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POMALIDOMIDE

ANDA

POMALIDOMIDE | A210275 | MYLAN PHARMACEUTICALS INC

4 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
CELGENE CORPORATION v. MYLAN PHARMACEUTICALS INC. et al 2:2018cv16035 1 patentANDA 210275pomalidomide	D.N.J.	2018-11-09	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.

Products (4)

Sort:

#001 — 1MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jan 26, 2022

No patent or exclusivity listings for this strength.

#002 — 2MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 26, 2022

#003 — 3MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 26, 2022

#004 — 4MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 26, 2022