Generic Emadine Availability

Emadine is a brand name of emedastine ophthalmic, approved by the FDA in the following formulation(s):

EMADINE (emedastine difumarate - solution/drops;ophthalmic)

  • Manufacturer: ALCON
    Approval date: December 29, 1997
    Strength(s): 0.05% [RLD]

Has a generic version of Emadine been approved?

No. There is currently no therapeutically equivalent version of Emadine available in the United States.

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

  • Ophthalmic compositions comprising emedastine and methods for their use
    Patent 5,441,958
    Issued: August 15, 1995
    Inventor(s): Yanni; John M. & Robertson; Stella M. & Okumura; Shigetoshi & Tanaka; Hitoshi & Saito; Tadayuki
    Assignee(s): Alcon Laboratories, Inc.
    Topical ophthalmic compositions comprising 1-(2-ethoxyethyl)-2-(4-methyl-1-homopiperazinyl)-benzimidazole and its ophthalmically acceptable acid addition salts have been found to be useful in treating allergic conjunctivitis and related ailments.
    Patent expiration dates:
    • December 8, 2013
      ✓ 
      Patent use: TREATMENT OF ALLERGIC CONJUNCTIVITIS

Glossary

TermDefinition
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.
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