Is there a generic for Ospemifene?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Ospemifene, referencing the brand OSPHENA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ospemifene?

OSPHENA (NDA 203505, DUCHESNAY) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Ospemifene?

The Orange Book lists 2 patents against Ospemifene products, with the earliest listed expiry in 2026. 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.

What dosage forms of Ospemifene are approved?

Ospemifene is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Ospemifene

Ospemifene: 1 brand, 1 generic; first approved Feb 26, 2013; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 1 ANDA application approved.

Earliest patent expiry Aug 11, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Aug 11, 2026

in 1 mo

Originator applications

Brand (NDA) products

OSPHENARLDRS

DUCHESNAYNDA 2035052013

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
60MG	TABLET	ORAL	Rx	—

Abbreviated applications

Generic (ANDA) products (1)

OSPEMIFENE

HETERO LABS LTD VANDA 2155742024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
60MG	TABLET	ORAL	Discontinued	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8236861	Aug 11, 2026	in 1 mo	U-905
8642079	Jul 09, 2028	in 2 yr	Product

FDA approval span

Approval history

First approval

Feb 26, 2013

13 yr 7 mo ago

Most recent approval

Feb 13, 2024

2 yr 5 mo ago

Approvals span 2013–2024 across 2 FDA applications.

Brand (NDA) 150%

Generic (ANDA) 150%

Ospemifene — 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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