Viewing data from:

PROVERA

NDA

MEDROXYPROGESTERONE ACETATE | N011839 | PFIZER INC

3 strengths0 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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-0750 The law firm Hyman, Phelps & McNamara P.C., on behalf of a client, submitted a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that FDA declare Medroxyprogesterone Acetate Tablets in 1.25 mg and 7.5 mg strengths suitable for submission in an ANDA	Suitability	2026-01-26	Open	Hyman

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Provera (2023)

Total Spending

$34K

Total Claims

159

Beneficiaries

Avg Cost/Unit

$3.87

Spending Trend

$82K(2019)→$54K(2020)→$51K(2021)→$43K(2022)→$34K(2023)

YoY Change:-3.4%

5yr CAGR:+6.3%

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

6 letters from Drugs@FDA

Date	Submission	Document
Feb 16, 2024	SUPPL -83	View Letter (PDF)
Oct 30, 2023	SUPPL -78	View Letter (PDF)
May 11, 2015	SUPPL -80	View Letter (PDF)
May 11, 2015	SUPPL -79	View Letter (PDF)
Oct 4, 2007	SUPPL -71	View Letter (PDF)
Aug 4, 1998	SUPPL -68	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 2.5MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#003 — 5MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#004 — 10MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982