Question 1

Is there a generic for Estrogens, conjugated?

Accepted Answer

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Estrogens, conjugated, referencing the brand PREMARIN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Estrogens, conjugated?

Accepted Answer

PREMARIN (NDA 020216, WYETH PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

Does Estrogens, conjugated have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 5 marketing-exclusivity periods for Estrogens, conjugated. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 4

What dosage forms of Estrogens, conjugated are approved?

Accepted Answer

Estrogens, conjugated is approved in the following dosage forms: cream, injectable, tablet.

Product	Applicant	Application	TE	Approved
PREMARINRLD	WYETH PHARMS	NDA 020216	—	Approved Prior to Jan 1, 1982
PREMARINRLD	WYETH PHARMS	NDA 010402	—	Approved Prior to Jan 1, 1982
PREMARINRLD×6	WYETH PHARMS	NDA 004782	AB	Approved Prior to Jan 1, 1982

Product	Applicant	Application	TE	Approved
CONJUGATED ESTROGENS×3	NOVAST LABS	ANDA 214025	AB	Oct 15, 2025
CONJUGATED ESTROGENS×2	NOVAST LABS	ANDA 214023	AB	Oct 15, 2025

Estrogens, conjugated

Brand (NDA) products · cream, injectable, tablet

Generic (ANDA) products (2)

Marketing exclusivity (5)

Listed patents

Estrogens, conjugated — frequently asked questions

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