You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 24, 2024

ADAPALENE; BENZOYL PEROXIDE - Generic Drug Details

✉ Email this page to a colleague

« Back to Dashboard

What are the generic sources for adapalene; benzoyl peroxide and what is the scope of freedom to operate?

Adapalene; benzoyl peroxide is the generic ingredient in four branded drugs marketed by Actavis Labs Ut Inc, Actavis Mid Atlantic, Alembic, Encube, Glenmark Pharms Ltd, Padagis Israel, Taro, Zydus Pharms, Galderma Labs Lp, Galderma Labs, and Bausch, and is included in thirteen NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Adapalene; benzoyl peroxide has sixty-eight patent family members in twenty-five countries.

Thirteen suppliers are listed for this compound.

Summary for ADAPALENE; BENZOYL PEROXIDE

International Patents:	68
US Patents:	10
Tradenames:	4
Applicants:	11
NDAs:	13
Finished Product Suppliers / Packagers:	13
Clinical Trials:	42
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADAPALENE; BENZOYL PEROXIDE
DailyMed Link:	ADAPALENE; BENZOYL PEROXIDE at DailyMed

Recent Clinical Trials for ADAPALENE; BENZOYL PEROXIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Oklahoma	Phase 3
Treatment and Diagnostic Center of Private Enterprise "Asklepiy"	N/A
delta medical promotions ag	N/A

See all ADAPALENE; BENZOYL PEROXIDE clinical trials

Pharmacology for ADAPALENE; BENZOYL PEROXIDE

Drug Class	Retinoid

Paragraph IV (Patent) Challenges for ADAPALENE; BENZOYL PEROXIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EPIDUO FORTE	Gel	adapalene; benzoyl peroxide	0.3%/2.5%	207917	1	2016-05-04
EPIDUO	Gel	adapalene; benzoyl peroxide	0.1%/2.5%	022320	1	2011-12-30

US Patents and Regulatory Information for ADAPALENE; BENZOYL PEROXIDE

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or 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
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Padagis Israel	ADAPALENE AND BENZOYL PEROXIDE	adapalene; benzoyl peroxide	GEL;TOPICAL	212464-001	May 31, 2022	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	AB	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
Actavis Mid Atlantic	ADAPALENE AND BENZOYL PEROXIDE	adapalene; benzoyl peroxide	GEL;TOPICAL	203790-001	Sep 30, 2015		DISCN	No	No	⤷ 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	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

Expired US Patents for ADAPALENE; BENZOYL PEROXIDE

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015	⤷ Try a Trial	⤷ Try a Trial
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	⤷ Try a Trial	⤷ Try a Trial
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	⤷ Try a Trial	⤷ Try a Trial
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	⤷ Try a Trial	⤷ Try a Trial
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015	⤷ Try a Trial	⤷ Try a Trial
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	⤷ Try a Trial	⤷ Try a Trial
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ADAPALENE; BENZOYL PEROXIDE

Subscribe to access the full database, or Try a Trial
Country	Patent Number	Title	Estimated Expiration
Japan	2014040481	COMBINATIONS OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS	⤷ Try a Trial
Australia	2007274288	Combination of adapalene and benzoyl peroxide for treating acne lesions	⤷ Try a Trial
South Korea	101014586		⤷ Try a Trial
Hungary	230439	Legalább egy retinoidot és benzoil-peroxidot tartalmazó gél (Gel comprising at least a retinoid and benzoyl peroxide)	⤷ Try a Trial
China	1607946		⤷ Try a Trial
Brazil	0214264		⤷ Try a Trial
Cyprus	1107583		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ADAPALENE; BENZOYL PEROXIDE

Subscribe to access the full database, or Try a Trial
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1458369	122008000041	Germany	⤷ Try a Trial	PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
1458369	08C0024	France	⤷ Try a Trial	PRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218
1458369	C01458369/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
1458369	CA 2008 00029	Denmark	⤷ Try a Trial	PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
1458369	380	Finland	⤷ Try a Trial
1458369	SZ 31/2008	Austria	⤷ Try a Trial	PRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID
1458369	132008901685368	Italy	⤷ Try a Trial	PRODUCT NAME: ADAPALENE E BENZOILE PEROSSIDO(EPIDUO); AUTHORISATION NUMBER(S) AND DATE(S): 40440, 20071218;DA 038261018/M A 038261057/M, 20080618
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.