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Details for Generic Name: alendronate sodium

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Alendronate sodium is the generic ingredient in four branded drugs marketed by Roxane, Merck, Mission Pharma, Apotex, Aurobindo Pharma, Austarpharma Llc, Cadista Pharms, Cipla Ltd, Dr Reddys Labs Ltd, Mylan, Sandoz, Sun Pharma Global, Teva Pharms, Watson Labs, and Merck And Co Inc, and is included in nineteen NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has ten patent family members in seven countries.

There are twenty-five drug master file entries for alendronate sodium. Three suppliers are listed for this compound.

Summary for Generic Name: alendronate sodium

Tradenames:4
Patents:6
Applicants:15
NDAs:19
Drug Master File Entries: see list25
Suppliers / Packaging: see list9
Therapeutic Class:Metabolic Bone Disease Agents

Pharmacology for Ingredient: alendronate sodium

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

Clinical Trials for: alendronate sodium

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

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Status: Withdrawn Condition: Hyperparathyroidism

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

Alendronate Prevents Microarchitectural Deterioration of Trabecular Bone in Early Postmenopausal Women
Status: Completed Condition: Osteopenia; Osteoporosis

Alendronate Sodium 70 mg Tablet Versus Fosamax® Under Fasting Conditions.
Status: Completed Condition: Healthy

A Study of the Bioequivalence of 70-mg Alendronate and 70-mg Alendronate in Combination With 5600 IU Vitamin D (MK0217A-253)(COMPLETED)
Status: Completed Condition: Osteoporosis

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

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

A Study to Evaluate and Compare Alendronate and Risedronate on Bone Mineral Density in Women With Postmenopausal Osteoporosis (MK-0217-211)
Status: Completed Condition: Postmenopausal Osteoporosis

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

Alendronate Compared to Metformin in Chronic Periodontitis
Status: Completed Condition: Chronic Periodontitis

Parathyroid Hormone (PTH) With Alendronate for Osteoporosis
Status: Completed Condition: Osteoporosis

A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density
Status: Completed Condition: Postmenopausal Osteoporosis

Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Alendronate (MK-0822-050)
Status: Withdrawn Condition: Osteoporosis; Postmenopausal Osteoporosis

Study of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (MK-0217A-329)
Status: Completed Condition: Osteoporosis

Zoledronic Acid Versus Alendronate for Prevention of Bone Loss After Organ Transplantation
Status: Active, not recruiting Condition: Heart Transplantation; Liver Transplantation; Bone Resorption

Fasting Study of Alendronate Sodium Tablets (70 mg) and Fosamax Tablets (70 mg)
Status: Completed Condition: Healthy

Fasting Study of Alendronate Sodium Tablets (10 mg) and Fosamax Tablets (10 mg)
Status: Completed Condition: Healthy

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

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

A Study of the Bioequivalence of 70 mg Alendronate and 70 mg Alendronate in Combination With 2800 IU Vitamin D
Status: Completed Condition: Osteoporosis

Phase II Study of Alendronate Sodium in Children With High-Turnover Idiopathic Juvenile Osteoporosis
Status: Completed Condition: Osteoporosis

Efficacy and Safety of Brand Versus Generic Alendronate for Osteoporosis Treatment
Status: Recruiting Condition: Osteoporosis

Safety and Effectiveness of Oral Alendronate Therapy on Bone Mineral Density in HIV-infected Children and Adolescents With Low Bone Mineral Density
Status: Active, not recruiting Condition: HIV Infections

Drug Holidays in the Treatment With Alendronate in Postmenopausal Women With Osteoporosis
Status: Completed Condition: Osteoporosis

The Effect of Alendronate on the Immune Response to Hepatitis B Vaccine in Healthy Adults
Status: Active, not recruiting Condition: Hepatitis B

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

The Change of Bone Markers After Low Dose Alendronate in Postmenopausal Women With Bone Loss
Status: Completed Condition: Osteoporosis

Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteoporosis
Status: Completed Condition: Osteoporosis

Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplants
Status: Active, not recruiting Condition: Renal Insufficiency

Study of the Effect of Alendronate on Vascular Calcification and Arterial Stiffness in Chronic Kidney Disease
Status: Completed Condition: Vascular Calcification; Arteriosclerosis

99Tc-MDP in Postmenopausal Women With Differentiated Thyroid Cancer and Decreased Bone Mineral Density
Status: Recruiting Condition: Differentiated Thyroid Cancer; Osteoporosis

Testosterone and Alendronate in Hypogonadal Men
Status: Recruiting Condition: Hypogonadism; Osteopenia; Osteoporosis

Pharmacokinetics of a Single 14C-labeled Dose of Risedronate or Alendronate Followed by Once-a-week Unlabeled Oral Dose
Status: Completed Condition: Osteopenia; Osteoporosis

Biorest Liposomal Alendronate With Stenting sTudy (BLAST)
Status: Completed Condition: Coronary Artery Stenosis

Ketoconazole With or Without Alendronate Sodium in Treating Patients With Metastatic Prostate Cancer
Status: Terminated Condition: Stage IV Prostate Cancer; Bone Metastases; Adenocarcinoma of the Prostate; Recurrent Prostate Cancer

Osteoporosis Prevention With Low Dose Alendronate
Status: Completed Condition: Osteopenia

Denosumab Adherence Preference Satisfaction Study
Status: Completed Condition: Osteoporosis

A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264)
Status: Completed Condition: Osteoporosis, Postmenopausal

Sodium Alendronate in Non Surgical Periodontal Therapy
Status: Completed Condition: Periodontitis; Bone Resorption

Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment
Status: Completed Condition: Breast Cancer

A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density.
Status: Completed Condition: Osteoporosis; Osteopenia

Treatment of Low Bone Density in Cystic Fibrosis.
Status: Completed Condition: Osteoporosis; Cystic Fibrosis

Fosamax for Childhood Cancer Survivors
Status: Recruiting Condition: Osteoporosis

OPG/Soluble RANKL (sRANKL) and Bone Mineral Density in Primary Hyperparathyroidism
Status: Completed Condition: Primary Hyperparathyroidism

PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis
Status: Completed Condition: Osteoporosis

Bisphosphonate Action on the Appendicular Skeleton: Evidence for Differential Effects
Status: Active, not recruiting Condition: Post-menopausal Osteoporosis

The Effect of PTH(1-84) or Alendronate on Reduction of Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) (FP-005-IM)
Status: Terminated Condition: Back Pain

Study of Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Alendronate or Risedronate
Status: Completed Condition: Postmenopausal Osteoporosis

Cancer and Osteoporosis Research With Alendronate and Lupron (C.O.R.A.L )
Status: Terminated Condition: Osteoporosis

Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis
Status: Completed Condition: Osteoporosis

Treatment With Alendronate in Patients With Ankylosing Spondylitis (AS)
Status: Active, not recruiting Condition: Ankylosing Spondylitis; Osteoporosis

Study of Transitioning From Alendronate to Denosumab
Status: Completed Condition: Postmenopausal Osteoporosis

A Study of Ibandronate (Bonviva) in Patients With Post-Menopausal Osteoporosis
Status: Completed Condition: Postmenopausal Osteoporosis

MK-5442 in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With an Oral Bisphosphonate (MK-5442-012)
Status: Completed Condition: Osteoporosis; Postmenopausal Osteoporosis

The Forteo Alendronate Comparator Trial
Status: Completed Condition: Osteoporosis

Alendronate to Prevent Loss of Bronchoprotection in Asthma
Status: Recruiting Condition: Asthma

Can Alendronate Suppress Calcification and Improve Bone Density in Chronic Peritoneal Dialysis Patients?
Status: Completed Condition: End-Stage Renal Disease; Osteoporosis

Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
Status: Active, not recruiting Condition: Postmenopausal Women With Osteoporosis

1% Alendronate Gel in Treatment of Chronic Periodontitis Among Smokers
Status: Completed Condition: Chronic Periodontitis

Comparison of Alendronate With Atorvastatin in Chronic Periodontitis
Status: Completed Condition: Chronic Periodontitis

Alendronate for Vascular Calcification in Peritoneal Dialysis Patients?
Status: Not yet recruiting Condition: Peritoneal Dialysis

RA Denosumab on Bone Microstructure Study
Status: Completed Condition: Rheumatoid Arthritis

Alendronate and/or Parathyroid Hormone for Osteoporosis
Status: Completed Condition: Osteoporosis

Low-Dose Hormone Replacement Therapy and Alendronate for Osteoporosis
Status: Terminated Condition: Osteopenia; Osteoporosis

Evaluation Of Missed Osteoporosis Diagnoses, And Preference Between Once Monthly Ibandronate And Once Weekly Alendronate
Status: Completed Condition: Osteoporosis

Platelet Rich Fibrin+1% Alendronate in Treatment of Chronic Periodontitis
Status: Completed Condition: Chronic Periodontitis

A Study to Compare the Efficacy of Alendronate With and Without Calcium or Calcium Alone In the Treatment of Osteoporosis in Postmenopausal Women (0217-088)(COMPLETED)
Status: Completed Condition: Osteoporosis, Postmenopausal

Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial
Status: Recruiting Condition: HIV

Upper GI Handling of Branded vs. Generic Alendronate
Status: Completed Condition: Osteoporosis

Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta
Status: Completed Condition: Osteogenesis Imperfecta

Alendronate Osteoporosis Study
Status: Active, not recruiting Condition: Glucocorticoid-Associated Osteopenia and Osteoporosis

Determine the Efficacy, Safety and Tolerability of Denosumab (AMG 162) in the Treatment of Postmenopausal Women With Low Bone Mineral Density
Status: Completed Condition: Low Bone Mineral Density

Alendronate in the Prevention of Collapse of Femoral Head in Non-Traumatic Osteonecrosis
Status: Active, not recruiting Condition: Non-Traumatic Osteonecrosis

Efficacy of Alendronate Versus Placebo in the Treatment of HIV-associated Osteoporosis (ANRS120)
Status: Completed Condition: Osteoporosis; HIV Infections

Combined Administration of Teripapartide and Antiresorptive Agents in Postmenopausal Osteoporosis
Status: Completed Condition: Osteoporosis

Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol.
Status: Completed Condition: Rheumatoid Arthritis; Polymyalgia Rheumatica; Giant Cell Arteritis; Polymyositis; Wegener’s Granulomatosis

A Study to Test the Effect of MK0217A on Vitamin D Inadequacy in Postmenopausal Women With Osteoporosis (0217A-262)
Status: Completed Condition: Osteoporosis

Study Investigating the Effect of Drugs Used to Treat Osteoporosis on the Progression of Calcific Aortic Stenosis.
Status: Recruiting Condition: Calcific Aortic Stenosis

Fosamax Bone Loss Study: Alendronate to Prevent Bone Loss
Status: Completed Condition: Perimenopausal Bone Loss

OPTAMISE: Clinical Effectiveness of Teriparatide After Alendronate or Risedronate Therapy in Osteoporotic Postmenopausal Women
Status: Completed Condition: Osteoporosis, Postmenopausal

Phase II Randomized Study of Alendronate Sodium for Osteopenia in Patients With Gaucher's Disease
Status: Completed Condition: Gaucher's Disease; Osteopenia

A Study to Evaluate the Safety and Tolerability of MK0217 in Women (0217-219)
Status: Completed Condition: Postmenopausal Osteoporosis

Treatment of Childhood Osteoporosis With Alendronate (Fosamax)
Status: Completed Condition: Osteoporosis

4-Week Study to Assess the Effect of Alendronate and Vitamin D3 Once Weekly on Fractional Calcium Absorption in Postmenopausal Osteoporotic Women (0217A-230)
Status: Completed Condition: Osteoporosis

The Effect of Alendronate, Calcium, and Vitamin D on Bone Mineral Density in HIV Infected Patients
Status: Completed Condition: HIV Infections

Alendronate to Treat Polyostotic Fibrous Dysplasia and McCune-Albright Syndrome
Status: Completed Condition: Polyostotic Fibrous Dysplasia

Bone Healing After Dental Extraction in Postmenopausal Osteoporotic Women Treated With Alendronate Per os Weekly
Status: Recruiting Condition: Alveolar Bone Healing After Dental Extraction

Platelet Rich Fibrin+1% Alendronate in Treatment of Mandibular Degree II Furcation Defects
Status: Completed Condition: Furcation Defects

A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.
Status: Completed Condition: Post-Menopausal Osteoporosis

The Effectiveness of Two Osteoporosis Drugs on Prosthetic Bone Mineral Density (BMD) Loss After Total Hip Arthroplasty(THA)
Status: Active, not recruiting Condition: Bone Density; Arthroplasty, Replacement, Hip

Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy
Status: Recruiting Condition: Osteoporosis

The Study of the Early Administration of Alendronate on Prevention of Bone Loss After Hip Fracture.
Status: Recruiting Condition: Osteoporosis

A Study of Ibandronate [Bonviva/Boniva] and Alendronate in Female Patients With Post-Menopausal Osteoporosis
Status: Completed Condition: Postmenopausal Osteoporosis

Comparison of Autologous PRF, 1% Alendronate and 1.2% Atorvastatin Gel in Chronic Periodontitis Treatment
Status: Completed Condition: Chronic Periodontitis

Osteoporosis and Dental Implant
Status: Recruiting Condition: Osteoporosis

Efficacy of Cinacalcet in the Control of Primary Hyperparathyroidism
Status: Completed Condition: Hyperparathyroidism, Primary; Osteoporosis

Transition From Alendronate to AMG 785
Status: Completed Condition: OSTEOPOROSIS, POSTMENOPAUSAL

Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis
Status: Completed Condition: Osteoporosis; Cystic Fibrosis

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cipla Ltd
ALENDRONATE SODIUM
alendronate sodium
TABLET;ORAL076768-005Aug 4, 2008RXNo<disabled><disabled>
Teva Pharms
ALENDRONATE SODIUM
alendronate sodium
TABLET;ORAL075710-005Feb 6, 2008RXNo<disabled><disabled>
Cipla Ltd
ALENDRONATE SODIUM
alendronate sodium
TABLET;ORAL076768-002Aug 4, 2008RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: alendronate sodium

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck And Co Inc
FOSAMAX
alendronate sodium
TABLET;ORAL020560-001Sep 29, 19956,194,004*PED<disabled>
Merck And Co Inc
FOSAMAX
alendronate sodium
TABLET;ORAL020560-003Apr 25, 19976,008,207*PED<disabled>
Merck And Co Inc
FOSAMAX
alendronate sodium
TABLET;ORAL020560-004Oct 20, 20006,008,207*PED<disabled>
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International Patent Family for Ingredient: alendronate sodium

Country Document Number Publication Date
World Intellectual Property Organization (WIPO)03075884Sep 18, 2003
Canada2495886Sep 18, 2004
Austria541575Feb 15, 2012
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

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

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