Generic Comtan Availability

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

COMTAN (entacapone - tablet;oral)

  • Manufacturer: ORION PHARMA
    Approval date: October 19, 1999
    Strength(s): 200MG [RLD] [AB]

Has a generic version of Comtan been approved?

A generic version of Comtan has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Comtan and have been approved by the FDA:

entacapone tablet;oral

  • Manufacturer: MYLAN PHARMS INC
    Approval date: May 13, 2013
    Strength(s): 200MG [AB]
  • Manufacturer: SUN PHARMA GLOBAL
    Approval date: July 16, 2012
    Strength(s): 200MG [AB]
  • Manufacturer: WOCKHARDT LTD
    Approval date: August 16, 2012
    Strength(s): 200MG [AB]

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

  • Pharmacologically active catechol derivatives
    Patent 5,446,194
    Issued: August 29, 1995
    Inventor(s): Backstrom; Reijo J. & Heinola; Kalevi E. & Honkanen; Erkki J. & Kaakkola; Seppo K. & Kairisalo; Pekka J. & Linden; Inge-Britt Y. & Mannisto; Pekka I. & Nissinen; Erkki A. O. & Pohto; Pentti & Pippuri; Aino K. & Pystynen; Jarmo J.
    Assignee(s): Orion-yhtyma Oy
    A compound according to formula 1 ##STR1## wherein R.sub.1 and R.sub.2 independently represent hydrogen, carbamoyl which is substituted by an alkyl of 1 to 4 carbon atoms, alkylcarbonyl of 2 to 5 carbon atoms or phenyl carbonyl, X represents halogen nitro or cyano and R.sub.3 represents ##STR2## wherein R.sub.4 represents cyano or alkylcarbonyl of 2 to 5 carbon atoms and R.sub.5 represents carbamoyl which is unsubstituted or substituted with alkyl of 1 to 8 carbon atoms or which is substituted with hydroxyalkyl of 1 to 8 carbon atoms or pharmaceutically acceptable esters and salts thereof, and a pharmaceutically acceptable carrier therefor, as well as pharmaceutical compositions containing said compounds as COMT inhibitors.
    Patent expiration dates:
    • October 19, 2013
      ✓ 
      Drug substance
  • Oral compacted composition comprising catechol derivatives
    Patent 6,599,530
    Issued: July 29, 2003
    Inventor(s): Kari; Vahervuo
    Assignee(s): Orion Corporation
    The present invention relates to an oral compacted composition comprising entacapone, nitecapone, or a pharmaceutically acceptable salt thereof and croscarmellose sodium. The composition is premised on the discovery that croscarmellose sodium increases the release rate of entacapone or nitecapone from an oral compacted composition. Preferably the amount of croscarmellose sodium in the composition is at least 6% by weight, preferably from about 8% to about 16% by weight, especially from about 10% to about 14% by weight.
    Patent expiration dates:
    • September 14, 2018
      ✓ 
      Patent use: TREATMENT OF PARKINSON'S DISEASE
      ✓ 
      Drug product

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.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
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