.

Deeper Knowledge, Faster

  • Analyze global market entry opportunities
  • Predict branded drug patent expiration
  • Identify first generic entrants

► See Plans & Pricing

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

Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
Moodys
Argus Health
Teva
Boehringer Ingelheim
Fish and Richardson
QuintilesIMS
US Army
Harvard Business School
Mallinckrodt

Generated: June 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203109

« Back to Dashboard
NDA 203109 describes REVATIO, which is a drug marketed by Pfizer and is included in three NDAs. It is available from five suppliers. Additional details are available on the REVATIO profile page.

The generic ingredient in REVATIO is sildenafil citrate. There are twenty drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.

Summary for NDA: 203109

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 203109

Suppliers and Packaging for NDA: 203109

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REVATIO
sildenafil citrate
FOR SUSPENSION;ORAL 203109 NDA Pfizer Laboratories Div Pfizer Inc 0069-0336 0069-0336-21 1 BOTTLE in 1 CARTON (0069-0336-21) > 112 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 10MG BASE/ML
Approval Date:Aug 30, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 31, 2017
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING REGARDING THE ADDITION OF SILDENAFIL TO BOSENTAN THERAPY
Regulatory Exclusivity Expiration:Jan 31, 2017
Regulatory Exclusivity Use:NEW LOWER DOSING REGIMEN FOR REVATIO IN THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (WHO GROUP 1) IN ADULTS


Complete Access Available with Subscription
« Back to Dashboard

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

Serving 500+ biopharmaceutical companies globally:

AstraZeneca
US Army
Argus Health
Daiichi Sankyo
Fuji
Fish and Richardson
Boehringer Ingelheim
Merck
Federal Trade Commission
Baxter

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot