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Tadalafil - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for tadalafil?

Tadalafil is the generic ingredient in two branded drugs marketed by Eli Lilly Co and Lilly, and is included in two NDAs. There are five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tadalafil has three hundred and five patent family members in sixty-two countries.

There are twenty-three drug master file entries for tadalafil. Ten suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for Generic Name: tadalafil

Tradenames:2
Patents:5
Applicants:2
NDAs:2
Drug Master File Entries: see list23
Suppliers / Packagers: see list10
Bulk Api Vendors: see list60
Clinical Trials: see list34
Patent Applications: see list6,669
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:tadalafil at DailyMed

Pharmacology for Ingredient: tadalafil

Tentative approvals for TADALAFIL

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET; ORAL20MG
► Subscribe► SubscribeTABLET;ORAL2.5MG
► Subscribe► SubscribeTABLET;ORAL5MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-002Nov 21, 2003RXYesNo7,182,958► SubscribeY ► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-003Nov 21, 2003RXYesYes6,140,329► SubscribeY ► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-001Nov 21, 2003RXYesNo5,859,006► SubscribeYY ► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-002Nov 21, 2003RXYesNo6,140,329► SubscribeY ► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-003Nov 21, 2003RXYesYes5,859,006► SubscribeYY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: tadalafil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-004Jan 7, 20086,140,329► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-003Nov 21, 20036,140,329► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-002Nov 21, 20036,140,329► Subscribe
Lilly
CIALIS
tadalafil
TABLET;ORAL021368-001Nov 21, 20036,140,329► Subscribe
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Non-Orange Book Patents for Generic Ingredient: tadalafil

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
6,451,807 Methods of treating sexual dysfunction in an individual suffering from a retinal disease, class 1 congestive heart failure, or myocardial infarction using a PDE5 inhibitor► Subscribe
5,981,527 Cyclic GMP-specific phosphodiesterase inhibitors► Subscribe
6,608,065 Use of cGMP phosphodiesterase inhibitors in methods to treat female sexual dysfunction► Subscribe
6,841,167 .beta.-carboline pharmaceutical compositions► 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 Ingredient: tadalafil

Country Document Number Estimated Expiration
Peru04802001► Subscribe
Czech Republic20023577► Subscribe
China1069318► Subscribe
Norway20015275► Subscribe
China1446091► 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: TADALAFIL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
017Luxembourg► Subscribe
C/GB03/007United Kingdom► SubscribePRODUCT NAME: TADALAFIL AND PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF.; REGISTERED: UK EU/1/02/237/001-004 20021114
0740668/01Switzerland► SubscribePRODUCT NAME: TADALAFILUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56018 04.05.2004
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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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