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Generic DermOtic Oil Availability

DermOtic Oil is a brand name of fluocinolone otic, approved by the FDA in the following formulation(s):

DERMOTIC (fluocinolone acetonide - oil/drops;otic)

  • Manufacturer: HILL DERMAC
    Approval date: November 9, 2005
    Strength(s): 0.01% [RLD] [AT]

Has a generic version of DermOtic Oil been approved?

Yes. The following products are equivalent to DermOtic Oil:

fluocinolone acetonide oil/drops;otic

  • Manufacturer: AKORN
    Approval date: September 9, 2016
    Strength(s): 0.01% [AT]
  • Manufacturer: IDENTI PHARMS INC
    Approval date: October 17, 2011
    Strength(s): 0.01% [AT]
  • Manufacturer: LYNE
    Approval date: April 25, 2016
    Strength(s): 0.01% [AT]

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

More about DermOtic Oil (fluocinolone otic)

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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.
ATTopical products. There are a variety of topical dosage forms available for dermatologic, ophthalmic, otic, rectal, and vaginal administration, including creams, gels, lotions, oils, ointments, pastes, solutions, sprays and suppositories. Even though different topical dosage forms may contain the same active ingredient and potency, these dosage forms are not considered pharmaceutically equivalent. Therefore, they are not considered therapeutically equivalent. All solutions and DESI drug products containing the same active ingredient in the same topical dosage form for which a waiver of in vivo bioequivalence has been granted and for which chemistry and manufacturing processes are adequate to demonstrate bioequivalence, are considered therapeutically equivalent and coded AT. Pharmaceutically equivalent topical products that raise questions of bioequivalence, including all post-1962 non-solution topical drug products, are coded AB when supported by adequate bioequivalence data, and BT in the absence of such data.