Generic Fosamax Availability

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

FOSAMAX (alendronate sodium - solution; oral)

  • Manufacturer: MERCK
    Approval date: September 17, 2003
    Strength(s): EQ 70MG BASE/75ML [RLD] [AA]

FOSAMAX (alendronate sodium - tablet; oral)

  • Manufacturer: MERCK AND CO INC
    Approval date: September 29, 1995
    Strength(s): EQ 10MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: MERCK AND CO INC
    Approval date: April 25, 1997
    Strength(s): EQ 5MG BASE [AB]
  • Manufacturer: MERCK AND CO INC
    Approval date: October 20, 2000
    Strength(s): EQ 35MG BASE [AB], EQ 70MG BASE [RLD] [AB]

Has a generic version of Fosamax been approved?

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

alendronate sodium solution; oral

  • Manufacturer: ROXANE
    Approval date: February 25, 2013
    Strength(s): EQ 70MG BASE/75ML [AA]

alendronate sodium tablet; oral

  • Manufacturer: APOTEX
    Approval date: August 4, 2008
    Strength(s): EQ 10MG BASE [AB], EQ 35MG BASE [AB], EQ 5MG BASE [AB], EQ 70MG BASE [AB]
  • Manufacturer: AUROBINDO PHARMA
    Approval date: August 4, 2008
    Strength(s): EQ 10MG BASE [AB], EQ 35MG BASE [AB], EQ 70MG BASE [AB]
  • Manufacturer: AUSTARPHARMA LLC
    Approval date: September 24, 2009
    Strength(s): EQ 10MG BASE [AB], EQ 35MG BASE [AB], EQ 5MG BASE [AB], EQ 70MG BASE [AB]
  • Manufacturer: CADISTA PHARMS
    Approval date: February 18, 2010
    Strength(s): EQ 10MG BASE [AB], EQ 35MG BASE [AB], EQ 5MG BASE [AB], EQ 70MG BASE [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: August 4, 2008
    Strength(s): EQ 10MG BASE [AB], EQ 35MG BASE [AB], EQ 5MG BASE [AB], EQ 70MG BASE [AB]
  • Manufacturer: MYLAN
    Approval date: August 4, 2008
    Strength(s): EQ 10MG BASE [AB], EQ 35MG BASE [AB], EQ 35MG BASE [AB], EQ 5MG BASE [AB], EQ 70MG BASE [AB], EQ 70MG BASE [AB]
  • Manufacturer: SUN PHARMA GLOBAL
    Approval date: September 10, 2008
    Strength(s): EQ 10MG BASE [AB], EQ 35MG BASE [AB], EQ 5MG BASE [AB], EQ 70MG BASE [AB]
  • Manufacturer: TEVA PHARMS
    Approval date: February 6, 2008
    Strength(s): EQ 10MG BASE [AB], EQ 35MG BASE [AB], EQ 40MG BASE [AB], EQ 5MG BASE [AB], EQ 70MG BASE [AB]
  • Manufacturer: WATSON LABS
    Approval date: August 4, 2008
    Strength(s): EQ 10MG BASE [AB], EQ 35MG BASE [AB], EQ 35MG BASE [AB], EQ 40MG BASE [AB], EQ 40MG BASE [AB], EQ 5MG BASE [AB], EQ 70MG BASE [AB], EQ 70MG BASE [AB]

