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DEPO-TESTOSTERONE

ANDA

TESTOSTERONE CYPIONATE | A085635 | PFIZER INC

3 strengths0 unique patents0 unique exclusivities

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from BPI Labs, LLC FDA-2025-P-2525 BPI Labs, LLC submitted this petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting a determination that an additional pack size of 2.5 mL (500 mg fill) for Testosterone Cypionate Injection, USP 200 mg/mL is suitable for ANDA submission, arguing the new intermedia	Suitability	2025-07-21	Open	BPI Labs

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

Medicare Part D Spending

CMS annual spending data for Depo-Testosterone (2023)

Total Spending

$988K

Total Claims

19,910

Beneficiaries

11,681

Avg Cost/Unit

$13.33

Spending Trend

$891K(2019)→$1.0M(2020)→$820K(2021)→$370K(2022)→$988K(2023)

YoY Change:-13.1%

5yr CAGR:-4.4%

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

Medicare Part B Spending

CMS physician-administered drug spending for Depo-Testosterone (2023)

Total Spending

$1.7M

Total Claims

337,396

Beneficiaries

35,115

ASP Price

—

HCPCS: J1071 — Injection, testosterone cypionate, 1 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain8 active DMFs3 inactive

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

ASPEN OSS BVTESTOSTERONE CYPIONATE

DMF 38571980

PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INCTESTOSTERONE CYPIONATE USP

DMF 42451981

TRIFARMA SPATESTOSTERONE CYPIONATE USP

DMF 210912007

SYMBIOTEC PHARMALAB PRIVATE LTDTESTOSTERONE CYPIONATE USP

DMF 290232015

CURIA SPAIN SAUTESTOSTERONE CYPIONATE

DMF 318602017

STEROID SPATESTOSTERONE CYPIONATE

DMF 329322018

FARMABIOS SPATESTOSTERONE CYPIONATE

DMF 423052025

HUBEI ZHUXI HUMANWELL PHARMACEUTICAL CO LTDTESTOSTERONE CYPIONATE

DMF 424972025

DIOSYNTH BVInactiveTESTOSTERONE CYPIONATE

DMF 29941977

ROUSSELL UCLAFInactiveTESTOSTERONE CYPIONATE

DMF 32201978

FIS FABBRICA ITALIANA SINTETICI SPAInactiveTESTOSTERONE CYPIONATE

DMF 334112018

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

Products (3)

Sort:

#001 — 50MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 100MG/ML

RLDAO

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#003 — 200MG/ML

RLDAO

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982