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Last Updated: March 29, 2024

Lenalidomide - Generic Drug Details


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What are the generic drug 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, Sun Pharm, Torrent, Zydus Pharms, and Bristol Myers Squibb, and is included in thirteen 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.

Drug Prices for lenalidomide

See drug prices for lenalidomide

Recent Clinical Trials for lenalidomide

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

SponsorPhase
Innovent Biologics (Suzhou) Co. Ltd.Phase 1
BeiGenePhase 2
SWOG Cancer Research NetworkPhase 2

See all lenalidomide clinical trials

Pharmacology for lenalidomide
Drug ClassThalidomide 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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cipla LENALIDOMIDE lenalidomide CAPSULE;ORAL 210435-001 Sep 6, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hetero Labs Ltd V LENALIDOMIDE lenalidomide CAPSULE;ORAL 212414-003 May 11, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys LENALIDOMIDE lenalidomide CAPSULE;ORAL 209348-001 Oct 14, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eugia Pharma LENALIDOMIDE lenalidomide CAPSULE;ORAL 213885-003 Mar 6, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Arrow Intl LENALIDOMIDE lenalidomide CAPSULE;ORAL 201452-006 Mar 6, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm LENALIDOMIDE lenalidomide CAPSULE;ORAL 211846-001 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

EU/EMA Drug Approvals for lenalidomide

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
Krka, d.d., Novo mesto  Lenalidomide Krka d.d. lenalidomide EMEA/H/C/005729
Multiple myelomaLenalidomide Krka d.d. 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 d.d. 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 d.d. 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 d.d. 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.Follicular lymphomaLenalidomide Krka d.d. in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).
Withdrawn yes no no 2021-02-11
Krka, d.d., Novo mesto  Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka) lenalidomide EMEA/H/C/005734
Multiple myelomaLenalidomide krka d.d. Novo mesto 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 d.d. Novo mesto 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 d.d. Novo mesto 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 krka d.d. Novo mesto 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 d.d. Novo mesto 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 d.d. Novo mesto 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 d.d. Novo mesto 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 krka d.d. Novo mesto 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

Country Patent Number Title Estimated Expiration
Slovenia 2105135 ⤷  Try a Trial
Morocco 28084 FORMES POLYMORPHES DE 3-(4-AMINO-1-OXO-1, 3-DIHYDRO-ISOINDOL-2-YL)-PIPERIDINE-2, 6-DIONE ⤷  Try a Trial
Australia 2013203194 POLYMORPHIC FORMS OF 3-(4-AMINO-1-OXO-1,3 DIHYDRO-ISOINDOL-2-YL)-PIPERIDINE-2,6-DIONE ⤷  Try a Trial
Russian Federation 2010137395 СПОСОБЫ ПРИМЕНЕНИЯ 3-(4-АМИНО-1-ОКСО-1,3-ДИГИДРОИЗОИНДОЛ-2-ИЛ)ПИПЕРИДИН-2,6-ДИОНА ДЛЯ ЛЕЧЕНИЯ ОПРЕДЕЛЕННЫХ ТИПОВ ЛЕЙКОЗА ⤷  Try a Trial
Hungary E041265 ⤷  Try a Trial
Australia 2004270211 Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione ⤷  Try a Trial
Japan 2009510171 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for lenalidomide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
0925294 07C0056 France ⤷  Try a Trial PRODUCT NAME: LENALIDOMIDE; REGISTRATION NO/DATE: EU/1/07/391/001-004 20070618
2105135 212 50002-2015 Slovakia ⤷  Try a Trial PRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808
2105135 92642 Luxembourg ⤷  Try a Trial PRODUCT NAME: POMALIDOMIDE ET SES SELS, SOLVATES, HYDRATES OU STEREOISOMERES PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT (IMNOVID); FIRST REGISTRATION DATE: 20130805
2105135 00140 Estonia ⤷  Try a Trial
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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