Generic Naprelan Availability

Naprelan is a brand name of naproxen, approved by the FDA in the following formulation(s):

NAPRELAN (naproxen sodium - tablet, extended release;oral)

  • Manufacturer: ALMATICA PHARMA INC
    Approval date: January 5, 1996
    Strength(s): EQ 375MG BASE, EQ 500MG BASE, EQ 750MG BASE [RLD]

Has a generic version of Naprelan been approved?

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

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

  • Controlled absorption naproxen formulation for once-daily administration
    Patent 5,637,320
    Issued: June 10, 1997
    Inventor(s): Bourke; Edward A. & Mulligan; Seamus
    Assignee(s): Elan Corporation, PLC
    A once-daily naproxen formulation for oral administration having a first portion of the naproxen as a multi-particulate pellet form, each pellet having a core of naproxen or a pharmaceutically acceptable salt thereof in association with an organic acid, the core being surrounded by a multi-layer membrane and optionally a second portion of naproxen formulated to release the drug promptly following oral administration.
    Patent expiration dates:
    • June 10, 2014

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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