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
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Questions you can ask:
- What is the 5 year forecast for RHOPRESSA?
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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
*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 ⤷ 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 RHOPRESSA
Dual mechanism inhibitors for the treatment of disease
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Combination therapy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Dual mechanism inhibitors for the treatment of disease
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Combination therapy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Dual mechanism inhibitors for the treatment of disease
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Compositions for treating glaucoma or reducing intraocular pressure
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Dual mechanism inhibitors for the treatment of disease
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Combination therapy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Combination therapy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Alcon Labs Inc | RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254-001 | Dec 18, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Alcon Labs Inc | RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254-001 | Dec 18, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Alcon Labs Inc | RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254-001 | Dec 18, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Alcon Labs Inc | RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254-001 | Dec 18, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Alcon Labs Inc | RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254-001 | Dec 18, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Alcon Labs Inc | RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254-001 | Dec 18, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | 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 |
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: ⤷ Sign Up
Patent: 18202965
Patent: Combination therapy
Estimated Expiration: ⤷ Sign Up
Patent: 18202990
Patent: Combination therapy
Estimated Expiration: ⤷ Sign Up
Patent: 20203976
Patent: COMBINATION THERAPY
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 05089
Patent: COMPOSE D'ISOQUINOLINE POUR TRAITER DES MALADIES OCULAIRES (ISOQUINOLINE COMPOUNDS FOR THE TREATMENT OF OCULAR DISEASES)
Estimated Expiration: ⤷ Sign Up
China
Patent: 5263494
Patent: Combination therapy
Estimated Expiration: ⤷ Sign Up
Patent: 9528721
Patent: 联合治疗 (Combination therapy)
Estimated Expiration: ⤷ Sign Up
Patent: 0396085
Patent: 联合治疗 (Combination therapy)
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 11943
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 76080
Patent: CONJUGÉS DE COMPOSÉS ISOQUINOLINE ET DE PROSTAGLANDINES (CONJUGATES OF ISOQUINOLINE COMPOUNDS AND PROSTAGLANDINS)
Estimated Expiration: ⤷ Sign Up
Patent: 61484
Patent: TRAITEMENT COMBINÉ (COMBINATION THERAPY)
Estimated Expiration: ⤷ Sign Up
Patent: 11943
Patent: COMPOSÉ POUR L'UTILISATION DANS LE TRAITEMENT DES MALADIES OCULAIRES (COMPOUND FOR USE IN THE TREATMENT OF OCULAR DISORDERS)
Estimated Expiration: ⤷ Sign Up
Patent: 18759
Patent: TRAITMENT COMBINÉ (COMBINATION THERAPY)
Estimated Expiration: ⤷ Sign Up
Finland
Patent: 11943
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 61618
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 16515520
Patent: 併用療法
Estimated Expiration: ⤷ Sign Up
Patent: 19094339
Patent: 併用療法 (COMBINATORY TREATMENT)
Estimated Expiration: ⤷ Sign Up
Patent: 20125355
Patent: 併用療法 (COMBINATION THERAPY)
Estimated Expiration: ⤷ Sign Up
Patent: 20143163
Patent: 併用療法 (COMBINATION THERAPY)
Estimated Expiration: ⤷ Sign Up
Patent: 21046439
Patent: 併用療法 (COMBINATION THERAPY)
Estimated Expiration: ⤷ Sign Up
Patent: 23030072
Patent: 併用療法
Estimated Expiration: ⤷ Sign Up
Netherlands
Patent: 1101
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 11943
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 11943
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 76199
Estimated Expiration: ⤷ Sign Up
Patent: 52377
Estimated Expiration: ⤷ Sign Up
Patent: 42898
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 RHOPRESSA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2852377 | ⤷ Sign Up | |
| Japan | 2016515520 | 併用療法 | ⤷ Sign Up |
| European Patent Office | 3811943 | COMPOSÉ POUR L'UTILISATION DANS LE TRAITEMENT DES MALADIES OCULAIRES (COMPOUND FOR USE IN THE TREATMENT OF OCULAR DISORDERS) | ⤷ Sign Up |
| European Patent Office | 3828172 | ⤷ Sign Up | |
| Canada | 2731869 | COMPOSES AMIDES BETA ET GAMMA-AMINO ISOQUINOLINE ET COMPOSES BENZAMIDE SUBSTITUE (BETA-AND GAMMA-AMINO-ISOQUINOLINE AMIDE COMPOUNDS AND SUBSTITUTED BENZAMIDE COMPOUNDS) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2010126626 | ⤷ Sign Up | |
| China | 109528721 | 联合治疗 (Combination therapy) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RHOPRESSA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3461484 | 122021000036 | Germany | ⤷ Sign Up | PRODUCT NAME: LATANOPROST, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND NETARSUDIL MESYLAT; REGISTRATION NO/DATE: EU/1/20/1502 20210107 |
| 3053913 | 132020000000043 | Italy | ⤷ Sign Up | PRODUCT NAME: NETARSUDIL(RHOKIINSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1400, 20191121 |
| 3461484 | 21C1024 | France | ⤷ Sign Up | PRODUCT NAME: ASSOCIATION DE NETARSUDIL OU L'UN DE SES SELS ET DE LATANOPROST; REGISTRATION NO/DATE: EU/1/20/1502 20210108 |
| 3461484 | 2021C/515 | Belgium | ⤷ Sign Up | PRODUCT NAME: ROCLANDA - LATANOPROST / NETARSUDIL; AUTHORISATION NUMBER AND DATE: EU/1/20/1502 20210108 |
| 3461484 | SPC/GB21/033 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF LATANOPROST AND NETARSUDIL; REGISTERED: UK EU/1/20/1502(FOR NI) 20210107; UK PLGB 16053/0034 20210107 |
| 3053913 | C202030018 | Spain | ⤷ Sign Up | 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 |
| 3053913 | 122020000016 | Germany | ⤷ Sign Up | PRODUCT NAME: NETARSUDIL, ODER EIN ENANTIOMER, DIASTEREOMER, SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1400 20191119 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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