Available EU DMF/CEP
EU DMF
CEP
API Status
Commercial
Pipeline
Therapeutic Category
Alimentary tract & metabolism
Anti-infectives for systemic use
Antipyretic, analgesic and anti-inflammatory
Antineoplastic & immunomodulating agents
Blood & blood forming organs
Cardiovascular system
Genito-urinary system & sex hormones
Injectable forms
Musculo-skeletal system
Nervous system
Opthalmological preparations
Respiratory system
Available US DMF
US DMF
Available Japanese/Chinese DMF
Japanese DMF
Chinese DMF
Korean DMF

Alendronate sodium

CAS No.

121268-17-5

Innovator/marketer

Fosamax

Polymorphic form

Trihydrate

Therapeutic Area

Musculo-skeletal system

Status

Commercial

EU DMF readiness

US DMF readiness

016962

CEP

Other documentation

Japanese DMF
Korean DMF - under registration

Drug description:

Alendronate sodium is indicated for the treatment of post-menopausal osteoporosis; reduces the risk of vertebral and hip fractures. Alendronate sodium is indicated for the treatment of osteoporosis in men at increased risk of fracture. A reduction in the incidence of vertebral, but not of non-vertebral fractures has been demonstrated. Alendronate sodium is used in the prophylaxis of glucocorticoid-induced osteoporosis.
It is formulated as tablets for oral route of administration.

Mechanism of action:

Alendronate sodium is a bisphosphonate that inhibits osteoclastic bone resorption with no direct effect on bone formation. Preclinical studies have shown preferential localization of alendronate sodium to sites of active resorption. Activity of osteoclasts is inhibited, but recruitment or attachment of osteoclasts is not affected. The bone formed during treatment with alendronate sodium is of normal quality.

DISCLAIMER
Products protected by valid patents are not offered for commercial sale in countries where the sale of such products constitutes patent infringement but are offered solely for uses reasonably related to the development and submission of information under a law regulating the manufacture, use or sale of drugs. It is within the buyer’s responsibility and liability to check the patent situation of the product in the imported market(s).

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