Generic Starlix Availability

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

STARLIX (nateglinide - tablet;oral)

  • Manufacturer: NOVARTIS
    Approval date: December 22, 2000
    Strength(s): 60MG [AB], 120MG [RLD] [AB]

Has a generic version of Starlix been approved?

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

nateglinide tablet;oral

  • Manufacturer: DR REDDYS LABS LTD
    Approval date: September 9, 2009
    Strength(s): 60MG [AB], 120MG [AB]
  • Manufacturer: PAR PHARM
    Approval date: September 9, 2009
    Strength(s): 60MG [AB], 120MG [AB]
  • Manufacturer: WATSON LABS
    Approval date: March 30, 2011
    Strength(s): 60MG [AB], 120MG [AB]

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

  • Method of treating metabolic disorders especially diabetes, or a disease or condition associated with diabetes
    Patent 6,559,188
    Issued: May 6, 2003
    Inventor(s): Marjorie Regan; Gatlin & Michele Ann; Ball & Richard Owen; Mannion & Anees Abdulquadar; Karnachi & Christiane; Guitard & Malcolm; Allison
    Assignee(s): Novartis AG
    The invention relates to a combination, such as a combined preparation or pharmaceutical composition, respectively, which comprises nateglinide (I) or repaglinide and at least one other antidiabetic compound selected from the group consisting of thiazolidinedione derivatives (glitazones), sulfonyl urea derivatives and metformin for simultaneous, separate or sequential use in the prevention, delay of progression or treatment of diseases, especially metabolic disorders and in particular type 2 diabetes and diseases and conditions associated with diabetes; to a composition, respectively, which comprises nateglinide and a pharmaceutically acceptable carrier and to a process of making such composition; the use of such combination or composition for the preparation of a medicament for the prevention, delay of progression or treatment of metabolic disorders; a method of prevention, delay of progression or treatment of diseases in warm-blooded animals; the use of such combination or composition for the cosmetic treatment of a mammal in order to effect a cosmetically beneficial loss of body weight; and to a method of improving the bodily appearance of a warm-blooded animal.
    Patent expiration dates:
    • September 15, 2020
      ✓ 
      Patent use: USE FOR TREATMENT OF DIABETES, PARTICULARLY TYPE 2 DIABETES
      ✓ 
      Drug product
  • Tablet composition
    Patent 6,641,841
    Issued: November 4, 2003
    Inventor(s): Akira; Yabuki & Masato; Kaida & Takahiko; Ando & Nobutaka; Ninomiya & Masanao; Ozaki
    Assignee(s): Ajinomoto Co., Inc.
    A tablet composition containing N-(trans-4-isopropylcyclohexanecarbonyl)-D-phenylalanine and low substituted hydroxypropylcellulose is disclosed. This tablet composition is rapidly disintegrated in the stomach after the administration and absorbed without being influenced by meals to inhibit the rise of the blood sugar levels of diabetics after meals.
    Patent expiration dates:
    • November 14, 2017
      ✓ 
      Patent use: USE AS A BLOOD GLUCOSE-LOWERING AGENT
      ✓ 
      Drug product
  • Tablet composition
    Patent 6,844,008
    Issued: January 18, 2005
    Inventor(s): Yabuki; Akira & Kaida; Masato & Ando; Takahiko & Ninomiya; Nobutaka & Ozaki; Masanao
    Assignee(s): Ajinomoto Co., Inc.
    A tablet composition containing N-(trans-4-isopropylcyclohexanecarbonyl)-D-phenylalanine and a disintegrant, selected from a low substituted hydroxypropylcellulose, sodium carboxymethyl cellulose, calcium carboxymethyl cellulose and sodium croscaramellose sodium, is disclosed. This tablet composition is rapidly disintegrated in the stomach after the administration and absorbed without being influenced by meals to inhibit the rise of the blood sugar levels of diabetics after meals.
    Patent expiration dates:
    • November 14, 2017
      ✓ 
      Patent use: USE AS A BLOOD GLUCOSE-LOWERING AGENT
      ✓ 
      Drug product
  • Method of treating metabolic disorders, especially diabetes, or a disease or condition associated with diabetes
    Patent 6,878,749
    Issued: April 12, 2005
    Inventor(s): Gatlin; Marjorie Regan & Ball; Michele Ann & Mannion; Richard Owen & Karnachi; Anees Abdulquadar & Guitard; Christiane & Allison; Malcolm
    Assignee(s): Novartis AG
    The invention relates to a combination, such as a combined preparation or pharmaceutical composition, respectively, which comprises nateglinide (1) stet or repaglinide and at least one other antidiabetic compound selected from the group consisting of thiazolidinedione derivatives (glitazones), sulfonyl urea derivatives and metformin for simultaneous, separate or sequential use in the prevention, delay of progression or treatment of diseases, especially metabolic disorders and in particular type 2 diabetes and diseases and conditions associated with diabetes; to a composition, respectively, which comprises nateglinide and a pharmaceutically acceptable carrier and to a process of making such composition; the use of such combination or composition for the preparation of a medicament for the prevention, delay of progression or treatment of metabolic disorders; a method of prevention, delay of progression or treatment of diseases in warm-blooded animals; the use of such combination or composition for the cosmetic treatment of a mammal in order to effect a cosmetically beneficial loss of body weight; and to a method of improving the bodily appearance of a warm-blooded animal.
    Patent expiration dates:
    • September 15, 2020
      ✓ 
      Drug product

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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