Generic Boniva Availability

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

BONIVA (ibandronate sodium - injectable;intravenous)

  • Manufacturer: ROCHE
    Approval date: January 6, 2006
    Strength(s): EQ 3MG BASE/3ML [RLD] [AP]

BONIVA (ibandronate sodium - tablet;oral)

  • Manufacturer: HOFFMANN LA ROCHE
    Approval date: March 24, 2005
    Strength(s): EQ 150MG BASE [RLD] [AB]

Has a generic version of Boniva been approved?

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

ibandronate sodium injectable;intravenous

  • Manufacturer: SUN PHARM INDS LTD
    Approval date: February 14, 2014
    Strength(s): EQ 3MG BASE/3ML [AP]

ibandronate sodium tablet;oral

  • Manufacturer: APOTEX INC
    Approval date: March 19, 2012
    Strength(s): EQ 150MG BASE [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: April 30, 2012
    Strength(s): EQ 150MG BASE [AB]
  • Manufacturer: MUTUAL PHARM CO INC
    Approval date: August 15, 2012
    Strength(s): EQ 150MG BASE [AB]
  • Manufacturer: MYLAN PHARMS INC
    Approval date: March 19, 2012
    Strength(s): EQ 150MG BASE [AB]
  • Manufacturer: ORCHID HLTHCARE
    Approval date: March 19, 2012
    Strength(s): EQ 150MG BASE [AB]
  • Manufacturer: WATSON LABS INC
    Approval date: March 20, 2012
    Strength(s): EQ 150MG BASE [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Boniva. 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 agents containing diphosphonic acids and salts thereof
    Patent 5,662,918
    Issued: September 2, 1997
    Inventor(s): Winter; Gerhard & Pichler; Bernhard & Woog; Heinrich & Heller; Werner
    Assignee(s): Boehringer Mannheim GmbH
    The invention concerns pharmaceutical preparations that are stable on storage, which contain at least one diphosphonic acid and/or at least one physiologically acceptable salt of such an acid as the active substance.
    Patent expiration dates:
    • September 2, 2014
      ✓ 
      Drug product
  • Oral pharmaceutical preparation containing ibandronat
    Patent 6,143,326
    Issued: November 7, 2000
    Inventor(s): Mockel; Jorn & Gabel; Rolf-Dieter & Woog; Heinrich
    Assignee(s): Roche Diagnostics GmbH
    The invention is directed to well-tolerated pharmaceutical compositions for oral application, containing ibandronate or a physiologically tolerable salt thereof as active substance, the administration form consisting of an active substance-containing inner portion enclosed in such fashion by a coat free of active substance that rapid release of the active substance takes place.
    Patent expiration dates:
    • April 21, 2017
      ✓ 
      Patent use: TREATMENT AND PREVENTION OF OSTEOPOROSIS
  • Pharmaceutical composition containing diphosphonic acid or salt thereof
    Patent 6,294,196
    Issued: September 25, 2001
    Inventor(s): Gabel; Rolf-Dieter & Preis; Walter & Woog; Heinrich
    Assignee(s): Hoffmann-La Roche Inc.
    The invention relates to a solid pharmaceutical form of administration containing a diphosphonic acid or a physiologically compatible salt thereof as the active substance, wherein the active substance is present in granulate form, optionally together with pharmaceutical adjuvants in the inner phase, and the outer phase contains a lubricant in the form of less than 5% by weight of stearic acid relative to the total weight of the form of administration.
    Patent expiration dates:
    • October 7, 2019
      ✓ 
      Drug product
  • Method of treatment using bisphosphonic acid
    Patent 7,192,938
    Issued: March 20, 2007
    Inventor(s): Bauss; Frieder & Pichler; Bernhard & Turley; Stephen
    Assignee(s): Hoffmann-La Roche Inc.
    The present invention refers to a pharmaceutical composition of a bisphosphonic acid or salt thereof, and an excipient thereof, and a method of treating disorder characterized by pathologically increased bone resorption comprising orally administering at least 150% of the expected efficious daily dose of a bisphosphonic acid or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients thereof and administering the dose at a period of one two or three consecutive days per month.
    Patent expiration dates:
    • May 6, 2023
      ✓ 
      Patent use: TREATMENT AND PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN BY ONCE-MONTHLY ORAL ADMINISTRATION OF IBANDRONATE SODIUM MONOHYDRATE EQUIVALENT TO 150MG OF IBANDRONIC ACID
  • Method of treatment using bisphosphonic acid
    Patent 7,410,957
    Issued: August 12, 2008
    Inventor(s): Bauss; Frieder & Pichler; Bernhard & Turley; Stephen
    Assignee(s): Hoffmann-La Roche Inc.
    The present invention refers to a pharmaceutical composition of a bisphosphonic acid or salt thereof, and an excipient thereof, and a method of treating disorder characterized by pathologically increased bone resorption comprising orally administering at least 150% of the expected efficious daily dose of a bisphosphonic acid or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients thereof and administering the dose at a period of one two or three consecutive days per month.
    Patent expiration dates:
    • May 6, 2023
      ✓ 
      Patent use: TREATMENT AND PREVENTION OF OSTEOPOROSIS
  • Method of treatment using bisphosphonic acid
    Patent 7,718,634
    Issued: May 18, 2010
    Inventor(s): Bauss; Frieder & Pichler; Bernhard & Turley; Stephen
    Assignee(s): Hoffman-La Roche Inc.
    The present invention refers to a pharmaceutical composition of a bisphosphonic acid or salt thereof, and an excipient thereof, and a method of treating disorder characterized by pathologically increased bone resorption comprising orally administering at least 150% of the expected efficious daily dose of a bisphosphonic acid or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients thereof and administering the dose at a period of one two or three consecutive days per month.
    Patent expiration dates:
    • May 6, 2023
      ✓ 
      Patent use: TREATMENT AND PREVENTION OF OSTEOPOROSIS

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.
APInjectable 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.
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