Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

How our clients use DrugPatentWatch

DrugPatentWatch Database Preview

LETAIRIS Drug Profile

« Back to Dashboard

Which patents cover Letairis, and what substitute generic drugs 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 ninety-four patent family members in thirty-two countries.

The generic ingredient in LETAIRIS is ambrisentan. There are eight 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 Tradename: LETAIRIS

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list53
Clinical Trials: see list17
Patent Applications: see list782
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:LETAIRIS at DailyMed

Pharmacology for Tradename: LETAIRIS

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-001Jun 15, 2007RXYesNo8,377,933► Subscribe ► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-002Jun 15, 2007RXYesYes9,549,926► Subscribe ► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-001Jun 15, 2007RXYesNoRE42462► SubscribeY ► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-002Jun 15, 2007RXYesYes9,474,752► Subscribe ► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-001Jun 15, 2007RXYesNo9,549,926► Subscribe ► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Patents for Tradename: LETAIRIS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-002Jun 15, 20075,932,730► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-001Jun 15, 20075,703,017► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-001Jun 15, 20077,109,205► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-001Jun 15, 20077,601,730► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-001Jun 15, 20075,840,722► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Paragraph IV activity for: LETAIRIS

Drugname Dosage Strength RLD Submissiondate
ambrisentanTablets5 mg and 10 mgLetairis2/9/2015

Non-Orange Book Patents for Tradename: 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
7,109,205Carboxylic acid derivatives, their preparation and use► Subscribe
9,504,685Method for treating a pulmonary hypertension condition► Subscribe
5,969,134 Carboxylic acid derivatives, their preparation and use► Subscribe
RE42477Carboxylic acid derivatives, their preparation and use► Subscribe
6,197,958 Carboxylic acid derivatives, their preparation and use► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: LETAIRIS

Country Document Number Estimated Expiration
HungaryT77443► Subscribe
CroatiaP20040364► Subscribe
China1513844► Subscribe
Japan4512106► Subscribe
Finland120492► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: LETAIRIS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C029/2008Ireland► SubscribeSPC029/2008: 20091119, EXPIRES: 20201006
0361Netherlands► Subscribe300361, 20151007, EXPIRES: 20201006
2016 00024Denmark► SubscribePRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125
2008 00037Denmark► Subscribe
0813Netherlands► SubscribePRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How our clients use DrugPatentWatch

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.

`abc