Generic Avandia Availability

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

AVANDIA (rosiglitazone maleate - tablet;oral)

  • Manufacturer: SB PHARMCO
    Approval date: May 25, 1999
    Strength(s): EQ 2MG BASE [AB], EQ 4MG BASE [AB], EQ 8MG BASE [RLD] [AB]

Has a generic version of Avandia been approved?

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

rosiglitazone maleate tablet;oral

  • Manufacturer: TEVA
    Approval date: January 25, 2013
    Strength(s): EQ 2MG BASE [AB], EQ 4MG BASE [AB], EQ 8MG BASE [AB]

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

  • Substituted thiazolidinedionle derivatives
    Patent 5,741,803
    Issued: April 21, 1998
    Inventor(s): Pool; Colin Ripley & Tremper; Alan William & Brightwell; Malcolm David & Roman; Robin Sherwood
    Assignee(s): SmithKline Beecham plc
    ##STR1## A compound of formula (I) or a tautomeric form therof and/or a pharmaceutically acceptable solvate thereof, wherein R1,A1,A2,M are as defined in the, specification. A process for preparing such a compound, a pharmaceutical composition containin such a compound and the use of such a compound for treating hyperglycemia.
    Patent expiration dates:
    • April 21, 2015
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      Patent use: USE OF AVANDIA IN COMBINATION WITH A SULFONYLUREA, AND IN COMBINATION WITH METFORMIN AND A SULFONYLUREA TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
      ✓ 
      Drug substance
      ✓ 
      Drug product
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      Sponsor has requested patent be delisted
    • April 21, 2015
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      Patent use: USE OF AVANDIA AS MONOTHERAPY, IN COMBINATION WITH METFORMIN, AND IN COMBINATION WITH SULFONYLUREAS TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
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      Drug substance
      ✓ 
      Drug product
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      Sponsor has requested patent be delisted
    • October 21, 2015
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      Pediatric exclusivity
  • Compounds
    Patent 6,288,095
    Issued: September 11, 2001
    Inventor(s): Hindley; Richard Mark & Cawthorne; Michael Antony
    Assignee(s): Beecham Group p.l.c.
    A method is provided for the treatment and/or prophylaxis of cardiovascular diseases or eating disorders in a human or non-human mammal, which comprises administering to a human or non-human mammal in need thereof, an effective, non-toxic amount of a compound of formula (I): ##STR1## or a tautomeric form thereof and/or a pharmaceuticlaly acceptable salt thereof and/or a pharmaceutically acceptable solvate thereof, in which A.sup.1 represents a substituted or unsubstituted aromatic heterocyclyl group; R.sup.1 represents a hydrogen atom, an alkyl group, an acyl group, an aralkyl group, wherein the aryl moiety may be substituted or unsubstituted, or a substituted or unsubstituted aryl group; R.sup.2 and R.sup.3 each represent hydrogen, or R.sup.2 and R.sup.3 together represent a bond; A.sup.2 represents a benzene ring having in total up to five substituents; and n represents an integer in the range of from 2 to 6.
    Patent expiration dates:
    • February 11, 2017
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      Patent use: METHOD OF TREATMENT OF TYPE II DIABETES
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      Sponsor has requested patent be delisted
    • August 11, 2017
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      Pediatric exclusivity
  • Thiazolidinedione derivative and its use as antidiabetic
    Patent 7,358,366
    Issued: April 15, 2008
    Inventor(s): Blackler; Paul David James & Giles; Robert Gordon & Moore; Stephen & Sasse; Michael John
    Assignee(s): SmithKline Beecham p.l.c.
    A polymorphic form of 5-[4-[2-(N-methyl-N-(2-pyridyl)amino)ethoxy]benzyl]thiazolidine-2,4-dione, maleic acid salt (the “Polymorph”) characterised in that it provides: (i) an infra red spectrum containing peaks at 1752, 1546, 1154, 621, and 602 cm−1; and/or (ii) a Raman spectrum containing peaks at 1751, 1243 and 602 cm−1; and/or (iii) a solid-state nuclear magnetic resonance spectrum containing peaks at 111.9, 114.8, 119.6, 129.2, 134.0, 138.0, 144.7, 153.2, 157.1, 170.7, 172.0, and 175.0 ppm; and/or (iv) an X-ray powder diffraction (XRPD) pattern which gives calculated lattice spacings of 6.46, 5.39, 4.83, 4.68, 3.71, 3.63, 3.58, and 3.48 Angstroms; a process for preparing such a compound, a pharmaceutical composition containing such a compound and the use of such a compound in medicine.
    Patent expiration dates:
    • April 19, 2020
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      Drug substance
    • October 19, 2020
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      Pediatric exclusivity

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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