Lenalidomide Patent Expiration
Lenalidomide is used for treating mantle cell lymphoma, multiple myeloma, and myelodysplastic syndromes. It was first introduced by Bristol Myers Squibb
Lenalidomide Patents
Given below is the list of patents protecting Lenalidomide, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Revlimid | US5635517 | Method of reducing TNFα levels with amino substituted 2-(2,6-dioxopiperidin-3-yl)-1-oxo-and 1,3-dioxoisoindolines |
Oct 04, 2019
(Expired) | Bristol Myers Squibb |
| Revlimid | US5635517 | Method of reducing TNFα levels with amino substituted 2-(2,6-dioxopiperidin-3-yl)-1-oxo-and 1,3-dioxoisoindolines |
Oct 04, 2019
(Expired) | Bristol Myers Squibb |
| Revlimid | US6045501 | Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug |
Aug 28, 2018
(Expired) | Bristol Myers Squibb |
| Revlimid | US6281230 | Isoindolines, method of use, and pharmaceutical compositions |
Jul 24, 2016
(Expired) | Bristol Myers Squibb |
| Revlimid | US6315720 | Methods for delivering a drug to a patient while avoiding the occurrence of an adverse side effect known or suspected of being caused by the drug |
Oct 23, 2020
(Expired) | Bristol Myers Squibb |
| Revlimid | US6555554 | Isoindolines, method of use, and pharmaceutical compositions |
Jul 24, 2016
(Expired) | Bristol Myers Squibb |
| Revlimid | US6561976 | Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug |
Aug 28, 2018
(Expired) | Bristol Myers Squibb |
| Revlimid | US6561977 | Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated |
Oct 23, 2020
(Expired) | Bristol Myers Squibb |
| Revlimid | US6755784 | Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated |
Oct 23, 2020
(Expired) | Bristol Myers Squibb |
| Revlimid | US6908432 | Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug |
Aug 28, 2018
(Expired) | Bristol Myers Squibb |
| Revlimid | US7119106 | Pharmaceutical compositions of 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline |
Jul 24, 2016
(Expired) | Bristol Myers Squibb |
| Revlimid | US7189740 | 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 |
Apr 11, 2023
(Expired) | Bristol Myers Squibb |
| Revlimid | US7465800 | Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione | Apr 27, 2027 | Bristol Myers Squibb |
| Revlimid | US7468363 | Methods for treatment of cancers using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione |
Oct 07, 2023
(Expired) | Bristol Myers Squibb |
| Revlimid | US7855217 | Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione | Nov 24, 2024 | Bristol Myers Squibb |
| Revlimid | US7968569 | Methods for treatment of multiple myeloma using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione |
Oct 07, 2023
(Expired) | Bristol Myers Squibb |
| Revlimid | US8204763 | Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug |
Aug 28, 2018
(Expired) | Bristol Myers Squibb |
| Revlimid | US8288415 | Pharmaceutical compositions of 3-(4-amino-1-oxoisoindolin-2yl)-piperidine-2,6-dione |
Jul 24, 2016
(Expired) | Bristol Myers Squibb |
| Revlimid | US8288415 | Pharmaceutical compositions of 3-(4-amino-1-oxoisoindolin-2yl)-piperidine-2,6-dione |
Jul 24, 2016
(Expired) | Bristol Myers Squibb |
| Revlimid | US8315886 | Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated |
Oct 23, 2020
(Expired) | Bristol Myers Squibb |
| Revlimid | US8404717 | Methods of treating myelodysplastic syndromes using lenalidomide |
Apr 11, 2023
(Expired) | Bristol Myers Squibb |
| Revlimid | US8492406 | Methods for treatment of follicular lymphoma using 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione |
Oct 07, 2023
(Expired) | Bristol Myers Squibb |
| Revlimid | US8530498 | Methods for treating multiple myeloma with 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)piperidine-2,6-dione |
May 15, 2023
(Expired) | Bristol Myers Squibb |
| Revlimid | US8589188 | Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug |
Aug 28, 2018
(Expired) | Bristol Myers Squibb |
| Revlimid | US8626531 | Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated |
Oct 23, 2020
(Expired) | Bristol Myers Squibb |
| Revlimid | US8648095 | 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 |
May 15, 2023
(Expired) | Bristol Myers Squibb |
| Revlimid | US8741929 | Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of mantle cell lymphomas | Mar 08, 2028 | Bristol Myers Squibb |
| Revlimid | US9056120 | Methods of treating myelodysplastic syndromes with a combination therapy using lenalidomide and azacitidine |
Apr 11, 2023
(Expired) | Bristol Myers Squibb |
| Revlimid | US9101621 | 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 |
May 15, 2023
(Expired) | Bristol Myers Squibb |
| Revlimid | US9101622 | 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 |
May 15, 2023
(Expired) | Bristol Myers Squibb |
| Revlimid | US9155730 | 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 |
May 15, 2023
(Expired) | Bristol Myers Squibb |
| Revlimid | US9393238 | 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 |
May 15, 2023
(Expired) | Bristol Myers Squibb |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Lenalidomide's patents.
