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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 nine suppliers. There are five 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-three drug master file entries for this compound. Ten suppliers are listed for this compound. There are ten tentative approvals for this compound. Additional details are available on the tadalafil profile page.

Summary for NDA: 021368

Tradename:
CIALIS
Applicant:
Lilly
Ingredient:
tadalafil
Patents:5
Formulation / Manufacturing:see details

Pharmacology for NDA: 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Nov 21, 2003TE:RLD:No
Patent:5,859,006Patent Expiration:Nov 21, 2017Product Flag?YSubstance Flag?YDelist Request?
Patent:6,821,975Patent Expiration:Nov 19, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:ERECTILE DYSFUNCTION
Patent:6,140,329Patent Expiration:Jul 11, 2016Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ERECTILE DYSFUNCTION

Expired Orange Book Patents for NDA: 021368

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-003Nov 21, 20036,140,329► subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-004Jan 7, 20086,140,329► subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-001Nov 21, 20036,140,329► subscribe
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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.

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