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Last Updated: May 12, 2024

LENALIDOMIDE - Generic Drug Details

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What are the generic sources for lenalidomide and what is the scope of freedom to operate?

Lenalidomide is the generic ingredient in two branded drugs marketed by Apotex, Arrow Intl, Cipla, Dr Reddys, Eugia Pharma, Hetero Labs Ltd V, Lotus Pharm Co Ltd, Mylan, Qilu, Sun Pharm, Torrent, Zydus Pharms, and Bristol Myers Squibb, and is included in fourteen NDAs. There are three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lenalidomide has three hundred and thirty-one patent family members in forty-one countries.

There are fourteen drug master file entries for lenalidomide. Thirteen suppliers are listed for this compound.

Summary for LENALIDOMIDE

International Patents:	331
US Patents:	3
Tradenames:	2
Applicants:	13
NDAs:	14
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	149
Clinical Trials:	1,107
Patent Applications:	989
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for LENALIDOMIDE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LENALIDOMIDE
What excipients (inactive ingredients) are in LENALIDOMIDE?	LENALIDOMIDE excipients list
DailyMed Link:	LENALIDOMIDE at DailyMed

Drug Prices for LENALIDOMIDE

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Recent Clinical Trials for LENALIDOMIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Innovent Biologics (Suzhou) Co. Ltd.	Phase 1
Ipsen	Phase 2
BeiGene	Phase 2

See all LENALIDOMIDE clinical trials

Pharmacology for LENALIDOMIDE

Drug Class	Thalidomide Analog

Paragraph IV (Patent) Challenges for LENALIDOMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
REVLIMID	Capsules	lenalidomide	2.5 mg and 20 mg	021880	1	2016-07-12
REVLIMID	Capsules	lenalidomide	5 mg, 10 mg and 15 mg	021880	1	2010-08-30
REVLIMID	Capsules	lenalidomide	25 mg	021880	1	2010-07-12

US Patents and Regulatory Information for LENALIDOMIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	213912-006	Mar 6, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-005	Dec 21, 2011	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Qilu	LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	217265-003	Feb 22, 2024	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apotex	LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	211022-002	Aug 30, 2022	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for LENALIDOMIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-001	Dec 27, 2005	⤷ Try a Trial	⤷ Try a Trial
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-003	Jun 29, 2006	⤷ Try a Trial	⤷ Try a Trial
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-002	Dec 27, 2005	⤷ Try a Trial	⤷ Try a Trial
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-006	Jun 5, 2013	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for LENALIDOMIDE

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan Ireland Limited	Lenalidomide Mylan	lenalidomide	EMEA/H/C/005306 Multiple myelomaLenalidomide Mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.Lenalidomide Mylan as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.Lenalidomide Mylan in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.Follicular lymphomaLenalidomide Mylan in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1-3a).	Authorised	yes	no	no	2020-12-18
Accord Healthcare S.L.U.	Lenalidomide Accord	lenalidomide	EMEA/H/C/004857 Multiple myelomaLenalidomide Accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.Lenalidomide Accord as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.Lenalidomide Accord in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.Follicular lymphomaLenalidomide Accord in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).	Authorised	yes	no	no	2018-09-20
Bristol-Myers Squibb Pharma EEIG	Revlimid	lenalidomide	EMEA/H/C/000717 Multiple myelomaRevlimid as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.Revlimid as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.Myelodysplastic syndromesRevlimid as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.Mantle cell lymphomaRevlimid as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.Follicular lymphomaRevlimid in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).	Authorised	no	no	no	2007-06-14
Krka, d.d., Novo mesto	Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto)	lenalidomide	EMEA/H/C/005348 Multiple myelomaLenalidomide Krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.Lenalidomide Krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.Lenalidomide Krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.Myelodysplastic syndromesLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.Mantle cell lymphomaLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4.4 and 5.1).Follicular lymphomaLenalidomide Krka in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).Multiple myelomaLenalidomide Krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.Lenalidomide Krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.Lenalidomide Krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.Myelodysplastic syndromesLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.Mantle cell lymphomaLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4.4 and 5.1).Follicular lymphomaLenalidomide Krka in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).	Authorised	yes	no	no	2021-02-11
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for LENALIDOMIDE

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Country	Patent Number	Title	Estimated Expiration
Canada	2537092	FORMES POLYMORPHES DE 3-(4-AMINO-1-OXO-1,3-DIHYDRO-ISOINDOL-2-YL)-PIPERIDINE-2,6-DIONE (POLYMORPHIC FORMS OF 3-(4-AMINO-1-OXO-1,3 DIHYDRO-ISOINDOL-2-YL)-PIPERIDINE-2,6-DIONE)	⤷ Try a Trial
Argentina	062265	USO DE LA 3-(4-AMINO-1 OXO-1,3- DHIDRO -ISOINDOL-2-IL) PIPERIDIN-2,6- DIONA, PARA LA PREPARACION DE UN MEDICAMENTO PARA EL TRATAMIENTO DEL LINFOMA DE LAS CELULAS DEL MANTO EN UN SER HUMANO Y LAS COMPOSICIONES FARMACEUTICAS SINERGICAS QUE CONTIENEN DICHO COMPUESTO EN COMBINACION CON UN SEGUNDO PRINCI	⤷ Try a Trial
Norway	337446		⤷ Try a Trial
Ecuador	SP056229	UNA COMPOSICIÓN FARMACÉUTICA QUE COMPRENDE FORMAS POLIMÓRFICAS DE 3-(4-AMINO-1-OXO-1.3 DYHIDRO-ISOINDOL-2-IL)-PIPERIDINA-2,6-DIONA PARA EL TRATAMIENTO Y MANEJO DE CÁNCERES	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for LENALIDOMIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2105135	1590004-6	Sweden	⤷ Try a Trial	PRODUCT NAME: POMALIDOMIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS, SOLVATES, HYDRATES OR STEREOISOMERS THEREOF; REG. NO/DATE: EU/1/13/850 20130808
2105135	C300717	Netherlands	⤷ Try a Trial	PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135	300717	Netherlands	⤷ Try a Trial	PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
0925294	07C0056	France	⤷ Try a Trial	PRODUCT NAME: LENALIDOMIDE; REGISTRATION NO/DATE: EU/1/07/391/001-004 20070618
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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