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Ambrisentan - Generic Drug Details

What are the generic sources for ambrisentan and what is the scope of ambrisentan freedom to operate?

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:	70
Clinical Trials:	51
Patent Applications:	1,681
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ambrisentan
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

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Glossary

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

Expired US Patents for ambrisentan

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-002	Jun 15, 2007	➤ Try a Free Trial	➤ Try a Free Trial
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-002	Jun 15, 2007	➤ Try a Free Trial	➤ Try a Free Trial
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-002	Jun 15, 2007	➤ Try a Free Trial	➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

International Patents for ambrisentan

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Country	Document Number	Estimated Expiration
Norway	308846	➤ Try a Free Trial
Czech Republic	294603	➤ Try a Free Trial
China	1513844	➤ Try a Free Trial
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for ambrisentan

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C029/2008	Ireland	➤ Try a Free Trial	SPC029/2008: 20091119, EXPIRES: 20201006
0160017 00199	Estonia	➤ Try a Free Trial	PRODUCT NAME: AMBRISENTAAN;REG NO/DATE: EU/1/08/451 25.11.2015
2008 00037	Denmark	➤ Try a Free Trial
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description