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Serving hundreds of leading biopharmaceutical companies globally:

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Express Scripts
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Generated: October 21, 2018

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Ambrisentan - Generic Drug Details

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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.

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

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

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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 ➤ Sign Up ➤ Sign Up
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 ➤ Sign Up ➤ Sign Up
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for ambrisentan

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0361 Netherlands ➤ Sign Up 300361, 20151007, EXPIRES: 20201006
487 Luxembourg ➤ Sign Up 91487, EXPIRES: 20201007
C/GB08/047 United Kingdom ➤ Sign Up PRODUCT NAME: AMBRISENTAN; REGISTERED: UK EU/1/08/451/001 20080421; UK EU/1/08/451/002 20080421; UK EU/1/08/451/003 20080421; UK EU/1/08/451/004 20080421
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
McKinsey
Cerilliant
Citi
Medtronic
Julphar
Express Scripts
Queensland Health
QuintilesIMS

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.