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).

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$8.52

per ea

Lowest NADAC/Unit

$8.52

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
42794005208AMBRISENTAN 10 MG TABLET	$8.52	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

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