Orange Book product · Brand (NDA)

PEMETREXED

PEMETREXED DISODIUM

Brand (NDA)NDA 215179RX SHILPA

May 22, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 22, 2023
3 yr 1 mo ago
Today
Patent 11147817 expires
Listed drug product patent expiration.
Mar 26, 2035
in 8 yr 11 mo

Active ingredient

PEMETREXED DISODIUM

Strength

EQ 1GM/100ML BASE (10MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 215179

Product number

003

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11147817	Mar 26, 2035	in 8 yr 11 mo	Product