Generic Epiduo Availability
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]
Has a generic version of Epiduo been approved?
No. There is currently no therapeutically equivalent version of Epiduo available.
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: About generic drugs.
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 & Willcox; Nathalie
Assignee(s): Galderma Research & Development
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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Method for treatment of common acne
Patent 7,964,202
Issued: June 21, 2011
Inventor(s): Orsoni; Sandrine & Willcox; Nathalie
Assignee(s): Galderma Research & Development, S.N.C.
Dermatological/cosmetic compositions suited for preventing or treating cell differentiation and/or proliferation and/or keratinization disorders, including preventing or treating common acne, comprise, in a physiologically acceptable medium, (i) at least one dispersed retinoid, (ii) dispersed benzoyl peroxide, in free or encapsulated form, and (iii) at least one pH-independent gelling agent, said dermatological/cosmetic composition having physical stability without loss of viscosity over time at a temperature ranging from 4° C. to 40° C., said dermatological/cosmetic composition having a stable flow threshold over time as measured by viscosity measurements for rheograms which measure a shear stress τ for a given rate gradient γ and which measure a rate gradient γ for a given shear stress τ, the yield value (τ0) being extrapolated visually or by calculation.Patent expiration dates:- September 1, 2024✓✓
- September 1, 2024
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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 & Gross; Denis & Loesche; Christian & Poncet; Michel
Assignee(s): Galderma Research & Development
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 & Gross; Denis & Loesche; Christian & Poncet; Michel
Assignee(s): Galderma Research & Development
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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Dermatological/cosmetic gels comprising at least one retinoid and/or retinoid salt and benzoyl peroxide
Patent 8,105,618
Issued: January 31, 2012
Inventor(s): Orsoni-Segona; Sandrine & Willcox; Nathalie
Assignee(s): Galderma Research & Development
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:- December 23, 2022✓
- December 23, 2022
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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 & Development
Acne 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
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Dermatological/cosmetic gels comprising at least one retinoid and/or retinoid salt and benzoyl peroxide
Patent 8,241,649
Issued: August 14, 2012
Inventor(s): Orsoni; Sandrine & Willcox; Nathalie
Assignee(s): Galderma Research & Development
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:- December 23, 2022✓
- December 23, 2022
Related Exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
- Exclusivity expiration dates:
- February 1, 2016 - NEW PATIENT POPULATION
See also...
- Epiduo Consumer Information (Drugs.com)
- Epiduo gel Consumer Information (Wolters Kluwer)
- Epiduo topical Consumer Information (Cerner Multum)
- Epiduo Advanced Consumer Information (Micromedex)
- Adapalene and benzoyl peroxide gel Consumer Information (Wolters Kluwer)
- Adapalene and benzoyl peroxide topical Consumer Information (Cerner Multum)
- Adapalene and benzoyl peroxide Topical application Advanced Consumer Information (Micromedex)
Glossary
| Term | Definition |
|---|---|
| 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. |
