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.
Summary for LENALIDOMIDE
International Patents: | 331 |
US Patents: | 3 |
Tradenames: | 2 |
Applicants: | 14 |
NDAs: | 15 |
Drug Master File Entries: | 14 |
Finished Product Suppliers / Packagers: | 13 |
Raw Ingredient (Bulk) Api Vendors: | 149 |
Clinical Trials: | 1,131 |
Patent Applications: | 6,850 |
Drug Prices: | Drug price trends for LENALIDOMIDE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LENALIDOMIDE |
What excipients (inactive ingredients) are in LENALIDOMIDE? | LENALIDOMIDE excipients list |
DailyMed Link: | LENALIDOMIDE at DailyMed |
Recent Clinical Trials for LENALIDOMIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Myeloma Canada | Phase 3 |
Canadian Institutes of Health Research (CIHR) | Phase 3 |
Canadian Cancer Trials Group | Phase 3 |
Pharmacology for LENALIDOMIDE
Drug Class | Thalidomide Analog |
Anatomical Therapeutic Chemical (ATC) Classes 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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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