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Last Updated: April 15, 2024

~ Buy the CABTREO (adapalene; benzoyl peroxide; clindamycin phosphate) Drug Profile, 2024 PDF Report in the Report Store ~

CABTREO Drug Patent Profile


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When do Cabtreo patents expire, and what generic alternatives are available?

Cabtreo is a drug marketed by Bausch and is included in one NDA. There are five patents protecting this drug.

This drug has twenty-eight patent family members in fifteen countries.

The generic ingredient in CABTREO is adapalene; benzoyl peroxide; clindamycin phosphate. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the adapalene; benzoyl peroxide; clindamycin phosphate profile page.

DrugPatentWatch® Generic Entry Outlook for Cabtreo

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 5, 2029. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for CABTREO
International Patents:28
US Patents:5
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Formulation / Manufacturing:see details
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for CABTREO
What excipients (inactive ingredients) are in CABTREO?CABTREO excipients list
DailyMed Link:CABTREO at DailyMed
Drug patent expirations by year for CABTREO
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CABTREO
Generic Entry Date for CABTREO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
GEL;TOPICAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for CABTREO

US Patents and Regulatory Information for CABTREO

CABTREO is protected by five US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of CABTREO is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting CABTREO

Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

FDA Regulatory Exclusivity protecting CABTREO

NEW PRODUCT
Exclusivity Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch CABTREO adapalene; benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 216632-001 Oct 20, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bausch CABTREO adapalene; benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 216632-001 Oct 20, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bausch CABTREO adapalene; benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 216632-001 Oct 20, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch CABTREO adapalene; benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 216632-001 Oct 20, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bausch CABTREO adapalene; benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 216632-001 Oct 20, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch CABTREO adapalene; benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 216632-001 Oct 20, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for CABTREO

When does loss-of-exclusivity occur for CABTREO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 09255679
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0913326
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 23029
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2056481
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0200450
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 99810
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 77693
Estimated Expiration: ⤷  Try a Trial

Patent: 06272
Estimated Expiration: ⤷  Try a Trial

Patent: 11522820
Estimated Expiration: ⤷  Try a Trial

Patent: 15038093
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 10013152
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 99810
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 93847
Estimated Expiration: ⤷  Try a Trial

Patent: 45087
Estimated Expiration: ⤷  Try a Trial

Patent: 10146038
Estimated Expiration: ⤷  Try a Trial

Patent: 13122395
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1008265
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 110014651
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 73931
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering CABTREO around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2021019092 ⤷  Try a Trial
Japan 2011522820 ⤷  Try a Trial
Russian Federation 2493847 ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ НИЗКУЮ КОНЦЕНТРАЦИЮ БЕНЗОИЛПЕРОКСИДА В СУСПЕНЗИИ В ВОДЕ И СМЕШИВАЮЩИМСЯ С ВОДОЙ ОРГАНИЧЕСКОМ РАСТВОРИТЕЛЕ (PHARMACEUTICAL FORMULATIONS FOR LOCAL APPLICATION CONTAINING LOW CONCENTRATIONS OF BENZOYL PEROXIDE IN SUSPENSION IN WATER AND WATER-MISCIBLE ORGANIC SOLVENT) ⤷  Try a Trial
Portugal 2299810 ⤷  Try a Trial
Russian Federation 2010146038 ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ НИЗКУЮ КОНЦЕНТРАЦИЮ БЕНЗОИЛПЕРОКСИДА В СУСПЕНЗИИ В ВОДЕ И СМЕШИВАЮЩИМСЯ С ВОДОЙ ОРГАНИЧЕСКОМ РАСТВОРИТЕЛЕ ⤷  Try a Trial
Spain 2773931 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.