Viewing data from:

POMALIDOMIDE

ANDA

POMALIDOMIDE | A210111 | BRECKENRIDGE PHARMACEUTICAL INC

4 strengths0 unique patents1 unique exclusivity

Reference Listed Drug: POMALYST(TE code: AB)

Patent Timeline

0 unique patents, 1 exclusivity by expiration date

TodayExclusivity

Today

Aug. 29, 2026

Hatch-Waxman Litigation

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
CELGENE CORPORATION v. BRECKENRIDGE PHARMACEUTICAL, INC. et al 2:2019cv05804 13 patentsANDA 210111pomalidomide	D.N.J.	2019-02-14	Terminated 2020-10-28	—
CELGENE CORPORATION v. BRECKENRIDGE PHARMACEUTICAL, INC. et al 2:2018cv14715 1 patentANDA 210111pomalidomide	D.N.J.	2018-10-05	Terminated 2019-02-07	—
CELGENE CORPORATION v. HETERO LABS LIMITED et al 2:2017cv03387 4 patentsANDA 210236, 210249, 210164, 210275, 210111pomalidomide	D.N.J.	2017-05-11	Terminated 2021-08-19	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain15 active DMFs1 inactive

14 active API suppliers hold Drug Master Files for this ingredient.

MATRIX PHARMACORP PRIVATE LTDPOMALIDOMIDE

DMF 294512015

MSN LABORATORIES PRIVATE LTDPOMALIDOMIDE [ROUTE CODE "PO"]

DMF 304082016

OLON SPAPOMALIDOMIDE

DMF 305492016

HETERO LABS LTDPOMALIDOMIDE

DMF 306682016

SYNTHON BVPOMALIDOMIDE

DMF 306962016

MATRIX PHARMACORP PRIVATE LTDPOMALIDOMIDE

DMF 309532016

NATCO PHARMA LTDPOMALIDOMIDE

DMF 311032016

DR REDDYS LABORATORIES LTDPOMALIDOMIDE

DMF 315432017

TIANJIN WEIJIE PHARMACEUTICAL CO LTDPOMALIDOMIDE

DMF 315812017

SHILPA PHARMA LIFESCIENCES LTDPOMALIDOMIDE

DMF 323092017

CHANGZHOU PHARMACEUTICAL FACTORYPOMALIDOMIDE

DMF 390692023

DEVA HOLDING ASPOMALIDOMIDE

DMF 390882024

CIPLA LTDPOMALIDOMIDE

DMF 392862023

MACLEODS PHARMACEUTICALS LTDPOMALIDOMIDE

DMF 410922025

WANYANG HENGSHUI PHARMACEUTICAL CO LTDPOMALIDOMIDE

DMF 421042025

CIPLA LTDInactivePOMALIDOMIDE

DMF 328942018

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 23, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 1MG

0 patents1 exclusivity▴

CAPSULE;ORAL | Approved: Oct 30, 2020

Exclusivities (1)

Code	Date	Status
PC	Aug 29, 2026	< 1 year

#002 — 2MG

0 patents1 exclusivity▾

CAPSULE;ORAL | Approved: Oct 30, 2020

#003 — 3MG

0 patents1 exclusivity▾

CAPSULE;ORAL | Approved: Oct 30, 2020

#004 — 4MG

0 patents1 exclusivity▾

CAPSULE;ORAL | Approved: Oct 30, 2020

Change History (4)

Recent changes detected for this application.

MODIFIEDExclusivity Expiration7/1/2026

Old: Aug 30, 2026

New: Aug 29, 2026

MODIFIEDExclusivity Expiration7/1/2026

Old: Aug 30, 2026

New: Aug 29, 2026

MODIFIEDExclusivity Expiration7/1/2026

Old: Aug 30, 2026

New: Aug 29, 2026

MODIFIEDExclusivity Expiration7/1/2026

Old: Aug 30, 2026

New: Aug 29, 2026