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Generated: September 20, 2018

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LETAIRIS Drug Profile

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When do Letairis patents expire, and when can generic versions of Letairis launch?

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.

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:
REVISED INDICATION TO INCLUDE LANGUAGE ABOUT THE BENEFITS OF USING LETAIRIS IN COMBINATION WITH TADALAFIL TO REDUCE THE RISK OF DISEASE PROGRESSION AND HOSPITALIZATION FOR WORSENING PAH AND TO IMPROVE EXERCISE ABILITY, BASED ON THE AMBITION STUDY
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
(+-)-(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
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
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 022081-002 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
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

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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

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
7,601,730 Carboxylic acid derivatives, their preparation and use ➤ Try a Free Trial
7,863,445 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
5,969,134 Carboxylic acid derivatives, their preparation and use ➤ Try a Free Trial
5,932,730 Carboxylic acid derivatives, their preparation and use ➤ Try a Free Trial
8,349,843 Carboxylic acid derivatives, their preparation and use ➤ Try a Free Trial
5,772,589 Measurement process for blood gas analysis sensors ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for LETAIRIS

Supplementary Protection Certificates for LETAIRIS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0160017 00199 Estonia ➤ Try a Free Trial PRODUCT NAME: AMBRISENTAAN;REG NO/DATE: EU/1/08/451 25.11.2015
2016018 Lithuania ➤ Try a Free Trial PRODUCT NAME: AMBRISENTANAS; REGISTRATION NO/DATE: EU/1/08/451 (001-004) 20151120
2016 00024 Denmark ➤ Try a Free Trial PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125
C0041 France ➤ Try a Free Trial PRODUCT NAME: AMBRISENTAN; REGISTRATION NO/DATE: EU/1/08/451/001-004 20080421
487 Luxembourg ➤ Try a Free Trial 91487, EXPIRES: 20201007
C029/2008 Ireland ➤ Try a Free Trial SPC029/2008: 20091119, EXPIRES: 20201006
0361 Netherlands ➤ Try a Free Trial 300361, 20151007, EXPIRES: 20201006
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Farmers Insurance
Chinese Patent Office
Julphar
Mallinckrodt
Moodys
Citi
Teva
Deloitte

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