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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Medtronic
Daiichi Sankyo
Express Scripts
Fuji
Julphar
US Department of Justice
Colorcon
McKinsey

Generated: July 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021368

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NDA 021368 describes CIALIS, which is a drug marketed by Lilly and is included in one NDA. It is available from eight suppliers. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the CIALIS profile page.

The generic ingredient in CIALIS is tadalafil. There are twenty-four drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the tadalafil profile page.
Summary for 021368
Tradename:CIALIS
Applicant:Lilly
Ingredient:tadalafil
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 021368
Medical Subject Heading (MeSH) Categories for 021368
Suppliers and Packaging for NDA: 021368
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIALIS tadalafil TABLET;ORAL 021368 NDA Eli Lilly and Company 0002-4462 N 0002-4462-30
CIALIS tadalafil TABLET;ORAL 021368 NDA Eli Lilly and Company 0002-4462 N 0002-4462-34

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Nov 21, 2003TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Feb 15, 2021
Regulatory Exclusivity Use:INFORMATION ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING REGARDING A NEW CLINICAL TRIAL IN PATIENTS 7 TO 14 YEARS OF AGE WITH DUCHENNE MUSCULAR DYSTROPHY
Regulatory Exclusivity Expiration:Aug 15, 2021
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:➤ Sign UpPatent Expiration:May 21, 2018Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 021368

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly CIALIS tadalafil TABLET;ORAL 021368-003 Nov 21, 2003 ➤ Sign Up ➤ Sign Up
Lilly CIALIS tadalafil TABLET;ORAL 021368-004 Jan 7, 2008 ➤ Sign Up ➤ Sign Up
Lilly CIALIS tadalafil TABLET;ORAL 021368-002 Nov 21, 2003 ➤ Sign Up ➤ Sign Up
Lilly CIALIS tadalafil TABLET;ORAL 021368-003 Nov 21, 2003 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Boehringer Ingelheim
Daiichi Sankyo
AstraZeneca
Baxter
Colorcon
Johnson and Johnson
Cerilliant
US Army

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