Revlimid is a drug owned by Bristol Myers Squibb. It is protected by 30 US drug patents filed from 2013 to 2019. Out of these, 3 drug patents are active and 27 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 08, 2028. Details of Revlimid's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US8288415 | Pharmaceutical compositions of 3-(4-amino-1-oxoisoindolin-2yl)-piperidine-2,6-dione |
Jul, 2016
(8 years ago) |
Expired
|
| US5635517 | Method of reducing TNFα levels with amino substituted 2-(2,6-dioxopiperidin-3-yl)-1-oxo-and 1,3-dioxoisoindolines |
Oct, 2019
(4 years ago) |
Expired
|
| US7855217 | Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione |
Nov, 2024
(3 months from now) | Active |
| US7465800 | Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione |
Apr, 2027
(2 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8288415 | Pharmaceutical compositions of 3-(4-amino-1-oxoisoindolin-2yl)-piperidine-2,6-dione |
Jul, 2016
(8 years ago) |
Expired
|
| US6281230 | Isoindolines, method of use, and pharmaceutical compositions |
Jul, 2016
(8 years ago) |
Expired
|
| US6555554 | Isoindolines, method of use, and pharmaceutical compositions |
Jul, 2016
(8 years ago) |
Expired
|
| US7119106 | Pharmaceutical compositions of 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline |
Jul, 2016
(8 years ago) |
Expired
|
| US6561976 | Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug |
Aug, 2018
(5 years ago) |
Expired
|
| US6045501 | Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug |
Aug, 2018
(5 years ago) |
Expired
|
| US8589188 | Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug |
Aug, 2018
(5 years ago) |
Expired
|
| US6908432 | Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug |
Aug, 2018
(5 years ago) |
Expired
|
| US8204763 | Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug |
Aug, 2018
(5 years ago) |
Expired
|
| US5635517 | Method of reducing TNFα levels with amino substituted 2-(2,6-dioxopiperidin-3-yl)-1-oxo-and 1,3-dioxoisoindolines |
Oct, 2019
(4 years ago) |
Expired
|
| 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, 2020
(3 years ago) |
Expired
|
| 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, 2020
(3 years ago) |
Expired
|
| 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, 2020
(3 years ago) |
Expired
|
| 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, 2020
(3 years ago) |
Expired
|
| 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, 2020
(3 years ago) |
Expired
|
| US9056120 | Methods of treating myelodysplastic syndromes with a combination therapy using lenalidomide and azacitidine |
Apr, 2023
(1 year, 3 months ago) |
Expired
|
| US8404717 | Methods of treating myelodysplastic syndromes using lenalidomide |
Apr, 2023
(1 year, 3 months ago) |
Expired
|
| 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, 2023
(1 year, 3 months ago) |
Expired
|
| 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, 2023
(1 year, 2 months ago) |
Expired
|
| 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, 2023
(1 year, 2 months ago) |
Expired
|
| 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, 2023
(1 year, 2 months ago) |
Expired
|
| 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, 2023
(1 year, 2 months ago) |
Expired
|
| 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, 2023
(1 year, 2 months ago) |
Expired
|
| US8530498 | Methods for treating multiple myeloma with 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)piperidine-2,6-dione |
May, 2023
(1 year, 2 months ago) |
Expired
|
| US7968569 | Methods for treatment of multiple myeloma using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione |
Oct, 2023
(9 months ago) |
Expired
|
| US8492406 | Methods for treatment of follicular lymphoma using 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione |
Oct, 2023
(9 months ago) |
Expired
|
| US7468363 | Methods for treatment of cancers using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione |
Oct, 2023
(9 months ago) |
Expired
|
| 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, 2028
(3 years from now) | Active |
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 Revlimid's patents.
Latest Legal Activities on Revlimid's Patents
Given below is the list of recent legal activities going on the following patents of Revlimid.
| 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 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Revlimid and ongoing litigations to help you estimate the early arrival of Revlimid generic.
Revlimid's Litigations
Revlimid has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Feb 23, 2018, against patent number US8741929. The petitioner Apotex Inc., challenged the validity or infringement of this patent, with Celgene Corporation as the respondent. Click below to track the latest information on how companies are challenging Revlimid's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7968569 | September, 2018 | Terminated-Denied | Celgene Corporation | Alvogen Pine Brook LLC |
| US7189740 | August, 2018 | Terminated-Denied | Celgene Corporation | Dr. Reddy's Laboratories, Inc. |
| US8404717 | August, 2018 | Terminated-Denied | Celgene Corporation | Dr. Reddy's Laboratories, Inc |
| US9056120 | August, 2018 | Terminated-Denied | Celgene Corporation | Dr. Reddy's Laboratories, Inc. |
| US8741929 | February, 2018 | Terminated-Denied | Celgene Corporation | Apotex Inc. |
FDA has granted some exclusivities to Revlimid. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Revlimid, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Revlimid.
