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Generic Reclast Availability

Last updated on Mar 9, 2023.

Reclast is a brand name of zoledronic acid, approved by the FDA in the following formulation(s):

RECLAST (zoledronic acid - injectable;intravenous)

  • Manufacturer: NOVARTIS
    Approval date: April 16, 2007
    Strength(s): EQ 5MG BASE/100ML [RLD] [AP]

Has a generic version of Reclast been approved?

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

zoledronic acid injectable;intravenous

  • Manufacturer: AKORN
    Approval date: August 21, 2014
    Strength(s): EQ 5MG BASE/100ML [AP]
  • Manufacturer: APOTEX
    Approval date: December 24, 2015
    Strength(s): EQ 5MG BASE/100ML [AP]
  • Manufacturer: BRECKENRIDGE
    Approval date: August 5, 2013
    Strength(s): EQ 5MG BASE/100ML [AP]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: March 29, 2013
    Strength(s): EQ 5MG BASE/100ML [AP]
  • Manufacturer: GLAND
    Approval date: August 18, 2016
    Strength(s): EQ 5MG BASE/100ML [AP]
  • Manufacturer: GLAND PHARMA LTD
    Approval date: August 8, 2019
    Strength(s): EQ 5MG BASE/100ML [AP]
  • Manufacturer: HOSPIRA INC
    Approval date: April 5, 2013
    Strength(s): EQ 5MG BASE/100ML [AP]
  • Manufacturer: INFORLIFE
    Approval date: September 23, 2013
    Strength(s): EQ 5MG BASE/100ML [AP]
  • Manufacturer: MYLAN LABS LTD
    Approval date: February 14, 2017
    Strength(s): EQ 5MG BASE/100ML [AP]
  • Manufacturer: MYLAN LABS LTD
    Approval date: October 27, 2017
    Strength(s): EQ 5MG BASE/100ML [AP]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Reclast. 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: Generic Drug FAQ.

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 products comprising bisphosphonates
    Patent 7,932,241
    Issued: April 26, 2011
    Inventor(s): Glausch; Alexandra & Löffler; Rolf & Sigg; Juergen
    Assignee(s): Novartis AG

    A pharmaceutical product comprises a container containing a bisphosphonate solution, in which at least the internal surface of the container comprises a plastic material and in which the container is heat sterilisable, and which is in the form of a ready to use infusion solution, for administration of the bisphosphonate to a patient in need of bisphosphonate treatment.

    Patent expiration dates:

    • February 5, 2028
      ✓ 
      Drug product
    • August 5, 2028
      ✓ 
      Pediatric exclusivity
  • Method of administering bisphosphonates
    Patent 8,052,987
    Issued: November 8, 2011
    Inventor(s): Horowitz; Zebulun D. & Richardson; Peter C. & Trechsel; Ulrich
    Assignee(s): Novartis Pharmaceuticals Corporation

    The invention relates to bisphosphonates, in particular more potent N-bisphosphonates such as zoledronic acid and derivatives, and to methods of treatment using bisphosphonates. These bisphosphonates are used with satisfactory results for prolonged inhibition of bone resorption in conditions of abnormally increased bone turnover, e.g. osteoporosis, by intermittent administration, the periods between bisphosphonate administrations are longer than was previously considered appropriate, e.g. a dosing interval of at least about 6 months or less frequently.

    Patent expiration dates:

    • October 27, 2023
      ✓ 
      Patent use: TREATMENT AND PREVENTION OF POSTMENOPAUSAL OR GLUCOCORTICOID-INDUCED OSTEOPOROSIS AND TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS

Glossary

Term Definition
Drug Patent A 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 Exclusivity Exclusivity 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.
RLD A 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.
AP Injectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions. It should be noted that even though injectable (parenteral) products under a specific listing may be evaluated as therapeutically equivalent, there may be important differences among the products in the general category, Injectable; Injection. For example, some injectable products that are rated therapeutically equivalent are labeled for different routes of administration. In addition, some products evaluated as therapeutically equivalent may have different preservatives or no preservatives at all. Injectable products available as dry powders for reconstitution, concentrated sterile solutions for dilution, or sterile solutions ready for injection are pharmaceutical alternative drug products. They are not rated as therapeutically equivalent (AP) to each other even if these pharmaceutical alternative drug products are designed to produce the same concentration prior to injection and are similarly labeled. Consistent with accepted professional practice, it is the responsibility of the prescriber, dispenser, or individual administering the product to be familiar with a product's labeling to assure that it is given only by the route(s) of administration stated in the labeling.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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