Question 1

Is there a generic for Progesterone?

Accepted Answer

Yes. The FDA Orange Book lists 15 approved generic (ANDA) applications for Progesterone, referencing the brand MILPROSA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Progesterone?

Accepted Answer

MILPROSA (NDA 201110, FERRING PHARMS INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Progesterone?

Accepted Answer

The Orange Book lists 3 patents against Progesterone products, with the earliest listed expiry in 2029. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Progesterone have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Progesterone. 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 5

What dosage forms of Progesterone are approved?

Accepted Answer

Progesterone is approved in the following dosage forms: capsule, gel, injectable, insert, insert, extended release, system.

Product	Applicant	Application	TE	Approved
MILPROSARLD	FERRING PHARMS INC	NDA 201110	—	Apr 29, 2020
ENDOMETRINRLD	FERRING	NDA 022057	AB	Jun 21, 2007
PROMETRIUMRLD×3	ACERTIS PHARMS	NDA 019781	AB	May 14, 1998
CRINONERLD×2	ABBVIE	NDA 020701	—	Jul 31, 1997
PROGESTERONERLD	ACTAVIS LABS UT INC	NDA 017362	—	Approved Prior to Jan 1, 1982
PROGESTERONE×2	LILLY	NDA 009238	—	Approved Prior to Jan 1, 1982
PROGESTASERT	ALZA	NDA 017553	—	Approved Prior to Jan 1, 1982

Product	Applicant	Application	TE	Approved
PROGESTERONE	GLENMARK PHARMS	ANDA 216363	AB	Apr 08, 2026
PROGESTERONE	XIROMED	ANDA 218391	AB	Sep 19, 2025
PROGESTERONE	ACCORD HLTHCARE	ANDA 217707	—	Nov 21, 2023
PROGESTERONE	XIROMED	ANDA 215634	AO	Jan 05, 2022
PROGESTERONE	EUGIA PHARMA	ANDA 210965	AO	Dec 06, 2018
PROGESTERONE×2	EUGIA PHARMA	ANDA 211285	AB	Oct 26, 2018
PROGESTERONE×2	XIROMED	ANDA 205229	AB	Oct 20, 2017
PROGESTERONE×2	AMNEAL PHARMS NY	ANDA 207724	AB	Sep 07, 2017
PROGESTERONE×2	DR REDDYS	ANDA 208801	AB	Feb 28, 2017
PROGESTERONE×2	BIONPHARMA	ANDA 200900	AB	Aug 16, 2013
PROGESTERONE×2	SOFGEN PHARMS	ANDA 200456	AB	Sep 28, 2012
PROGESTERONE×2	TEVA PHARMS	ANDA 202121	—	Feb 29, 2012
PROGESTERONE	HIKMA FARMACEUTICA	ANDA 091033	AO	Oct 28, 2010
PROGESTERONE	AM REGENT	ANDA 090845	—	Jun 22, 2009
PROGESTERONE	FRESENIUS KABI USA	ANDA 075906	AO	Apr 25, 2001

Patent	Expires	In	Type
10548904	Feb 03, 2029	in 2 yr 8 mo	U-2810
10537584	Feb 03, 2029	in 2 yr 8 mo	Product
8580293	Jan 21, 2030	in 3 yr 8 mo	U-2810

Progesterone

Brand (NDA) products · capsule, gel, injectable, insert, insert, extended release, system

Generic (ANDA) products (15)

Marketing exclusivity (1)

Listed patents (3)

Progesterone — frequently asked questions

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