FDA Orange Book

Generic for Imvexxy

Imvexxy 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 Imvexxy is estradiol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Imvexxy products in the Orange Book

Imvexxy products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
insert, vaginal	0.004MG	Marketed (Rx)	AB	1	AB
insert, vaginal	0.01MG	Marketed (Rx)	AB	1	AB

NDA 208564, held by MAYNE PHARMA LLC. 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 Imvexxy
Company	ANDA	TE code	Approved	Strengths
TEVA PHARMACEUTICALS USA INC	214137	AB (A-rated, therapeutically equivalent)	December 8, 2025	0.004MG, 0.01MG

Imvexxy patents

Patents listed for Imvexxy
Patent	Expires	Covers	Use code	NDA
10258630	November 21, 2032	Method of use	U-2316	208564
10258630	November 21, 2032	Method of use	U-2317	208564
10398708	November 21, 2032	Method of use	U-2317	208564
10471072	November 21, 2032	Method of use	U-2317	208564
10471072	November 21, 2032	Method of use	U-2316	208564
10398708	November 21, 2032	Method of use	U-2614	208564
10537581	November 21, 2032	Drug product	U-2316	208564
10537581	November 21, 2032	Drug product	U-2317	208564
11246875	November 21, 2032	Method of use	U-2316	208564
11246875	November 21, 2032	Method of use	U-2317	208564
11241445	November 21, 2032	Method of use	U-2316	208564
11241445	November 21, 2032	Method of use	U-2317	208564
10668082	November 21, 2032	Method of use	U-2317	208564
10668082	November 21, 2032	Method of use	U-2316	208564
10568891	November 21, 2032	Method of use	U-2316	208564
10568891	November 21, 2032	Method of use	U-2317	208564
9180091	November 21, 2032	Drug product	U-2317	208564
10835487	November 21, 2032	Method of use	U-2316	208564
10835487	November 21, 2032	Method of use	U-2317	208564
9180091	November 21, 2032	Drug product	U-2316	208564
10888516	November 21, 2032	Method of use	U-2316	208564
10888516	November 21, 2032	Method of use	U-2317	208564
11351182	November 21, 2032	Method of use	U-2316	208564
11351182	November 21, 2032	Method of use	U-2317	208564
11065197	November 21, 2032	Drug product	None	208564
9289382	November 21, 2032	Drug product	None	208564
10806697	November 21, 2032	Drug product	None	208564
11123283	November 21, 2032	Drug product	None	208564
11304959	November 21, 2032	Drug product	None	208564
11116717	November 21, 2032	Drug product	None	208564
11497709	November 21, 2032	Method of use	U-2316	208564
11497709	November 21, 2032	Method of use	U-2317	208564
11266661	February 2, 2034	Method of use	U-2316	208564
11266661	February 2, 2034	Method of use	U-2317	208564

Questions

Is there a generic for Imvexxy?

Yes. The generic name for Imvexxy is estradiol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Imvexxy?

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

When does the Imvexxy patent expire?

The last patent listed for Imvexxy in the Orange Book expires February 2, 2034. 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.