REVLIMID Drug Patent Profile
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Which patents cover Revlimid, and what generic alternatives are available?
Revlimid is a drug marketed by Bristol Myers Squibb and is included in one NDA. There are three patents protecting this drug and three Paragraph IV challenges.
This drug has three hundred and thirty-one patent family members in forty-one countries.
The generic ingredient in REVLIMID is lenalidomide. There are fourteen drug master file entries for this compound. Thirteen 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.
Summary for REVLIMID
International Patents: | 331 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 149 |
Clinical Trials: | 546 |
Patent Applications: | 633 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for REVLIMID |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for REVLIMID |
What excipients (inactive ingredients) are in REVLIMID? | REVLIMID excipients list |
DailyMed Link: | REVLIMID at DailyMed |
Recent Clinical Trials for REVLIMID
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Ipsen | Phase 2 |
BeiGene | Phase 2 |
SWOG Cancer Research Network | Phase 2 |
Pharmacology for REVLIMID
Drug Class | Thalidomide Analog |
Anatomical Therapeutic Chemical (ATC) Classes 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 three US patents and three FDA Regulatory Exclusivities.
Patents protecting REVLIMID
Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
FDA Regulatory Exclusivity protecting REVLIMID
TREATMENT OF MULTIPLE MYELOMA (MM), AS MAINTENANCE FOLLOWING AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION (AUTO-HSCT)
Exclusivity Expiration: ⤷ Try a Trial
INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED FOLLICULAR LYMPHOMA (FL)
Exclusivity Expiration: ⤷ Try a Trial
INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED MARGINAL ZONE LYMPHOMA (MZL)
Exclusivity Expiration: ⤷ Try a Trial
Expired US Patents for REVLIMID
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 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 REVLIMID
See the table below for patents covering REVLIMID around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 5925418 | ⤷ Try a Trial | |
Japan | 2015131863 | 置換2−(2,6−ジオキソピペリジン−3−イル)フタルイミド類及び−1−オキソイソインドリン類ならびにTNFαレベルの減少方法 (SUBSTITUTED 2-(2,6-DIOXOPIPERIDIN-3-YL)PHTHALIMIDES AND 1-OXOISOINDOLINES, AND METHOD OF REDUCING TNF-α LEVELS) | ⤷ Try a Trial |
Denmark | 3045176 | ⤷ Try a Trial | |
Hong Kong | 1157772 | ⤷ Try a Trial | |
China | 100579527 | ⤷ Try a Trial | |
Czech Republic | 304569 | 1,3-Dioxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindolin pro použití pro snížení nežádoucí hladiny TNFα u savce (1,3-Dioxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline intended for use in the reduction of undesired level of TNF{alpha} in a mammal) | ⤷ Try a Trial |
Israel | 178748 | שימוש ב-3- (4-אמינו- 1-אוקסו- 3-1- דיהידרואיזוינדול-2-יל)-פיפרידין-2,6 דיון) בשילוב עם מלפאלאן ופרדניסון לטיפול במללטיפל מילומה (3-( 4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6--dione in combination with melphalan and prednisone for use in treating multiple myeloma) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for REVLIMID
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0925294 | SZ 56/2007 | Austria | ⤷ Try a Trial | PRODUCT NAME: 1-OXO-2(2,6-DIOXOPIPERIDIN-3-YL)-4- AMINOISOINDOLIN, AUCH 3-(4'AMINOISOINDOLIN-1'-ON)- 1-PIPERIDIN-2,6DION GENANNT, GEGEBENENFALLS IN FORM EINES SAEUREADDITIONSSALZES |
0925294 | 07C0056 | France | ⤷ Try a Trial | PRODUCT NAME: LENALIDOMIDE; REGISTRATION NO/DATE: EU/1/07/391/001-004 20070618 |
0925294 | CA 2007 00054 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LENALIDOMID, EVT. I FORM AF SYREADDITIONSSALT |
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 |
0925294 | 56/2007 | Austria | ⤷ Try a Trial | PRODUCT NAME: 1-OXO-2(2,6-DIOXOPIPERIDIN-3-YL)-4- AMINOISOINDOLIN, AUCH 3-(4'AMINOISOINDOLIN-1'-ON)- 1-PIPERIDIN-2,6DION GENANNT, GEGEBENENFALLS IN FORM EINES SAEUREADDITIONSSALZES; REGISTRATION NO/DATE: EU/1/07/391/001 - EU/1/07/391/004 20070614 |
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 |
0925294 | C00925294/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: LENALIDOMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 57712 29.08.2007 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |