Thursday, October 27, 2016

Fosamax


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]

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 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: No generic formulation of the following product is available.


  • alendronate sodium - solution; oral

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...

  • Fosamax Consumer Information (Drugs.com)
  • Fosamax Consumer Information (Wolters Kluwer)
  • Fosamax Solution Consumer Information (Wolters Kluwer)
  • Fosamax Consumer Information (Cerner Multum)
  • Fosamax Advanced Consumer Information (Micromedex)
  • Fosamax AHFS DI Monographs (ASHP)
  • Alendronate Consumer Information (Wolters Kluwer)
  • Alendronate Solution Consumer Information (Wolters Kluwer)
  • Alendronate Consumer Information (Cerner Multum)
  • Alendronate Advanced Consumer Information (Micromedex)
  • Alendronate Sodium AHFS DI Monographs (ASHP)

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