Viewing data from:

DEPO-PROVERA

NDA

MEDROXYPROGESTERONE ACETATE | N020246 | PFIZER INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

3 petitions (3 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Contraceptive Study Group FDA-2026-P-2641 · 38 docket documents The Contraceptive Study Group, led by Joel Brind and others, filed this citizen petition requesting that the FDA remove the injectable contraceptive Depot Medroxyprogesterone Acetate (DMPA or Depo-Provera) from the market based on evidence that it uniquely facilitates HIV transmission from men to wo	Other	2026-03-13	Open	Contraceptive Study Group
Citizen Petition from Contraceptive Study Group FDA-2026-P-2301 · 93 docket documents The Contraceptive Study Group filed this citizen petition requesting that the FDA remove Depot Medroxyprogesterone Acetate (DMPA/Depo Provera) from the market based on its pronounced effects on bone mineral density, or alternatively modify its black box warning to include specific language about bon	Other	2026-03-06	Open	Contraceptive Study Group
Citizen Petition from Heidi Jones FDA-2015-P-1900 · 3 docket documents Heidi Jones and colleagues filed this petition on May 27, 2015, pursuant to 21 U.S.C. § 352 and 21 C.F.R. §§ 10.30 and 201.56, requesting that the FDA require the addition of a warning to the prescribing information for depot-medroxyprogesterone acetate (Depo-Provera) stating that it may increase th	Other	2015-05-29	Open	Heidi Jones

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

82 trials from ClinicalTrials.gov — 1 recruiting, 69 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC NCT03463252	Phase 2/3	Recruiting	West China Second University Hospital	224	2018-04-01 → 2030-12-30
Postmenopausal Estrogen/Progestin Interventions (PEPI)NCT00000466	Phase 3	Completed	National Heart, Lung, and Blood Institute (NHLBI)	—	1987-09 → 2000-10
Study of Self or Clinic Administration of DepoProvera NCT01019369	N/A	Completed	Carolyn L. Westhoff	132	2010-03 → 2012-11
Efficacy of Injectable Contraceptive and Oral Contraceptive Administered After Surgical Treatment of Endometriosis With Pain NCT01056042	Phase 4	Completed	Prince of Songkla University	112	2007-06 → 2011-10
Hormonal Birth Control and the Risk of Acquiring HIV NCT00006324	N/A	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	6,360	1999-12 → 2002-12
Hormone Therapy in Preventing Endometrial Cancer in Patients With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer NCT00033358	Phase 2	Completed	National Cancer Institute (NCI)	52	2002-02
HSG and Tubal Patency Study NCT02146248	N/A	Completed	Jeffrey Jensen	11	2014-05 → 2015-04
Everolimus and Letrozole or Hormonal Therapy to Treat Endometrial Cancer NCT02228681	Phase 2	Completed	GOG Foundation	74	2015-05-21 → 2024-08-22
PK Study of Rifampicin Interactions With DMPA and Efavirenz in TB NCT02412436	Phase 2	Completed	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	62	2015-11-03 → 2017-06-15
Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use With Certain Anti-HIV Drugs in HIV-Infected Women NCT00016601	N/A	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	76	2001-06 → 2004-05

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 5 NDCs (2 brand, 3 generic)

Highest NADAC/Unit

$52.45

per ml

Lowest NADAC/Unit

$18.76

per ml

Brand NDCs

Generic NDCs

Avg Brand: $51.72

Avg Generic: $22.30

57% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00009737611DEPO-PROVERA 150 MG/ML SYRINGE	$52.45	ML	Brand	$26.90	2026-06-17
00009074630DEPO-PROVERA 150 MG/ML VIAL	$50.99	ML	Brand	$18.76	2026-04-22
66993037179MEDROXYPROGESTERONE 150 MG/ML	$26.90	ML	Generic	—	2026-06-17
66993037025MEDROXYPROGESTERONE 150 MG/ML	$21.24	ML	Generic	—	2026-06-17
66993037083MEDROXYPROGESTERONE 150 MG/ML	$18.76	ML	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 12 NDCs (6 FSS, 6 Big4)

