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FDA Orange Book · active-ingredient family

Pemetrexed

Pemetrexed is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:PEMETREXED · NDA 208419

2

Brand (NDA)

0

Generics (ANDA)

3

Listed patents

0

Exclusivity periods

Brand (NDA) products · solution

ProductApplicantApplicationTEApproved
PEMETREXEDRLD×3ACTAVISNDA 208419Aug 21, 2020
PEMFEXYRLDEAGLE PHARMSNDA 209472Feb 08, 2020

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9604990Oct 28, 2035in 9 yr 6 mo
Substance
12115164Feb 19, 2036in 9 yr 10 mo
U-4246
11793813Feb 19, 2036in 9 yr 10 mo
Product

Pemetrexed — frequently asked questions

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

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.