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Last Updated: February 9, 2023

Lenalidomide - Generic Drug Details


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What are the generic drug sources for lenalidomide and what is the scope of patent protection?

Lenalidomide is the generic ingredient in two branded drugs marketed by Apotex, Arrow Intl, Cipla, Dr Reddys, Lotus Pharm Co Ltd, Mylan, Zydus Pharms, and Celgene, and is included in eight NDAs. There are fifteen 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 seventy-seven patent family members in forty-one countries.

There are fourteen drug master file entries for lenalidomide. Ten suppliers are listed for this compound. There are seven tentative approvals for this compound.

Recent Clinical Trials for lenalidomide

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

SponsorPhase
Daiichi Sankyo, Inc.Phase 1/Phase 2
University of ColognePhase 2
SanofiPhase 4

See all lenalidomide clinical trials

Generic filers with tentative approvals for LENALIDOMIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing25MGCAPSULE;ORAL
See Plans and PricingSee Plans and Pricing15MGCAPSULE;ORAL
See Plans and PricingSee Plans and Pricing10MGCAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for lenalidomide
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
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-002 Dec 27, 2005 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dr Reddys LENALIDOMIDE lenalidomide CAPSULE;ORAL 209348-003 Aug 30, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-004 Jun 29, 2006 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-004 Jun 29, 2006 See Plans and Pricing See Plans and Pricing
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-006 Jun 5, 2013 See Plans and Pricing See Plans and Pricing
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-006 Jun 5, 2013 See Plans and Pricing See Plans and Pricing
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-001 Dec 27, 2005 See Plans and Pricing See Plans and Pricing
>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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for lenalidomide

Country Patent Number Title Estimated Expiration
Portugal 2426118 See Plans and Pricing
Canada 2505128 PROCEDES ET COMPOSITIONS UTILISANT DES COMPOSES IMMUNOMODULATEURS POUR TRAITER ET MAITRISER DES CANCERS ET D'AUTRES MALADIES (METHODS AND COMPOSITIONS USING IMMUNOMODULATORY COMPOUNDS FOR TREATMENT AND MANAGEMENT OF CANCERS AND OTHER DISEASES) See Plans and Pricing
Japan 2006528973 See Plans and Pricing
European Patent Office 2046331 PROCÉDÉS UTILISANT LA 3-(4-AMINO-1-OXO-1,3-DIHYDRO-ISOINDOL-2-YL)-PIPÉRIDINE-2,6-DIONE POUR LE TRAITEMENT DES LYMPHOMES À CELLULES DU MANTEAU (USE OF 3- (4-AMINO-1-OXO-1,3-DIHYDRO-ISOINDOL-2-YL)-PIPERIDINE-2,6-DIONE FOR THE TREATMENT OF MANTLE CELL LYMPHOMAS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for lenalidomide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2105135 122015000013 Germany See Plans and Pricing PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE (IMNOVID); REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135 C300717 Netherlands See Plans and Pricing PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135 1590004-6 Sweden See Plans and Pricing PRODUCT NAME: POMALIDOMIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS, SOLVATES, HYDRATES OR STEREOISOMERS THEREOF; REG. NO/DATE: EU/1/13/850 20130808
2105135 92642 Luxembourg See Plans and Pricing PRODUCT NAME: POMALIDOMIDE ET SES SELS, SOLVATES, HYDRATES OU STEREOISOMERES PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT (IMNOVID); FIRST REGISTRATION DATE: 20130805
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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