Generic Exelon Availability

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

EXELON (rivastigmine - film, extended release;transdermal)

  • Manufacturer: NOVARTIS
    Approval date: July 6, 2007
    Strength(s): 4.6MG/24HR, 9.5MG/24HR [RLD]
  • Manufacturer: NOVARTIS
    Approval date: August 31, 2012
    Strength(s): 13.3MG/24HR

EXELON (rivastigmine tartrate - capsule;oral)

  • Manufacturer: NOVARTIS
    Approval date: April 21, 2000
    Strength(s): EQ 1.5MG BASE [RLD] [AB], EQ 3MG BASE [AB], EQ 4.5MG BASE [AB], EQ 6MG BASE [AB]

Has a generic version of Exelon been approved?

A generic version of Exelon 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 Exelon and have been approved by the FDA:

rivastigmine tartrate capsule;oral

  • Manufacturer: ALEMBIC PHARMS LTD
    Approval date: June 12, 2012
    Strength(s): EQ 1.5MG BASE [AB], EQ 3MG BASE [AB], EQ 4.5MG BASE [AB], EQ 6MG BASE [AB]
  • Manufacturer: APOTEX INC
    Approval date: May 16, 2013
    Strength(s): EQ 1.5MG BASE [AB], EQ 3MG BASE [AB], EQ 4.5MG BASE [AB], EQ 6MG BASE [AB]
  • Manufacturer: DR REDDYS LABS INC
    Approval date: October 31, 2007
    Strength(s): EQ 1.5MG BASE [AB], EQ 3MG BASE [AB], EQ 4.5MG BASE [AB], EQ 6MG BASE [AB]
  • Manufacturer: MACLEODS PHARMS LTD
    Approval date: August 22, 2014
    Strength(s): EQ 1.5MG BASE [AB], EQ 3MG BASE [AB], EQ 4.5MG BASE [AB], EQ 6MG BASE [AB]
  • Manufacturer: SUN PHARM INDS
    Approval date: October 22, 2007
    Strength(s): EQ 1.5MG BASE [AB], EQ 3MG BASE [AB], EQ 4.5MG BASE [AB], EQ 6MG BASE [AB]
  • Manufacturer: WATSON LABS
    Approval date: January 8, 2008
    Strength(s): EQ 1.5MG BASE [AB], EQ 3MG BASE [AB], EQ 4.5MG BASE [AB], EQ 6MG BASE [AB]

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

  • rivastigmine - film, extended release;transdermal

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

  • Phenyl carbamate
    Patent 5,602,176
    Issued: February 11, 1997
    Inventor(s): Enz; Albert
    Assignee(s): Sandoz Ltd.
    The (S)-N-ethyl-3-[(1-dimethylamino)ethyl]-N-methyl-phenylncarbamate in free base or acid addition salt form is useful as pharmaceutical, particularly for systemic transdermal administration.
    Patent expiration dates:
    • February 11, 2014
      ✓ 
      Patent use: TREATMENT OF ALZHEIMER'S DEMENTIA
    • February 11, 2014
      ✓ 
      Patent use: TREATMENT OF ALZHEIMER'S DEMENTIA
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • TTS containing an antioxidant
    Patent 6,316,023
    Issued: November 13, 2001
    Inventor(s): Asmussen; Bodo & Horstmann; Michael & Kopke; Kai & Tiemessen; Henricus L. G. M. & Dinh; Steven Minh & Gargiulo; Paul M.
    Assignee(s): Novartis AG LTS Lohmann Therapie-Systeme GmbH
    Pharmaceutical composition comprising (S)-N-ethyl-3-[1-dimethylamino)ethyl]-N-methyl-phenyl-carbamate in free base or acid addition salt form and an antioxidant. Said pharmaceutical compositions may be delivered to a patient using a transdermal delivery device.
    Patent expiration dates:
    • January 8, 2019
      ✓ 
      Drug product
  • TTS containing an antioxidant
    Patent 6,335,031
    Issued: January 1, 2002
    Inventor(s): Bodo; Asmussen & Michael; Horstmann & Kai; Köpke & Henricus L. G. M.; Tiemessen & Steven Minh; Dinh & Paul M.; Gargiulo
    Assignee(s): Novartis AG LTS Lohmann Therapie-Systeme GmbH Co. KG
    Pharmaceutical composition comprising (S)-N-ethyl-3-[1-dimethylamino)ethyl]-N-methyl-phenyl-carbamate in free base or acid addition salt form and an anti-oxidant. Said pharmaceutical compositions may be delivered to a patient using a transdermal delivery device.
    Patent expiration dates:
    • January 8, 2019
      ✓ 
      Drug product

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • August 31, 2015 -
    • June 27, 2016 -

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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