Rocklatan is a drug owned by Alcon Laboratories Inc. It is protected by 17 US drug patents filed from 2019 to 2024 out of which none have expired yet. Rocklatan's patents have been open to challenges since 18 December, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 14, 2034. Details of Rocklatan's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9415043 | Combination therapy |
Mar, 2034
(8 years from now) | Active |
| US9993470 | Combination therapy |
Mar, 2034
(8 years from now) | Active |
| US9931336 | Combination therapy |
Mar, 2034
(8 years from now) | Active |
| US10588901 | Combination therapy |
Mar, 2034
(8 years from now) | Active |
| US8394826 | Dual mechanism inhibitors for the treatment of disease |
Nov, 2030
(5 years from now) | Active |
| US10654844 | Dual mechanism inhibitors for the treatment of disease |
Jan, 2030
(4 years from now) | Active |
| US10174017 | Dual mechanism inhibitors for the treatment of disease |
Jan, 2030
(4 years from now) | Active |
| US9096569 | Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds |
Jul, 2026
(1 year, 1 month from now) | Active |
| US8450344 | Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds |
Jul, 2026
(1 year, 1 month from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11197853 | Combination therapy |
Mar, 2034
(8 years from now) | Active |
| US11020385 | Combination therapy |
Mar, 2034
(8 years from now) | Active |
| US11185538 | Compositions for treating glaucoma or reducing intraocular pressure |
Mar, 2034
(8 years from now) | Active |
| US11618748 | Dual mechanism inhibitors for the treatment of disease |
Jan, 2030
(4 years from now) | Active |
| US11028081 | Dual mechanism inhibitors for the treatment of disease |
Jan, 2030
(4 years from now) | Active |
| US11021456 | Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds |
Jul, 2026
(1 year, 1 month from now) | Active |
| US10882840 | Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds |
Jul, 2026
(1 year, 1 month from now) | Active |
| US10532993 | Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds |
Jul, 2026
(1 year, 1 month from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Rocklatan's patents.
Latest Legal Activities on Rocklatan's Patents
Given below is the list of recent legal activities going on the following patents of Rocklatan.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 19 Jun, 2024 | US10882840 |
| Correspondence Address Change Critical | 25 Mar, 2024 | US8394826 |
| Correspondence Address Change Critical | 25 Mar, 2024 | US9415043 |
| Correspondence Address Change Critical | 25 Mar, 2024 | US9993470 |
| Correspondence Address Change Critical | 25 Mar, 2024 | US8450344 |
| Correspondence Address Change Critical | 25 Mar, 2024 | US10174017 |
| Correspondence Address Change Critical | 20 Mar, 2024 | US10588901 |
| Correspondence Address Change Critical | 20 Mar, 2024 | US11028081 |
| Correspondence Address Change Critical | 20 Mar, 2024 | US11021456 |
| Correspondence Address Change Critical | 20 Mar, 2024 | US10532993 |
FDA has granted several exclusivities to Rocklatan. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Rocklatan, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Rocklatan.
Exclusivity Information
Rocklatan holds 2 exclusivities. All of its exclusivities have expired in 2022. Details of Rocklatan's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Combination(NC) | Mar 12, 2022 |
| New Chemical Entity Exclusivity(NCE) | Dec 18, 2022 |
Several oppositions have been filed on Rocklatan's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Rocklatan's generic, the next section provides detailed information on ongoing and past EP oppositions related to Rocklatan patents.
Rocklatan's Oppositions Filed in EPO
Rocklatan has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 13, 2021, by Alfred E. Tiefenbacher (Gmbh & Co. Kg). This opposition was filed on patent number EP18206195A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP18206195A | Aug, 2021 | Isarpatent - Patent- und Rechtsanwälte Barth Charles Hassa Peckmann und Partner mbB | Granted and Under Opposition |
| EP18206195A | Aug, 2021 | df-mp Dörries Frank-Molnia & Pohlman Patentanwälte Rechtsanwälte ParG mbB | Granted and Under Opposition |
| EP18206195A | Aug, 2021 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Rocklatan is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Rocklatan's family patents as well as insights into ongoing legal events on those patents.
Rocklatan's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Rocklatan's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 14, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Rocklatan Generics:
There are no approved generic versions for Rocklatan as of now.
How can I launch a generic of Rocklatan before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Rocklatan's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Rocklatan's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Rocklatan -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.005%/0.02% | 20 Dec, 2021 | 2 | 14 Mar, 2034 |
Alternative Brands for Rocklatan
Rocklatan which is used for lowering high eye pressure., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
About Rocklatan
Rocklatan is a drug owned by Alcon Laboratories Inc. It is used for lowering high eye pressure. Rocklatan uses Latanoprost; Netarsudil Dimesylate as an active ingredient. Rocklatan was launched by Alcon Labs Inc in 2019.
Approval Date:
Rocklatan was approved by FDA for market use on 12 March, 2019.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Rocklatan is 12 March, 2019, its NCE-1 date is estimated to be 18 December, 2021.
Active Ingredient:
Rocklatan uses Latanoprost; Netarsudil Dimesylate as the active ingredient. Check out other Drugs and Companies using Latanoprost; Netarsudil Dimesylate ingredient
Treatment:
Rocklatan is used for lowering high eye pressure.
Dosage:
Rocklatan is available in solution/drops form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.005%;EQ 0.02% BASE | SOLUTION/DROPS | Prescription | OPHTHALMIC |