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

  • Dry mix formulation for bisphosphonic acids with lactose
    Patent 5,358,941
    Issued: October 25, 1994
    Inventor(s): Bechard; Simon R. & Kramer; Kenneth A. & Katdare; Ashok V.
    Assignee(s): Merck & Co., Inc.
    Pharmaceutical compositions of bisphosphonic acids, and salts thereof, are prepared by direct compression/dry mix tablet formulation. These pharmaceutical compositions are useful in the treatment of disturbances involving calcium or phosphate metabolism, in particular, the treatment and prevention of diseases involving bone resorption, especially osteoporosis, Paget's disease, malignant hypercalcemia, and metastatic bone disease.
    Patent expiration dates:
    • December 2, 2012
    • June 2, 2013
      ✓ 
      Pediatric exclusivity
  • Oral liquid alendronate formulations
    Patent 5,462,932
    Issued: October 31, 1995
    Inventor(s): Brenner; Gerald S. & Katdare; Ashok V. & Pretzer; Denise & Whiteford; Donna T.
    Assignee(s): Merck & Co., Inc.
    Disclosed is a therapy protocol for treating and for preventing bone loss in patients who have difficulty in swallowing by administering a liquid formulation of alendronate which can be easily swallowed. Also described are pharmaceutical dosage forms of a syrup, aqueous solution, a solution formed from a reconstituted powder, of alendronate, for carrying out the therapeutic method.
    Patent expiration dates:
    • May 17, 2014
    • November 17, 2014
      ✓ 
      Pediatric exclusivity
  • Dry mix formulation for bisphosphonic acids
    Patent 5,681,590
    Issued: October 28, 1997
    Inventor(s): Bechard; Simon R. & Kramer; Kenneth A. & Katdare; Ashok V.
    Assignee(s): Merck & Co., Inc.
    Pharmaceutical compositions of bisphosphonic acids, and salts thereof, are prepared by direct compression/dry mix tablet formulation. These pharmaceutical compositions are useful in the treatment of disturbances involving calcium or phosphate metabolism, in particular, the treatment and prevention of diseases involving bone resorption, especially osteoporosis, Paget's disease, malignant hypercalcemia, and metastatic bone disease.
    Patent expiration dates:
    • December 2, 2012
    • June 2, 2013
      ✓ 
      Pediatric exclusivity
  • Method for inhibiting bone resorption
    Patent 5,994,329
    Issued: November 30, 1999
    Inventor(s): Daifotis; Anastasia G. & Santora, II; Arthur C. & Yates; A. John
    Assignee(s): Merck & Co., Inc.
    Disclosed are methods for inhibiting bone resorption in mammals while minimizing the occurrence of or potential for adverse gastrointestinal effects. Also disclosed are pharmaceutical compositions and kits for carrying out the therapeutic methods disclosed herein.
    Patent expiration dates:
    • July 17, 2018
      ✓ 
      Sponsor has requested patent be delisted
    • January 17, 2019
      ✓ 
      Pediatric exclusivity
  • Method for inhibiting bone resorption
    Patent 6,015,801
    Issued: January 18, 2000
    Inventor(s): Daifotis; Anastasia G. & Yates; A. John & Santora, II; Arthur C.
    Assignee(s): Merck & Co., Inc.
    Disclosed are methods for inhibiting bone resorption in mammals while minimizing the occurrence of or potential for adverse gastrointestinal effects. Also disclosed are pharmaceutical compositions and kits for caring out the therapeutic methods disclosed herein.
    Patent expiration dates:
    • July 17, 2018
      ✓ 
      Sponsor has requested patent be delisted
    • January 17, 2019
      ✓ 
      Pediatric exclusivity
  • Dry mix formulation for bisphosphonic acids
    Patent 6,090,410
    Issued: July 18, 2000
    Inventor(s): Bechard; Simon R. & Kramer; Kenneth A. & Katdare; Ashok V.
    Assignee(s): Merck & Co., Inc.
    Pharmaceutical compositions of bisphosphonic acids, and salts thereof, are prepared by direct compression/dry mix tablet formulation. These pharmaceutical compositions are useful in the treatment of disturbances involving calcium or phosphate metabolism, in particular, the treatment and prevention of diseases involving bone resorption, especially osteoporosis, Paget's disease, malignant hypercalcemia, and metastatic bone disease.
    Patent expiration dates:
    • December 2, 2012
    • June 2, 2013
      ✓ 
      Pediatric exclusivity
  • Dry mix formulation for bisphosphonic acids
    Patent 6,194,004
    Issued: February 27, 2001
    Inventor(s): Bechard; Simon R. & Kramer; Kenneth A. & Katdare; Ashok V.
    Assignee(s): Merck & Co., Inc.
    Pharmaceutical compositions of bisphosphonic acids, and salts thereof, are prepared by direct compression/dry mix tablet formulation. These pharmaceutical compositions are useful in the treatment of disturbances involving calcium or phosphate metabolism, in particular, the treatment and prevention of diseases involving bone resorption, especially osteoporosis, Paget's disease, malignant hypercalcemia, and metastatic bone disease.
    Patent expiration dates:
    • December 2, 2012
    • June 2, 2013
      ✓ 
      Pediatric exclusivity
  • Method for inhibiting bone resorption
    Patent 6,225,294
    Issued: May 1, 2001
    Inventor(s): Daifotis; Anastasia G. & Santora, II; Arthur C. & Yates; A. John
    Assignee(s): Merck & Co., Inc.
    Disclosed are methods for inhibiting bone resorption in mammals while minimizing the occurrence of or potential for adverse gastrointestinal effects. Also disclosed are pharmaceutical compositions and kits for carrying out the therapeutic methods disclosed herein.
    Patent expiration dates:
    • July 17, 2018
      ✓ 
      Sponsor has requested patent be delisted
    • January 17, 2019
      ✓ 
      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.
AAProducts in conventional dosage forms not presenting bioequivalence problems. Products coded as AA contain active ingredients and dosage forms that are not regarded as presenting either actual or potential bioequivalence problems or drug quality or standards issues. However, all oral dosage forms must, nonetheless, meet an appropriate in vitro bioequivalence standard that is acceptable to the Agency in order to be approved.
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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