LENALIDOMIDE Drug Patent Profile
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Which patents cover Lenalidomide, and when can generic versions of Lenalidomide launch?
Lenalidomide is a drug marketed by Apotex, Arrow Intl, Cipla, Dr Reddys, Eugia Pharma, Hetero Labs Ltd V, Lotus Pharm Co Ltd, Mylan, Qilu, Sun Pharm, Torrent, and Zydus Pharms. and is included in thirteen NDAs.
The generic ingredient in LENALIDOMIDE 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 Lenalidomide
A generic version of LENALIDOMIDE was approved as lenalidomide by ARROW INTL on May 21st, 2021.
Summary for LENALIDOMIDE
Recent Clinical Trials for LENALIDOMIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Innovent Biologics (Suzhou) Co. Ltd. | Phase 1 |
| SWOG Cancer Research Network | Phase 2 |
| Ipsen | Phase 2 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lotus Pharm Co Ltd | LENALIDOMIDE | lenalidomide | CAPSULE;ORAL | 210480-006 | Mar 6, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hetero Labs Ltd V | LENALIDOMIDE | lenalidomide | CAPSULE;ORAL | 212414-002 | May 11, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Qilu | LENALIDOMIDE | lenalidomide | CAPSULE;ORAL | 217265-001 | Feb 22, 2024 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity 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 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
