FDA Orange Book

Generic for Vivelle-Dot

Vivelle-Dot 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 Vivelle-Dot is estradiol. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1.

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Vivelle-Dot products in the Orange Book

Vivelle-Dot products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
system, transdermal	0.025MG/24HR	Marketed (Rx)	AB1	3	AB1
system, transdermal	0.0375MG/24HR	Marketed (Rx)	AB1	3	AB1
system, transdermal	0.05MG/24HR	Marketed (Rx)	AB1	3	AB1
system, transdermal	0.075MG/24HR	Marketed (Rx)	AB1	3	AB1
system, transdermal	0.1MG/24HR	Marketed (Rx)	AB1	3	AB1

NDA 020538, held by SANDOZ 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 Vivelle-Dot
Company	ANDA	TE code	Approved	Strengths
MYLAN TECHNOLOGIES INC	201675	AB1 (A-rated, therapeutically equivalent)	December 19, 2014	0.025MG/24HR, 0.0375MG/24HR, 0.05MG/24HR, 0.075MG/24HR, 0.1MG/24HR
AMNEAL PHARMACEUTICALS LLC	211293	AB1 (A-rated, therapeutically equivalent)	February 4, 2019	0.025MG/24HR, 0.0375MG/24HR, 0.05MG/24HR, 0.075MG/24HR, 0.1MG/24HR
ZYDUS PHARMACEUTICALS USA INC	206241	AB1 (A-rated, therapeutically equivalent)	December 1, 2022	0.025MG/24HR, 0.0375MG/24HR, 0.05MG/24HR, 0.075MG/24HR, 0.1MG/24HR

Vivelle-Dot NDC codes

Questions

Is there a generic for Vivelle-Dot?

Yes. The generic name for Vivelle-Dot is estradiol. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1.

What is the generic name for Vivelle-Dot?

The active ingredient in Vivelle-Dot is estradiol, per the FDA Orange Book.

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.