NEVANAC Drug Patent Profile
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Which patents cover Nevanac, and when can generic versions of Nevanac launch?
Nevanac is a drug marketed by Harrow Eye and is included in one NDA. There are three patents protecting this drug.
This drug has twenty-seven patent family members in twenty-three countries.
The generic ingredient in NEVANAC 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 Nevanac
Nevanac was eligible for patent challenges on August 19, 2009.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 2, 2025. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Questions you can ask:
- What is the 5 year forecast for NEVANAC?
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Summary for NEVANAC
International Patents: | 27 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 119 |
Clinical Trials: | 25 |
Patent Applications: | 2,245 |
Drug Prices: | Drug price information for NEVANAC |
What excipients (inactive ingredients) are in NEVANAC? | NEVANAC excipients list |
DailyMed Link: | NEVANAC at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for NEVANAC
Generic Entry Date for NEVANAC*:
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.
Recent Clinical Trials for NEVANAC
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Kafrelsheikh University | Phase 4 |
The Research Council of Norway | Phase 4 |
Ifocus Oyeklinikk | Phase 4 |
Pharmacology for NEVANAC
Drug Class | Nonsteroidal Anti-inflammatory Drug |
Mechanism of Action | Cyclooxygenase Inhibitors |
US Patents and Regulatory Information for NEVANAC
NEVANAC is protected by three US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of NEVANAC is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting NEVANAC
Topical nepafenac formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING OCULAR INFLAMMATION
Topical nepafenac formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Topical nepafenac formulations
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 | NEVANAC | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 021862-001 | Aug 19, 2005 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Harrow Eye | NEVANAC | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 021862-001 | Aug 19, 2005 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Harrow Eye | NEVANAC | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 021862-001 | Aug 19, 2005 | 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 NEVANAC
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Harrow Eye | NEVANAC | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 021862-001 | Aug 19, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for NEVANAC
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 NEVANAC
When does loss-of-exclusivity occur for NEVANAC?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 2252
Patent: FORMULACIONES TOPICAS DE NEPAFENAC
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 05311738
Patent: Topical nepafenac formulations
Estimated Expiration: ⤷ Sign Up
Austria
Patent: 76200
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0518904
Patent: formulaÇÕes de nepafenac tàpicas
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 86807
Patent: PREPARATIONS TOPIQUES A BASE DE NEPAFENAC (TOPICAL NEPAFENAC FORMULATIONS)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1068573
Patent: Topical nepafenac formulations
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 10780
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 19362
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 19362
Patent: PREPARATIONS TOPIQUES A BASE DE NEPAFENAC (TOPICAL NEPAFENAC FORMULATIONS)
Estimated Expiration: ⤷ Sign Up
Germany
Patent: 2005022756
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 04225
Patent: TOPICAL NEPAFENAC FORMULATIONS
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 68844
Estimated Expiration: ⤷ Sign Up
Patent: 08521926
Estimated Expiration: ⤷ Sign Up
Patent: 12041368
Patent: TOPICAL NEPAFENAC FORMULATION
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 07006558
Patent: FORMULACIONES TOPICAS DE NEPAFENAC. (TOPICAL NEPAFENAC FORMULATIONS.)
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 19362
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 19362
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 07124638
Patent: ПРЕПАРАТЫ НЕПАФЕНАКА ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 19362
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 0704763
Patent: Topical nepafenac formulations
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1289661
Estimated Expiration: ⤷ Sign Up
Patent: 070089687
Patent: TOPICAL NEPAFENAC FORMULATIONS
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 48249
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 58290
Estimated Expiration: ⤷ Sign Up
Patent: 0626132
Patent: Topical nepafenac formulations
Estimated Expiration: ⤷ Sign Up
Uruguay
Patent: 238
Patent: FORMULACIONES DE NEPAFENAC PARA SU ADMINISTRACION TOPICA
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering NEVANAC around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 689277 | ⤷ Sign Up | |
Russian Federation | 2007124638 | ПРЕПАРАТЫ НЕПАФЕНАКА ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ | ⤷ Sign Up |
Japan | 4968844 | ⤷ Sign Up | |
European Patent Office | 1819362 | PREPARATIONS TOPIQUES A BASE DE NEPAFENAC (TOPICAL NEPAFENAC FORMULATIONS) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2006060618 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NEVANAC
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 | 92301 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: NEPAFENAC-SUSPENSION OPHTALMIQUE |
0999825 | C300622 | Netherlands | ⤷ Sign Up | PRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503 |
0716600 | C00716600/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: NEPAFENAC; REGISTRATION NUMBER/DATE: SWISSMEDIC 58745 24.09.2008 |
0999825 | 122013000085 | Germany | ⤷ Sign Up | PRODUCT NAME: NEPAFENAC (OPHTHALMISCHE SUSPENSION); REGISTRATION NO/DATE: EU 1/07/433/002 20130503 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |