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Generated: April 23, 2019

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LETAIRIS Drug Profile

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When do Letairis patents expire, and what generic alternatives are available?

Letairis is a drug marketed by Gilead and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has forty-nine patent family members in twenty-six countries.

The generic ingredient in LETAIRIS is ambrisentan. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ambrisentan profile page.

Drug patent expirations by year for LETAIRIS
Generic Entry Opportunity Date for LETAIRIS
Generic Entry Date for LETAIRIS*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for LETAIRIS
Synonyms for LETAIRIS
(?S)-?-[(4,6-Dimethyl-2-pyrimidinyl)oxy]-?-methoxy-?-phenylbenzenepropanoic acid
(+-)-(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
A812234
AB0009811
AB01566890_01
AB2000501
AC-9015
AC1OCFHZ
AJ-23403
AK-38379
AKOS015994540
Ambrisentan
Ambrisentan (JAN/INN)
Ambrisentan [INN:BAN:JAN]
ANW-59416
AX8118907
BC224510
BDBM50146710
Benzenepropanoic acid, alpha-[(4,6-dimethyl-2-pyrimidinyl)oxy]-beta-methoxy-beta-phenyl-, (alphaS)-
BSF 208075
BSF 208075; Letairis; Volibris
BSF 208075;AMBRISENTAN
BSF-208075
CA0131
CAS-177036-94-1
CHEBI:135949
CHEMBL1111
CS-0447
CTK8B8152
D07077
DB06403
DE-0223
DSSTox_CID_26282
DSSTox_GSID_46282
DSSTox_RID_81508
DTXSID4046282
FD7219
FT-0650339
GTPL3951
HW6NV07QEC
HY-13209
J-519579
K-5435
KS-00000FU3
Letairis (TN)
LU 208075
LU-208075
LU208075
MLS006010218
MolPort-005-942-453
NCGC00160662-01
NCGC00160662-02
NCGC00346730-01
OUJTZYPIHDYQMC-LJQANCHMSA-N
PubChem18318
s2097
SB17358
SCHEMBL3679
SMR004701307
SW219060-1
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 LETAIRIS

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 ➤ 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
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 022081-001 Jun 15, 2007 RX Yes No ➤ 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

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Expired US Patents for LETAIRIS

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

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Paragraph IV (Patent) Challenges for LETAIRIS
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 5 mg and 10 mg ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for LETAIRIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2101777 2016C/032 Belgium ➤ Try a Free Trial PRODUCT NAME: AMBRISENTAN EN COMBINAISON AVEC LE TADALAFIL; AUTHORISATION NUMBER AND DATE: EU/1/08/451 20151125
0785926 08C0041 France ➤ Try a Free Trial PRODUCT NAME: AMBRISENTAN; REGISTRATION NO/DATE: EU/1/08/451/001-004 20080421
2101777 93081 Luxembourg ➤ Try a Free Trial PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
2101777 122016000039 Germany ➤ Try a Free Trial PRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Cantor Fitzgerald
Chinese Patent Office
Fish and Richardson
Healthtrust
Argus Health

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