Zerviate Patent Expiration

Zerviate is a drug owned by Harrow Eye Llc. It is protected by 6 US drug patents filed from 2017 to 2018 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 09, 2033. Details of Zerviate's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9254286

(Pediatric)

Ophthalmic formulations of cetirizine and methods of use
Jan, 2033

(8 years from now)

Active
US9254286 Ophthalmic formulations of cetirizine and methods of use
Jul, 2032

(7 years from now)

Active
US8829005

(Pediatric)

Ophthalmic formulations of cetirizine and methods of use
Sep, 2030

(5 years from now)

Active
US8829005 Ophthalmic formulations of cetirizine and methods of use
Mar, 2030

(5 years from now)

Active
US9750684 Ophthalmic formulations of cetirizine and methods of use
Mar, 2030

(5 years from now)

Active
US9993471 Ophthalmic formulations of cetirizine and methods of use
Mar, 2030

(5 years 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 Zerviate's patents.

Given below is the list of recent legal activities going on the following patents of Zerviate.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 8th Yr, Small Entity 09 Aug, 2023 US9254286
Payment of Maintenance Fee, 8th Yr, Small Entity 02 Mar, 2022 US8829005
Payment of Maintenance Fee, 4th Yr, Small Entity 11 Nov, 2021 US9993471
Payment of Maintenance Fee, 4th Yr, Small Entity 23 Feb, 2021 US9750684
Payment of Maintenance Fee, 4th Yr, Small Entity 30 Jul, 2019 US9254286
Recordation of Patent Grant Mailed 12 Jun, 2018 US9993471
Patent Issue Date Used in PTA Calculation 12 Jun, 2018 US9993471
Email Notification 24 May, 2018 US9993471
Issue Notification Mailed 23 May, 2018 US9993471
Dispatch to FDC 15 May, 2018 US9993471


FDA has granted several exclusivities to Zerviate. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zerviate, 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 Zerviate.

Exclusivity Information

Zerviate holds 2 exclusivities. All of its exclusivities have expired in 2020. Details of Zerviate's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Dosage Form(NDF) May 30, 2020
Pediatric Exclusivity(PED) Nov 30, 2020

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US patents provide insights into the exclusivity only within the United States, but Zerviate 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 Zerviate's family patents as well as insights into ongoing legal events on those patents.

Zerviate's Family Patents

Zerviate has patent protection in a total of 7 countries. It's US patent count contributes only to 46.7% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Zerviate.

Family Patents

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Generic Launch

Generic Release Date:

Zerviate's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 09, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Zerviate Generic API suppliers:

Cetirizine Hydrochloride is the generic name for the brand Zerviate. 47 different companies have already filed for the generic of Zerviate, with Taro having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Zerviate's generic

Alternative Brands for Zerviate

Zerviate which is used for providing relief from ocular itching associated with allergic conjunctivitis., has several other brand drugs in the same treatment category and using the same active ingredient (Cetirizine Hydrochloride). 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.

Drug Owner Drug Name Treatment Area
Alcon Labs Inc
Pataday Once Daily Relief Used for treating allergic conjunctivitis and relieving ocular itching associated with allergic conjunctivitis.

Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Cetirizine Hydrochloride. Given below is the list of those drugs and companies owning them.



Apart from brand drugs containing the same ingredient, some generics have also been filed for Cetirizine Hydrochloride, Zerviate's active ingredient. Check the complete list of approved generic manufacturers for Zerviate





About Zerviate

Zerviate is a drug owned by Harrow Eye Llc. It is used for providing relief from ocular itching associated with allergic conjunctivitis. Zerviate uses Cetirizine Hydrochloride as an active ingredient. Zerviate was launched by Harrow Eye in 2017.

Approval Date:

Zerviate was approved by FDA for market use on 30 May, 2017.

Active Ingredient:

Zerviate uses Cetirizine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Cetirizine Hydrochloride ingredient

Treatment:

Zerviate is used for providing relief from ocular itching associated with allergic conjunctivitis.

Dosage:

Zerviate is available in solution/drops form for ophthalmic use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 0.24% BASE SOLUTION/DROPS Prescription OPHTHALMIC