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NDA

TESTOSTERONE CYPIONATE | N216318 | AZURITY PHARMACEUTICALS INC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

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Today

11311554

Mar. 25, 2039

11642355

Mar. 25, 2039

12138271

Mar. 25, 2039

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

2 trials from ClinicalTrials.gov — 1 recruiting, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Anabolic Effect of Testosterone on Pelvic Floor Muscles NCT06111209	Phase 2	Active	Brigham and Women's Hospital	30	2025-02-15 → 2027-12-01
Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC NCT06100705	Phase 2	Recruiting	Yale University	26	2023-12-20 → 2028-03

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

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.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Jul 15, 2025	SUPPL -5	View Letter (PDF)
Dec 19, 2024	SUPPL -3	View Letter (PDF)
Feb 2, 2024	SUPPL -2	View Letter (PDF)
Jun 3, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG/ML (200MG/ML)

RLD

3 patents0 exclusivities▴

SOLUTION;INTRAMUSCULAR | Approved: Jun 2, 2022

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11311554	Mar 25, 2039	—	—	Yes	—	—
11642355	Mar 25, 2039	—	—	Yes	—	—
12138271	Mar 25, 2039	—	—	Yes	—	—