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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10918635 | Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts |
Apr, 2030
(4 years from now) | Active |
| US11850245 | Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts |
Apr, 2030
(4 years from now) | Active |
| US11202752 | Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy |
Apr, 2030
(4 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
(4 years from now) | Active |
| US8299109 | Method of treating actinic keratosis with 3.75% imiquimod cream |
Dec, 2029
(4 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
(4 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
(4 years from now) | Active |
| US11318130 | 2x2x2 week dosing regimen for treating actinic keratosis with pharmaceutical compositions formulated with 3.75% imiquimod |
Dec, 2029
(4 years from now) | Active |
| US10238645 | Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts |
Aug, 2029
(4 years from now) | Active |
| US8598196 | Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy |
Aug, 2029
(4 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 Zyclara's patents.
Latest Legal Activities on Zyclara's Patents
Given below is the list of recent legal activities going on the following patents of Zyclara.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Mar, 2024 | US8299109 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 23 Jan, 2024 | US8236816 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 26 Dec, 2023 | US11850245 |
| Recordation of Patent Grant Mailed Critical | 26 Dec, 2023 | US11850245 |
| Mail Patent eGrant Notification | 26 Dec, 2023 | US11850245 |
| Email Notification Critical | 26 Dec, 2023 | US11850245 |
| Recordation of Patent eGrant | 26 Dec, 2023 | US11850245 |
| Patent eGrant Notification | 26 Dec, 2023 | US11850245 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 19 Dec, 2023 | US8222270 |
| Email Notification Critical | 07 Dec, 2023 | US11850245 |
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 |
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
Explore Our Curated Drug Screens
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 Generic API suppliers:
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 |
Alternative Brands for Zyclara
Zyclara which is used for treating skin conditions caused by certain types of viruses., has several other brand drugs in the same treatment category and using the same active ingredient (Imiquimod). 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.
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. Imiquimod. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Bausch |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Imiquimod, Zyclara's active ingredient. Check the complete list of approved generic manufacturers for Zyclara
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.
Approval 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 |