RHOPRESSA Drug Patent Profile
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When do Rhopressa patents expire, and what generic alternatives are available?
Rhopressa is a drug marketed by Alcon Labs Inc and is included in one NDA. There are fifteen patents protecting this drug and one Paragraph IV challenge.
This drug has sixty-eight patent family members in fourteen countries.
The generic ingredient in RHOPRESSA is netarsudil mesylate. One supplier is listed for this compound. Additional details are available on the netarsudil mesylate profile page.
DrugPatentWatch® Generic Entry Outlook for Rhopressa
Rhopressa was eligible for patent challenges on December 18, 2021.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be March 14, 2034. This may change due to patent challenges or generic licensing.
There has been one patent litigation case 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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for RHOPRESSA?
- What are the global sales for RHOPRESSA?
- What is Average Wholesale Price for RHOPRESSA?
Summary for RHOPRESSA
International Patents: | 68 |
US Patents: | 15 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 18 |
Clinical Trials: | 6 |
Patent Applications: | 106 |
Drug Prices: | Drug price information for RHOPRESSA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RHOPRESSA |
What excipients (inactive ingredients) are in RHOPRESSA? | RHOPRESSA excipients list |
DailyMed Link: | RHOPRESSA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for RHOPRESSA
Generic Entry Date for RHOPRESSA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION/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 RHOPRESSA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Massachusetts Eye and Ear Infirmary | Phase 1/Phase 2 |
Wills Eye | Phase 2/Phase 3 |
Salus University | Phase 4 |
Pharmacology for RHOPRESSA
Drug Class | Rho Kinase Inhibitor |
Mechanism of Action | Rho Kinase Inhibitors |
Paragraph IV (Patent) Challenges for RHOPRESSA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
RHOPRESSA | Ophthalmic Solution | netarsudil mesylate | 0.02% | 208254 | 2 | 2021-12-20 |
US Patents and Regulatory Information for RHOPRESSA
RHOPRESSA is protected by fifteen US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of RHOPRESSA is ⤷ Subscribe.
This potential generic entry date is based on patent 9,415,043.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Alcon Labs Inc | RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254-001 | Dec 18, 2017 | RX | Yes | Yes | 8,450,344 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Alcon Labs Inc | RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254-001 | Dec 18, 2017 | RX | Yes | Yes | 9,931,336 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Alcon Labs Inc | RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254-001 | Dec 18, 2017 | RX | Yes | Yes | 10,882,840 | ⤷ Subscribe | ⤷ Subscribe | ||||
Alcon Labs Inc | RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254-001 | Dec 18, 2017 | RX | Yes | Yes | 11,021,456 | ⤷ Subscribe | ⤷ Subscribe | ||||
Alcon Labs Inc | RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254-001 | Dec 18, 2017 | RX | Yes | Yes | 11,020,385 | ⤷ Subscribe | ⤷ Subscribe | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for RHOPRESSA
When does loss-of-exclusivity occur for RHOPRESSA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 14228790
Patent: Combination therapy
Estimated Expiration: ⤷ Subscribe
Patent: 18202965
Patent: Combination therapy
Estimated Expiration: ⤷ Subscribe
Patent: 18202990
Patent: Combination therapy
Estimated Expiration: ⤷ Subscribe
Patent: 20203976
Patent: COMBINATION THERAPY
