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Last Updated: October 1, 2022

REVLIMID Drug Patent Profile


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When do Revlimid patents expire, and what generic alternatives are available?

Revlimid is a drug marketed by Celgene and is included in one NDA. There are fifteen patents protecting this drug and three Paragraph IV challenges.

This drug has three hundred and seventy-seven patent family members in forty-one countries.

The generic ingredient in REVLIMID is lenalidomide. There are fourteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the lenalidomide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Revlimid

A generic version of REVLIMID was approved as lenalidomide by ARROW INTL on May 21st, 2021.

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Drug patent expirations by year for REVLIMID
Drug Prices for REVLIMID

See drug prices for REVLIMID

Recent Clinical Trials for REVLIMID

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

SponsorPhase
Antengene CorporationPhase 1/Phase 2
Xia ZhongjunPhase 1/Phase 2
Incyte CorporationPhase 1/Phase 2

See all REVLIMID clinical trials

Pharmacology for REVLIMID
Paragraph IV (Patent) Challenges for REVLIMID
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 REVLIMID

REVLIMID is protected by seventeen US patents and six FDA Regulatory Exclusivities.

Patents protecting REVLIMID

Methods of using 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for the treatment and management of myelodysplastic syndromes
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF REVLIMID (LENALIDOMIDE) FOR TREATMENT OF PATIENTS WITH TRANSFUSION-DEPENDENT ANEMIA DUE TO LOW-OR INTERMEDIATE-1-RISK MYELODYSPLASTIC SYNDROMES ASSOCIATED WITH A DELETION 5Q ABNORMALITY WITH OR WITHOUT ADDITIONAL CYTOGENETIC ABNORMALITIES

Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for treatment of cancers using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PREVIOUSLY TREATED MARGINAL ZONE LYMPHOMA IN COMBINATION WITH A RITUXIMAB PRODUCT

Methods for treatment of cancers using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA WHOSE DISEASE HAS RELAPSED OR PROGRESSED AFTER TWO PRIOR THERAPIES, ONE OF WHICH INCLUDED BORTEZOMIB

Methods for treatment of cancers using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PREVIOUSLY TREATED FOLLICULAR LYMPHOMA IN COMBINATION WITH A RITUXIMAB PRODUCT

Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for treatment of multiple myeloma using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA, IN COMBINATION WITH DEXAMETHASONE

Methods of treating myelodysplastic syndromes using lenalidomide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF REVLIMID (LENALIDOMIDE) FOR TREATMENT OF PATIENTS WITH TRANSFUSION-DEPENDENT ANEMIA DUE TO LOW-OR INTERMEDIATE-1-RISK MYELODYSPLASTIC SYNDROMES ASSOCIATED WITH A DELETION 5Q ABNORMALITY WITH OR WITHOUT ADDITIONAL CYTOGENETIC ABNORMALITIES

Methods for treatment of follicular lymphoma using 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PREVIOUSLY TREATED FOLLICULAR LYMPHOMA IN COMBINATION WITH A RITUXIMAB PRODUCT

Methods for treating multiple myeloma with 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)piperidine-2,6-dione
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA, IN COMBINATION WITH DEXAMETHASONE

Methods for treating multiple myeloma using 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with proteasome inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA, IN COMBINATION WITH DEXAMETHASONE

Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of mantle cell lymphomas
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA WHOSE DISEASE HAS RELAPSED OR PROGRESSED AFTER TWO PRIOR THERAPIES, ONE OF WHICH INCLUDED BORTEZOMIB

Methods of treating myelodysplastic syndromes with a combination therapy using lenalidomide and azacitidine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF REVLIMID (LENALIDOMIDE) FOR TREATMENT OF PATIENTS WITH TRANSFUSION-DEPENDENT ANEMIA DUE TO LOW-OR INTERMEDIATE-1-RISK MYELODYSPLASTIC SYNDROMES ASSOCIATED WITH A DELETION 5Q ABNORMALITY WITH OR WITHOUT ADDITIONAL CYTOGENETIC ABNORMALITIES

Methods for treating multiple myeloma with 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione after stem cell transplantation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA, AS MAINTENANCE FOLLOWING AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION (AUTO-HSCT)

