Generic Diovan HCT Availability

Diovan HCT is a brand name of hydrochlorothiazide/valsartan, approved by the FDA in the following formulation(s):

DIOVAN HCT (hydrochlorothiazide; valsartan - tablet; oral)

  • Manufacturer: NOVARTIS
    Approval date: March 6, 1998
    Strength(s): 12.5MG;160MG [AB], 12.5MG;80MG [AB]
  • Manufacturer: NOVARTIS
    Approval date: January 17, 2002
    Strength(s): 25MG;160MG [AB]
  • Manufacturer: NOVARTIS
    Approval date: April 28, 2006
    Strength(s): 12.5MG;320MG [AB], 25MG;320MG [RLD] [AB]

Has a generic version of Diovan HCT been approved?

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

VALSARTAN AND HYDROCHLOROTHIAZIDE (hydrochlorothiazide; valsartan tablet; oral)

  • Manufacturer: ALEMBIC LTD
    Approval date: March 21, 2013
    Strength(s): 12.5MG;160MG [AB], 12.5MG;320MG [AB], 12.5MG;80MG [AB], 25MG;160MG [AB], 25MG;320MG [AB]
  • Manufacturer: APOTEX INC
    Approval date: March 21, 2013
    Strength(s): 12.5MG;160MG [AB], 12.5MG;320MG [AB], 12.5MG;80MG [AB], 25MG;160MG [AB], 25MG;320MG [AB]
  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: March 21, 2013
    Strength(s): 12.5MG;160MG [AB], 12.5MG;320MG [AB], 12.5MG;80MG [AB], 25MG;160MG [AB], 25MG;320MG [AB]
  • Manufacturer: LUPIN LTD
    Approval date: March 21, 2013
    Strength(s): 12.5MG;160MG [AB], 12.5MG;320MG [AB], 12.5MG;80MG [AB], 25MG;160MG [AB], 25MG;320MG [AB]
  • Manufacturer: MACLEODS PHARMS LTD
    Approval date: April 19, 2013
    Strength(s): 12.5MG;160MG [AB], 12.5MG;320MG [AB], 12.5MG;80MG [AB], 25MG;160MG [AB], 25MG;320MG [AB]
  • Manufacturer: MYLAN PHARMS INC
    Approval date: September 21, 2012
    Strength(s): 12.5MG;160MG [AB], 12.5MG;320MG [AB], 12.5MG;80MG [AB], 25MG;160MG [AB], 25MG;320MG [AB]
  • Manufacturer: WATSON LABS INC
    Approval date: March 21, 2013
    Strength(s): 12.5MG;160MG [AB], 12.5MG;320MG [AB], 12.5MG;80MG [AB], 25MG;160MG [AB], 25MG;320MG [AB]

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

  • Acyl compounds
    Patent 5,399,578
    Issued: March 21, 1995
    Inventor(s): Buhlmayer; Peter & Ostermayer; Franz & Schmidlin; Tibur
    Assignee(s): Ciba-Geigy Corp
    Compounds of the formula ##STR1## in which R.sub.1 is an aliphatic hydrocarbon radical which is unsubstituted or substituted by halogen or hydroxyl, or a cycloaliphatic or araliphatic hydrocarbon radical; X.sub.1 is CO, SO.sub.2, or --O--C(.dbd.O)-- with the carbon atom of the carbonyl group being attached to the nitrogen atom shown in formula I; X.sub.2 is a divalent aliphatic hydrocarbon radical which is unsubstituted or substituted by hydroxyl, carboxyl, amino, guanidino or a cycloaliphatic or aromatic radical, or is a divalent cycloaliphatic hydrocarbon radical, it being possible for a carbon atom of the aliphatic hydrocarbon radical to be additionally bridged by a divalent aliphatic hydrocarbon radical; R.sub.2 is carboxyl which, if desired, is esterified or amidated, substituted or unsubstituted amino, formyl which, if desired, is acetalized, 1H-tetrazol-5-yl, pyridyl, hydroxyl which, if desired, is etherified, S(O).sub.m --R where m is 0, 1 or 2 and R is hydrogen or an aliphatic hydrocarbon radical, alkanoyl, unsubstituted or N-substituted sulfamoyl or PO.sub.n H.sub.2 where n is 2 or 3; X.sub.3 is a divalent aliphatic hydrocarbon; R.sub.3 is carboxyl, 5-tetrazolyl, SO.sub.3 H, PO.sub.2 H.sub.2, PO.sub.3 H.sub.2 or haloalkylsulfamoyl; and the rings A and B independently of one another are substituted or unsubstituted; in free form or in salt form, can be prepared in a manner known per se and can be used, for example, as medicament active ingredients.
    Patent expiration dates:
    • September 21, 2012
      ✓ 
      Pediatric exclusivity
  • 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
    • December 18, 2017
      ✓ 
      Pediatric exclusivity

See also...

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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