Pomalidomide Patent Expiration

Pomalidomide is used for treating multiple myeloma in patients who have already received other prior therapies. It was first introduced by Bristol Myers Squibb Co in its drug Pomalyst on Feb 8, 2013. 7 different companies have introduced drugs containing Pomalidomide.


Pomalidomide Patents

Given below is the list of patents protecting Pomalidomide, 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
Pomalyst US8828427

(Pediatric)

Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione Dec 21, 2031 Bristol
Pomalyst US8828427 Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione Jun 21, 2031 Bristol
Pomalyst US10555939

(Pediatric)

Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione Nov 19, 2030 Bristol
Pomalyst US9993467

(Pediatric)

Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione Nov 19, 2030 Bristol
Pomalyst US10555939 Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione May 19, 2030 Bristol
Pomalyst US9993467 Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione May 19, 2030 Bristol
Pomalyst US8198262

(Pediatric)

Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione Dec 17, 2025 Bristol
Pomalyst US8198262 Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione Jun 17, 2025 Bristol
Pomalyst US8673939

(Pediatric)

Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione Nov 15, 2023

(Expired)

Bristol
Pomalyst US8735428

(Pediatric)

Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione Nov 15, 2023

(Expired)

Bristol
Pomalyst US8673939 Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione May 15, 2023

(Expired)

Bristol
Pomalyst US8735428 Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione May 15, 2023

(Expired)

Bristol
Pomalyst 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
Pomalyst 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
Pomalyst 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
Pomalyst 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
Pomalyst 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
Pomalyst 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
Pomalyst 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
Pomalyst 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
Pomalyst 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
Pomalyst 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
Pomalyst US6316471 Isoindolines, method of use, and pharmaceutical compositions Aug 10, 2016

(Expired)

Bristol
Pomalyst US8158653 Pharmaceutical compositions of 1,3-dioxo-2-(2,6-dioxopiperidin-3-yl)-4-amino isoindoline Aug 10, 2016

(Expired)

Bristol
Pomalyst US5635517 Method of reducing TNFα levels with amino substituted 2-(2,6-dioxopiperidin-3-yl)-1-oxo-and 1,3-dioxoisoindolines Jul 24, 2016

(Expired)

Bristol
Pomalyst US5653517 Process and system for determination of friction/slip characteristics of road vehicle tires Jul 24, 2016

(Expired)

Bristol
Pomalyst US6476052 Isoindolines, method of use, and pharmaceutical compositions Jul 24, 2016

(Expired)

Bristol



Pomalidomide's Family Patents

Family Patents

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Pomalidomide Generic API Manufacturers

Several generic applications have been filed for Pomalidomide. The first generic version for Pomalidomide was by Breckenridge Pharmaceutical Inc and was approved on Oct 30, 2020. And the latest generic version is by Hetero Labs Ltd Unit V and was approved on Sep 26, 2024.

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


1. APOTEX

Apotex Inc has filed for 4 different strengths of generic version for Pomalidomide. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
4MG

capsule Prescription ORAL AB Jun 11, 2024
1MG

capsule Prescription ORAL AB Jun 11, 2024
2MG

capsule Prescription ORAL AB Jun 11, 2024
3MG

capsule Prescription ORAL AB Jun 11, 2024


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. BRECKENRIDGE

Breckenridge Pharmaceutical Inc has filed for 4 different strengths of generic version for Pomalidomide. Given below are the details of the strengths of this generic introduced by Breckenridge.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG

capsule Discontinued ORAL N/A Oct 30, 2020
2MG

capsule Discontinued ORAL N/A Oct 30, 2020
3MG

capsule Discontinued ORAL N/A Oct 30, 2020
4MG

capsule Discontinued ORAL N/A Oct 30, 2020


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Boca Raton Breckenridge Pharmaceutical, Inc.
Berlin Breckenridge Pharmaceutical, Inc





3. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 4 different strengths of generic version for Pomalidomide. 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
1MG

capsule Discontinued ORAL N/A Oct 30, 2020
4MG

capsule Discontinued ORAL N/A Oct 30, 2020
3MG

capsule Discontinued ORAL N/A Oct 30, 2020
2MG

capsule Discontinued ORAL N/A Oct 30, 2020


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





4. HETERO LABS LTD V

Hetero Labs Ltd Unit V has filed for 4 different strengths of generic version for Pomalidomide. 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
2MG

capsule Prescription ORAL AB Sep 26, 2024
1MG

capsule Prescription ORAL AB Sep 26, 2024
4MG

capsule Prescription ORAL AB Sep 26, 2024
3MG

capsule Prescription ORAL AB Sep 26, 2024





5. MYLAN

Mylan Pharmaceuticals Inc has filed for 4 different strengths of generic version for Pomalidomide. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
4MG

capsule Discontinued ORAL N/A Jan 26, 2022
1MG

capsule Discontinued ORAL N/A Jan 26, 2022
2MG

capsule Discontinued ORAL N/A Jan 26, 2022
3MG

capsule Discontinued ORAL N/A Jan 26, 2022


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





6. TEVA PHARMS USA

Teva Pharmaceuticals Usa Inc has filed for 4 different strengths of generic version for Pomalidomide. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG

capsule Discontinued ORAL N/A May 4, 2022
4MG

capsule Discontinued ORAL N/A May 4, 2022
2MG

capsule Discontinued ORAL N/A May 4, 2022
3MG

capsule Discontinued ORAL N/A May 4, 2022