Is there a generic for Pemetrexed?

The FDA Orange Book does not currently list an approved generic (ANDA) for Pemetrexed. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Pemetrexed?

PEMETREXED (NDA 208419, ACTAVIS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Pemetrexed?

The Orange Book lists 3 patents against Pemetrexed 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 are approved?

Pemetrexed is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Pemetrexed

Pemetrexed: 2 brands, 0 generics; first approved Feb 08, 2020; on patent until Oct 28, 2035.

On patent

Generic status & protection

Protected until Oct 28, 2035 (earliest listed patent expiry).

Earliest patent expiry Oct 28, 2035

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Oct 28, 2035

in 9 yr 5 mo

Originator applications

Brand (NDA) products

PEMETREXEDRLDRS

ACTAVISNDA 20841920203 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/4ML (25MG/ML)	SOLUTION	INTRAVENOUS	Rx	—
500MG/20ML (25MG/ML)	SOLUTION	INTRAVENOUS	Rx	—
1GM/40ML (25MG/ML)	SOLUTION	INTRAVENOUS	Rx	—

PEMFEXYRLDRS

EAGLE PHARMSNDA 2094722020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG/20ML (25MG/ML)	SOLUTION	INTRAVENOUS	Rx	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9604990	Oct 28, 2035	in 9 yr 5 mo	Substance
12115164	Feb 19, 2036	in 9 yr 9 mo	U-4246
11793813	Feb 19, 2036	in 9 yr 9 mo	Product

FDA approval span

Approval history

First approval

Feb 08, 2020

6 yr 6 mo ago

Most recent approval

Aug 21, 2020

6 yr ago

All 2 applications were approved in 2020.

Brand (NDA) 2100%

Generic (ANDA) 00%

Pemetrexed — frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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