Generic Azilect Availability

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

AZILECT (rasagiline mesylate - tablet;oral)

  • Manufacturer: TEVA
    Approval date: May 16, 2006
    Strength(s): EQ 0.5MG BASE [AB], EQ 1MG BASE [RLD] [AB]

Has a generic version of Azilect been approved?

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

rasagiline mesylate tablet;oral

  • Manufacturer: APOTEX INC
    Approval date: September 12, 2013
    Strength(s): EQ 0.5MG BASE [AB], EQ 1MG BASE [AB]

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

  • Use of the R-enantiomers of N-propargyl 1-aminoindan compounds for treating Parkinson's disease.
    Patent 5,453,446
    Issued: September 26, 1995
    Inventor(s): Youdim; Moussa B. H. & Finberg; John P. M. & Levy; Ruth & Sterling; Jeffrey & Lerner; David & Berger-Paskin; Tirtsah & Yellin; Haim
    Assignee(s): Teva Pharmaceutical Industries, Ltd. Technion Research and Development Foundation Ltd.
    R(+)-N-p-opargyl-1-aminoindan, its preparation and use and pharmaceutical compositions containing it. The novel compound was found to be useful for the treatment of human patients for Parkinson's disease, memory disorders, dementia of the Alzheimer type (DAT), depression and the hyperactive syndrome.
    Patent expiration dates:
    • February 7, 2017
      ✓ 
      Patent use: TREATMENT OF PARKINSON'S DISEASE
  • R-enantiomer of N-propargyl-1-aminoindan, salts, compositions and uses thereof
    Patent 5,532,415
    Issued: July 2, 1996
    Inventor(s): Youdim; Moussa B. H. & Finberg; John P. M. & Levy; Ruth & Sterling; Jeffrey & Lerner; David & Berger-Paskin; Tirtsah & Yellin; Haim & Veinberg; Alex
    Assignee(s): Teva Pharmaceutical Industries Ltd. Technion Research and Development Foundation Ltd.
    The subject invention provides R(+)-N-propargyl-1-aminoindan and pharmaceutically acceptable salts thereof, as well as pharmaceutical compositions containing same. The subject invention also provides methods of treating a subject afflicted with Parkinson's disease, a memory disorder, dementia, depression, hyperactive syndrome, an affective illness, a neurodegenerative disease, a neurotoxic injury, brain ischemia, a head trauma injury, a spinal trauma injury, schizophrenia, an attention deficit disorder, multiple sclerosis, or withdrawal symptoms, using R(+)-N-propargyl-1-aminoindan or the pharmaceutically acceptable salt of the subject invention. The subject invention further provides a method of preventing nerve damage in a subject. Finally, the subject invention provides methods of preparing R(+)-N-propargyl-1-aminoindan, a salt thereof, and racemic N-propargyl-1-aminoindan.
    Patent expiration dates:
    • July 2, 2013
      ✓ 
      Drug substance
  • Stable compositions containing N-propargyl-1-aminoindan
    Patent 6,126,968
    Issued: October 3, 2000
    Inventor(s): Peskin; Tirtsah Berger & Caciularu; Fanny
    Assignee(s): Teva Pharmaceutical Industries, Ltd.
    A pharmaceutical composition comprising as active ingredient a racemic, S(-), and R(+)-N-propargyl-1-aminoindan or a pharmaceutically acceptable salt thereof, and at least 60% by weight of at least one pentahydric or hexahydric alcohol. Optionally the composition may contain citric acid and magnesium stearate.
    Patent expiration dates:
    • September 18, 2016
      ✓ 
      Drug product
  • Rasagiline formulations and processes for their preparation
    Patent 7,572,834
    Issued: August 11, 2009
    Inventor(s): Sterling; Jeffrey & Lerner; David & Rosen; Harel & Bronov; Leonid & Medini-Green; Dalia & Iosefzon; Berta & Berger-Peskin; Tirtsah & Lidor-Hadas; Ramy & Bahar; Eliezer
    Assignee(s): Teva Pharmaceutical Industries, Ltd.
    The subject invention provides a pharmaceutical composition comprising N-propargyl-1(R)-aminoindan mesylate; a pharmaceutically acceptable carrier; and greater than 0.7 ppm but less than 30 ppm in total of a compound having the structure: and any salts of the compound.
    Patent expiration dates:
    • December 5, 2026
      ✓ 
      Drug product
  • Rasagiline formulations of improved content uniformity
    Patent 7,815,942
    Issued: October 19, 2010
    Inventor(s): Peskin; Tirtza Berger
    Assignee(s): Teva Pharmaceutical Industries, Ltd.
    Disclosed are pharmaceutical preparations of R(+)-N-propargyl-1-aminoindan salts having enhanced content uniformity, processes for preparation of the compositions, and their uses.
    Patent expiration dates:
    • August 27, 2027
      ✓ 
      Patent use: TREATMENT OF PARKINSON'S DISEASE
      ✓ 
      Drug substance
      ✓ 
      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:
    • May 29, 2017 - EXPANDED INDICATION OF RASAGILINE AS AN ADD-ON THERAPY TO STABLE DOSES OF DOPAMINE AGONISTS IN THE TREATMENT OF EARLY PARKINSON'S DISEASE

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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