Is there a generic for Estradiol valerate; testosterone enanthate?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Estradiol valerate; testosterone enanthate. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What dosage forms of Estradiol valerate; testosterone enanthate are approved?

Estradiol valerate; testosterone enanthate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Estradiol valerate; testosterone enanthate

Estradiol valerate; testosterone enanthate: 0 brands, 3 generics; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 3 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Abbreviated applications

Generic (ANDA) products (3)

DITATE-DS

SAVAGE LABSANDA 086423—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8MG/ML;180MG/ML	INJECTABLE	INJECTION	Discontinued	—

TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE

WATSON LABSANDA 085865—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4MG/ML;90MG/ML	INJECTABLE	INJECTION	Discontinued	—

TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE

WATSON LABSANDA 085860—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8MG/ML;180MG/ML	INJECTABLE	INJECTION	Discontinued	—

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.

Estradiol valerate; testosterone enanthate — 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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