Acanya Patent Expiration

Acanya is a drug owned by Bausch Health Americas Inc. It is protected by 7 US drug patents filed from 2013 to 2020. Out of these, 6 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 05, 2029. Details of Acanya'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).
US8288434 Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Aug, 2029

(4 years from now)

Active
US8895070 Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Jun, 2029

(4 years from now)

Active
US10220049 Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Jun, 2029

(4 years from now)

Active
US9078870 Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Jun, 2029

(4 years from now)

Active
US10624918 Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Jun, 2029

(4 years from now)

Active
US8663699 Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Jun, 2029

(4 years from now)

Active
US5733886 Compositions of clindamycin and benzoyl peroxide for acne treatment
Mar, 2015

(9 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 Acanya's patents.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 20 Mar, 2024 US8288434 (Litigated)
Payment of Maintenance Fee, 4th Year, Large Entity 20 Sep, 2023 US10624918
Payment of Maintenance Fee, 8th Year, Large Entity 20 Dec, 2022 US9078870
Payment of Maintenance Fee, 4th Year, Large Entity 18 Aug, 2022 US10220049
Payment of Maintenance Fee, 8th Year, Large Entity 21 Apr, 2022 US8895070
Payment of Maintenance Fee, 8th Year, Large Entity 30 Aug, 2021 US8663699 (Litigated)
Patent Issue Date Used in PTA Calculation 21 Apr, 2020 US10624918
Recordation of Patent Grant Mailed 21 Apr, 2020 US10624918
Payment of Maintenance Fee, 8th Year, Large Entity 06 Apr, 2020 US8288434 (Litigated)
Email Notification 02 Apr, 2020 US10624918

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

Acanya's Family Patents

Acanya has patent protection in a total of 14 countries. It's US patent count contributes only to 50.0% 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 Acanya.

Family Patents

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Generic Launch

Generic Release Date:

Acanya's generic launch date based on the expiry of its last outstanding patent is estimated to be Aug 05, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Acanya Generics:

Benzoyl Peroxide; Clindamycin Phosphate is the generic name for the brand Acanya. 8 different companies have already filed for the generic of Acanya, with Padagis Israel having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Acanya's generic

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

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

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
1.2%/2.5% 20 Dec, 2012 1 19 Jun, 2015 05 Aug, 2029 Eligible
1.2%/3.75% 30 Sep, 2015 1 05 Jun, 2018 05 Aug, 2029 Eligible

Alternative Brands for Acanya

Acanya which is used for treating acne vulgaris in patients 12 years or older., has several other brand drugs in the same treatment category and using the same active ingredient (Benzoyl Peroxide; Clindamycin Phosphate). 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
Abbvie
Aczone used for treating acne vulgaris through topical application.
Almirall
Aczone used for treating acne vulgaris through topical application.
Bausch
Ziana Used for treating acne vulgaris in patients 12 years or older.
Onexton

(uses Benzoyl Peroxide; Clindamycin Phosphate)

Used for treating acne vulgaris in patients 12 years or older.
Solodyn Used for managing moderate to severe acne vulgaris by treating inflammatory lesions.
Journey
Ximino Used for treating acne, including inflammatory lesions in moderate to severe cases.

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. Benzoyl Peroxide; Clindamycin Phosphate. Given below is the list of those drugs and companies owning them.

Drug Owner Drug Name
Bausch
Cabtreo
Stiefel
Duac


Apart from brand drugs containing the same ingredient, some generics have also been filed for Benzoyl Peroxide; Clindamycin Phosphate, Acanya's active ingredient. Check the complete list of approved generic manufacturers for Acanya





About Acanya

Acanya is a drug owned by Bausch Health Americas Inc. It is used for treating acne vulgaris in patients 12 years or older. Acanya uses Benzoyl Peroxide; Clindamycin Phosphate as an active ingredient. Acanya was launched by Bausch in 2008.

Approval Date:

Acanya was approved by FDA for market use on 23 October, 2008.

Active Ingredient:

Acanya uses Benzoyl Peroxide; Clindamycin Phosphate as the active ingredient. Check out other Drugs and Companies using Benzoyl Peroxide; Clindamycin Phosphate ingredient

Treatment:

Acanya is used for treating acne vulgaris in patients 12 years or older.

Dosage:

Acanya is available in gel form for topical use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
2.5%;EQ 1.2% BASE GEL Prescription TOPICAL