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RHOPRESSA Drug Profile
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When do Rhopressa patents expire, and what generic alternatives are available?
Rhopressa is a drug marketed by Aerie Pharms Inc and is included in one NDA. There are nine patents protecting this drug.
This drug has fifty patent family members in eight 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.
US ANDA Litigation and Generic Entry Outlook for Rhopressa
Rhopressa will be eligible for patent challenges on December 18, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
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.
Indicators of Generic Entry
Summary for RHOPRESSA
| International Patents: | 50 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 9 |
| Clinical Trials: | 3 |
| Patent Applications: | 62 |
| Drug Prices: | Drug price information for RHOPRESSA |
| DailyMed Link: | RHOPRESSA at DailyMed |
Generic Entry Opportunity 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 |
|---|---|
| Price Vision Group | Phase 2/Phase 3 |
| Cornea Research Foundation of America | Phase 2/Phase 3 |
| Aerie Pharmaceuticals | Phase 4 |
Pharmacology for RHOPRESSA
| Drug Class | Rho Kinase Inhibitor |
| Mechanism of Action | Rho Kinase Inhibitors |
US Patents and Regulatory Information for RHOPRESSA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aerie Pharms Inc | RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254-001 | Dec 18, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Aerie Pharms Inc | RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254-001 | Dec 18, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Aerie Pharms Inc | RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254-001 | Dec 18, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Aerie Pharms Inc | RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254-001 | Dec 18, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Aerie Pharms Inc | RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254-001 | Dec 18, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Aerie Pharms Inc | RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254-001 | Dec 18, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Aerie Pharms Inc | RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254-001 | Dec 18, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start 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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Spain | 2474150 | Start Trial |
| China | 110396085 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2010127330 | Start Trial |
| Canada | 2731869 | Start Trial |
| European Patent Office | 2326623 | Start Trial |
| Canada | 2760562 | Start Trial |
| Japan | 2012525442 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for RHOPRESSA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3053913 | 2020C/510 | Belgium | Start Trial | PRODUCT NAME: RHOKIINSA - NETARSUDIL; AUTHORISATION NUMBER AND DATE: EU/1/19/1400 20191121 |
| 3053913 | 301038 | Netherlands | Start Trial | PRODUCT NAME: NETARSUDIL, OF EEN ZOUT OF SOLVAAAT DAARVAN, IN HET BIJZONDER NETARSUDILMESYLAAT; REGISTRATION NO/DATE: EU/1/19/1400 20191121 |
| 3053913 | 132020000000043 | Italy | Start Trial | PRODUCT NAME: NETARSUDIL(RHOKIINSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1400, 20191121 |
| 3053913 | 122020000016 | Germany | Start Trial | 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 |
