Viewing data from:

POMALIDOMIDE

ANDA

POMALIDOMIDE | A213234 | DR REDDYS LABORATORIES LTD

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: POMALYST(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
CELGENE CORPORATION v. DR. REDDY'S LABORATORIES, LTD. et al 2:2019cv15343 5 patentsANDA 213234pomalidomide	D.N.J.	2019-07-12	Terminated 2022-04-06	—

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

WANYANG HENGSHUI PHARMACEUTICAL CO LTDPOMALIDOMIDE

DMF 421042025

CHANGZHOU PHARMACEUTICAL FACTORYPOMALIDOMIDE

DMF 390692023

DEVA HOLDING ASPOMALIDOMIDE

DMF 390882024

CIPLA LTDPOMALIDOMIDE

DMF 392862023

MACLEODS PHARMACEUTICALS LTDPOMALIDOMIDE

DMF 410922025

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
Feb 14, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 1MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Aug 31, 2026

No patent or exclusivity listings for this strength.

#002 — 2MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 31, 2026

#003 — 3MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 31, 2026

#004 — 4MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 31, 2026