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APREMILAST

ANDA

APREMILAST | A211734 | MANKIND PHARMA LTD

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: OTEZLA(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
AMGEN INC. v. MANKIND PHARMA LTD. 3:2018cv11081 2 patentsANDA 211734apremilast	D.N.J.	2018-06-26	Terminated 2020-08-06	—

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

API Supply Chain34 active DMFs1 inactive

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

LUPIN MANUFACTURING SOLUTIONS LTDAPREMILAST

DMF 302482016

MSN LIFE SCIENCES PRIVATE LTDAPREMILAST [ROUTE CODE LI]

DMF 303322016

DR REDDYS LABORATORIES LTDAPREMILAST (FORM B)

DMF 307322016

MSN LIFE SCIENCES PRIVATE LTDAPREMILAST (FORM-M)

DMF 308662016

ZAKLADY FARMACEUTYCZNE POLPHARMA SAAPREMILAST

DMF 311412016

MSN LIFE SCIENCES PRIVATE LTDAPREMILAST (AMORPHOUS)

DMF 311592016

RAKS PHARMA PVT LTDAPREMILAST

DMF 311802016

LUPIN MANUFACTURING SOLUTIONS LTDAPREMILAST (FORM M)

DMF 312662017

DR REDDYS LABORATORIES LTDAPREMILAST [AMORPHOUS]

DMF 313562017

MSN LIFE SCIENCES PRIVATE LTDAPREMILAST

DMF 313602017

ALIVUS LIFE SCIENCES LTDAPREMILAST

DMF 314902017

LEK PHARMACEUTICALS DDAPREMILAST

DMF 318092017

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDAPREMILAST

DMF 318822017

CIPLA LTDAPREMILAST

DMF 320032017

SCINOPHARM TAIWAN LTDAPREMILAST

DMF 320582017

ALKEM LABORATORIES LTDAPREMILAST

DMF 321142017

QUIMICA SINTETICA SAAPREMILAST

DMF 321192017

APITORIA PHARMA PRIVATE LTDAPREMILAST

DMF 321262017

MACLEODS PHARMACEUTICALS LTDAPREMILAST

DMF 321492017

MATRIX PHARMACORP PRIVATE LTDAPREMILAST (CRYSTALLINE)

DMF 321502017

ALEMBIC PHARMACEUTICALS LTDAPREMILAST

DMF 321772017

ZYDUS LIFESCIENCES LTDAPREMILAST

DMF 322232017

HETERO DRUGS LTDAPREMILAST (FORM-B)

DMF 322362017

UNICHEM LABORATORIES LTDAPREMILAST

DMF 323732017

SUN PHARMACEUTICAL INDUSTRIES LTDAPREMILAST

DMF 324732018

NEULAND LABORATORIES LTDAPREMILAST

DMF 329532018

ALEMBIC PHARMACEUTICALS LTDAPREMILAST (FORM-B)

DMF 336552019

RUYUAN HEC PHARM CO LTDAPREMILAST NON-STERILE BULK DRUG SUBSTANCE

DMF 340882019

JUBILANT PHARMOVA LTDAPREMILAST

DMF 344472020

QUIMICA SINTETICA SAAPREMILAST (PROCESS II)

DMF 349152020

CHANGZHOU PHARMACEUTICAL FACTORYAPREMILAST

DMF 378822022

ANHUI POLY PHARM CO LTDAPREMILAST

DMF 384372023

ZHEJIANG HUAYI PHARMACEUTICAL CO LTDAPREMILAST

DMF 391012023

MEGAFINE PHARMA P LTDAPREMILAST (NON-STERILE DRUG SUBSTANCE)

DMF 408342024

INTAS PHARMACEUTICALS LTDInactiveAPREMILAST (AMORPHOUS)

DMF 321792017

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 24, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 10MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 7, 2024

No patent or exclusivity listings for this strength.

#002 — 20MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 7, 2024

#003 — 30MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 7, 2024