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Last Updated: September 24, 2022

ROCKLATAN Drug Patent Profile


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Which patents cover Rocklatan, and when can generic versions of Rocklatan launch?

Rocklatan is a drug marketed by Aerie Pharms Inc and is included in one NDA. There are fifteen patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-nine patent family members in nine countries.

The generic ingredient in ROCKLATAN is latanoprost; netarsudil dimesylate. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the latanoprost; netarsudil dimesylate profile page.

DrugPatentWatch® Generic Entry Outlook for Rocklatan

Rocklatan 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 is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for ROCKLATAN
International Patents:59
US Patents:15
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 1
Formulation / Manufacturing:see details
Drug Prices: Drug price information for ROCKLATAN
What excipients (inactive ingredients) are in ROCKLATAN?ROCKLATAN excipients list
DailyMed Link:ROCKLATAN at DailyMed
Drug patent expirations by year for ROCKLATAN
Drug Prices for ROCKLATAN

See drug prices for ROCKLATAN

DrugPatentWatch® Estimated Generic Entry Opportunity Date for ROCKLATAN
Generic Entry Date for ROCKLATAN*:
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 ROCKLATAN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Aerie PharmaceuticalsPhase 4

See all ROCKLATAN clinical trials

Pharmacology for ROCKLATAN
Paragraph IV (Patent) Challenges for ROCKLATAN
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 ROCKLATAN

ROCKLATAN is protected by fifteen US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ROCKLATAN is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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 ROCKLATAN

Dual mechanism inhibitors for the treatment of disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

Combination therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

Dual mechanism inhibitors for the treatment of disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

Dual mechanism inhibitors for the treatment of disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

Compositions for treating glaucoma or reducing intraocular pressure
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Combination therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dual mechanism inhibitors for the treatment of disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

Combination therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Combination therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

Combination therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

FDA Regulatory Exclusivity protecting ROCKLATAN

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

NEW COMBINATION
Exclusivity Expiration: See Plans and Pricing

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 ROCKLATAN latanoprost; netarsudil dimesylate SOLUTION/DROPS;OPHTHALMIC 208259-001 Mar 12, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Aerie Pharms Inc ROCKLATAN latanoprost; netarsudil dimesylate SOLUTION/DROPS;OPHTHALMIC 208259-001 Mar 12, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aerie Pharms Inc ROCKLATAN latanoprost; netarsudil dimesylate SOLUTION/DROPS;OPHTHALMIC 208259-001 Mar 12, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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 ROCKLATAN

When does loss-of-exclusivity occur for ROCKLATAN?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 14228790
Estimated Expiration: See Plans and Pricing

Patent: 18202965
Estimated Expiration: See Plans and Pricing

Patent: 18202990
Estimated Expiration: See Plans and Pricing

Patent: 20203976
Estimated Expiration: See Plans and Pricing

Canada

Patent: 05089
Estimated Expiration: See Plans and Pricing

China

Patent: 5263494
Estimated Expiration: See Plans and Pricing

Patent: 9528721
Estimated Expiration: See Plans and Pricing

Patent: 0396085
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 76080
Estimated Expiration: See Plans and Pricing

Patent: 61484
Estimated Expiration: See Plans and Pricing

Patent: 11943
Estimated Expiration: See Plans and Pricing

Japan

Patent: 16515520
Estimated Expiration: See Plans and Pricing

Patent: 19094339
Estimated Expiration: See Plans and Pricing

Patent: 20125355
Estimated Expiration: See Plans and Pricing

Patent: 20143163
Estimated Expiration: See Plans and Pricing

Patent: 21046439
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 1101
Estimated Expiration: See Plans and Pricing

Spain

Patent: 76199
Estimated Expiration: See Plans and Pricing

Patent: 52377
Estimated Expiration: See Plans and Pricing

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 ROCKLATAN around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 3461484 TRAITEMENT COMBINÉ (COMBINATION THERAPY) See Plans and Pricing
Netherlands 301038 See Plans and Pricing
Canada 2760562 INHIBITEURS A MECANISME DOUBLE POUR LE TRAITEMENT DE MALADIE (DUAL MECHANISM INHIBITORS FOR THE TREATMENT OF DISEASE) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ROCKLATAN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3461484 2021C/515 Belgium See Plans and Pricing PRODUCT NAME: ROCLANDA - LATANOPROST / NETARSUDIL; AUTHORISATION NUMBER AND DATE: EU/1/20/1502 20210108
3053913 20C1017 France See Plans and Pricing PRODUCT NAME: NETARSUDIL, OU ENANTIOMERE, DIASTEREOMERE, SEL OU SOLVATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/19/1400 20191121
3461484 21C1024 France See Plans and Pricing PRODUCT NAME: ASSOCIATION DE NETARSUDIL OU L'UN DE SES SELS ET DE LATANOPROST; REGISTRATION NO/DATE: EU/1/20/1502 20210108
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Merck
Johnson and Johnson
Moodys
McKesson
Baxter

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.