Lowest Price

$12.20

Highest Price

$1315.74

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
66993-0370-83MEDROXYPROGESTERONE ACETATE 150MG/ML INJ,SUSP	$39.30	FSS	Prasco, LLC	06/30/2026
66993-0370-83MEDROXYPROGESTERONE ACETATE 150MG/ML INJ,SUSP	$22.96	Big4	Prasco, LLC	06/30/2026
00009-0746-30DEPO-PROVERA CONTRACEPTIVE INJ	$52.62	FSS	Pfizer Inc.	06/30/2029
00009-0746-30DEPO-PROVERA CONTRACEPTIVE INJ	$39.39	Big4	Pfizer Inc.	06/30/2029
00009-0746-35DEPO-PROVERA STERILE AQUEOUS SUSPENSION	$1315.74	FSS	Pfizer Inc.	06/30/2029
00009-0746-35DEPO-PROVERA STERILE AQUEOUS SUSPENSION	$984.89	Big4	Pfizer Inc.	06/30/2029

Showing 6 of 12 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain10 active DMFs8 inactive

10 active API suppliers hold Drug Master Files for this ingredient.

PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INCMEDROXYPROGESTERONE ACETATE USP KALAMAZOO

DMF 49751983

BAYER AGMEDROXYPROGESTERONE ACETATE

DMF 53891984

FARMABIOS SPAMEDROXYPROGESTERONE ACETATE

DMF 126951997

TAPI NL BVMEDROXYPROGESTERONE ACETATE

DMF 127031997

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDMEDROXYPROGESTERONE ACETATE USP, NON-STERILE BULK DRUG SUBSTANCE

DMF 194332006

TAIZHOU TAIFA PHARMACEUTICALS CO LTDMEDROXYPROGESTERONE ACETATE

DMF 275462014

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTDMEDROXYPROGESTERONE ACETATE

DMF 279952014

CURIA SPAIN SAUMEDROXYPROGESTERONE ACETATE STERILE MICRONIZED

DMF 288002014

AMPHASTAR NANJING PHARMACEUTICALS INCMEDROXYPROGESTERONE ACETATE, USP

DMF 322822018

ZHEJIANG XIANJU YANGGUANG BIOPRODUCTS CO LTDMEDROXYPROGESTERONE ACETATE

DMF 349772020

ANTIBIOTICOS SPAInactiveMEDROXYPROGESTERONE ACETATE

DMF 27241976

NV ORGANONInactiveMEDROXYPROGESTERONE ACETATE MICRO

DMF 37471980

FARMABOISInactiveMEDROXYPROGESTERONE ACETATE USPXX

DMF 48091982

FINE CHEMICALS CORPInactiveMEDROXYPROGESTERONE ACETATE

DMF 54861984

SYNTEX USA INCInactiveMEDROXYPROGESTERONE ACETATE,BULK

DMF 60071985

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveMEDROXYPROGESTERONE ACETATE

DMF 64881986

STERLING SRLInactiveMEDROXYPROGESTERONE ACETATE

DMF 152232001

YANCHENG XINYI PHARM AND CHEM CO LTDInactiveMEDROXYPROGESTERONE ACETATE (NON-STERILE BULK FORM)

DMF 215632008

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Dec 15, 2025	SUPPL -74	View Letter (PDF)
Jul 15, 2024	SUPPL -68	View Letter (PDF)
Dec 8, 2020	SUPPL -62	View Letter (PDF)
Dec 8, 2020	SUPPL -60	View Letter (PDF)
Sep 10, 2020	SUPPL -43	View Letter (PDF)
Sep 10, 2020	SUPPL -57	View Letter (PDF)
Mar 20, 2017	SUPPL -63	View Letter (PDF)
Dec 21, 2016	SUPPL -58	View Letter (PDF)
Feb 2, 2015	SUPPL -53	View Letter (PDF)
Jan 26, 2015	SUPPL -54	View Letter (PDF)
Aug 1, 2011	SUPPL -35	View Letter (PDF)
Oct 19, 2010	SUPPL -36	View Letter (PDF)
Nov 1, 2005	SUPPL -13	View Letter (PDF)
Dec 2, 2004	SUPPL -25	View Letter (PDF)
Jun 8, 2003	SUPPL -19	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 150MG/ML

RLDAB

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Oct 29, 1992

No patent or exclusivity listings for this strength.