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Last Updated: April 25, 2024

Medroxyprogesterone acetate - Generic Drug Details

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What are the generic sources for medroxyprogesterone acetate and what is the scope of freedom to operate?

Medroxyprogesterone acetate is the generic ingredient in seven branded drugs marketed by Pfizer, Amneal, Amphastar Pharms Inc, Cipla, Eugia Pharma, Hikma, Hong Kong, Mylan Labs Ltd, Sandoz, Sun Pharm, Teva Pharms Usa, Amarin Pharms, Solvay, Esi , Barr, Duramed Pharms Barr, and Upsher Smith Labs, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for medroxyprogesterone acetate. Twenty-two suppliers are listed for this compound.

Summary for medroxyprogesterone acetate

US Patents:	0
Tradenames:	7
Applicants:	17
NDAs:	25
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	121
Patent Applications:	7,178
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for medroxyprogesterone acetate
What excipients (inactive ingredients) are in medroxyprogesterone acetate?	medroxyprogesterone acetate excipients list
DailyMed Link:	medroxyprogesterone acetate at DailyMed

See drug prices for medroxyprogesterone acetate

Recent Clinical Trials for medroxyprogesterone acetate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Bezmialem Vakif University	N/A
Oregon Health and Science University	Early Phase 1
Peking University People's Hospital	Phase 2

See all medroxyprogesterone acetate clinical trials

Pharmacology for medroxyprogesterone acetate

Drug Class	Progestin

Medical Subject Heading (MeSH) Categories for medroxyprogesterone acetate

Antineoplastic Agents, Hormonal
Contraceptive Agents, Female
Contraceptive Agents, Male
Contraceptives, Oral, Synthetic

US Patents and Regulatory Information for medroxyprogesterone acetate

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Esi	CYCRIN	medroxyprogesterone acetate	TABLET;ORAL	089386-001	Sep 9, 1987		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Amarin Pharms	AMEN	medroxyprogesterone acetate	TABLET;ORAL	083242-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sandoz	MEDROXYPROGESTERONE ACETATE	medroxyprogesterone acetate	INJECTABLE;INJECTION	078711-001	May 20, 2009		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Amphastar Pharms Inc	MEDROXYPROGESTERONE ACETATE	medroxyprogesterone acetate	INJECTABLE;INJECTION	077235-001	Nov 28, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for medroxyprogesterone acetate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	DEPO-SUBQ PROVERA 104	medroxyprogesterone acetate	INJECTABLE;SUBCUTANEOUS	021583-001	Dec 17, 2004	⤷ Try a Trial	⤷ Try a Trial
Pfizer	DEPO-PROVERA	medroxyprogesterone acetate	INJECTABLE;INJECTION	012541-002	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Pfizer	DEPO-PROVERA	medroxyprogesterone acetate	INJECTABLE;INJECTION	012541-003	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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