Is there a generic for Tapentadol hydrochloride?

Yes. The FDA Orange Book lists 4 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.

What is the reference-listed drug for Tapentadol hydrochloride?

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.

What patents protect Tapentadol hydrochloride?

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.

Does Tapentadol hydrochloride have FDA marketing exclusivity?

Yes. The Orange Book records 2 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.

What dosage forms of Tapentadol hydrochloride are approved?

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

FDA Orange Book · active-ingredient family

Tapentadol hydrochloride

Tapentadol hydrochloride: 3 brands, 4 generics; first approved Nov 20, 2008; generic available.

Generic available2 exclusivity periodsHas discontinued products

Generic status & protection

Generic available: 4 ANDA applications approved.

Earliest patent expiry Apr 21, 2028Latest exclusivity ends Jan 03, 2027

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Apr 21, 2028

in 1 yr 6 mo

Brand (NDA) products

Originator applications

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NUCYNTARLD
COLLEGIUM PHARM INCNDA 2037942012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 20MG BASE/ML SOLUTION ORAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 20MG BASE/ML	SOLUTION	ORAL	Discontinued	-

NUCYNTA ERRLD

COLLEGIUM PHARM INCNDA 20053320115 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	-
EQ 100MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	-
EQ 150MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	-
EQ 200MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	-
EQ 250MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	-

NUCYNTARLD
COLLEGIUM PHARM INCNDA 02230420083 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE TABLET ORAL Rx AB
EQ 75MG BASE TABLET ORAL Rx AB
EQ 100MG BASE TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE	TABLET	ORAL	Rx	AB
EQ 75MG BASE	TABLET	ORAL	Rx	AB
EQ 100MG BASE	TABLET	ORAL	Rx	AB

Generic (ANDA) products (4)

Abbreviated applications

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TAPENTADOL HYDROCHLORIDE
MSNANDA 22086520263 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE TABLET ORAL Rx AB
EQ 75MG BASE TABLET ORAL Rx AB
EQ 100MG BASE TABLET ORAL Rx AB
TAPENTADOL HYDROCHLORIDE
HIKMAANDA 20505720263 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE TABLET ORAL Discontinued -
EQ 75MG BASE TABLET ORAL Discontinued -
EQ 100MG BASE TABLET ORAL Discontinued -
TAPENTADOL HYDROCHLORIDE
EPIC PHARMA LLCANDA 21437820263 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE TABLET ORAL Rx AB
EQ 75MG BASE TABLET ORAL Rx AB
EQ 100MG BASE TABLET ORAL Rx AB
TAPENTADOL HYDROCHLORIDE
NOVITIUM PHARMAANDA 2191192026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 20MG BASE/ML SOLUTION ORAL Rx -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE	TABLET	ORAL	Rx	AB
EQ 75MG BASE	TABLET	ORAL	Rx	AB
EQ 100MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE	TABLET	ORAL	Discontinued	-
EQ 75MG BASE	TABLET	ORAL	Discontinued	-
EQ 100MG BASE	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE	TABLET	ORAL	Rx	AB
EQ 75MG BASE	TABLET	ORAL	Rx	AB
EQ 100MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 20MG BASE/ML	SOLUTION	ORAL	Rx	-

Patent & exclusivity timeline

Protection horizon

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Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

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NPPNew patient population exclusivity (3 years)
Jul 03, 2026
4 mo ago
PEDPediatric exclusivity (adds 6 months)
Jan 03, 2027
in 2 mo

Listed patents

Orange Book patent file

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Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11344512	Apr 21, 2028	in 1 yr 6 mo	U-3391
8536130	Sep 22, 2028	in 1 yr 11 mo	U-1276
11344512*PED	Oct 21, 2028	in 2 yr
8536130*PED	Mar 22, 2029	in 2 yr 5 mo

Approval history

FDA approval span

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First approval

Nov 20, 2008

18 yr 2 mo ago

Most recent approval

Sep 03, 2026

2 mo ago

Approvals span 2008–2026 across 7 FDA applications.

Brand (NDA) 343%

Generic (ANDA) 457%

Tapentadol hydrochloride: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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Key facts