Viewing data from:

PURIFIED CORTROPHIN GEL

NDA

CORTICOTROPIN | N008975 | ANI PHARMACEUTICALS INC

2 strengths5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Active (5)Today

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Today

Oct. 27, 2043

Oct. 27, 2043

Oct. 27, 2043

Oct. 27, 2043

Oct. 27, 2043

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

API Supply Chain0 active DMFs7 inactive

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

ORTHANA KEMISK FABRIK A SInactiveCORTICOTROPIN - GEL

DMF 2781957

FREDERIKSBERG CHEMICAL LABORATORIES LTDInactiveCORTICOTROPIN (ACTH)

DMF 17801971

MERCK SHARP AND DOHME BVInactiveCORTICOTROPIN

DMF 41811981

SALK INSTITUTEInactiveCORTICOTROPIN RELEASING FACTOR (CRF)

DMF 43841981

PENINSULA LABS INCInactiveCORTICOTROPIN RELEASING FACTOR (HUMAN RAT CRF)

DMF 58321985

BACHEM FINE CHEMICALS INCInactiveCORTICOTROPIN RELEASING FACTORS (CRF), (HUMAN, RAT)

DMF 62401986

PENINSULA LABS INCInactiveCORTICOTROPIN RELEASING FACTOR

DMF 73781988

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Mar 4, 2025	SUPPL -16	View Letter (PDF)
Dec 16, 2024	SUPPL -15	View Letter (PDF)
Oct 27, 2023	SUPPL -12	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 40 UNITS/ML

1 patent0 exclusivities▴

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

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
12102662	Oct 27, 2043	—	—	—		—

#002 — 80 UNITS/ML

RLD

5 patents0 exclusivities▾

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