FDA Orange Book

Generic for Minivelle

Minivelle contains estradiol. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Minivelle is estradiol. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB2, AB3.

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Minivelle products in the Orange Book

Minivelle products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
film, extended release, transdermal	0.025MG/24HR	Marketed (Rx)	AB3	4	AB2, AB3
film, extended release, transdermal	0.0375MG/24HR	Marketed (Rx)	AB3	4	AB2, AB3
film, extended release, transdermal	0.05MG/24HR	Marketed (Rx)	AB3	4	AB2, AB3
film, extended release, transdermal	0.075MG/24HR	Marketed (Rx)	AB3	4	AB2, AB3
film, extended release, transdermal	0.1MG/24HR	Marketed (Rx)	AB3	4	AB2, AB3

NDA 203752, held by NOVEN PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic estradiol

Approved generic versions of Minivelle
Company	ANDA	TE code	Approved	Strengths
MYLAN TECHNOLOGIES INC	075182	AB2 (A-rated, therapeutically equivalent)	January 26, 2005	0.025MG/24HR, 0.0375MG/24HR, 0.05MG/24HR, 0.075MG/24HR, 0.1MG/24HR
MYLAN TECHNOLOGIES INC	206685	AB3 (A-rated, therapeutically equivalent)	August 15, 2018	0.025MG/24HR, 0.0375MG/24HR, 0.05MG/24HR, 0.075MG/24HR, 0.1MG/24HR
AMNEAL PHARMACEUTICALS LLC	211396	AB3 (A-rated, therapeutically equivalent)	September 28, 2020	0.025MG/24HR, 0.0375MG/24HR, 0.05MG/24HR, 0.075MG/24HR, 0.1MG/24HR
ZYDUS PHARMACEUTICALS USA INC	202985	AB2 (A-rated, therapeutically equivalent)	March 29, 2023	0.025MG/24HR, 0.0375MG/24HR, 0.05MG/24HR, 0.075MG/24HR, 0.1MG/24HR

Minivelle patents

Patents listed for Minivelle
Patent	Expires	Covers	Use code	NDA
9730900	July 10, 2028	Drug product	U-2086	203752
9833419	July 10, 2028	Drug product	None	203752
9724310	July 10, 2028	Drug substance, Drug product	None	203752
8231906	July 4, 2030	Drug substance, Drug product	None	203752

Minivelle NDC codes

Questions

Is there a generic for Minivelle?

Yes. The generic name for Minivelle is estradiol. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB2, AB3.

What is the generic name for Minivelle?

The active ingredient in Minivelle is estradiol, per the FDA Orange Book.

When does the Minivelle patent expire?

The last patent listed for Minivelle in the Orange Book expires July 4, 2030. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.