Tapentadol hydrochloride?

Accepted Answer

NUCYNTA (NDA 203794, COLLEGIUM PHARM INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Tapentadol hydrochloride?

Accepted Answer

The Orange Book lists 4 patents against Tapentadol hydrochloride products, with the earliest listed expiry in 2028. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Tapentadol hydrochloride have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 8 marketing-exclusivity periods for Tapentadol hydrochloride. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Tapentadol hydrochloride are approved?

Accepted Answer

Tapentadol hydrochloride is approved in the following dosage forms: solution, tablet, tablet, extended release.

Product	Applicant	Application	TE	Approved
NUCYNTARLD	COLLEGIUM PHARM INC	NDA 203794	—	Oct 15, 2012
NUCYNTA ERRLD×5	COLLEGIUM PHARM INC	NDA 200533	—	Aug 25, 2011
NUCYNTARLD×3	COLLEGIUM PHARM INC	NDA 022304	AB	Nov 20, 2008

Product	Applicant	Application	TE	Approved
TAPENTADOL HYDROCHLORIDE×3	HIKMA	ANDA 205057	—	Feb 10, 2026
TAPENTADOL HYDROCHLORIDE×3	EPIC PHARMA LLC	ANDA 214378	AB	Jan 27, 2026
TAPENTADOL HYDROCHLORIDE	NOVITIUM PHARMA	ANDA 219119	—	Jan 26, 2026

Patent	Expires	In	Type
11344512	Apr 21, 2028	in 1 yr 10 mo	U-3391
8536130	Sep 22, 2028	in 2 yr 4 mo	U-1276
11344512*PED	Oct 21, 2028	in 2 yr 5 mo
8536130*PED	Mar 22, 2029	in 2 yr 10 mo

Tapentadol hydrochloride

Brand (NDA) products · solution, tablet, tablet, extended release

Generic (ANDA) products (3)

Marketing exclusivity (8)

Listed patents (4)

Tapentadol hydrochloride — frequently asked questions

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