Is there a generic for Pemetrexed disodium?

Yes. The FDA Orange Book lists 20 approved generic (ANDA) applications for Pemetrexed disodium, referencing the brand PEMETREXED. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Pemetrexed disodium?

PEMETREXED (NDA 215179, SHILPA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Pemetrexed disodium?

The Orange Book lists 1 patent against Pemetrexed disodium products, with the earliest listed expiry in 2035. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Pemetrexed disodium are approved?

Pemetrexed disodium is approved in the following dosage forms: powder, solution.

FDA Orange Book · active-ingredient family

Pemetrexed disodium

Pemetrexed disodium is approved as 5 brand and 20 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PEMETREXED · NDA 215179

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · powder, solution

Product	Applicant	Application	TE	Approved
PEMETREXEDRLD×3	SHILPA	NDA 215179	—	May 22, 2023
PEMETREXED DISODIUMRLD×4	ACCORD HLTHCARE	NDA 214408	—	Jul 19, 2022
PEMETREXED DISODIUMRLD×3	HOSPIRA	NDA 214218	—	Jun 22, 2022
PEMETREXED DISODIUMRLD×3	SANDOZ	NDA 214657	—	May 26, 2022
ALIMTARLD×2	LILLY	NDA 021462	AP	Sep 07, 2007

Generic (ANDA) products (20)

Product	Applicant	Application	TE	Approved
PEMETREXED DISODIUM×2	HETERO LABS LTD VI	ANDA 215460	AP	Jun 14, 2024
PEMETREXED DISODIUM	PRINSTON INC	ANDA 216582	AP	Dec 11, 2023
PEMETREXED DISODIUM×2	AMNEAL	ANDA 210047	—	May 08, 2023
PEMETREXED DISODIUM	PHARMOBEDIENT	ANDA 203628	—	Mar 10, 2023
PEMETREXED DISODIUM×4	MEITHEAL	ANDA 215479	AP	Dec 13, 2022
PEMETREXED DISODIUM×2	BAXTER HLTHCARE CORP	ANDA 214436	—	Aug 18, 2022
PEMETREXED DISODIUM×3	ACCORD HLTHCARE	ANDA 203485	AP	May 25, 2022
PEMETREXED DISODIUM	APOTEX	ANDA 209085	AP	May 25, 2022
PEMETREXED DISODIUM×2	APOTEX	ANDA 203774	AP	May 25, 2022
PEMETREXED DISODIUM	APOTEX	ANDA 209851	AP	May 25, 2022
PEMETREXED DISODIUM	BIOCON PHARMA	ANDA 211090	—	May 25, 2022
PEMETREXED DISODIUM×3	DR REDDYS	ANDA 202596	AP	May 25, 2022
PEMETREXED DISODIUM×3	EUGIA PHARMA	ANDA 214632	AP	May 25, 2022
PEMETREXED DISODIUM×4	FRESENIUS KABI USA	ANDA 090384	AP	May 25, 2022
PEMETREXED DISODIUM×3	HOSPIRA	ANDA 202111	—	May 25, 2022
PEMETREXED DISODIUM×2	JIANGSU HANSOH PHARM	ANDA 208696	AP	May 25, 2022
PEMETREXED DISODIUM×2	NANG KUANG PHARM CO	ANDA 207352	AP	May 25, 2022
PEMETREXED DISODIUM×2	QILU PHARM HAINAN	ANDA 204890	AP	May 25, 2022
PEMETREXED DISODIUM×2	RELIANCE LIFE	ANDA 211899	AP	May 25, 2022
PEMETREXED DISODIUM×3	ZYDUS PHARMS	ANDA 214073	AP	May 25, 2022

Listed patents (1)

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

Pemetrexed disodium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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