Viewing data from:

HALOTESTIN

NDA

FLUOXYMESTERONE | N010611 | PHARMACIA AND UPJOHN CO

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

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

Trial	Phase	Status	Sponsor	Enrollment	Dates
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control NCT07095894	Phase 3	Recruiting	Jaeb Center for Health Research	348	2026-06-01 → 2029-06-01
Visual Performance of Highly Aspherical Lenslet Spectacles in Children (Ancillary to WS10246)NCT07668102	N/A	Completed	Essilor International	88	2024-05-22 → 2024-10-20

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

API Supply Chain1 active DMF2 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CURIA WISCONSIN INCFLUOXYMESTERONE ACTIVE DRUG SUBSTANCE

DMF 272502013

BLASCHIM SPAInactiveFLUOXYMESTERONE

DMF 34941979

PFIZER INCInactiveFLUOXYMESTERONE USP

DMF 46071982

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

Products (3)

Sort:

#002 — 2MG

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#006 — 5MG

0 patents0 exclusivities▾

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

#010 — 10MG

0 patents0 exclusivities▾

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