Question 1

Is there a generic for Lenalidomide?

Accepted Answer

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

Question 2

What is the reference-listed drug for Lenalidomide?

Accepted Answer

REVLIMID (NDA 021880, BRISTOL MYERS SQUIBB) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Lenalidomide?

Accepted Answer

The Orange Book lists 2 patents against Lenalidomide products, with the earliest listed expiry in 2027. 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.

Question 4

Does Lenalidomide have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 12 marketing-exclusivity periods for Lenalidomide. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Lenalidomide are approved?

Accepted Answer

Lenalidomide is approved in the following dosage form: capsule.

Product	Applicant	Application	TE	Approved
LENALIDOMIDE×6	TORRENT	ANDA 213405	—	Feb 10, 2026
LENALIDOMIDE×5	CIPLA	ANDA 213165	AB	Feb 02, 2026
LENALIDOMIDE×6	ACCORD HLTHCARE	ANDA 218872	AB	Nov 14, 2025
LENALIDOMIDE×6	LUPIN	ANDA 214398	AB	Sep 16, 2025
LENALIDOMIDE×6	DEVA HOLDING AS	ANDA 217554	AB	May 22, 2025
LENALIDOMIDE×6	BIOCON PHARMA	ANDA 215759	AB	Mar 03, 2025
LENALIDOMIDE×6	AMNEAL	ANDA 216213	AB	Jan 31, 2025
LENALIDOMIDE×6	NOVUGEN	ANDA 217281	AB	Sep 11, 2024
LENALIDOMIDE×6	QILU	ANDA 217265	AB	Feb 22, 2024
LENALIDOMIDE×6	HETERO LABS LTD V	ANDA 212414	AB	May 11, 2023
LENALIDOMIDE×6	APOTEX	ANDA 211022	AB	Mar 07, 2023
LENALIDOMIDE×6	ALVOGEN	ANDA 210480	AB	Mar 06, 2023
LENALIDOMIDE×6	ARROW INTL	ANDA 201452	AB	Mar 06, 2023
LENALIDOMIDE	CIPLA	ANDA 214618	AB	Mar 06, 2023
LENALIDOMIDE×6	EUGIA PHARMA	ANDA 213885	AB	Mar 06, 2023
LENALIDOMIDE×6	MYLAN	ANDA 213912	AB	Mar 06, 2023
LENALIDOMIDE×6	SUN PHARM	ANDA 211846	AB	Mar 06, 2023
LENALIDOMIDE×6	ZYDUS PHARMS	ANDA 210154	AB	Mar 06, 2023
LENALIDOMIDE×5	CIPLA	ANDA 210435	AB	Sep 06, 2022
LENALIDOMIDE×6	DR REDDYS	ANDA 209348	AB	Oct 14, 2021

Patent	Expires	In	Type
7465800	Apr 27, 2027	in 10 mo	SubstanceProduct
8741929	Mar 08, 2028	in 1 yr 9 mo	U-1983

Lenalidomide

Brand (NDA) products · capsule

Generic (ANDA) products (20)

Marketing exclusivity (12)

Listed patents (2)

Lenalidomide — frequently asked questions

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