Generic Exforge Availability

Exforge is a brand name of amlodipine/valsartan, approved by the FDA in the following formulation(s):

EXFORGE (amlodipine besylate; valsartan - tablet;oral)

  • Manufacturer: NOVARTIS
    Approval date: June 20, 2007
    Strength(s): EQ 5MG BASE;160MG [AB], EQ 5MG BASE;320MG [AB], EQ 10MG BASE;160MG [RLD] [AB], EQ 10MG BASE;320MG [RLD] [AB]

Has a generic version of Exforge been approved?

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

AMLODIPINE BESYLATE AND VALSARTAN (amlodipine besylate; valsartan tablet;oral)

  • Manufacturer: PAR PHARM INC
    Approval date: March 28, 2013
    Strength(s): EQ 5MG BASE;160MG [AB], EQ 5MG BASE;320MG [AB], EQ 10MG BASE;160MG [AB], EQ 10MG BASE;320MG [AB]

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

  • Solid oral dosage forms of valsartan
    Patent 6,294,197
    Issued: September 25, 2001
    Inventor(s): Wagner; Robert Frank & Katakuse; Yoshimitsu & Taike; Takashi & Yamato; Fujiki & Kohlmeyer; Manfred
    Assignee(s): Novartis AG
    The present invention is concerned with solid dosage forms comprising a) valsartan and optionally HCTZ, and b) pharmaceutically acceptable additives suitable for the preparation of solid oral dosage forms by compression methods.
    Patent expiration dates:
    • June 18, 2017
      ✓ 
      Patent use: TREATMENT OF HYPERTENSION
      ✓ 
      Drug product
    • December 18, 2017
      ✓ 
      Pediatric exclusivity
  • Method of treatment and pharmaceutical composition
    Patent 6,395,728
    Issued: May 28, 2002
    Inventor(s): Randy Lee; Webb & Marc; de Gasparo
    Assignee(s): Novartis AG
    The invention relates to a method for the treatment or prevention of a condition or disease selected from the group consisting of hypertension, (acute and chronic) congestive heart failure, left ventricular dysfunction and hypertrophic cardiomyopathy, myocardial infarction and its sequelae, supraventricular and ventricular arrhythmias, atrial fibrillation or atrial flutter, atherosclerosis, angina (whether stable or ustable), renal insufficiency (diabetic and non-diabetic), heart failure, angina pectoris, diabetessecondary aldosteronism, primary and secondary pulmonary hyperaldosteronism, primary and pulmonary hypertension, renal failure conditions, such as diabetic nephropathy,glomerulonephritis, scleroderma, glomerular sclerosis, proteinuria of primary renal disease, and also renal vascular hypertension, diabetic retinopathy, the management of other vascular disorders, such as migraine, Raynaud's disease, luminal hyperplasia, cognitive dysfunction (such as Alzheimer's), and stroke, comprising administering a therapeutically effective amount of combination of (i) the AT1-antagonists valsartan or a pharmaceutically acceptable salt thereof and (ii) a Calcium channel blocker or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier to a mammal in need of such treatment and to corresponding pharmaceutical combination composition.
    Patent expiration dates:
    • July 8, 2019
      ✓ 
      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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