Generic Differin Availability
Differin is a brand name of adapalene topical, approved by the FDA in the following formulation(s):
DIFFERIN (adapalene - cream; topical)
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Manufacturer: GALDERMA LABS LP
Approval date: May 26, 2000
Strength(s): 0.1% [RLD] [AB]
DIFFERIN (adapalene - gel; topical)
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Manufacturer: GALDERMA LABS LP
Approval date: May 31, 1996
Strength(s): 0.1% [RLD] [AB] -
Manufacturer: GALDERMA LABS LP
Approval date: June 19, 2007
Strength(s): 0.3% [RLD] [AB]
DIFFERIN (adapalene - lotion; topical)
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Manufacturer: GALDERMA LABS LP
Approval date: March 17, 2010
Strength(s): 0.1% [RLD]
Has a generic version of Differin been approved?
A generic version of Differin 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 Differin and have been approved by the FDA:
adapalene cream; topical
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Manufacturer: FOUGERA PHARMS
Approval date: June 30, 2010
Strength(s): 0.1% [AB]
adapalene gel; topical
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Manufacturer: GLENMARK GENERICS
Approval date: July 1, 2010
Strength(s): 0.1% [AB] -
Manufacturer: PLIVA HRVATSKA DOO
Approval date: June 2, 2010
Strength(s): 0.1% [AB] -
Manufacturer: TOLMAR
Approval date: June 14, 2012
Strength(s): 0.3% [AB]
Note: No generic formulation of the following product is available.
- adapalene - lotion; topical
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Differin. 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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Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
Patent 7,579,377
Issued: August 25, 2009
Inventor(s): Graeber; Michael & Czernielewski; Janusz
Assignee(s): Galderma Research & Development
Dermatological disorders having an inflammatory or proliferative component are treated with pharmaceutical compositions containing on the order of 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthanoic acid (adapalene) or salt thereof, formulated into pharmaceutically acceptable media therefore, advantageously topically applicable gels, creams or lotions.Patent expiration dates:- February 23, 2025✓
- February 23, 2025
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Pharmaceutical compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
Patent 7,737,181
Issued: June 15, 2010
Inventor(s): Graeber; Michael & Czernielewski; Janusz
Assignee(s): Galderma Research & Development
Dermatological disorders having an inflammatory or proliferative component, notably common acne, are treated with topically applicable pharmaceutical compositions containing about 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthanoic acid (adapalene) or salt thereof, formulated into pharmaceutically acceptable media therefor, advantageously formulated into topically applicable gels, preferably aqueous gels, creams, lotions or solutions.Patent expiration dates:- August 29, 2024✓
- August 29, 2024
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Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphtoic acid for the treatment of dermatological disorders
Patent 7,834,060
Issued: November 16, 2010
Inventor(s): Graeber; Michael & Czernielewski; Janusz
Assignee(s): Galderma Research & Development
Dermatological disorders having an inflammatory or proliferative component are treated with pharmaceutical compositions containing on the order of 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthanoic acid (adapalene) or salt thereof, formulated into pharmaceutically acceptable media therefor, advantageously topically applicable gels, creams or lotions.Patent expiration dates:- March 12, 2023✓
- March 12, 2023
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Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
Patent 7,838,558
Issued: November 23, 2010
Inventor(s): Graeber; Michael & Czernielewski; Janusz
Assignee(s): Galderma Research & Development S.N.C.
Dermatological disorders having an inflammatory or proliferative component are treated with pharmaceutical compositions containing on the order of 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthanoic acid (adapalene) or salt thereof, formulated into pharmaceutically acceptable media therefor, advantageously topically applicable gels, creams or lotions.Patent expiration dates:- March 12, 2023✓
- March 12, 2023
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Method for the treatment of acne using compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid
Patent 7,868,044
Issued: January 11, 2011
Inventor(s): Graeber; Michael & Czernielewski; Janusz
Assignee(s): Galderma Research & Development
Dermatological disorders having an inflammatory or proliferative component, notably common acne, are treated with topically applicable pharmaceutical compositions containing about 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthanoic acid (adapalene) or salt thereof, formulated into pharmaceutically acceptable media therefor, advantageously formulated into topically applicable gels, preferably aqueous gels, creams, lotions or solutions.Patent expiration dates:- March 12, 2023✓
- March 12, 2023
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Cosmetic/dermatological compositions comprising naphthoic acid compounds and polyurethane polymers
Patent 7,998,467
Issued: August 16, 2011
Inventor(s): Mallard; Claire & Ferrara; Eve
Assignee(s): Galderma Research & Development
Cosmetic/dermatological compositions for topical application and useful for the treatment, e.g., of acne, contain, formulated into a physiologically acceptable medium, at least one naphthoic acid compound and at least one polyurethane polymer or derivative thereof, the at least one naphthoic acid compound being dispersed therein.Patent expiration dates:- May 31, 2028✓✓
- May 31, 2028
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:
- March 17, 2013 - NEW DOSAGE FORM
See also...
- Differin Consumer Information (Drugs.com)
- Differin cream Consumer Information (Wolters Kluwer)
- Differin lotion Consumer Information (Wolters Kluwer)
- Differin pads Consumer Information (Wolters Kluwer)
- Differin solution Consumer Information (Wolters Kluwer)
- Differin Consumer Information (Cerner Multum)
- Differin Topical Advanced Consumer Information (Micromedex)
- Differin AHFS DI Monographs (ASHP)
- Adapalene cream Consumer Information (Wolters Kluwer)
- Adapalene lotion Consumer Information (Wolters Kluwer)
- Adapalene pads Consumer Information (Wolters Kluwer)
- Adapalene solution Consumer Information (Wolters Kluwer)
- Adapalene topical Consumer Information (Cerner Multum)
- Adapalene Topical Advanced Consumer Information (Micromedex)
- Adapalene AHFS DI Monographs (ASHP)
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. |
| AB | Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) 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 (i.e., AB1, AB2, AB3, etc.). 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. |