Latest Legal Activities on Lenalidomide's Patents
Given below is the list recent legal activities going on the following patents of Lenalidomide.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed | 11 Mar, 2024 | US9393238 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 29 Mar, 2023 | US9155730 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 25 Jan, 2023 | US9101622(Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 25 Jan, 2023 | US9101621(Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Dec, 2022 | US7968569(Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Nov, 2022 | US9056120 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 08 Jun, 2022 | US7855217(Litigated) |
| Issue Notification Mailed | 28 Feb, 2022 | US7465800(Litigated) |
| Court Processing Terminated | 28 Feb, 2022 | US7465800(Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Nov, 2021 | US8741929 |
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Lenalidomide Generics
Several generic applications have been filed for Lenalidomide. The first generic version for Lenalidomide was by Arrow International Ltd and was approved on May 21, 2021. And the latest generic version is by Qilu Pharmaceutical Co Ltd and was approved on Feb 22, 2024.
Given below is the list of companies who have filed for Lenalidomide generic.
1. TORRENT
Torrent Pharmaceuticals Ltd has filed for 3 different strengths of generic version for Lenalidomide. Given below are the details of the strengths of this generic introduced by Torrent.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG | capsule | Discontinued | ORAL | N/A | Feb 17, 2023 |
| 25MG | capsule | Discontinued | ORAL | N/A | Feb 17, 2023 |
| 20MG | capsule | Discontinued | ORAL | N/A | Aug 3, 2023 |
2. MYLAN
Mylan Pharmaceuticals Inc has filed for 6 different strengths of generic version for Lenalidomide. Given below are the details of the strengths of this generic introduced by Mylan.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 25MG | capsule | Prescription | ORAL | AB | Aug 30, 2022 |
| 5MG | capsule | Prescription | ORAL | AB | Aug 30, 2022 |
| 15MG | capsule | Prescription | ORAL | AB | Aug 30, 2022 |
| 10MG | capsule | Prescription | ORAL | AB | Aug 30, 2022 |
| 2.5MG | capsule | Prescription | ORAL | AB | Mar 6, 2023 |
| 20MG | capsule | Prescription | ORAL | AB | Mar 6, 2023 |
3. DR REDDYS
Dr Reddys Laboratories Ltd has filed for 6 different strengths of generic version for Lenalidomide. Given below are the details of the strengths of this generic introduced by Dr Reddys.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 2.5MG | capsule | Prescription | ORAL | AB | Oct 14, 2021 |
| 20MG | capsule | Prescription | ORAL | AB | Oct 14, 2021 |
| 15MG | capsule | Prescription | ORAL | AB | Aug 30, 2022 |
| 25MG | capsule | Prescription | ORAL | AB | Aug 30, 2022 |
| 5MG | capsule | Prescription | ORAL | AB | Aug 30, 2022 |
| 10MG | capsule | Prescription | ORAL | AB | Aug 30, 2022 |
4. LOTUS PHARM CO LTD
Lotus Pharmaceutical Co Ltd Nantou Plant has filed for 6 different strengths of generic version for Lenalidomide. Given below are the details of the strengths of this generic introduced by Lotus Pharm Co Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 15MG | capsule | Prescription | ORAL | AB | Aug 31, 2022 |
| 5MG | capsule | Prescription | ORAL | AB | Aug 31, 2022 |
| 10MG | capsule | Prescription | ORAL | AB | Aug 31, 2022 |
| 25MG | capsule | Prescription | ORAL | AB | Aug 31, 2022 |
| 2.5MG | capsule | Prescription | ORAL | AB | Mar 6, 2023 |
| 20MG | capsule | Prescription | ORAL | AB | Mar 6, 2023 |
5. CIPLA
Cipla Ltd has filed for 6 different strengths of generic version for Lenalidomide. Given below are the details of the strengths of this generic introduced by Cipla.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | capsule | Prescription | ORAL | AB | Sep 6, 2022 |
| 10MG | capsule | Prescription | ORAL | AB | Sep 6, 2022 |
| 15MG | capsule | Prescription | ORAL | AB | Sep 6, 2022 |
| 25MG | capsule | Prescription | ORAL | AB | Sep 6, 2022 |
| 20MG | capsule | Prescription | ORAL | AB | Mar 6, 2023 |
| 2.5MG | capsule | Prescription | ORAL | AB | Mar 6, 2023 |
6. HETERO LABS LTD V
