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AXTLE

NDA

PEMETREXED DIPOTASSIUM | N210661 | AVYXA HOLDINGS LLC

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
ELI LILLY AND COMPANY v. APOTEX, INC. 1:2017cv02865 1 patentANDA 203774pemetrexed	INSD	2017-08-21	Terminated 2019-12-30	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

4 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 100MG BASE/VIAL

RLD

0 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Jun 28, 2024

No patent or exclusivity listings for this strength.

#002 — EQ 500MG BASE/VIAL

RLD

0 patents0 exclusivities▾

POWDER;INTRAVENOUS | Approved: Jun 28, 2024