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Last Updated: January 23, 2021

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 six suppliers. There is one patent 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-five drug master file entries for this compound. Thirty-eight 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:1
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 0002-4462-30 30 TABLET, FILM COATED in 1 BOTTLE (0002-4462-30)
CIALIS tadalafil TABLET;ORAL 021368 NDA Eli Lilly and Company 0002-4462 0002-4462-34 2 BLISTER PACK in 1 CARTON (0002-4462-34) > 15 TABLET, FILM COATED in 1 BLISTER PACK (0002-4462-79)
Paragraph IV (Patent) Challenges for 021368
Tradename Dosage Ingredient NDA Submissiondate
CIALIS TABLET;ORAL tadalafil 021368 2008-10-14
CIALIS TABLET;ORAL tadalafil 021368 2007-11-21

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Nov 21, 2003TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Aug 15, 2021
Regulatory Exclusivity Use:
Regulatory Exclusivity Expiration:Feb 15, 2021
Regulatory Exclusivity Use:
Patent:  Start TrialPatent Expiration:Oct 26, 2020Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021368

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly CIALIS tadalafil TABLET;ORAL 021368-004 Jan 7, 2008   Start Trial   Start Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003   Start Trial   Start Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003   Start Trial   Start Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-002 Nov 21, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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