Viewing data from:

AMBRISENTAN

ANDA

AMBRISENTAN | A208354 | SIGMAPHARM LABORATORIES LLC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: LETAIRIS(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
GILEAD SCIENCES, INC. et al v. SIGMAPHARM LABORATORIES, LLC 1:2015cv04898 1 patentANDA 208354ambrisentan	D.N.J.	2015-06-30	Terminated 2017-05-11	—

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

API Supply Chain9 active DMFs1 inactive

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

MATRIX PHARMACORP PRIVATE LTDAMBRISENTAN

DMF 245052010

MSN LABORATORIES PRIVATE LTDAMBRISENTAN [ROUTE CODE - AB]

DMF 261562012

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDAMBRISENTAN

DMF 275052013

MEDICHEM MANUFACTURING (MALTA) LTDAMBRISENTAN (MED-200028/M)

DMF 287812014

CIPLA LTDAMBRISENTAN

DMF 294902015

MEGAFINE PHARMA P LTDAMBRISENTAN

DMF 297922015

JIANGSU JOYGLORY PHARMACEUTICAL CO LTDAMBRISENTAN

DMF 307992016

TIANJIN WEIJIE PHARMACEUTICAL CO LTDAMBRISENTAN

DMF 311332016

SUN PHARMACEUTICAL INDUSTRIES LTDAMBRISENTAN

DMF 361052021

WATSON PHARMA PRIVATE LTDInactiveAMBRISENTAN

DMF 251342011

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

Products (2)

Sort:

#001 — 5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 10, 2019

No patent or exclusivity listings for this strength.

#002 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 10, 2019