LATANOPROST; NETARSUDIL DIMESYLATE - Generic Drug Details
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What are the generic sources for latanoprost; netarsudil dimesylate and what is the scope of patent protection?
Latanoprost; netarsudil dimesylate
is the generic ingredient in one branded drug marketed by Alcon Labs Inc and is included in one NDA. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Latanoprost; netarsudil dimesylate has sixty-eight patent family members in fourteen countries.
One supplier is listed for this compound.
Summary for LATANOPROST; NETARSUDIL DIMESYLATE
| International Patents: | 68 |
| US Patents: | 16 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LATANOPROST; NETARSUDIL DIMESYLATE |
| DailyMed Link: | LATANOPROST; NETARSUDIL DIMESYLATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LATANOPROST; NETARSUDIL DIMESYLATE
Generic Entry Date for LATANOPROST; NETARSUDIL DIMESYLATE*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for LATANOPROST; NETARSUDIL DIMESYLATE
| Drug Class | Prostaglandin Analog Rho Kinase Inhibitor |
| Mechanism of Action | Rho Kinase Inhibitors |
Paragraph IV (Patent) Challenges for LATANOPROST; NETARSUDIL DIMESYLATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ROCKLATAN | Ophthalmic Solution | latanoprost; netarsudil dimesylate | 0.005%/0.02% | 208259 | 2 | 2021-12-20 |
US Patents and Regulatory Information for LATANOPROST; NETARSUDIL DIMESYLATE
| 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 | ROCKLATAN | latanoprost; netarsudil dimesylate | SOLUTION/DROPS;OPHTHALMIC | 208259-001 | Mar 12, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Alcon Labs Inc | ROCKLATAN | latanoprost; netarsudil dimesylate | SOLUTION/DROPS;OPHTHALMIC | 208259-001 | Mar 12, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Alcon Labs Inc | ROCKLATAN | latanoprost; netarsudil dimesylate | SOLUTION/DROPS;OPHTHALMIC | 208259-001 | Mar 12, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Alcon Labs Inc | ROCKLATAN | latanoprost; netarsudil dimesylate | SOLUTION/DROPS;OPHTHALMIC | 208259-001 | Mar 12, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Alcon Labs Inc | ROCKLATAN | latanoprost; netarsudil dimesylate | SOLUTION/DROPS;OPHTHALMIC | 208259-001 | Mar 12, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Alcon Labs Inc | ROCKLATAN | latanoprost; netarsudil dimesylate | SOLUTION/DROPS;OPHTHALMIC | 208259-001 | Mar 12, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Alcon Labs Inc | ROCKLATAN | latanoprost; netarsudil dimesylate | SOLUTION/DROPS;OPHTHALMIC | 208259-001 | Mar 12, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ 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 LATANOPROST; NETARSUDIL DIMESYLATE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 2731869 | COMPOSES AMIDES BETA ET GAMMA-AMINO ISOQUINOLINE ET COMPOSES BENZAMIDE SUBSTITUE (BETA-AND GAMMA-AMINO-ISOQUINOLINE AMIDE COMPOUNDS AND SUBSTITUTED BENZAMIDE COMPOUNDS) | ⤷ Try a Trial |
| Poland | 3811943 | ⤷ Try a Trial | |
| Japan | 2020143163 | 併用療法 (COMBINATION THERAPY) | ⤷ Try a Trial |
| Japan | 5980846 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2010011853 | ⤷ Try a Trial | |
| Spain | 2553827 | ⤷ Try a Trial | |
| European Patent Office | 3828172 | INHIBITEURS À DOUBLE MECANISME POUR LE TRAITEMENT D'UNE MALADIE (DUAL MECHANISM INHIBITORS FOR THE TREATMENT OF DISEASE) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LATANOPROST; NETARSUDIL DIMESYLATE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3461484 | 301101 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LATANOPROST OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN NETARSUDILMESYLAAT; REGISTRATION NO/DATE: EU/1/20/1502 20210108 |
| 3053913 | C202030018 | Spain | ⤷ Try a Trial | 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 | ⤷ Try a Trial | PRODUCT NAME: NETARSUDIL, ODER EIN ENANTIOMER, DIASTEREOMER, SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1400 20191119 |
| 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 |
| 3053913 | 2020C/510 | Belgium | ⤷ Try a Trial | PRODUCT NAME: RHOKIINSA - NETARSUDIL; AUTHORISATION NUMBER AND DATE: EU/1/19/1400 20191121 |
| 0364417 | 97C0128 | France | ⤷ Try a Trial | PRODUCT NAME: LATANOPROST; REGISTRATION NO/DATE IN FRANCE: NL 22549 DU 19970724; REGISTRATION NO/DATE AT EEC: 12716 DU 19960718 |
| 3053913 | 20C1017 | France | ⤷ Try a Trial | PRODUCT NAME: NETARSUDIL, OU ENANTIOMERE, DIASTEREOMERE, SEL OU SOLVATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/19/1400 20191121 |
| >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.
ISSN: 2162-2639
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