FDA Orange Book · active-ingredient family
Lenalidomide
Lenalidomide: 1 brand, 20 generics; first approved Dec 27, 2005; generic available.
Generic available2 exclusivity periodsHas discontinued products
Generic status & protection
Generic available: 20 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
1
Generics (ANDA)
20
Listed patents
2
Next patent expiry
Apr 27, 2027
in 6 mo
Brand (NDA) products
Originator applications
- REVLIMIDRLDBRISTOL MYERS SQUIBBNDA 02188020116 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Rx AB 10MG CAPSULE ORAL Rx AB 15MG CAPSULE ORAL Rx AB 25MG CAPSULE ORAL Rx AB 2.5MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB
Generic (ANDA) products (20)
Abbreviated applications
- LENALIDOMIDETORRENTANDA 21340520266 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued - 25MG CAPSULE ORAL Discontinued - 20MG CAPSULE ORAL Discontinued - 15MG CAPSULE ORAL Discontinued - 2.5MG CAPSULE ORAL Discontinued - 5MG CAPSULE ORAL Discontinued - - LENALIDOMIDECIPLAANDA 21316520265 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Rx AB 10MG CAPSULE ORAL Rx AB 15MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB 25MG CAPSULE ORAL Rx AB - LENALIDOMIDEACCORD HLTHCAREANDA 21887220256 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG CAPSULE ORAL Rx AB 5MG CAPSULE ORAL Rx AB 10MG CAPSULE ORAL Rx AB 15MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB 25MG CAPSULE ORAL Rx AB - LENALIDOMIDELUPINANDA 21439820256 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG CAPSULE ORAL Rx AB 5MG CAPSULE ORAL Rx AB 10MG CAPSULE ORAL Rx AB 15MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB 25MG CAPSULE ORAL Rx AB - LENALIDOMIDEDEVA HOLDING ASANDA 21755420256 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG CAPSULE ORAL Rx AB 5MG CAPSULE ORAL Rx AB 10MG CAPSULE ORAL Rx AB 15MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB 25MG CAPSULE ORAL Rx AB - LENALIDOMIDEBIOCON PHARMAANDA 21575920256 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG CAPSULE ORAL Rx AB 5MG CAPSULE ORAL Rx AB 10MG CAPSULE ORAL Rx AB 15MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB 25MG CAPSULE ORAL Rx AB - LENALIDOMIDEAMNEALANDA 21621320256 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG CAPSULE ORAL Rx AB 5MG CAPSULE ORAL Rx AB 10MG CAPSULE ORAL Rx AB 15MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB 25MG CAPSULE ORAL Rx AB - LENALIDOMIDENOVUGENANDA 21728120246 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG CAPSULE ORAL Rx AB 5MG CAPSULE ORAL Rx AB 10MG CAPSULE ORAL Rx AB 15MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB 25MG CAPSULE ORAL Rx AB - LENALIDOMIDEQILUANDA 21726520246 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG CAPSULE ORAL Rx AB 5MG CAPSULE ORAL Rx AB 10MG CAPSULE ORAL Rx AB 15MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB 25MG CAPSULE ORAL Rx AB - LENALIDOMIDEHETERO LABS LTD VANDA 21241420236 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG CAPSULE ORAL Rx AB 5MG CAPSULE ORAL Rx AB 10MG CAPSULE ORAL Rx AB 15MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB 25MG CAPSULE ORAL Rx AB - LENALIDOMIDEAPOTEXANDA 21102220236 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Rx AB 10MG CAPSULE ORAL Rx AB 15MG CAPSULE ORAL Rx AB 25MG CAPSULE ORAL Rx AB 2.5MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB - LENALIDOMIDEALVOGENANDA 21048020236 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Rx AB 10MG CAPSULE ORAL Rx AB 15MG CAPSULE ORAL Rx AB 25MG CAPSULE ORAL Rx AB 2.5MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB - LENALIDOMIDEARROW INTLANDA 20145220236 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Rx AB 10MG CAPSULE ORAL Rx AB 15MG CAPSULE ORAL Rx AB 25MG CAPSULE ORAL Rx AB 2.5MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB - LENALIDOMIDECIPLAANDA 2146182023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG CAPSULE ORAL Rx AB - LENALIDOMIDEEUGIA PHARMAANDA 21388520236 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG CAPSULE ORAL Rx AB 5MG CAPSULE ORAL Rx AB 10MG CAPSULE ORAL Rx AB 15MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB 25MG CAPSULE ORAL Rx AB - LENALIDOMIDEMYLANANDA 21391220236 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Rx AB 10MG CAPSULE ORAL Rx AB 15MG CAPSULE ORAL Rx AB 25MG CAPSULE ORAL Rx AB 2.5MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB - LENALIDOMIDESUN PHARMANDA 21184620236 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Rx AB 10MG CAPSULE ORAL Rx AB 15MG CAPSULE ORAL Rx AB 25MG CAPSULE ORAL Rx AB 2.5MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB - LENALIDOMIDEZYDUS PHARMSANDA 21015420236 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Rx AB 10MG CAPSULE ORAL Rx AB 15MG CAPSULE ORAL Rx AB 25MG CAPSULE ORAL Rx AB 2.5MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB - LENALIDOMIDECIPLAANDA 21043520225 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Rx AB 10MG CAPSULE ORAL Rx AB 15MG CAPSULE ORAL Rx AB 25MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB - LENALIDOMIDEDR REDDYSANDA 20934820216 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG CAPSULE ORAL Rx AB 20MG CAPSULE ORAL Rx AB 5MG CAPSULE ORAL Rx AB 10MG CAPSULE ORAL Rx AB 15MG CAPSULE ORAL Rx AB 25MG CAPSULE ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- ODE-241Orphan-drug exclusivity (7 years)
5 mo ago
- ODE-245Orphan-drug exclusivity (7 years)
5 mo ago
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7465800 | in 6 mo | SubstanceProduct | |
| 8741929 | in 1 yr 5 mo | U-1983 |
Approval history
FDA approval span
First approval
21 yr 2 mo ago
Most recent approval
9 mo ago
Approvals span 2005–2026 across 21 FDA applications.
Brand (NDA) 15%
Generic (ANDA) 2095%
Lenalidomide: 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.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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