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Serving leading biopharmaceutical companies globally:

Baxter
Moodys
Cipla
McKinsey
Farmers Insurance
Cerilliant
Johnson and Johnson
Chinese Patent Office
Dow
Mallinckrodt

Generated: December 11, 2017

DrugPatentWatch Database Preview

ADCIRCA Drug Profile

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Which patents cover Adcirca, and what generic alternatives are available?

Adcirca is a drug marketed by Eli Lilly Co and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and twenty-four patent family members in fifty-two countries and thirteen supplementary protection certificates in nine countries.

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.
Drug patent expirations by year for ADCIRCA

Pharmacology for ADCIRCA

Medical Subject Heading (MeSH) Categories for ADCIRCA

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Eli Lilly CoADCIRCAtadalafilTABLET;ORAL022332-001May 22, 2009RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Eli Lilly CoADCIRCAtadalafilTABLET;ORAL022332-001May 22, 2009RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Eli Lilly CoADCIRCAtadalafilTABLET;ORAL022332-001May 22, 2009RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
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Paragraph IV (Patent) Challenges for ADCIRCA

Drugname Dosage Strength RLD Submissiondate
tadalafilTablets20 mgAdcirca10/15/2009

Non-Orange Book Patents for Tradename: ADCIRCA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,608,065 Use of cGMP phosphodiesterase inhibitors in methods to treat female sexual dysfunction► Subscribe
5,981,527 Cyclic GMP-specific phosphodiesterase inhibitors► Subscribe
6,784,179 Tetracyclic derivatives, process of preparation and use► Subscribe
6,841,167 .beta.-carboline pharmaceutical compositions► Subscribe
6,369,059 Tetracyclic derivatives, process of preparation and use► Subscribe
6,140,329 Use of cGMP-phosphodiesterase inhibitors in methods and compositions to treat impotence► Subscribe
6,143,746 Tetracyclic cyclic GMP-specific phosphodiesterase inhibitors, process of preparation and use► Subscribe
6,127,542 Tetracyclic derivatives, process of preparation and use► Subscribe
6,025,494 Tetracyclic derivatives, process of preparation and use► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: ADCIRCA

Country Document Number Estimated Expiration
Hungary0202513► Subscribe
Australia4491200► Subscribe
China1311828► Subscribe
Japan2002524516► Subscribe
Poland353268► Subscribe
Portugal1200090► Subscribe
Poland324527► Subscribe
South Africa9605934► Subscribe
China1365282► Subscribe
Russian Federation2142463► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ADCIRCA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C004/2003Ireland► SubscribeSPC004/2003, 20040610, EXPIRES: 20171111
0813Netherlands► SubscribePRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
2016000039Germany► SubscribePRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120
2003 00008Denmark► Subscribe
2016 00024Denmark► SubscribePRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125
C/GB03/007United Kingdom► SubscribePRODUCT NAME: TADALAFIL AND PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF.; REGISTERED: UK EU/1/02/237/001-004 20021114
081Luxembourg► SubscribePRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
2003001Lithuania► SubscribePRODUCT NAME: TADALAFILUM ((6R,12AR)-2,3,6,7,12,12A-HEKSAHIDRO-2-METIL-6-(3,4-METILENDIOKSIFENIL)-PIRAZINO(2',1':6,1)PIRIDO(3,4-B)INDOL-1,4-DIONAS); REGISTRATION NO/DATE: 03/8034/3, 03/8035/3 20030328
2003001,C0740668Lithuania► SubscribePRODUCT NAME: TADALAFILUM ((6R,12AR)-2,3,6,7,12,12A-HEKSAHIDRO-2-METIL-6-(3,4-METILENDIOKSIFENIL)-PIRAZINO(2',1':6,1)PIRIDO(3,4-B)INDOL-1,4-DIONAS); REGISTRATION NO/DATE: 03/8034/3, 03/8035/3 20030328
0740668/01Switzerland► SubscribePRODUCT NAME: TADALAFILUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56018 04.05.2004
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Serving leading biopharmaceutical companies globally:

Deloitte
Daiichi Sankyo
Boehringer Ingelheim
Chinese Patent Office
Queensland Health
Healthtrust
Novartis
Harvard Business School
Cipla
Teva

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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