Viewing data from:

DEPO-SUBQ PROVERA 104

NDA

MEDROXYPROGESTERONE ACETATE | N021583 | 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

No FDA citizen petitions matched from Regulations.gov

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 | 1 NDC

Highest NADAC/Unit

$77.38

per ml

Lowest NADAC/Unit

$77.38

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00009470913DEPO-SUBQ PROVERA 104 SYRINGE	$77.38	ML	Brand	—	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 | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$39.40

Highest Price

$51.84

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00009-4709-13DEPO-SUBQ PROVERA 104MG/0.65ML INJ SYRINGE	$51.84	FSS	Pfizer Inc.	06/30/2029
00009-4709-13DEPO-SUBQ PROVERA 104MG/0.65ML INJ SYRINGE	$39.40	Big4	Pfizer Inc.	06/30/2029

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

Medicare Part D Spending

CMS annual spending data for Depo-Subq Provera 104 (2024)

Total Spending

$53K

Total Claims

927

Beneficiaries

344

Avg Cost/Unit

$83.05

Spending Trend

$55K(2019)→$103K(2020)→$36K(2021)→$28K(2022)→$32K(2023)→$53K(2024)

YoY Change:-4.7%

5yr CAGR:-31.0%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

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

19 letters from Drugs@FDA

Date	Submission	Document
Dec 15, 2025	SUPPL -45	View Letter (PDF)
Dec 18, 2024	SUPPL -43	View Letter (PDF)
Jul 15, 2024	SUPPL -40	View Letter (PDF)
Dec 8, 2020	SUPPL -33	View Letter (PDF)
Dec 8, 2020	SUPPL -34	View Letter (PDF)
Dec 26, 2019	SUPPL -16	View Letter (PDF)
Dec 26, 2019	SUPPL -29	View Letter (PDF)
Dec 26, 2019	SUPPL -24	View Letter (PDF)
Mar 2, 2018	SUPPL -17	View Letter (PDF)
Feb 1, 2017	SUPPL -23	View Letter (PDF)
Dec 22, 2016	SUPPL -31	View Letter (PDF)
Oct 19, 2016	SUPPL -32	View Letter (PDF)
Feb 2, 2015	SUPPL -25	View Letter (PDF)
Jan 26, 2015	SUPPL -26	View Letter (PDF)
Jul 17, 2009	SUPPL -11	View Letter (PDF)
Oct 10, 2007	SUPPL -6	View Letter (PDF)
Nov 18, 2005	SUPPL -3	View Letter (PDF)
May 4, 2005	SUPPL -1	View Letter (PDF)
Dec 30, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 104MG/0.65ML

RLD

0 patents0 exclusivities▴

INJECTABLE;SUBCUTANEOUS | Approved: Dec 17, 2004

No patent or exclusivity listings for this strength.