Lenalidomide Patent Expiration

Lenalidomide is used for treating mantle cell lymphoma, multiple myeloma, and myelodysplastic syndromes. It was first introduced by Bristol Myers Squibb in its drug Revlimid on Dec 27, 2005. 14 different companies have introduced drugs containing Lenalidomide.


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 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 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 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 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 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 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 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 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
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 US8404717 Methods of treating myelodysplastic syndromes using lenalidomide Apr 11, 2023

(Expired)

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 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 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 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 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 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 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 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 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 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 US6281230 Isoindolines, method of use, and pharmaceutical compositions Jul 24, 2016

(Expired)

Bristol Myers Squibb
Revlimid US6555554 Isoindolines, method of use, and pharmaceutical compositions Jul 24, 2016

(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 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



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.

Given below is the list recent legal activities going on the following patents of Lenalidomide.

Activity Date Patent Number
Patent litigations
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


Lenalidomide's Family Patents

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Lenalidomide Generic API Manufacturers

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 Novugen Oncology Sdn Bhd and was approved on Sep 11, 2024.

Given below is the list of companies who have filed for Lenalidomide generic, along with the locations of their manufacturing plants worldwide.


1. 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
25MG

capsule Prescription ORAL AB Aug 30, 2022
15MG

capsule Prescription ORAL AB Aug 30, 2022
5MG

capsule Prescription ORAL AB Aug 30, 2022
20MG

capsule Prescription ORAL AB Mar 7, 2023
2.5MG

capsule Prescription ORAL AB Mar 7, 2023


Manufacturing Plant Locations
New

Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.

Country City Firm Name
United States
Weston Apotex Corp.
Canada
Brantford Apotex Pharmachem Inc.
Winnipeg Apotex Fermentation Inc.
Etobicoke Apotex, Inc.
North York Apotex Inc.
Richmond Hill Apotex Inc.
Toronto Apotex Inc.
India
Bangalore Apotex Research Private Limited - Bioequivalence Centre
Bengaluru Apotex Research Private Limited
Bangalore Apotex Pharmachem India Pvt Ltd.





2. 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
15MG

capsule Prescription ORAL AB May 21, 2021
5MG

capsule Prescription ORAL AB May 21, 2021
10MG

capsule Prescription ORAL AB May 21, 2021
25MG

capsule Prescription ORAL AB May 21, 2021
20MG

capsule Prescription ORAL AB Mar 6, 2023
2.5MG

capsule Prescription ORAL AB Mar 6, 2023





3. 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
25MG

capsule Prescription ORAL AB Sep 6, 2022
15MG

capsule Prescription ORAL AB Sep 6, 2022
10MG

capsule Prescription ORAL AB Sep 6, 2022
5MG

capsule Prescription ORAL AB Sep 6, 2022
20MG

capsule Prescription ORAL AB Mar 6, 2023
2.5MG

capsule Prescription ORAL AB Mar 6, 2023


Manufacturing Plant Locations
New

Cipla's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Cipla as present at those locations.

Country City Firm Name
India
Bengaluru Cipla Limited
Bangalore Cipla Ltd.
Vasco Da Gama Cipla Limited
Pithampur, District Dhar Cipla Limited
Mumbai Cipla Limited
Raigad Cipla Limited
Kurkumbh Village, Dist. Pune Cipla, Ltd.





4. 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
5MG

capsule Prescription ORAL AB Aug 30, 2022
10MG

capsule Prescription ORAL AB Aug 30, 2022
15MG

capsule Prescription ORAL AB Aug 30, 2022
25MG

capsule Prescription ORAL AB Aug 30, 2022





5. 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
20MG

capsule Prescription ORAL AB Mar 6, 2023
5MG

capsule Prescription ORAL AB Mar 6, 2023
15MG

capsule Prescription ORAL AB Mar 6, 2023
25MG

capsule Prescription ORAL AB Mar 6, 2023
2.5MG

capsule Prescription ORAL AB Mar 6, 2023
10MG

capsule Prescription ORAL AB Mar 6, 2023


Manufacturing Plant Locations
New

Eugia Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Eugia Pharma as present at those locations.

Country City Firm Name
India
Pashamylaram Eugia Pharma Specialities Limited
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited
Riico Industrial Area EUGIA Pharma Specialities Limited





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
15MG

capsule Prescription ORAL AB May 11, 2023
20MG

capsule Prescription ORAL AB May 11, 2023
2.5MG

capsule Prescription ORAL AB May 11, 2023
25MG

capsule Prescription ORAL AB May 11, 2023
10MG

capsule Prescription ORAL AB May 11, 2023
5MG

capsule Prescription ORAL AB May 11, 2023





7. 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
10MG

capsule Prescription ORAL AB Aug 31, 2022
5MG

capsule Prescription ORAL AB Aug 31, 2022
15MG

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





8. 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
5MG

capsule Prescription ORAL AB Aug 30, 2022
10MG

capsule Prescription ORAL AB Aug 30, 2022
15MG

capsule Prescription ORAL AB Aug 30, 2022
25MG

capsule Prescription ORAL AB Aug 30, 2022
20MG

capsule Prescription ORAL AB Mar 6, 2023
2.5MG

capsule Prescription ORAL AB Mar 6, 2023


Manufacturing Plant Locations
New

Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.

