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Last Updated: November 21, 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, Novugen, Qilu, Sun Pharm, Torrent, Zydus Pharms, and Bristol Myers Squibb, and is included in fifteen 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

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Recent Clinical Trials for LENALIDOMIDE

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

SponsorPhase
Myeloma CanadaPhase 3
Canadian Institutes of Health Research (CIHR)Phase 3
Canadian Cancer Trials GroupPhase 3

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
Arrow Intl LENALIDOMIDE lenalidomide CAPSULE;ORAL 201452-003 May 21, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb REVLIMID lenalidomide CAPSULE;ORAL 021880-005 Dec 21, 2011 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan LENALIDOMIDE lenalidomide CAPSULE;ORAL 213912-005 Mar 6, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb REVLIMID lenalidomide CAPSULE;ORAL 021880-002 Dec 27, 2005 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Lotus Pharm Co Ltd LENALIDOMIDE lenalidomide CAPSULE;ORAL 210480-004 Aug 31, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novugen LENALIDOMIDE lenalidomide CAPSULE;ORAL 217281-006 Sep 11, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb REVLIMID lenalidomide CAPSULE;ORAL 021880-001 Dec 27, 2005 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb REVLIMID lenalidomide CAPSULE;ORAL 021880-001 Dec 27, 2005 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb REVLIMID lenalidomide CAPSULE;ORAL 021880-004 Jun 29, 2006 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb REVLIMID lenalidomide CAPSULE;ORAL 021880-001 Dec 27, 2005 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb REVLIMID lenalidomide CAPSULE;ORAL 021880-002 Dec 27, 2005 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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
Poland 3045175 ⤷  Sign Up
Denmark 1667682 ⤷  Sign Up
Peru 20081311 METODOS QUE USAN 3-(4-AMINO-1-OXO-1,3-DIHIDRO-ISOINDOL-2-IL)-PIPERIDIN-2,6-DIONA PARA EL TRATAMIENTO DE LINFOMAS DE LAS CELULAS DEL MANTO ⤷  Sign Up
Japan 5309104 ⤷  Sign Up
Mexico 346261 FORMAS POLIMÓRFICAS DE 3-(4-AMINO-1-OXO-1, 3 DIHIDRO-ISOINDOL-2-IL )-PIPERIDIN-2, 6-DIONA. (POLYMORPHIC FORMS OF 3-(4-AMINO-1-OXO-1,3 DIHYDRO-ISOINDOL-2-YL)- PIPERIDINE-2,6-DIONE.) ⤷  Sign Up
European Patent Office 3045176 FORMES POLYMORPHES DE 3-(4-AMINO-1-OXO-1,3 DIHYDRO-ISOINDOL-2-YL)-PIPÉRIDINE-2,6-DIONE (POLYMORPHIC FORMS OF 3-(4-AMINO-1-OXO-1,3 DIHYDROISOINDOL-2-YL)-PIPERIDINE-2,6-DIONE) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LENALIDOMIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2105135 00140 Estonia ⤷  Sign Up
2105135 122015000013 Germany ⤷  Sign Up PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE (IMNOVID); REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135 92642 Luxembourg ⤷  Sign Up PRODUCT NAME: POMALIDOMIDE ET SES SELS, SOLVATES, HYDRATES OU STEREOISOMERES PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT (IMNOVID); FIRST REGISTRATION DATE: 20130805
2105135 212 50002-2015 Slovakia ⤷  Sign Up PRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808
0925294 SPC/GB07/047 United Kingdom ⤷  Sign Up 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 1590004-6 Sweden ⤷  Sign Up PRODUCT NAME: POMALIDOMIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS, SOLVATES, HYDRATES OR STEREOISOMERS THEREOF; REG. NO/DATE: EU/1/13/850 20130808
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.