Estimated Expiration: ⤷ Subscribe
Canada
Patent: 05089
Patent: COMPOSE D'ISOQUINOLINE POUR TRAITER DES MALADIES OCULAIRES (ISOQUINOLINE COMPOUNDS FOR THE TREATMENT OF OCULAR DISEASES)
Estimated Expiration: ⤷ Subscribe
China
Patent: 5263494
Patent: Combination therapy
Estimated Expiration: ⤷ Subscribe
Patent: 9528721
Patent: 联合治疗 (Combination therapy)
Estimated Expiration: ⤷ Subscribe
Patent: 0396085
Patent: 联合治疗 (Combination therapy)
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 11943
Estimated Expiration: ⤷ Subscribe
European Patent Office
Patent: 76080
Patent: CONJUGÉS DE COMPOSÉS ISOQUINOLINE ET DE PROSTAGLANDINES (CONJUGATES OF ISOQUINOLINE COMPOUNDS AND PROSTAGLANDINS)
Estimated Expiration: ⤷ Subscribe
Patent: 61484
Patent: TRAITEMENT COMBINÉ (COMBINATION THERAPY)
Estimated Expiration: ⤷ Subscribe
Patent: 11943
Patent: COMPOSÉ POUR L'UTILISATION DANS LE TRAITEMENT DES MALADIES OCULAIRES (COMPOUND FOR USE IN THE TREATMENT OF OCULAR DISORDERS)
Estimated Expiration: ⤷ Subscribe
Patent: 18759
Patent: TRAITMENT COMBINÉ (COMBINATION THERAPY)
Estimated Expiration: ⤷ Subscribe
Finland
Patent: 11943
Estimated Expiration: ⤷ Subscribe
Hungary
Patent: 61618
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 16515520
Patent: 併用療法
Estimated Expiration: ⤷ Subscribe
Patent: 19094339
Patent: 併用療法 (COMBINATORY TREATMENT)
Estimated Expiration: ⤷ Subscribe
Patent: 20125355
Patent: 併用療法 (COMBINATION THERAPY)
Estimated Expiration: ⤷ Subscribe
Patent: 20143163
Patent: 併用療法 (COMBINATION THERAPY)
Estimated Expiration: ⤷ Subscribe
Patent: 21046439
Patent: 併用療法 (COMBINATION THERAPY)
Estimated Expiration: ⤷ Subscribe
Patent: 23030072
Patent: 併用療法
Estimated Expiration: ⤷ Subscribe
Netherlands
Patent: 1101
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 11943
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 11943
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 76199
Estimated Expiration: ⤷ Subscribe
Patent: 52377
Estimated Expiration: ⤷ Subscribe
Patent: 42898
Estimated Expiration: ⤷ Subscribe
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 RHOPRESSA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Finland | 3811943 | ⤷ Subscribe | |
Poland | 3811943 | ⤷ Subscribe | |
Australia | 2021204320 | ⤷ Subscribe | |
Canada | 2929545 | INHIBITEURS A MECANISME DOUBLE POUR LE TRAITEMENT DE MALADIE (DUAL MECHANISM INHIBITORS FOR THE TREATMENT OF DISEASE) | ⤷ Subscribe |
World Intellectual Property Organization (WIPO) | 2014144781 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RHOPRESSA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3053913 | C202030018 | Spain | ⤷ Subscribe | PRODUCT NAME: NETARSUDIL O UN ENANTIOMERO, DIASTEREOMERO, SAL O SOLVATO DEL MISMO.; NATIONAL AUTHORISATION NUMBER: EU/1/19/1400; DATE OF AUTHORISATION: 20191119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1400; DATE OF FIRST AUTHORISATION IN EEA: 20191119 |
3461484 | 21C1024 | France | ⤷ Subscribe | PRODUCT NAME: ASSOCIATION DE NETARSUDIL OU L'UN DE SES SELS ET DE LATANOPROST; REGISTRATION NO/DATE: EU/1/20/1502 20210108 |
3053913 | SPC/GB20/019 | United Kingdom | ⤷ Subscribe | PRODUCT NAME: NETARSUDIL; REGISTERED: UK EU/1/19/1400(NI) 20191121; UK PLGB 16058/003 20191121 |
3053913 | 122020000016 | Germany | ⤷ Subscribe | PRODUCT NAME: NETARSUDIL, ODER EIN ENANTIOMER, DIASTEREOMER, SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1400 20191119 |
3053913 | 2020C/510 | Belgium | ⤷ Subscribe | PRODUCT NAME: RHOKIINSA - NETARSUDIL; AUTHORISATION NUMBER AND DATE: EU/1/19/1400 20191121 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
RHOPRESSA Market Analysis and Financial Projection Experimental
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