rhopressa Drug Patent Profile
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When do Rhopressa patents expire, and when can generic versions of Rhopressa launch?
Rhopressa is a drug marketed by Alcon Labs Inc and is included in one NDA. There are fourteen 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
Summary for rhopressa
International Patents: | 68 |
US Patents: | 14 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 18 |
Clinical Trials: | 5 |
Patent Applications: | 153 |
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 |
---|---|
Wills Eye | Phase 2/Phase 3 |
Salus University | Phase 4 |
Cornea Research Foundation of America | Phase 2/Phase 3 |
Pharmacology for rhopressa
Drug Class | Rho Kinase Inhibitor |
Mechanism of Action | Rho Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for rhopressa
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 fourteen US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of rhopressa is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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 rhopressa
Dual mechanism inhibitors for the treatment of disease
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Combination therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Dual mechanism inhibitors for the treatment of disease
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Dual mechanism inhibitors for the treatment of disease
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Compositions for treating glaucoma or reducing intraocular pressure
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Dual mechanism inhibitors for the treatment of disease
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Combination therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Combination therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Alcon Labs Inc | RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254-001 | Dec 18, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Alcon Labs Inc | RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254-001 | Dec 18, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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
Estimated Expiration: ⤷ Try a Trial
Patent: 18202965
Estimated Expiration: ⤷ Try a Trial
Patent: 18202990
Estimated Expiration: ⤷ Try a Trial
Patent: 20203976
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 05089
Estimated Expiration: ⤷ Try a Trial
China
Patent: 5263494
Estimated Expiration: ⤷ Try a Trial
Patent: 9528721
Estimated Expiration: ⤷ Try a Trial
Patent: 0396085
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 11943
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 76080
Estimated Expiration: ⤷ Try a Trial
Patent: 61484
Estimated Expiration: ⤷ Try a Trial
Patent: 11943
Estimated Expiration: ⤷ Try a Trial
Patent: 18759
Estimated Expiration: ⤷ Try a Trial
Finland
Patent: 11943
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 61618
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 16515520
Estimated Expiration: ⤷ Try a Trial
Patent: 19094339
Estimated Expiration: ⤷ Try a Trial
Patent: 20125355
Estimated Expiration: ⤷ Try a Trial
Patent: 20143163
Estimated Expiration: ⤷ Try a Trial
Patent: 21046439
Estimated Expiration: ⤷ Try a Trial
Patent: 23030072
Estimated Expiration: ⤷ Try a Trial
Netherlands
Patent: 1101
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 11943
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 11943
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 76199
Estimated Expiration: ⤷ Try a Trial
Patent: 52377
Estimated Expiration: ⤷ Try a Trial
Patent: 42898
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Canada | 2905089 | COMPOSE D'ISOQUINOLINE POUR TRAITER DES MALADIES OCULAIRES (ISOQUINOLINE COMPOUNDS FOR THE TREATMENT OF OCULAR DISEASES) | ⤷ Try a Trial |
Denmark | 3811943 | ⤷ Try a Trial | |
Hong Kong | 1258617 | 雙重機制抑制劑用於治療疾病 (DUAL MECHANISM INHIBITORS FOR THE TREATMENT OF DISEASE) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for rhopressa
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3053913 | 301038 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: NETARSUDIL, OF EEN ZOUT OF SOLVAAAT DAARVAN, IN HET BIJZONDER NETARSUDILMESYLAAT; REGISTRATION NO/DATE: EU/1/19/1400 20191121 |
3461484 | C202130024 | Spain | ⤷ Try a Trial | PRODUCT NAME: NETARSUDIL O UN ENANTIOMERO, DIASTEREIOISOMERO, SAL O SALVADO DEL MISMO EN COMBINACION CON LATANOPROST O UNA SAL DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/20/1502; DATE OF AUTHORISATION: 20210107; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1502; DATE OF FIRST AUTHORISATION IN EEA: 20210107 |
3053913 | SPC/GB20/019 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: NETARSUDIL; REGISTERED: UK EU/1/19/1400(NI) 20191121; UK PLGB 16058/003 20191121 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |