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Profile for Tradename: FOSAMAX

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Fosamax is a drug marketed by Merck and Merck And Co Inc and is included in three NDAs. It is available from two suppliers. There are four patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in FOSAMAX is alendronate sodium; cholecalciferol. There are twenty-five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the alendronate sodium; cholecalciferol profile page.

Summary for Tradename: FOSAMAX

Suppliers: see list2

Pharmacology for Tradename: FOSAMAX

Drug ClassBisphosphonate

Clinical Trials for: FOSAMAX

FOSAMAX PLUS and FOSAMAX PLUS D Re-examination Study (0217A-267)
Status: Completed Condition: Osteoporosis

The Effects of Alendronate After Cure of Primary Hyperparathyroidism
Status: Withdrawn Condition: Hyperparathyroidism

Pilot Study of Fosamax in Spinal Cord Injury
Status: Terminated Condition: Spinal Cord Injury; Osteoporosis

Bioequivalence Study of Alendronate Sodium Tablets 70 mg of Dr. Reddy's Under Fasting Conditions
Status: Completed Condition: Healthy

Effect of Alendronate on Bone in People With Chronic Spinal Cord Injury Previously Treated With Teriparatide
Status: Enrolling by invitation Condition: Spinal Cord Injury; Bone Loss; Osteoporosis

Alendronate for Prevention of AntiRetroviral Therapy-associated Bone Loss
Status: Not yet recruiting Condition: Bone Demineralization

Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)
Status: Completed Condition: Osteoporosis Postmenopausal

Alendronate in Juvenile Osteoporosis
Status: Completed Condition: Juvenile Osteoporosis; Low Bone Density; Fractures

Study of Alendronate to Prevent and Treat Osteoporosis in Cystic Fibrosis Patients
Status: Completed Condition: Cystic Fibrosis; Osteoporosis; Bone Diseases, Metabolic

Safety and Efficacy of Alendronate (Fosamax) in Children With Osteoporosis
Status: Completed Condition: Osteoporosis

Courtesy of
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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
alendronate sodium
SOLUTION;ORAL021575-001Sep 17, 2003RXYes6,225,294*PED<disabled>Y<disabled>
alendronate sodium; cholecalciferol
TABLET;ORAL021762-001Apr 7, 2005RXNo5,994,329*PED<disabled>Y<disabled>
Merck And Co Inc
alendronate sodium
TABLET;ORAL020560-001Sep 29, 1995DISCNNo<disabled><disabled>
Merck And Co Inc
alendronate sodium
TABLET;ORAL020560-005Oct 20, 2000RXYes<disabled><disabled>
alendronate sodium; cholecalciferol
TABLET;ORAL021762-002Apr 26, 2007RXNo<disabled><disabled>
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Paragraph IV activity for: FOSAMAX

Drugname Dosage Strength RLD Submissiondate
alendronate sodium and cholecalciferolTablets70 mg/2800 IU and 70 mg/5600 IUFosamax Plus D11/20/2007
alendronate sodiumOral Solution70 mg/75 mLFosamax9/7/2007
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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