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Generic Avandaryl Availability

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

AVANDARYL (glimepiride; rosiglitazone maleate - tablet;oral)

  • Manufacturer: SB PHARMCO
    Approval date: November 23, 2005
    Strength(s): 1MG;4MG [RLD], 2MG;4MG, 4MG;4MG
  • Manufacturer: SB PHARMCO
    Approval date: March 30, 2007
    Strength(s): 2MG;8MG, 4MG;8MG

Has a generic version of Avandaryl been approved?

No. There is currently no therapeutically equivalent version of Avandaryl available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Avandaryl. 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
      ✓ 
      Patent use: FOR TREATMENT OF ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO ARE NAIVE TO PHARMACOLOGIC THERAPY
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • April 21, 2015
      ✓ 
      Patent use: TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
      ✓ 
      Drug substance
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      Drug product
    • October 21, 2015
      ✓ 
      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
      ✓ 
      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.
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