Pomalyst is a drug owned by Bristol Myers Squibb Co. It is protected by 27 US drug patents filed from 2013 to 2021. Out of these, 8 drug patents are active and 19 have expired. Pomalyst's patents will be open to challenges from 14 November, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 21, 2031. Details of Pomalyst'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. | |||
| US8828427 | Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione |
Jun, 2031
(6 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US8828427 (Pediatric) | Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione |
Dec, 2031
(7 years from now) | Active |
|
US10555939 (Pediatric) | Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione |
Nov, 2030
(5 years from now) | Active |
|
US9993467 (Pediatric) | Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione |
Nov, 2030
(5 years from now) | Active |
| US9993467 | Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione |
May, 2030
(5 years from now) | Active |
| US10555939 | Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione |
May, 2030
(5 years from now) | Active |
|
US8198262 (Pediatric) | Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione |
Dec, 2025
(11 months from now) | Active |
| US8198262 | Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione |
Jun, 2025
(5 months from now) | Active |
|
US8735428 (Pediatric) | Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione |
Nov, 2023
(1 year, 1 month ago) |
Expired
|
|
US8673939 (Pediatric) | Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione |
Nov, 2023
(1 year, 1 month ago) |
Expired
|
| US8735428 | Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione |
May, 2023
(1 year, 7 months ago) |
Expired
|
| US8673939 | Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione |
May, 2023
(1 year, 7 months 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
(4 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
(4 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
(4 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
(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
(4 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
(6 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
(6 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
(6 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
(6 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
(6 years ago) |
Expired
|
| US6316471 | Isoindolines, method of use, and pharmaceutical compositions |
Aug, 2016
(8 years ago) |
Expired
|
| US8158653 | Pharmaceutical compositions of 1,3-dioxo-2-(2,6-dioxopiperidin-3-yl)-4-amino isoindoline |
Aug, 2016
(8 years ago) |
Expired
|
| US6476052 | Isoindolines, method of use, and pharmaceutical compositions |
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 |
Jul, 2016
(8 years ago) |
Expired
|
| US5653517 | Process and system for determination of friction/slip characteristics of road vehicle tires |
Jul, 2016
(8 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 Pomalyst's patents.
Latest Legal Activities on Pomalyst's Patents
Given below is the list of recent legal activities going on the following patents of Pomalyst.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 08 Jul, 2024 | US8315886 |
| Maintenance Fee Reminder Mailed Critical | 05 Feb, 2024 | US8204763 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 29 Nov, 2023 | US8198262 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 26 Jul, 2023 | US10555939 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 Feb, 2022 | US8828427 |
| Expire Patent Critical | 27 Dec, 2021 | US8589188 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 24 Nov, 2021 | US9993467 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Nov, 2021 | US8735428 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Sep, 2021 | US8673939 |
| Maintenance Fee Reminder Mailed Critical | 12 Jul, 2021 | US8589188 |
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 Pomalyst and ongoing litigations to help you estimate the early arrival of Pomalyst generic.
Pomalyst's Litigations
Pomalyst 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 Pomalyst's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6045501 | April, 2015 |
Final Written Decision
(26 Oct, 2016) | Celgene Corporation | Coalition For Affordable Drugs VI LLC |
| US6315720 | April, 2015 |
FWD Entered
(26 Oct, 2016) | Celgene Corporation | Coalition for Affordable Drugs VI LLC |
| US5635517 | May, 2015 |
Terminated-Denied
(16 Nov, 2015) | Celgene Corporation | Coalition for Affordable Drugs VI LLC |
FDA has granted some exclusivities to Pomalyst. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Pomalyst, 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 Pomalyst.
Exclusivity Information
Pomalyst holds 8 exclusivities out of which 5 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Pomalyst's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 08, 2018 |
| New Indication(I-707) | Apr 23, 2018 |
| Orphan Drug Exclusivity(ODE) | Feb 08, 2020 |
| Orphan Drug Exclusivity(ODE-43) | Feb 08, 2020 |
| M(M-14) | Nov 20, 2023 |
| Orphan Drug Exclusivity(ODE-296) | May 14, 2027 |
| Orphan Drug Exclusivity(ODE-297) | May 14, 2027 |
| Pediatric Exclusivity(PED) | Nov 14, 2027 |
Several oppositions have been filed on Pomalyst'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 Pomalyst's generic, the next section provides detailed information on ongoing and past EP oppositions related to Pomalyst patents.
Pomalyst's Oppositions Filed in EPO
Pomalyst 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 |
|---|---|---|---|
| | |||
| EP18160247A | Jan, 2020 | Hoffmann Eitle | Granted and Under Opposition |
| EP18160247A | Jan, 2020 | Generics (UK) Ltd | Granted and Under Opposition |
| EP18160247A | Jan, 2020 | HGF Limited | Granted and Under Opposition |
| EP18160247A | Dec, 2019 | Pruß, Timo | Granted and Under Opposition |
| 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 | Pruß, Timo | Revoked |
| EP15199521A | Jul, 2019 | Hoffman Eitle Patent- und Rechtsanwälte Partnerschaftsgesellschaft mbB | Revoked |
| EP10720107A | Oct, 2017 | Hoffmann Eitle | Revoked |
| EP10720107A | Oct, 2017 | STADA Arzneimittel AG | Revoked |
| EP10720107A | Oct, 2017 | HGF Limited | Revoked |
| EP10720107A | Oct, 2017 | Generics [UK] Ltd | Revoked |
| EP10720107A | Oct, 2017 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP09008756A | Jul, 2015 | Accord Healthcare Ltd | Revoked |
| EP09008756A | Jul, 2015 | Generics [UK] Limited (trading as Mylan) | Revoked |
| EP09008756A | Jul, 2015 | Hexal AG | 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 Pomalyst 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 Pomalyst's family patents as well as insights into ongoing legal events on those patents.
Pomalyst's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Pomalyst's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 21, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Pomalyst Generic API suppliers:
Pomalidomide is the generic name for the brand Pomalyst. 6 different companies have already filed for the generic of Pomalyst, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Pomalyst's generic
How can I launch a generic of Pomalyst before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Pomalyst's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Pomalyst'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 Pomalyst -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg, 2 mg, 3 mg and 4 mg | 08 Feb, 2017 | 6 | 03 Oct, 2020 | 21 Jun, 2031 | Non-Forfeiture Deferred |
About Pomalyst
Pomalyst is a drug owned by Bristol Myers Squibb Co. It is used for treating multiple myeloma in patients who have already received other prior therapies. Pomalyst uses Pomalidomide as an active ingredient. Pomalyst was launched by Bristol in 2013.
Can you believe Pomalyst 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.
Approval Date:
Pomalyst was approved by FDA for market use on 08 February, 2013.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Pomalyst is 08 February, 2013, its NCE-1 date is estimated to be 14 November, 2026.
Active Ingredient:
Pomalyst uses Pomalidomide as the active ingredient. Check out other Drugs and Companies using Pomalidomide ingredient
Treatment:
Pomalyst is used for treating multiple myeloma in patients who have already received other prior therapies.
Dosage:
Pomalyst is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1MG | CAPSULE | Prescription | ORAL |
| 2MG | CAPSULE | Prescription | ORAL |
| 4MG | CAPSULE | Prescription | ORAL |
| 3MG | CAPSULE | Prescription | ORAL |