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Ambrisentan - Generic Drug Details

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What are the generic drug sources for ambrisentan and what is the scope of ambrisentan patent protection?

Ambrisentan is the generic ingredient in one branded drug marketed by Gilead and is included in one NDA. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ambrisentan has one hundred and twelve patent family members in thirty-five countries.

There are nine drug master file entries for ambrisentan. One supplier is listed for this compound.

Summary for ambrisentan

International Patents:	112
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	9
Suppliers / Packagers:	1
Bulk Api Vendors:	65
Clinical Trials:	51
Patent Applications:	1,633
Formulation / Manufacturing:	see details
Drug Prices:	see low prices
DailyMed Link:	ambrisentan at DailyMed

Pharmacology for ambrisentan

Drug Class	Endothelin Receptor Antagonist
Mechanism of Action	Endothelin Receptor Antagonists

Synonyms for ambrisentan

(+-)-(2S)-2-((4,6-Dimethylpyrimidin-2-yl)oxy)-3-methoxy-3,3-diphenylpropanoic acid

(2S)-2-(4,6-dimethylpyrimidin-2-yl)oxy-3-methoxy-3,3-di(phenyl)propanoic acid

(2S)-2-(4,6-dimethylpyrimidin-2-yl)oxy-3-methoxy-3,3-diphenyl-propanoic acid

(2S)-2-(4,6-dimethylpyrimidin-2-yl)oxy-3-methoxy-3,3-diphenylpropanoic acid

(2S)-2-[(4,6-dimethyl-2-pyrimidinyl)oxy]-3-methoxy-3,3-diphenylpropanoic acid

(2S)-2-[(4,6-dimethylpyrimidin-2-yl)oxy]-3-methoxy- 3,3-diphenylpropanoic acid

(S)-2-((4,6-Dimethylpyrimidin-2-yl)oxy)-3-methoxy-3,3-diphenylpropanoic acid

(S)-2-(4,6-Dimethyl-pyrimidin-2-yloxy)-3-methoxy-3,3-diphenyl-propionic acid

(S)-2-(4,6-Dimethylpyrimidin-2-yloxy)-3-methoxy-3,3-diphenylpropanoic acid

(s)-2-[(4,6-dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenylpropionic acid

177036-94-1

2-(4,6-dimethylpyrimidin-2-yl)oxy-3-methoxy-3,3-diphenyl-propanoic acid

2-(4,6-dimethylpyrimidin-2-yl)oxy-3-methoxy-3,3-diphenylpropanoic acid

2-[(4,6-dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenylpropanoic acid

A812234

AB0009811

AB01566890_01

AB2000501

AC-9015

AC1OCFHZ

AJ-23403

AK-38379

AKOS015994540

Ambrisentan (JAN/INN)

Ambrisentan [INN:BAN:JAN]

Ambrisentan [INN]

ANW-59416

AX8118907

BC224510

BDBM50146710

Benzenepropanoic acid, .alpha.-[(4,6-dimethyl-2-pyrimidinyl)oxy]-.beta.-methoxy-.beta.-phe

BSF 208075

BSF 208075;AMBRISENTAN

BSF-208075

BSF208075

CA0131

CAS-177036-94-1

CHEBI:135949

CHEMBL1111

CS-0447

CTK8B8152

D07077

D0X5ZI

DB06403

DE-0223

DSSTox_CID_26282

DSSTox_GSID_46282

DSSTox_RID_81508

DTXSID4046282

FD7219

FT-0650339

Gilead brand of ambrisentan

GTPL3951

HE167810

HW6NV07QEC

HY-13209

J-519579

K-5435

KS-00000FU3

Letairis

Letairis (TN)

LU 208075

LU-208075

LU208075

MFCD08672619

MLS006010218

MolPort-005-942-453

NCGC00160662-01

NCGC00160662-02

NCGC00346730-01

OUJTZYPIHDYQMC-LJQANCHMSA-N

PubChem18318

s2097

SCHEMBL3679

SMR004701307

TC-148161

Tox21_111967

Tox21_111967_1

UNII-7B43003091 component OUJTZYPIHDYQMC-LJQANCHMSA-N

UNII-HW6NV07QEC

Volibris

Volibris (TN)

ZINC538627

US Patents and Regulatory Information for ambrisentan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007		RX	Yes	No
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007		RX	Yes	No				Y
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-002	Jun 15, 2007		RX	Yes	Yes
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007		RX	Yes	No

Expired US Patents for ambrisentan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007

Non-Orange Book US Patents for ambrisentan

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
5,772,589	Measurement process for blood gas analysis sensors
5,932,730	Carboxylic acid derivatives, their preparation and use
5,969,134	Carboxylic acid derivatives, their preparation and use
9,504,685	Method for treating a pulmonary hypertension condition

International Patents for ambrisentan

Country	Document Number	Estimated Expiration
Greece	3036931
Croatia	P20040364
Japan	4512105
China	1142918

Supplementary Protection Certificates for ambrisentan

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2016 00024	Denmark		PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125
0160017 00199	Estonia		PRODUCT NAME: AMBRISENTAAN;REG NO/DATE: EU/1/08/451 25.11.2015
487	Luxembourg		91487, EXPIRES: 20201007
C029/2008	Ireland		SPC029/2008: 20091119, EXPIRES: 20201006