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Generic Denavir Availability

Denavir is a brand name of penciclovir topical, approved by the FDA in the following formulation(s):

DENAVIR (penciclovir - cream;topical)

  • Manufacturer: MYLAN PHARMS INC
    Approval date: September 24, 1996
    Strength(s): 1% [RLD]

Has a generic version of Denavir been approved?

An Authorized Generic version of Denavir 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 unlike a generic, the Authorized Generic has exactly the same inactive ingredients.

List of authorized generic versions:

  • penciclovir TOPICAL CREAM 10 mg/g
    Renaissance Pharma, Inc.
    NDC Code: 400850415

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

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.

  • Pharmaceutical formulation
    Patent 6,469,015
    Issued: October 22, 2002
    Inventor(s): Hazel-Ann; Griffiths & Alan John; Goodall & Joshua; Oduro-Yeboah
    Assignee(s): Novartis International Pharmaceutical Ltd

    An oil-in-water topical pharmaceutical formulation or an aqueous formulation for the treatment of virus infections of the skin or mucosa, comprising at least 30% of propylene glycol and solubilized penciclovir.

    Patent expiration dates:

    • October 22, 2019
  • Antiviral guanine derivatives
    Patent 6,579,981
    Issued: June 17, 2003
    Inventor(s): Richard Lewis; Jarvest & Michael Raymond; Harnden
    Assignee(s): Novartis International Pharmaceutical Ltd.

    A compound of formula (I) or a salt or acyl derivative thereof, in which X represents chlorine, C1-6 alkoxy, phenoxy, phenyl C1-6 alkoxy, NH2, —OH or —SH, is useful in treating viral infections.

    Patent expiration dates:

    • June 17, 2020

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.