Skip to Content

Generic Cogentin Availability

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

COGENTIN (benztropine mesylate - injectable;injection)

  • Manufacturer: OAK PHARMS AKORN
    Approved Prior to Jan 1, 1982
    Strength(s): 1MG/ML [RLD] [AP]

COGENTIN (benztropine mesylate - tablet;oral)

  • Manufacturer: MERCK
    Approved Prior to Jan 1, 1982
    Strength(s): 0.5MG [RLD], 1MG [RLD], 2MG [RLD]

Has a generic version of Cogentin been approved?

Yes. The following products are equivalent to Cogentin:

benztropine mesylate injectable;injection

  • Manufacturer: FRESENIUS KABI USA
    Approval date: July 28, 2009
    Strength(s): 1MG/ML [AP]
  • Manufacturer: HIKMA FARMACEUTICA
    Approval date: August 31, 2009
    Strength(s): 1MG/ML [AP]
  • Manufacturer: LUITPOLD
    Approval date: March 29, 2010
    Strength(s): 1MG/ML [AP]
  • Manufacturer: NAVINTA LLC
    Approval date: February 5, 2013
    Strength(s): 1MG/ML [AP]

Note: No generic formulation of the following product is available.

  • benztropine mesylate - tablet;oral

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

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.
APInjectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions. It should be noted that even though injectable (parenteral) products under a specific listing may be evaluated as therapeutically equivalent, there may be important differences among the products in the general category, Injectable; Injection. For example, some injectable products that are rated therapeutically equivalent are labeled for different routes of administration. In addition, some products evaluated as therapeutically equivalent may have different preservatives or no preservatives at all. Injectable products available as dry powders for reconstitution, concentrated sterile solutions for dilution, or sterile solutions ready for injection are pharmaceutical alternative drug products. They are not rated as therapeutically equivalent (AP) to each other even if these pharmaceutical alternative drug products are designed to produce the same concentration prior to injection and are similarly labeled. Consistent with accepted professional practice, it is the responsibility of the prescriber, dispenser, or individual administering the product to be familiar with a product's labeling to assure that it is given only by the route(s) of administration stated in the labeling.