Generic Epiduo Availability
Last updated on Apr 10, 2025.
See also: Generic Epiduo Forte
Epiduo is a brand name of adapalene/benzoyl peroxide topical, approved by the FDA in the following formulation(s):
EPIDUO (adapalene; benzoyl peroxide - gel;topical)
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Manufacturer: GALDERMA LABS LP
Approval date: December 8, 2008
Strength(s): 0.1%;2.5% [RLD] [AB]
Is there a generic version of Epiduo available?
A generic version of Epiduo has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Epiduo and have been approved by the FDA:
ADAPALENE AND BENZOYL PEROXIDE (adapalene; benzoyl peroxide gel;topical)
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Manufacturer: ENCUBE
Approval date: May 23, 2018
Strength(s): 0.1%;2.5% [AB] -
Manufacturer: GLENMARK PHARMS LTD
Approval date: November 8, 2019
Strength(s): 0.1%;2.5% [AB] -
Manufacturer: PADAGIS ISRAEL
Approval date: January 23, 2018
Strength(s): 0.1%;2.5% [AB] -
Manufacturer: TARO
Approval date: January 24, 2018
Strength(s): 0.1%;2.5% [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Epiduo. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Gel composition for once-daily treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt
Patent 7,820,186
Issued: October 26, 2010
Inventor(s): Orsoni; Sandrine et al.
Assignee(s): Galderma Research & Development (N/A, FR)Dermatological/cosmetic gel compositions suited for preventing or treating cell differentiation and/or proliferation and/or keratinization disorders, including preventing or treating common acne, comprise (i) at least one retinoid, (ii) dispersed benzoyl peroxide and (iii) at least one pH-independent gelling agent, formulated into (iv) a physiologically acceptable medium therefor.
Patent expiration dates:
- November 23, 2025✓
- November 23, 2025
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Combinations of adapalene and benzoyl peroxide for treating acne lesions
Patent 8,071,644
Issued: December 6, 2011
Inventor(s): Abou-Chacra Vernet; Marie-line et al.
Assignee(s): Galderma Research & Development (Biot, FR)Adapalene or a pharmaceutically acceptable salt thereof formulated into a pharmaceutical composition is useful for reducing the number of acne lesions, via daily topical application, in combination or in association with benzoyl peroxide (BPO); such treatment may be via administration of a pharmaceutical composition combining adapalene and BPO or by a concomitant application of two pharmaceutical compositions, one containing adapalene and the other containing BPO.
Patent expiration dates:
- July 18, 2027✓✓
- July 18, 2027
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Combinations of adapalene and benzoyl peroxide for treating acne lesions
Patent 8,080,537
Issued: December 20, 2011
Inventor(s): Abou-Chacra Vernet; Marie-line et al.
Assignee(s): Galderma Research & Development (Biot, FR)Adapalene or a pharmaceutically acceptable salt thereof formulated into a pharmaceutical composition is useful for reducing the number of acne lesions, via daily topical application, in combination or in association with benzoyl peroxide (BPO); such treatment may be via administration of a pharmaceutical composition combining adapalene and BPO or by a concomitant application of two pharmaceutical compositions, one containing adapalene and the other containing BPO.
Patent expiration dates:
- July 18, 2027✓
- July 18, 2027
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Combination/association of adapalene and benzoyl peroxide for treating acne lesions
Patent 8,129,362
Issued: March 6, 2012
Inventor(s): Chacra Vernet Marie-Line Abou & Gross Denis & Loesche Christian & Poncet Michel
Assignee(s): Galderma Research & DevelopmentAcne lesions, whether of inflammatory and/or non-inflammatory type, are simultaneously or sequentially treated and their number reduced, via daily topical regimen, with the combination or association of adapalene or pharmaceutically acceptable salt thereof and benzoyl peroxide (BPO).
Patent expiration dates:
- July 18, 2027✓
- July 18, 2027
More about Epiduo (adapalene / benzoyl peroxide topical)
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- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: topical acne agents
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Glossary
Term | Definition |
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Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
AB | Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.