DrugPatentWatch Database Preview
ILEVRO Drug Profile
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When do Ilevro patents expire, 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.
This drug has one hundred and thirteen patent family members in twenty-six countries.
The generic ingredient in ILEVRO is nepafenac. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nepafenac profile page.
Summary for ILEVRO
| International Patents: | 113 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 72 |
| Clinical Trials: | 3 |
| Patent Applications: | 892 |
| Drug Prices: | Drug price information for ILEVRO |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ILEVRO |
| DailyMed Link: | ILEVRO at DailyMed |
Generic Entry Opportunity Date for ILEVRO
Generic Entry Date for ILEVRO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SUSPENSION/DROPS;OPHTHALMIC |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for ILEVRO
| Ingredient-type | Nonsteroidal Anti-inflammatory Compounds |
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
US Patents and Regulatory Information for ILEVRO
| 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 | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Novartis Pharms Corp | ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491-001 | Oct 16, 2012 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Novartis Pharms Corp | ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491-001 | Oct 16, 2012 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Expired US Patents for ILEVRO
| 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 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Novartis Pharms Corp | ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491-001 | Oct 16, 2012 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for ILEVRO
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Ophthalmic Suspension | 0.3% | ➤ Subscribe | ➤ Try a Free Trial |
Non-Orange Book US Patents for ILEVRO
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 |
|---|---|---|
| 8,313,754 | Ophthalmic compositions containing a synergistic combination of two polymers | ➤ Try a Free Trial |
| 6,486,138 | Ophthalmic compositions containing galactomannan polymers and borate | ➤ Try a Free Trial |
| 6,838,449 | Ophthalmic compositions containing galactomannan polymers and borate | ➤ Try a Free Trial |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for ILEVRO
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 1170164 | ➤ Try a Free Trial |
| Mexico | 2012006231 | ➤ Try a Free Trial |
| Portugal | 2506831 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for ILEVRO
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 00622 | Netherlands | ➤ Try a Free Trial | PRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503 |
| 2013 00055 | Denmark | ➤ Try a Free Trial | 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 |
| 0716600/01 | Switzerland | ➤ Try a Free Trial | PRODUCT NAME: NEPAFENAC; REGISTRATION NUMBER/DATE: SWISSMEDIC 58745 24.09.2008 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
