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

Ibandronate sodium

CAS No.

138926-19-9

Innovator/marketer

Bonviva

Polymorphic form

Monohydrate

Therapeutic Area

Musculo-skeletal system

Status

Commercial

EU DMF readiness

US DMF readiness

025638

Other documentation

Chinese DMF
Korean DMF

Available also in injectable form

Drug description:

Ibandronate sodium is a nitrogen-containing bisphosphonate.
It is indicated for the treatment and prevention of osteoporosis in postmenopausal women at increased risk of fracture and reduction in the risk of vertebral fractures.
It is formulated as film coated tablets and tablets for oral administration and formulated as injection solution for intravenous route of administration.

Mechanism of action:

Ibandronate sodium inhibits farnesyl pyrophosphate (FPP) synthase, an enzyme in the mevalonate pathway. Inhibition of this enzyme in osteoclasts prevents the biosynthesis of isoprenoid lipids (FPP and GGPP) that are essential for the post-translational farnesylation and geranylgeranylation of small GTPase signaling proteins. This activity inhibits osteoclast activity and reduces bone resorption and turnover. Ibandronate sodium leads to progressive net gains in bone mass and a decreased incidence of fractures through the reduction of elevated bone turnover towards premenopausal levels in postmenopausal women.

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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