Exclusivity Information
Revlimid holds 11 exclusivities out of which 9 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Revlimid's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE) | Jun 05, 2020 |
| New Indication(I-672) | Jun 05, 2016 |
| New Strength(NS) | Jun 05, 2016 |
| New Indication(I-706) | Feb 17, 2018 |
| Orphan Drug Exclusivity(ODE-49) | Jun 05, 2020 |
| Orphan Drug Exclusivity(ODE-88) | Feb 17, 2022 |
| New Indication(I-796) | May 28, 2022 |
| New Indication(I-797) | May 28, 2022 |
| Orphan Drug Exclusivity(ODE-131) | Feb 22, 2024 |
| Orphan Drug Exclusivity(ODE-245) | May 28, 2026 |
| Orphan Drug Exclusivity(ODE-241) | May 28, 2026 |
Several oppositions have been filed on Revlimid's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Revlimid's generic, the next section provides detailed information on ongoing and past EP oppositions related to Revlimid patents.
Revlimid's oppositions filed in EPO
Revlimid has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Nov 30, 2010, by Synthon B.V.. This opposition was filed on patent number EP03728969A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP15199540A | Aug, 2019 | Generics (UK) Ltd | Revoked |
| EP15199521A | Aug, 2019 | Hamm&Wittkopp Patentanwälte PartmbB | Revoked |
| EP15199521A | Aug, 2019 | Bachelin, Martin, Dr. | Revoked |
| EP15199521A | Aug, 2019 | Generics [UK] Ltd | Revoked |
| EP15199526A | Aug, 2019 | Generics [UK] Ltd | Revoked |
| EP15199521A | Jul, 2019 | Hoffman Eitle Patent- und Rechtsanwälte Partnerschaftsgesellschaft mbB | Revoked |
| EP15199521A | Jul, 2019 | Pruß, Timo | Revoked |
| EP09008756A | Jul, 2015 | Accord Healthcare Ltd | Revoked |
| EP09008756A | Jul, 2015 | Hexal AG | Revoked |
| EP09008756A | Jul, 2015 | Generics [UK] Limited (trading as Mylan) | Revoked |
| EP09008756A | Jul, 2015 | Intellectual Property Services | Revoked |
| EP09008756A | Jul, 2015 | Synthon B.V. | Revoked |
| EP09008756A | Jul, 2015 | Actavis Group PTC EHF | Revoked |
| EP04783095A | Aug, 2012 | Teva Pharmaceutical Industries Ltd. | Revoked |
| EP04783095A | Aug, 2012 | Generics [UK] Limited | Revoked |
| EP03728969A | Dec, 2010 | STRAWMAN LIMITED | Revoked |
| EP03728969A | Nov, 2010 | Synthon B.V. | Revoked |
US patents provide insights into the exclusivity only within the United States, but Revlimid is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Revlimid's family patents as well as insights into ongoing legal events on those patents.
Revlimid's family patents
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Generic Launch
Generic Release Date:
Revlimid's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 08, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Revlimid Generics:
Lenalidomide is the generic name for the brand Revlimid. 12 different companies have already filed for the generic of Revlimid, with Zydus Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Revlimid's generic
How can I launch a generic of Revlimid before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Revlimid's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Revlimid's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Revlimid -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg, 10 mg and 15 mg | 30 Aug, 2010 | 1 | 21 May, 2021 | 27 Apr, 2027 | Non-Forfeiture |
| 25 mg | 12 Jul, 2010 | 1 | 21 May, 2021 | 27 Apr, 2027 | Non-Forfeiture |
| 2.5 mg and 20 mg | 12 Jul, 2016 | 1 | 14 Oct, 2021 | 27 Apr, 2027 | Non-Forfeiture |
About Revlimid
Revlimid is a drug owned by Bristol Myers Squibb. It is used for treating mantle cell lymphoma, multiple myeloma, and myelodysplastic syndromes. Revlimid uses Lenalidomide as an active ingredient. Revlimid was launched by Bristol Myers Squibb in 2011.
Can you believe Revlimid received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Market Authorisation Date:
Revlimid was approved by FDA for market use on 21 December, 2011.
Active Ingredient:
Revlimid uses Lenalidomide as the active ingredient. Check out other Drugs and Companies using Lenalidomide ingredient
Treatment:
Revlimid is used for treating mantle cell lymphoma, multiple myeloma, and myelodysplastic syndromes.
Dosage:
Revlimid is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 25MG | CAPSULE | Prescription | ORAL |
| 5MG | CAPSULE | Prescription | ORAL |
| 10MG | CAPSULE | Prescription | ORAL |
| 2.5MG | CAPSULE | Prescription | ORAL |
| 20MG | CAPSULE | Prescription | ORAL |
| 15MG | CAPSULE | Prescription | ORAL |