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
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 |
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
Drug Class | Lincosamide Antibacterial Retinoid |
Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Anatomical Therapeutic Chemical (ATC) Classes 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 | |||
>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 |
---|---|---|---|
Japan | 2022542616 | 局所組成物 | ⤷ Try a Trial |
Colombia | 2022002253 | Composiciones topicas | ⤷ 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 |
Canada | 2723029 | FORMULATIONS PHARMACEUTIQUES TOPIQUES CONTENANT UNE FAIBLE CONCENTRATION DE PEROXYDE DE BENZOYLE EN SUSPENSION DANS DE L'EAU ET UN SOLVANT ORGANIQUE MISCIBLE AVEC L'EAU (TOPICAL PHARMACEUTICAL FORMULATIONS CONTAINING A LOW CONCENTRATION OF BENZOYL PEROXIDE IN SUSPENSION IN WATER AND A WATER-MISCIBLE ORGANIC SOLVENT) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |