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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Depo-Subq Provera 104 (2023)

Total Spending

$32K

Total Claims

505

Beneficiaries

196

Avg Cost/Unit

$87.12

Spending Trend

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

YoY Change:+0.3%

5yr CAGR:-30.2%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain9 active DMFs7 inactive

9 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

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

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.