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RHOPRESSA Drug Profile
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Which patents cover Rhopressa, and what generic alternatives are available?
Rhopressa is a drug marketed by Aerie Pharms Inc and is included in one NDA. There are six patents protecting this drug.
This drug has forty-five patent family members in eight countries.
The generic ingredient in RHOPRESSA is netarsudil dimesylate. One supplier is listed for this compound. Additional details are available on the netarsudil dimesylate 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: | 45 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 5 |
| Clinical Trials: | 3 |
| Patent Applications: | 13 |
| 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 |
Synonyms for RHOPRESSA
| (4-((1S)-1-(Aminomethyl)-2-(isoquinolin-6-ylamino)-2-oxoethyl)phenyl)methyl 2,4- dimethylbenzoate |
| [4-[(2S)-3-amino-1-(isoquinolin-6-ylamino)-1-oxopropan-2-yl]phenyl]methyl 2,4-dimethylbenzoate |
| 1254032-66-0 |
| 1628418-15-4 |
| AR 13324 |
| AR-11324 |
| AR-11324 free base |
| AR-13324 |
| AR11324 |
| Benzoic acid, 2,4-dimethyl-, (4-((1S)-1-(aminomethyl)-2-(6-isoquinolinylamino)-2-oxoethyl)phenyl)methyl ester |
| D11030 |
| ester 60 [PMID: 27072905] |
| GTPL9322 |
| Netarsudil |
| Netarsudil (USAN/INN) |
| Netarsudil [USAN:INN] |
| Netarsudil [USAN] |
| SB17091 |
| SCHEMBL16036278 |
| UNII-W6I5QDT7QI |
| W6I5QDT7QI |
| ZINC113149554 |
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 dimesylate | SOLUTION/DROPS;OPHTHALMIC | 208254-001 | Dec 18, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Aerie Pharms Inc | RHOPRESSA | netarsudil dimesylate | SOLUTION/DROPS;OPHTHALMIC | 208254-001 | Dec 18, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Aerie Pharms Inc | RHOPRESSA | netarsudil dimesylate | SOLUTION/DROPS;OPHTHALMIC | 208254-001 | Dec 18, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Aerie Pharms Inc | RHOPRESSA | netarsudil dimesylate | SOLUTION/DROPS;OPHTHALMIC | 208254-001 | Dec 18, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Aerie Pharms Inc | RHOPRESSA | netarsudil dimesylate | 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 |
|---|---|---|
| Canada | 2760562 | Start Trial |
| Japan | 2017160240 | Start Trial |
| Spain | 2474150 | Start Trial |
| Australia | 2019210632 | Start Trial |
| Japan | 5643758 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
