Zyclara Patent Expiration

Zyclara is a drug owned by Bausch Health Us Llc. It is protected by 10 US drug patents filed from 2013 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 30, 2030. Details of Zyclara'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10238645 Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts
Aug, 2029

(5 years from now)

Active
US8598196 Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy
Aug, 2029

(5 years from now)

Active
US11318130 2x2x2 week dosing regimen for treating actinic keratosis with pharmaceutical compositions formulated with 3.75% imiquimod
Dec, 2029

(5 years from now)

Active
US10238644 2×2×2 week dosing regimen for treating acting keratosis with pharmaceutical compositions formulated with 3.75% imiquimod
Dec, 2029

(5 years from now)

Active
US8236816 2×2×2 week dosing regimen for treating actinic keratosis with pharmaceutical compositions formulated with 3.75 % imiquimod
Dec, 2029

(5 years from now)

Active
US8222270 2×2×2 week treatment regimen for treating actinic keratosis with pharmaceutical compositions formulated with 2.5% imiquimod
Dec, 2029

(5 years from now)

Active
US8299109 Method of treating actinic keratosis with 3.75% imiquimod cream
Dec, 2029

(5 years from now)

Active
US11850245 Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts
Apr, 2030

(5 years from now)

Active
US11202752 Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy
Apr, 2030

(5 years from now)

Active
US10918635 Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts
Apr, 2030

(5 years from now)

Active


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

Exclusivity Information

Zyclara holds 3 exclusivities. All of its exclusivities have expired in 2014. Details of Zyclara's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Mar 25, 2013
New Indication(I-636) Mar 24, 2014
New Strength(NS) Jul 15, 2014

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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

Zyclara's family patents

Zyclara has patent protection in a total of 31 countries. It's US patent count contributes only to 46.9% of its total global patent coverage. 10 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Zyclara.

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Generic Launch

Generic Release Date:

Zyclara's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 30, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Zyclara Generics:

Imiquimod is the generic name for the brand Zyclara. 8 different companies have already filed for the generic of Zyclara, with Taro having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Zyclara's generic

How can I launch a generic of Zyclara before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Zyclara's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Zyclara'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 Zyclara -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
0.025 17 Jun, 2014 1 11 Dec, 2029
0.0375 08 Aug, 2012 1 11 Dec, 2029 Non-Forfeiture




About Zyclara

Zyclara is a drug owned by Bausch Health Us Llc. It is used for treating skin conditions caused by certain types of viruses. Zyclara uses Imiquimod as an active ingredient. Zyclara was launched by Bausch in 2011.

Market Authorisation Date:

Zyclara was approved by FDA for market use on 15 July, 2011.

Active Ingredient:

Zyclara uses Imiquimod as the active ingredient. Check out other Drugs and Companies using Imiquimod ingredient

Treatment:

Zyclara is used for treating skin conditions caused by certain types of viruses.

Dosage:

Zyclara is available in cream form for topical use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
3.75% CREAM Prescription TOPICAL
2.5% CREAM Prescription TOPICAL