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Generic Onexton Availability

Last updated on Jan 11, 2023.

Onexton is a brand name of benzoyl peroxide/clindamycin topical, approved by the FDA in the following formulation(s):

ONEXTON (benzoyl peroxide; clindamycin phosphate - gel;topical)

  • Manufacturer: BAUSCH
    Approval date: November 24, 2014
    Strength(s): 3.75%;EQ 1.2% BASE [RLD]

Has a generic version of Onexton been approved?

An Authorized Generic version of Onexton has been approved. An Authorized Generic is a prescription drug that is produced by a brand company under a New Drug Application (NDA) and marketed as a generic under a private label. It is identical to the branded product in appearance and has exactly the same inactive ingredients.

List of authorized generic versions:

  • Clindamycin Phosphate and Benzoyl Peroxide TOPICAL GEL 25; 10 mg/g; mg/g
    Oceanside Pharmaceuticals
    NDC Code: 686820132

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Onexton. 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.

  • Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
    Patent 10,137,142
    Issued: November 27, 2018
    Assignee(s): Dow Pharmaceutical Sciences, Inc.

    An aqueous formulation for topical application to the skin comprising water, a water-miscible organic solvent, and benzoyl peroxide, wherein the concentration of the organic solvent is sufficient to provide a stable suspension of benzoyl peroxide in the aqueous formulation without the inclusion of a surfactant in the formulation, wherein the ratio of concentrations of water and organic solvent in the formulation is sufficient to maintain the benzoyl peroxide in saturated solubility in the formulation following application to the skin, and wherein the concentration of benzoyl peroxide in the formulation is less than 5.0% and at least 1.0% w/w. The formulation may further contain a chemical compound in addition to benzoyl peroxide that is effective in the treatment of acne. The aqueous formulations of the invention are useful in the treatment of acne and acne rosacea.

    Patent expiration dates:

    • June 3, 2029
      ✓ 
      Patent use: TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
      ✓ 
      Drug product
  • Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
    Patent 10,220,049
    Issued: March 5, 2019
    Assignee(s): Dow Pharmaceutical Sciences, Inc.

    An aqueous formulation for topical application to the skin comprising water, a water-miscible organic solvent, and benzoyl peroxide, wherein the concentration of the organic solvent is sufficient to provide a stable suspension of benzoyl peroxide in the aqueous formulation without the inclusion of a surfactant in the formulation, wherein the ratio of concentrations of water and organic solvent in the formulation is sufficient to maintain the benzoyl peroxide in saturated solubility in the formulation following application to the skin, and wherein the concentration of benzoyl peroxide in the formulation is less than 5.0% and at least 1.0% w/w. The formulation may further contain a chemical compound in addition to benzoyl peroxide that is effective in the treatment of acne. The aqueous formulations of the invention are useful in the treatment of acne and acne rosacea.

    Patent expiration dates:

    • June 3, 2029
      ✓ 
      Patent use: TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
      ✓ 
      Drug product
  • Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
    Patent 8,288,434
    Issued: October 16, 2012
    Inventor(s): Chang; Yunik & Dow; Gordon J.
    Assignee(s): Dow Pharmaceutical Sciences, Inc.

    An aqueous formulation for topical application to the skin comprising water, a water-miscible organic solvent, and benzoyl peroxide, wherein the concentration of the organic solvent is sufficient to provide a stable suspension of benzoyl peroxide in the aqueous formulation without the inclusion of a surfactant in the formulation, wherein the ratio of concentrations of water and organic solvent in the formulation is sufficient to maintain the benzoyl peroxide in saturated solubility in the formulation following application to the skin, and wherein the concentration of benzoyl peroxide in the formulation is less than 5.0% and at least 1.0% w/w. The formulation may further contain a chemical compound in addition to benzoyl peroxide that is effective in the treatment of acne. The aqueous formulations of the invention are useful in the treatment of acne and acne rosacea.

    Patent expiration dates:

    • August 5, 2029
      ✓ 
      Patent use: TOPICAL TREATMENT OF ACNE VULGARIS
      ✓ 
      Drug product
    • August 5, 2029
      ✓ 
      Patent use: TREATMENT OF ACNE
      ✓ 
      Drug product
    • August 5, 2029
      ✓ 
      Patent use: TREATMENT OF ACNE VULGARIS
      ✓ 
      Drug product
    • August 5, 2029
      ✓ 
      Patent use: TOPICAL TREATMENT OF ACNE VULGARIS
      ✓ 
      Drug product
    • August 5, 2029
      ✓ 
      Patent use: TREATMENT OF ACNE VULGARIS
      ✓ 
      Drug product
    • August 5, 2029
      ✓ 
      Patent use: TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
      ✓ 
      Drug product
  • Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
    Patent 9,504,704
    Issued: November 29, 2016
    Assignee(s): DOW PHARMACEUTICAL SCIENCES, INC.

    An aqueous formulation for topical application to the skin comprising water, a water-miscible organic solvent, and benzoyl peroxide, wherein the concentration of the organic solvent is sufficient to provide a stable suspension of benzoyl peroxide in the aqueous formulation without the inclusion of a surfactant in the formulation, wherein the ratio of concentrations of water and organic solvent in the formulation is sufficient to maintain the benzoyl peroxide in saturated solubility in the formulation following application to the skin, and wherein the concentration of benzoyl peroxide in the formulation is less than 5.0% and at least 1.0% w/w. The formulation may further contain a chemical compound in addition to benzoyl peroxide that is effective in the treatment of acne. The aqueous formulations of the invention are useful in the treatment of acne and acne rosacea.

    Patent expiration dates:

    • June 3, 2029
      ✓ 
      Patent use: TREATMENT OF ACNE VULGARIS
      ✓ 
      Drug product
    • June 3, 2029
      ✓ 
      Patent use: TOPICAL TREATMENT OF ACNE VULGARIS
      ✓ 
      Drug product
    • June 3, 2029
      ✓ 
      Patent use: TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
      ✓ 
      Drug product
    • June 3, 2029
      ✓ 
      Patent use: TREATMENT OF ACNE
      ✓ 
      Drug product
  • Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
    Patent 9,561,208
    Issued: February 7, 2017
    Assignee(s): Dow Pharmaceutical Sciences, Inc.

    An aqueous formulation for topical application to the skin comprising water, a water-miscible organic solvent, and benzoyl peroxide, wherein the concentration of the organic solvent is sufficient to provide a stable suspension of benzoyl peroxide in the aqueous formulation without the inclusion of a surfactant in the formulation, wherein the ratio of concentrations of water and organic solvent in the formulation is sufficient to maintain the benzoyl peroxide in saturated solubility in the formulation following application to the skin, and wherein the concentration of benzoyl peroxide in the formulation is less than 5.0% and at least 1.0% w/w. The formulation may further contain a chemical compound in addition to benzoyl peroxide that is effective in the treatment of acne. The aqueous formulations of the invention are useful in the treatment of acne and acne rosacea.

    Patent expiration dates:

    • June 3, 2029
      ✓ 
      Patent use: TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
      ✓ 
      Drug product

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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.

Further information

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