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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022332

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NDA 022332 describes ADCIRCA, which is a drug marketed by Eli Lilly Co and is included in one NDA. It is available from three suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ADCIRCA profile page.

The generic ingredient in ADCIRCA is tadalafil. There are twenty-three drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the tadalafil profile page.

Summary for 022332

Tradename:1
Applicant:1
Ingredient:1
Patents:3
Formulation / Manufacturing:see details

Pharmacology for NDA: 022332

Medical Subject Heading (MeSH) Categories for 022332

Suppliers and Packaging for NDA: 022332

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADCIRCA tadalafil TABLET;ORAL 022332 NDA Aphena Pharma Solutions - Tennessee, LLC 43353-070 43353-070-12 12 TABLET in 1 BOTTLE (43353-070-12)
ADCIRCA tadalafil TABLET;ORAL 022332 NDA United Therapeutics Corporation 66302-467 66302-467-60 60 TABLET in 1 BOTTLE (66302-467-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:May 22, 2009TE:RLD:Yes
Patent:► SubscribePatent Expiration:Nov 21, 2017Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PULMONARY HYPERTENSION
Patent:► SubscribePatent Expiration:Nov 19, 2020Product Flag?YSubstance Flag?YDelist Request?
Patent:► SubscribePatent Expiration:Apr 26, 2020Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022332

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eli Lilly CoADCIRCAtadalafilTABLET;ORAL022332-001May 22, 2009► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

McKinsey
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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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