Is there a generic for Dutasteride; tamsulosin hydrochloride?

Yes. The FDA Orange Book lists 4 approved generic (ANDA) applications for Dutasteride; tamsulosin hydrochloride, referencing the brand JALYN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Dutasteride; tamsulosin hydrochloride?

JALYN (NDA 022460, WAYLIS THERAP) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Dutasteride; tamsulosin hydrochloride are approved?

Dutasteride; tamsulosin hydrochloride is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Dutasteride; tamsulosin hydrochloride

Dutasteride; tamsulosin hydrochloride: 1 brand, 4 generics; first approved Jun 14, 2010; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 4 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

JALYNRLD

WAYLIS THERAPNDA 0224602010

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG;0.4MG	CAPSULE	ORAL	Rx	AB

Abbreviated applications

Generic (ANDA) products (4)

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

AUROBINDO PHARMAANDA 2133002024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG;0.4MG	CAPSULE	ORAL	Rx	AB

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDERS

ZYDUS PHARMSANDA 2077692018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG;0.4MG	CAPSULE	ORAL	Rx	AB

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

ACTAVIS LABS FL INCANDA 2029752015

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG;0.4MG	CAPSULE	ORAL	Discontinued	—

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

PH HEALTHANDA 2025092014

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG;0.4MG	CAPSULE	ORAL	Rx	AB

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

FDA approval span

Approval history

First approval

Jun 14, 2010

16 yr 4 mo ago

Most recent approval

Jul 18, 2024

2 yr ago

Approvals span 2010–2024 across 5 FDA applications.

Brand (NDA) 120%

Generic (ANDA) 480%

Dutasteride; tamsulosin 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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