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Generated: September 25, 2017
What is the patent landscape for Ilevro, and when can generic versions of Ilevro launch?
Ilevro is a drug marketed by Novartis Pharms Corp and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.| Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 65 |
| Clinical Trials: see list | 3 |
| Patent Applications: see list | 767 |
| Drug Prices: | see details |
| DailyMed Link: | ILEVRO at DailyMed |
| Ingredient-type | Nonsteroidal Anti-inflammatory Compounds |
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis Pharms Corp | ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491-001 | Oct 16, 2012 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||
Novartis Pharms Corp | ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491-001 | Oct 16, 2012 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||
Novartis Pharms Corp | ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491-001 | Oct 16, 2012 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||
Novartis Pharms Corp | ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491-001 | Oct 16, 2012 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis Pharms Corp | ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491-001 | Oct 16, 2012 | ► Subscribe | ► Subscribe | ||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| nepafenac | Ophthalmic Suspension | 0.3% | Ilevro | 12/21/2015 |
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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,486,138 | Ophthalmic compositions containing galactomannan polymers and borate | ► Subscribe | |||||||||||||
| 7,169,767 | Ophthalmic compositions containing galactomannan polymers and borate | ► Subscribe | |||||||||||||
| 6,838,449 | Ophthalmic compositions containing galactomannan polymers and borate | ► Subscribe | |||||||||||||
| 7,709,012 | Ophthalmic compositions containing a synergistic combination of two polymers | ► Subscribe | |||||||||||||
| 6,583,124 | Ophthalmic compositions containing galactomannan polymers and borate | ► Subscribe | |||||||||||||
| 8,313,754 | Ophthalmic compositions containing a synergistic combination of two polymers | ► 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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 2013512912 | ► Subscribe | |||||||||||||
| China | 100475192 | ► Subscribe | |||||||||||||
| Spain | 2570856 | ► Subscribe | |||||||||||||
| China | 102724965 | ► Subscribe | |||||||||||||
| European Patent Office | 2526929 | ► Subscribe | |||||||||||||
| European Patent Office | 1348427 | ► Subscribe | |||||||||||||
| Australia | 2010326099 | ► Subscribe | |||||||||||||
| Portugal | 2586426 | ► Subscribe | |||||||||||||
| Japan | 2007500244 | ► Subscribe | |||||||||||||
| Uruguay | 33081 | ► 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 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0716600/01 | Switzerland | ► Subscribe | PRODUCT NAME: NEPAFENAC; REGISTRATION NUMBER/DATE: SWISSMEDIC 58745 24.09.2008 | ||||||||||||
| 301 | Luxembourg | ► Subscribe | PRODUCT NAME: NEPAFENAC-SUSPENSION OPHTALMIQUE | ||||||||||||
| 2013000085 | Germany | ► Subscribe | PRODUCT NAME: NEPAFENAC (OPHTHALMISCHE SUSPENSION); REGISTRATION NO/DATE: EU 1/07/433/002 20130503 | ||||||||||||
| 00622 | Netherlands | ► Subscribe | PRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503 | ||||||||||||
| 2013 00055 | Denmark | ► Subscribe | PRODUCT NAME: NEPAFENAC (3 MG/ML), HERUNDER NEPAFENAC I KOMBINATION MED GLACTOMANNANPOLYMERER, ISAER 3 MG/ML NEPAFENAC I KOMBINATION MED GALACTOMANNANPOLYMERER, SAMT OFTALMISKE SAMMENSAETNINGER DERAF; REG. NO/DATE: EU1/07/433/002 20130503 | ||||||||||||
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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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