Arazlo is a drug owned by Bausch Health Us Llc. It is protected by 3 US drug patents filed from 2019 to 2023. Out of these, 2 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 11, 2038. Details of Arazlo'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). | |||
| US11311482 | Topical compositions and methods for treating skin diseases |
May, 2038
(13 years from now) | Active |
| US11679116 | Topical compositions and methods for treating psoriasis |
Jun, 2036
(11 years from now) | Active |
| US6517847 | Topical gel delivery system |
Aug, 2020
(4 years ago) |
Expired
|
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 Arazlo's patents.
Latest Legal Activities on Arazlo's Patents
Given below is the list of recent legal activities going on the following patents of Arazlo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Request for Trial Denied Critical | 12 Jan, 2024 | US11311482 |
| Petition Requesting Trial | 24 Jul, 2023 | US11311482 |
| Electronic Review Critical | 22 Jun, 2023 | US11679116 |
| Email Notification Critical | 21 Jun, 2023 | US11679116 |
| Patent eGrant Notification | 20 Jun, 2023 | US11679116 |
| Recordation of Patent eGrant | 20 Jun, 2023 | US11679116 |
| Patent Issue Date Used in PTA Calculation Critical | 20 Jun, 2023 | US11679116 |
| Mail Patent eGrant Notification | 20 Jun, 2023 | US11679116 |
| Recordation of Patent Grant Mailed Critical | 20 Jun, 2023 | US11679116 |
| Electronic Review Critical | 01 Jun, 2023 | US11679116 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Arazlo and ongoing litigations to help you estimate the early arrival of Arazlo generic.
Arazlo's Litigations
Arazlo been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jun 21, 2023, against patent number US11311482. The petitioner Padagis Israel Pharmaceuticals Ltd. et al., challenged the validity of this patent, with Bausch Health Ireland Limited et al. as the respondent. Click below to track the latest information on how companies are challenging Arazlo's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US11311482 | June, 2023 |
Institution Denied
(12 Jan, 2024) | Bausch Health Ireland Limited et al. | Padagis Israel Pharmaceuticals Ltd. et al. |
FDA has granted some exclusivities to Arazlo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Arazlo, 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 Arazlo.
Exclusivity Information
Arazlo holds 1 exclusivities. All of its exclusivities have expired in 2022. Details of Arazlo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Dec 18, 2022 |
US patents provide insights into the exclusivity only within the United States, but Arazlo 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 Arazlo's family patents as well as insights into ongoing legal events on those patents.
Arazlo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Arazlo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 11, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Arazlo Generic API suppliers:
Tazarotene is the generic name for the brand Arazlo. 5 different companies have already filed for the generic of Arazlo, with Cosette having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Arazlo's generic
How can I launch a generic of Arazlo before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Arazlo's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Arazlo'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 Arazlo -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.00045 | 12 May, 2022 | 1 | 11 May, 2038 |
Alternative Brands for Arazlo
Arazlo which is used for treating acne vulgaris in patients 9 years of age and older., has several other brand drugs in the same treatment category and using the same active ingredient (Tazarotene). 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 | ||
|---|---|---|---|---|
| Dow Pharm |
| |||
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. Tazarotene. 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 Tazarotene, Arazlo's active ingredient. Check the complete list of approved generic manufacturers for Arazlo
About Arazlo
Arazlo is a drug owned by Bausch Health Us Llc. It is used for treating acne vulgaris in patients 9 years of age and older. Arazlo uses Tazarotene as an active ingredient. Arazlo was launched by Bausch in 2019.
Approval Date:
Arazlo was approved by FDA for market use on 18 December, 2019.
Active Ingredient:
Arazlo uses Tazarotene as the active ingredient. Check out other Drugs and Companies using Tazarotene ingredient
Treatment:
Arazlo is used for treating acne vulgaris in patients 9 years of age and older.
Dosage:
Arazlo is available in lotion form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.045% | LOTION | Prescription | TOPICAL |