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Last Updated: May 18, 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
SWOG Cancer Research Network	Phase 2
Ipsen	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
Qilu	LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	217265-004	Feb 22, 2024	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-006	Jun 5, 2013	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Cipla	LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	210435-005	Mar 6, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm	LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	211846-004	Feb 8, 2023	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	021880-005	Dec 21, 2011	⤷ Try a Trial	⤷ Try a Trial
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-006	Jun 5, 2013	⤷ 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	021880-004	Jun 29, 2006	⤷ 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	2687924	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
South Korea	101483802		⤷ Try a Trial
Japan	2010013482	METHOD AND COMPOSITION USING SELECTIVE CYTOKINE INHIBITORY DRUG FOR TREATMENT AND MANAGEMENT OF CANCERS AND OTHER DISEASES	⤷ Try a Trial
China	102675281	Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione	⤷ 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	CA 2015 00006	Denmark	⤷ Try a Trial	PRODUCT NAME: POMALIDOMID OG FARMACEUTISK ACCEPTABLE SALTE, SOLVATER, HYDRATER ELLER STEREOISOMERER HERAF; REG. NO/DATE: EU/1/13/850 20130805
0925294	SPC/GB07/047	United Kingdom	⤷ Try a Trial	PRODUCT NAME: LENALIDOMIDE (COMMON NAME) 1-OXO-2-(2,6-DIOXOPIPERIDIN-3-YL)-4-AMINOSOINDOLINE OPTIONALLY IN THE FORM OF AN ACID ADDITION SALT; REGISTERED: UK EU/1/07/391/001 20070619; UK EU/1/07/391/002 20070619; UK EU/1/07/391/003 20070619; UK EU/1/07/391/004 20070619
2105135	122015000013	Germany	⤷ Try a Trial	PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE (IMNOVID); REGISTRATION NO/DATE: EU/1/13/850 20130805
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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