Generic ActoPlus Met Availability

See also: Generic ActoPlus Met XR

ActoPlus Met is a brand name of metformin/pioglitazone, approved by the FDA in the following formulation(s):

ACTOPLUS MET (metformin hydrochloride; pioglitazone hydrochloride - tablet;oral)

  • Manufacturer: TAKEDA PHARMS USA
    Approval date: August 29, 2005
    Strength(s): 500MG;EQ 15MG BASE [AB], 850MG;EQ 15MG BASE [RLD] [AB]

Has a generic version of ActoPlus Met been approved?

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

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE (metformin hydrochloride; pioglitazone hydrochloride tablet;oral)

  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: February 13, 2013
    Strength(s): 500MG;EQ 15MG BASE [AB], 850MG;EQ 15MG BASE [AB]
  • Manufacturer: MYLAN
    Approval date: February 25, 2011
    Strength(s): 500MG;EQ 15MG BASE [AB], 850MG;EQ 15MG BASE [AB]
  • Manufacturer: SANDOZ
    Approval date: April 16, 2013
    Strength(s): 500MG;EQ 15MG BASE [AB], 850MG;EQ 15MG BASE [AB]
  • Manufacturer: TEVA PHARMS USA
    Approval date: March 10, 2014
    Strength(s): 500MG;EQ 15MG BASE [AB], 850MG;EQ 15MG BASE [AB]
  • Manufacturer: TORRENT PHARMS LTD
    Approval date: February 13, 2013
    Strength(s): 500MG;EQ 15MG BASE [AB], 850MG;EQ 15MG BASE [AB]

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

  • Pharmaceutical composition
    Patent 5,965,584
    Issued: October 12, 1999
    Inventor(s): Ikeda; Hitoshi & Sohda; Takashi & Odaka; Hiroyuki
    Assignee(s): Takeda Chemical Industries, Ltd.
    Pharmaceutical composition which comprises an insulin sensitivity enhancer in combination with other antidiabetics differing from the enhancer in the mechanism of action, which shows a potent depressive effect on diabetic hyperglycemia and is useful for prophylaxis and treatment of diabetes.
    Patent expiration dates:
    • June 19, 2016
      ✓ 
      Patent use: AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHO ARE ALREADY TREATED WITH A THIAZOLIDINEDIONE (TZD) AND METFORMIN OR WHO HAVE INADEQUATE GLYCEMIC CONTROL ON A TZD OR METFORMIN ALONE
      ✓ 
      Drug product
  • Pharmaceutical composition
    Patent 6,166,042
    Issued: December 26, 2000
    Inventor(s): Ikeda; Hitoshi & Sohda; Takashi & Odaka; Hiroyuki
    Assignee(s): Takeda Chemical Industries, Ltd.
    Pharmaceutical composition which comprises an insulin sensitivity enhancer in combination with other antidiabetics differing from the enhancer in the mechanism of action, which shows a potent depressive effect on diabetic hyperglycemia and is useful for prophylaxis and treatment of diabetes.
    Patent expiration dates:
    • June 19, 2016
      ✓ 
      Patent use: ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES WHO ARE ALREADY TREATED WITH A PIOGLITAZONE AND METFORMIN
  • Pharmaceutical composition
    Patent 6,166,043
    Issued: December 26, 2000
    Inventor(s): Ikeda; Hitoshi & Sohda; Takashi & Odaka; Hiroyuki
    Assignee(s): Takeda Chemical Industries, Ltd.
    Pharmaceutical composition which comprises an insulin sensitivity enhancer in combination with other antidiabetics differing from the enhancer in the mechanism of action, which shows a potent depressive effect on diabetic hyperglycemia and is useful for prophylaxis and treatment of diabetes.
    Patent expiration dates:
    • June 19, 2016
      ✓ 
      Patent use: ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES WHO ARE ALREADY TREATED WITH A PIOGLITAZONE AND METFORMIN
  • Pharmaceutical composition
    Patent 6,172,090
    Issued: January 9, 2001
    Inventor(s): Ikeda; Hitoshi & Sohda; Takashi & Odaka; Hiroyuki
    Assignee(s): Takeda Chemical Industries, Ltd.
    Pharmaceutical composition which comprises an insulin sensitivity enhancer in combination with other antidiabetics differing from the enhancer in the mechanism of action, which shows a potent depressive effect on diabetic hyperglycemia and is useful for prophylaxis and treatment of diabetes.
    Patent expiration dates:
    • June 19, 2016
      ✓ 
      Patent use: ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES WHO ARE ALREADY TREATED WITH A PIOGLITAZONE AND METFORMIN

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 17, 2015 - LABELING CHANGES BASED ON RESULTS FROM CLINICAL STUDY 01-06-TL-OPIMET-008

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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