Country City Firm Name
United States
San Carlos Mylan Pharmaceuticals Inc.
Rockford Mylan Institutional, Inc.
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
Morgantown Mylan Specialty, L.P.
Greensboro Mylan Pharmaceuticals Inc
Saint Albans Mylan Technologies, Inc.
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
India
Sinnar Mylan Laboratories Limited
Aurangabad Mylan Laboratories Limited (FDF-2)
Hosur Mylan Laboratories Limited
Bangalore Mylan Laboratories Limited
Hyderabad Mylan Laboratories Limited
Sarigam Mylan Laboratories Limited
Pithampur, District Dhar Mylan Laboratories Limited
Anekal Taluk, Bangalore Mylan Laboratories Limited
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta





9. NOVUGEN

Novugen Oncology Sdn Bhd has filed for 6 different strengths of generic version for Lenalidomide. Given below are the details of the strengths of this generic introduced by Novugen.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2.5MG

capsule Prescription ORAL AB Sep 11, 2024
5MG

capsule Prescription ORAL AB Sep 11, 2024
10MG

capsule Prescription ORAL AB Sep 11, 2024
15MG

capsule Prescription ORAL AB Sep 11, 2024
20MG

capsule Prescription ORAL AB Sep 11, 2024
25MG

capsule Prescription ORAL AB Sep 11, 2024





10. 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
10MG

capsule Discontinued ORAL N/A Feb 22, 2024
2.5MG

capsule Discontinued ORAL N/A Feb 22, 2024
5MG

capsule Discontinued ORAL N/A Feb 22, 2024
15MG

capsule Discontinued ORAL N/A Feb 22, 2024
20MG

capsule Discontinued ORAL N/A Feb 22, 2024
25MG

capsule Discontinued ORAL N/A Feb 22, 2024


Manufacturing Plant Locations
New

Qilu's manufacturing plants are situated in 1 country - China. Given below are the details of these plant locations as well as the firm names of Qilu as present at those locations.

Country City Firm Name
China
Hulunbeier Qilu Pharmaceutical Hulun Buir Branch
Jinan Qilu Pharmaceutical Co., Ltd.
Jinan Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site)
Jinan Qilu Antibiotics Pharmaceutical Co. , Ltd.
Haikou Qilu Pharmaceutical (Hainan) Co. Ltd.
Hohhot Qilu Pharmaceutical (Inner Mongolia) Co., Ltd.
Dezhou Qilu SYNVA Pharmaceutical Co. Ltd





11. 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
25MG

capsule Prescription ORAL AB Feb 8, 2023
5MG

capsule Prescription ORAL AB Feb 8, 2023
10MG

capsule Prescription ORAL AB Feb 8, 2023
15MG

capsule Prescription ORAL AB Feb 8, 2023
2.5MG

capsule Prescription ORAL AB Mar 6, 2023
20MG

capsule Prescription ORAL AB Mar 6, 2023


Manufacturing Plant Locations
New

Sun Pharm's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Sun Pharm as present at those locations.

Country City Firm Name
United States
Lexington Sun Pharmaceutical Industries Inc
Billerica Sun Pharmaceutical Industries, Inc.
Princeton SUN PHARMACEUTICAL INDUSTRIES INC
India
Halol Sun Pharmaceutical Industries Ltd.
New Delhi Sun Pharmaceutical Industries Limited
Punjab Sun Pharmaceutical Industries, Inc.
Ahmednagar Sun Pharmaceutical Industries Limited
Malanpur, Bhind (District) Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Ltd
Gurugram Sun Pharmaceutical Industries Limited (prev. Ranbaxy)
Mohali Sun Pharmaceutical Industries Limited
Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam
Baruch Sun Pharmaceutical Industries Ltd.
Vadodara Sun Pharmaceutical Industries Ltd.
Vadodara Sun Pharmaceutical Industries Limited - Karkhadi
Dadra Sun Pharmaceutical Industries Limited
Bharuch Sun Pharmaceutical Industries Ltd





12. 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
25MG

capsule Discontinued ORAL N/A Feb 17, 2023
10MG

capsule Discontinued ORAL N/A Feb 17, 2023
20MG

capsule Discontinued ORAL N/A Aug 3, 2023


Manufacturing Plant Locations
New

Torrent's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Torrent as present at those locations.

Country City Firm Name
India
Bharuch Torrent Pharmaceuticals Limited
Pithampur Torrent Pharmaceuticals Limited
Indrad Torrent Pharmaceuticals Limited
Gandhi Nagar Torrent Pharmaceuticals Limited
Thanam Torrent Pharmaceuticals Limited
United States
Kalamazoo Torrent Pharma Inc.
Basking Ridge Torrent Pharma Inc.





13. 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
10MG

capsule Prescription ORAL AB Sep 12, 2022
15MG

capsule Prescription ORAL AB Sep 12, 2022
2.5MG

capsule Prescription ORAL AB Mar 6, 2023
20MG

capsule Prescription ORAL AB Mar 6, 2023





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