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LUTREPULSE KIT

NDA

GONADORELIN ACETATE | N019687 | FERRING PHARMACEUTICALS INC

2 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

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs3 inactive

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

ASPEN OSS BVGONADORELIN ACETATE

DMF 102201993

BACHEM AGGONADORELIN ACETATE

DMF 352962020

DIOSYNTH BVInactiveGONADORELIN ACETATE

DMF 53381983

FERRING GMBHInactiveGONADORELIN ACETATE

DMF 70041987

PEPTECH EUROPE ASInactiveGONADORELIN ACETATE

DMF 108781994

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

Products (2)

Sort:

#001 — 0.8MG/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Oct 10, 1989

No patent or exclusivity listings for this strength.

#002 — 3.2MG/VIAL

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 10, 1989