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EXENATIDE SYNTHETIC

ANDA

EXENATIDE SYNTHETIC | A206697 | AMNEAL EU LTD

2 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
AstraZeneca Pharmaceuticals LP et al v. Amneal Pharmaceuticals LLC et al 1:2015cv01139 2 patentsANDA 206697exenatide	D. Del.	2015-12-09	Terminated 2017-09-21	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain6 active DMFs1 inactive

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

BACHEM AMERICAS INCEXENATIDE (BULK)

DMF 172272004

TAPI NL BVEXENATIDE

DMF 271232013

SUN PHARMACEUTICAL INDUSTRIES LTDEXENATIDE

DMF 298632015

POLYPEPTIDE LABORATORIES SWEDEN ABEXENATIDE USP

DMF 309242016

MSN LIFE SCIENCES PRIVATE LTDEXENATIDE USP

DMF 345662020

ALP PHARM BEIJING CO LTDEXENATIDE

DMF 354762020

SPECGX LLCInactiveEXENATIDE

DMF 171142004

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

Products (2)

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#001 — 300MCG/1.2ML (250MCG/ML)

0 patents0 exclusivities▴

INJECTABLE;SUBCUTANEOUS | Approved: Nov 19, 2024

No patent or exclusivity listings for this strength.

#002 — 600MCG/2.4ML (250MCG/ML)

0 patents0 exclusivities▾

INJECTABLE;SUBCUTANEOUS | Approved: Nov 19, 2024