.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

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

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022081

« Back to Dashboard
NDA 022081 describes LETAIRIS, which is a drug marketed by Gilead and is included in one NDA. It is available from one supplier. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LETAIRIS profile page.

The generic ingredient in LETAIRIS is ambrisentan. There are seven 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 NDA: 022081

Tradename:
LETAIRIS
Applicant:
Gilead
Ingredient:
ambrisentan
Patents:6
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 022081

Suppliers and Packaging for NDA: 022081

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LETAIRIS
ambrisentan
TABLET;ORAL 022081 NDA Gilead Sciences, Inc 61958-0801 61958-0801-1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0801-1)
LETAIRIS
ambrisentan
TABLET;ORAL 022081 NDA Gilead Sciences, Inc 61958-0801 61958-0801-2 3 BLISTER PACK in 1 CARTON (61958-0801-2) > 10 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jun 15, 2007TE:RLD:No
Patent:7,109,205Patent Expiration:Oct 7, 2015Product Flag?YSubstance Flag?YDelist Request?
Patent:8,349,843Patent Expiration:Oct 7, 2015Product Flag?YSubstance Flag?YDelist Request?
Patent:RE42462Patent Expiration:Jul 29, 2018Product Flag?Substance Flag?YDelist Request?

Expired Orange Book Patents for NDA: 022081

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-001Jun 15, 20075,703,017► subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-001Jun 15, 20077,601,730► subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-002Jun 15, 20078,349,843► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

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

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