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ZOLADEX

NDA

GOSERELIN ACETATE | N020578 | TERSERA THERAPEUTICS LLC

1 strength0 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 Chain5 active DMFs1 inactive

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

ALP PHARM BEIJING CO LTDGOSERELIN ACETATE

DMF 297132015

ASTRAZENECA PHARMACEUTICALS LPGOSERELIN ACETATE

DMF 314882017

ASTRAZENECA PHARMACEUTICALS LPGOSERELIN ACETATE IMPLANT

DMF 314892017

BACHEM AGGOSERELIN ACETATE

DMF 343632019

BACHEM AGGOSERELIN ACETATE

DMF 356892024

CHEMI SPAInactiveGOSERELIN ACETATE

DMF 177682004

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

Approval Letters

16 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 10.8MG BASE

RLD

0 patents0 exclusivities▴

IMPLANT;IMPLANTATION | Approved: Jan 11, 1996

No patent or exclusivity listings for this strength.