ILEVRO Drug Patent Profile
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Which patents cover Ilevro, and what generic alternatives are available?
Ilevro is a drug marketed by Harrow Eye and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has ninety-four patent family members in twenty-six countries.
The generic ingredient in ILEVRO is nepafenac. There are eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the nepafenac profile page.
DrugPatentWatch® Generic Entry Outlook for Ilevro
There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
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Questions you can ask:
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Summary for ILEVRO
| International Patents: | 94 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 119 |
| Clinical Trials: | 5 |
| Patent Applications: | 2,245 |
| Drug Prices: | Drug price information for ILEVRO |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ILEVRO |
| What excipients (inactive ingredients) are in ILEVRO? | ILEVRO excipients list |
| DailyMed Link: | ILEVRO at DailyMed |
Recent Clinical Trials for ILEVRO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Vance Thompson Vision - MT | Phase 4 |
| MDbackline, LLC | N/A |
| Alcon Research | N/A |
Pharmacology for ILEVRO
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
US Patents and Regulatory Information for ILEVRO
ILEVRO is protected by three US patents.
Patents protecting ILEVRO
Ophthalmic compositions containing a synergistic combination of two polymers
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Carboxyvinyl polymer-containing nanoparticle suspensions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Carboxylvinyl polymer-containing nanoparticle suspensions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Harrow Eye | ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491-001 | Oct 16, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Harrow Eye | ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491-001 | Oct 16, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Harrow Eye | ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491-001 | Oct 16, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ILEVRO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Harrow Eye | ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491-001 | Oct 16, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Harrow Eye | ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491-001 | Oct 16, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Harrow Eye | ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491-001 | Oct 16, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ILEVRO
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Novartis Europharm Limited | Nevanac | nepafenac | EMEA/H/C/000818 Nevanac is indicated for:, , , prevention and treatment of postoperative pain and inflammation associated with cataract surgery;, reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients., , |
Authorised | no | no | no | 2007-12-11 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ILEVRO
See the table below for patents covering ILEVRO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 4673339 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 9533457 | ⤷ Sign Up | |
| European Patent Office | 2361610 | Compositions ophtalmologiques contenant une association synergique de deux polymères (Ophthalmic compositions containing a synergistic combination of two polymers) | ⤷ Sign Up |
| Spain | 2206965 | ⤷ Sign Up | |
| Portugal | 2116227 | ⤷ Sign Up | |
| Spain | 2684752 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ILEVRO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0999825 | CA 2013 00055 | Denmark | ⤷ Sign Up | 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 |
| 0999825 | 122013000085 | Germany | ⤷ Sign Up | PRODUCT NAME: NEPAFENAC (OPHTHALMISCHE SUSPENSION); REGISTRATION NO/DATE: EU 1/07/433/002 20130503 |
| 0999825 | 92301 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: NEPAFENAC-SUSPENSION OPHTALMIQUE |
| 0716600 | C00716600/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: NEPAFENAC; REGISTRATION NUMBER/DATE: SWISSMEDIC 58745 24.09.2008 |
| 0999825 | C300622 | Netherlands | ⤷ Sign Up | PRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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 verification 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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