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Generated: July 20, 2017
What is the patent landscape for Cialis, and when can generic versions of Cialis launch?
Cialis is a drug marketed by Lilly and is included in one NDA. There are five patents protecting this drug and two Paragraph IV challenges.| Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 9 |
| Bulk Api Vendors: see list | 60 |
| Clinical Trials: see list | 28 |
| Patent Applications: see list | 3,376 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | CIALIS at DailyMed |
| Drug Class | Phosphodiesterase 5 Inhibitor |
| Mechanism of Action | Phosphodiesterase 5 Inhibitors |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-003 | Nov 21, 2003 | RX | Yes | Yes | 6,821,975 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-004 | Jan 7, 2008 | RX | Yes | No | 5,859,006 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-002 | Nov 21, 2003 | RX | Yes | No | 5,859,006 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-002 | Nov 21, 2003 | RX | Yes | No | 6,140,329 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-001 | Nov 21, 2003 | RX | Yes | No | 5,859,006 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-004 | Jan 7, 2008 | 6,140,329 | ► Subscribe | ||||||||||||||||||||||
Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-001 | Nov 21, 2003 | 6,140,329 | ► Subscribe | ||||||||||||||||||||||
Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-002 | Nov 21, 2003 | 6,140,329 | ► Subscribe | ||||||||||||||||||||||
Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-003 | Nov 21, 2003 | 6,140,329 | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| tadalafil | Tablets | 2.5 mg | Cialis | 10/14/2008 |
| tadalafil | Tablets | 5 mg, 10 mg and 20 mg | Cialis | 11/21/2007 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,369,059 | Tetracyclic derivatives, process of preparation and use | ► Subscribe | |||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||
| 6,127,542 | 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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Canada | 2181377 | ► Subscribe | |||||||||||||||||||||||||||
| Italy | MI20000922 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 0108688 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 1113800 | ► Subscribe | |||||||||||||||||||||||||||
| Portugal | 1200090 | ► 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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0124 | Netherlands | ► Subscribe | 300124, 20150119, EXPIRES: 20171111 | ||||||||||||||||||||||||||
| 2003001,C0740668 | Lithuania | ► Subscribe | PRODUCT 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 | ||||||||||||||||||||||||||
| 2003 00008 | Denmark | ► Subscribe | |||||||||||||||||||||||||||
| C004/2003 | Ireland | ► Subscribe | SPC004/2003, 20040610, EXPIRES: 20171111 | ||||||||||||||||||||||||||
| C/GB03/007 | United Kingdom | ► Subscribe | PRODUCT NAME: TADALAFIL AND PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF.; REGISTERED: UK EU/1/02/237/001-004 20021114 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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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