Hetero Labs Ltd Unit V has filed for 6 different strengths of generic version for Lenalidomide. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd V.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 2.5MG | capsule | Prescription | ORAL | AB | May 11, 2023 |
| 20MG | capsule | Prescription | ORAL | AB | May 11, 2023 |
| 10MG | capsule | Prescription | ORAL | AB | May 11, 2023 |
| 15MG | capsule | Prescription | ORAL | AB | May 11, 2023 |
| 5MG | capsule | Prescription | ORAL | AB | May 11, 2023 |
| 25MG | capsule | Prescription | ORAL | AB | May 11, 2023 |
7. SUN PHARM
Sun Pharmaceutical Industries Ltd has filed for 6 different strengths of generic version for Lenalidomide. Given below are the details of the strengths of this generic introduced by Sun Pharm.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | capsule | Prescription | ORAL | AB | Feb 8, 2023 |
| 15MG | capsule | Prescription | ORAL | AB | Feb 8, 2023 |
| 10MG | capsule | Prescription | ORAL | AB | Feb 8, 2023 |
| 25MG | capsule | Prescription | ORAL | AB | Feb 8, 2023 |
| 2.5MG | capsule | Prescription | ORAL | AB | Mar 6, 2023 |
| 20MG | capsule | Prescription | ORAL | AB | Mar 6, 2023 |
8. ZYDUS PHARMS
Zydus Pharmaceuticals Usa Inc has filed for 6 different strengths of generic version for Lenalidomide. Given below are the details of the strengths of this generic introduced by Zydus Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | capsule | Prescription | ORAL | AB | Sep 12, 2022 |
| 25MG | capsule | Prescription | ORAL | AB | Sep 12, 2022 |
| 15MG | capsule | Prescription | ORAL | AB | Sep 12, 2022 |
| 10MG | capsule | Prescription | ORAL | AB | Sep 12, 2022 |
| 2.5MG | capsule | Prescription | ORAL | AB | Mar 6, 2023 |
| 20MG | capsule | Prescription | ORAL | AB | Mar 6, 2023 |
9. EUGIA PHARMA
Eugia Pharma Specialities Ltd has filed for 6 different strengths of generic version for Lenalidomide. Given below are the details of the strengths of this generic introduced by Eugia Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 2.5MG | capsule | Prescription | ORAL | AB | Mar 6, 2023 |
| 5MG | capsule | Prescription | ORAL | AB | Mar 6, 2023 |
| 10MG | capsule | Prescription | ORAL | AB | Mar 6, 2023 |
| 15MG | capsule | Prescription | ORAL | AB | Mar 6, 2023 |
| 20MG | capsule | Prescription | ORAL | AB | Mar 6, 2023 |
| 25MG | capsule | Prescription | ORAL | AB | Mar 6, 2023 |
10. APOTEX
Apotex Inc has filed for 6 different strengths of generic version for Lenalidomide. Given below are the details of the strengths of this generic introduced by Apotex.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG | capsule | Prescription | ORAL | AB | Aug 30, 2022 |
| 5MG | capsule | Prescription | ORAL | AB | Aug 30, 2022 |
| 25MG | capsule | Prescription | ORAL | AB | Aug 30, 2022 |
| 15MG | capsule | Prescription | ORAL | AB | Aug 30, 2022 |
| 2.5MG | capsule | Prescription | ORAL | AB | Mar 7, 2023 |
| 20MG | capsule | Prescription | ORAL | AB | Mar 7, 2023 |
11. QILU
Qilu Pharmaceutical Co Ltd has filed for 6 different strengths of generic version for Lenalidomide. Given below are the details of the strengths of this generic introduced by Qilu.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 2.5MG | capsule | Prescription | ORAL | AB | Feb 22, 2024 |
| 10MG | capsule | Prescription | ORAL | AB | Feb 22, 2024 |
| 15MG | capsule | Prescription | ORAL | AB | Feb 22, 2024 |
| 20MG | capsule | Prescription | ORAL | AB | Feb 22, 2024 |
| 25MG | capsule | Prescription | ORAL | AB | Feb 22, 2024 |
| 5MG | capsule | Prescription | ORAL | AB | Feb 22, 2024 |
12. ARROW INTL
Arrow International Ltd has filed for 6 different strengths of generic version for Lenalidomide. Given below are the details of the strengths of this generic introduced by Arrow Intl.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 25MG | capsule | Prescription | ORAL | AB | May 21, 2021 |
| 15MG | capsule | Prescription | ORAL | AB | May 21, 2021 |
| 10MG | capsule | Prescription | ORAL | AB | May 21, 2021 |
| 5MG | capsule | Prescription | ORAL | AB | May 21, 2021 |
| 2.5MG | capsule | Prescription | ORAL | AB | Mar 6, 2023 |
| 20MG | capsule | Prescription | ORAL | AB | Mar 6, 2023 |