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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Farmers Insurance
Deloitte
Merck
Julphar
AstraZeneca
Cerilliant
Cantor Fitzgerald
Queensland Health

Generated: April 19, 2018

DrugPatentWatch Database Preview

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 four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twelve patent family members in thirty-five 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.
Summary for LETAIRIS
Drug patent expirations by year for LETAIRIS
Pharmacology for LETAIRIS
Synonyms for LETAIRIS
(+-)-(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
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 (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 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 Y ➤ 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

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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 022081-001 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
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 Submissiondate
➤ Subscribe Tablets 5 mg and 10 mg ➤ Subscribe 2015-02-09

Non-Orange Book US Patents for LETAIRIS

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 ➤ Try a Free Trial
5,932,730 Carboxylic acid derivatives, their preparation and use ➤ Try a Free Trial
5,969,134 Carboxylic acid derivatives, their preparation and use ➤ Try a Free Trial
9,504,685 Method for treating a pulmonary hypertension condition ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for LETAIRIS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0813 Netherlands ➤ Try a Free Trial PRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
2008 00037 Denmark ➤ Try a Free Trial
0785926/01 Switzerland ➤ Try a Free Trial FORMER OWNER: ABBVIE DEUTSCHLAND GMBH AND CO. KG, DE
2016018 Lithuania ➤ Try a Free Trial PRODUCT NAME: AMBRISENTANAS; REGISTRATION NO/DATE: EU/1/08/451 (001-004) 20151120
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Moodys
Federal Trade Commission
Citi
Boehringer Ingelheim
UBS
Deloitte
Baxter
US Army

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