Methods for treating newly diagnosed multiple myeloma 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione in combination with dexamethasone
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA, IN COMBINATION WITH DEXAMETHASONE, WHEREIN THOSE PATIENTS HAVE NOT RECEIVED PREVIOUS TREATMENT FOR MULTIPLE MYELOMA

Methods for treating non-hodgkin's lymphoma with 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with a second active agent
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PREVIOUSLY TREATED FOLLICULAR LYMPHOMA IN COMBINATION WITH A RITUXIMAB PRODUCT

Methods for treating non-hodgkin's lymphoma with 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione in combination with a second active agent
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PREVIOUSLY TREATED FOLLICULAR LYMPHOMA IN COMBINATION WITH A RITUXIMAB PRODUCT

FDA Regulatory Exclusivity protecting REVLIMID

FOR USE IN COMBINATION WITH DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE NOT RECEIVED AT LEAST ONE PRIOR THERAPY (FIRST LINE TREATMENT)
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF MULTIPLE MYELOMA (MM), AS MAINTENANCE FOLLOWING AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION (AUTO-HSCT)
Exclusivity Expiration: See Plans and Pricing

USED IN COMBINATION WITH A RITUXIMAB PRODUCT, ARE INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED FOLLICULAR LYMPHOMA (FL)
Exclusivity Expiration: See Plans and Pricing

USED IN COMBINATION WITH A RITUXIMAB PRODUCT, ARE INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED MARGINAL ZONE LYMPHOMA (MZL)
Exclusivity Expiration: See Plans and Pricing

INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED FOLLICULAR LYMPHOMA (FL)
Exclusivity Expiration: See Plans and Pricing

INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED MARGINAL ZONE LYMPHOMA (MZL)
Exclusivity Expiration: 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
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
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-006 Jun 5, 2013 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-001 Dec 27, 2005 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-001 Dec 27, 2005 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 REVLIMID

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-001 Dec 27, 2005 See Plans and Pricing See Plans and Pricing
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-002 Dec 27, 2005 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
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 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 REVLIMID

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 myeloma, , Lenalidomide 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 lymphoma, , Lenalidomide 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 REVLIMID

When does loss-of-exclusivity occur for REVLIMID?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Patent: 24
Estimated Expiration: See Plans and Pricing

Argentina

Patent: 7994
Estimated Expiration: See Plans and Pricing

Patent: 7868
Estimated Expiration: See Plans and Pricing

Patent: 2756
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering REVLIMID around the world.

Country Patent Number Title Estimated Expiration
Serbia 20120340 POLIMORFNI OBLICI 3-4(4-AMINO-1-OKSO-1, 3-DIHIDRO-IZOINDOL-2-IL)-PIPERIDIN-2, 6-DIONA (POLYMORPHIC FORMS OF 3-(4-AMINO-1-OXO-1,3DIHYDRO-ISOINDOL-2-YL)-PIPERIDINE-2,9-DIONE) See Plans and Pricing
Ukraine 83504 ПОЛІМОРФНІ ФОРМИ 3-(4-АМІНО-1-ОКСО-1,3-ДИГІДРОІЗОІНДОЛ-2-ІЛ)ПІПЕРИДИН-2,6-ДІОНУ[ПОЛИМОРФНЫЕ ФОРМЫ 3-(4-АМИНО-1-ОКСО-1,3-ДИГИДРОИЗОИНДОЛ-2-ИЛ) ПИПЕРИДИН-2,6-ДИОНА (POLYMORPHIC FORMS OF 3-(4-AMINO-1-OXO-1,3 DIHYDRO-ISOINDOL-2-YL)-PIPERIDINE-2,6-DIONE) See Plans and Pricing
New Zealand 536908 Treating or preventing cancer comprising administering an effective amount of cytokine inhibitory drug plus a second active ingredient See Plans and Pricing
Norway 2012004 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for REVLIMID

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0925294 CA 2007 00054 Denmark See Plans and Pricing PRODUCT NAME: LENALIDOMID, EVT. I FORM AF SYREADDITIONSSALT
0925294 C00925294/01 Switzerland See Plans and Pricing PRODUCT NAME: LENALIDOMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 57712 29.08.2007
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
2105135 C20150005 00140 Estonia See Plans and Pricing PRODUCT NAME: POMALIDOMIID;REG NO/DATE: EU/1/13/850 08.08.2013
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Colorcon
Moodys
Baxter
Dow
McKinsey

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.