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, 2 drug patents are active and 28 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7465800 | Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione |
Apr, 2027
(6 months from now) | Active |
| US7855217 | Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione |
Nov, 2024
(1 year, 10 months 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
(7 years ago) |
Expired
|
| US8288415 | Pharmaceutical compositions of 3-(4-amino-1-oxoisoindolin-2yl)-piperidine-2,6-dione |
Jul, 2016
(10 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| 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
(1 year, 5 months from now) | Active |
| US8492406 | Methods for treatment of follicular lymphoma using 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione |
Oct, 2023
(2 years 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
(2 years 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
(2 years 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
(3 years 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
(3 years 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
(3 years 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
(3 years 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
(3 years 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
(3 years ago) |
Expired
|
| US8404717 | Methods of treating myelodysplastic syndromes using lenalidomide |
Apr, 2023
(3 years 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
(3 years ago) |
Expired
|
| US9056120 | Methods of treating myelodysplastic syndromes with a combination therapy using lenalidomide and azacitidine |
Apr, 2023
(3 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
(5 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
(5 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
(5 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
(5 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
(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
(7 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
(8 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
(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
(8 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
(8 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
(8 years ago) |
Expired
|
| US8288415 | Pharmaceutical compositions of 3-(4-amino-1-oxoisoindolin-2yl)-piperidine-2,6-dione |
Jul, 2016
(10 years ago) |
Expired
|
| US6281230 | Isoindolines, method of use, and pharmaceutical compositions |
Jul, 2016
(10 years ago) |
Expired
|
| US7119106 | Pharmaceutical compositions of 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline |
Jul, 2016
(10 years ago) |
Expired
|
| US6555554 | Isoindolines, method of use, and pharmaceutical compositions |
Jul, 2016
(10 years ago) |
Expired
|
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.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent | 09 Feb, 2026 | US8626531 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 19 Nov, 2025 | US8741929 |
| Expire Patent | 13 Oct, 2025 | US8530498 (Litigated) |
| Maintenance Fee Reminder Mailed | 29 Sep, 2025 | US8648095 (Litigated) |
| Maintenance Fee Reminder Mailed | 25 Aug, 2025 | US8626531 |
| Expire Patent | 25 Aug, 2025 | US8492406 |
| Maintenance Fee Reminder Mailed | 28 Apr, 2025 | US8530498 (Litigated) |
| Expire Patent | 28 Apr, 2025 | US8404717 |
| Maintenance Fee Reminder Mailed | 10 Mar, 2025 | US8492406 |
| Expire Patent | 23 Dec, 2024 | US8315886 |
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 been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on May 07, 2015, against patent number US5635517. The petitioner Coalition for Affordable Drugs VI LLC, challenged the validity 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 |
Institution Denied
(14 Mar, 2019) | Celgene Corporation | Alvogen Pine Brook LLC et al. |
| US7189740 | August, 2018 |
Institution Denied
(11 Feb, 2019) | Celgene Corporation | Dr. Reddy's Laboratories, Inc. et al. |
| US8404717 | August, 2018 |
Institution Denied
(11 Feb, 2019) | Celgene Corporation | Dr. Reddy's Laboratories, Inc et al. |
| US9056120 | August, 2018 |
Institution Denied
(11 Feb, 2019) | Celgene Corporation | Dr. Reddy's Laboratories, Inc. et al. |
| US8741929 | February, 2018 |
Institution Denied
(27 Sep, 2018) | Celgene Corporation | Apotex Inc. et al. |
| US6045501 | April, 2015 |
Final Written Decision
(26 Oct, 2016) | Celgene Corporation | Coalition For Affordable Drugs VI LLC |
| US6315720 | April, 2015 |
Final Written Decision
(26 Oct, 2016) | Celgene Corporation | Coalition for Affordable Drugs VI LLC |
| US5635517 | May, 2015 |
Institution Denied
(16 Nov, 2015) | Celgene Corporation | Coalition for Affordable Drugs VI LLC |
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. All of its exclusivities have expired 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-241) | May 28, 2026 |
| Orphan Drug Exclusivity(ODE-245) | 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
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Revlimid:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
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 Generic API suppliers:
Lenalidomide is the generic name for the brand Revlimid. 18 different companies have already filed for the generic of Revlimid, with Cipla 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 | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 12 Jul, 2016 | 27 Apr, 2027 | Non-Forfeiture | 14 Oct, 2021 | Less | |
| 30 Aug, 2010 | 27 Apr, 2027 | Non-Forfeiture | 21 May, 2021 | Less | |
| 12 Jul, 2010 | 27 Apr, 2027 | Non-Forfeiture | 21 May, 2021 | Less |
Alternative Brands for Revlimid
Revlimid which is used for treating mantle cell lymphoma, multiple myeloma, and myelodysplastic syndromes., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Bristol-myers |
| |||
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 in 2011.
Approval 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 |
|---|---|---|---|
| 15MG | CAPSULE | Prescription | ORAL |
| 5MG | CAPSULE | Prescription | ORAL |
| 10MG | CAPSULE | Prescription | ORAL |
| 20MG | CAPSULE | Prescription | ORAL |
| 2.5MG | CAPSULE | Prescription | ORAL |
| 25MG | CAPSULE | Prescription | ORAL |