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Generic Boniva

Generic boniva

Description

The first patent for Boniva (ibandronate sodium) has expired, and now the tablet form of the drug is available in generic form. The injection is still unavailable as a generic. Apotex and Mylan are two of the companies that make generic Boniva. Ibandronate is used to prevent and treat certain types of bone loss (osteoporosis). Osteoporosis causes bones to become thinner and break more easily. Your chance of developing osteoporosis increases after menopause, as you age, or if you take corticosteroid medications (such as prednisone) for long periods. This medication works by slowing bone loss to help maintain strong bones and reduce the risk of broken bones (fractures). Ibandronate belongs to a class of medications called bisphosphonates.

Mylan Pharmaceuticals Inc and privately held Apotex Inc and Orchid Healthcare are the manufacturers that have gained approval to make generic 150-milligram ibandronate tablets, the FDA said. Ibandronate is in a class of medications called bisphosphonates, which help increase bone mass and reduce the chance of having a spinal fracture. An estimated 10 million Americans over the age of 50 have osteoporosis, and another 34 million have low bone mass, according to the National Osteoporosis Foundation.

Availability of Generic Boniva

Generic Boniva is available in one strength -- Ibandronate 150 mg tablets. It is made by various manufacturers, including but not limited to:

  • Mylan Pharmaceuticals, Inc.
  • Apotex Corporation
  • Watson Laboratories, Inc.

Is Generic Ibandronate as Good as Boniva?

All generic medications must undergo certain tests to compare them to brand-name medications. The U.S. Food and Drug Administration (FDA) then looks at these tests to decide if the generics are equivalent to the brand-name medications and assigns a rating to each one. An "AB" rating means that the FDA has determined that a generic medication is equivalent to a brand-name medication. All of the versions of generic ibandronate currently available have an "AB" rating, meaning they should be equivalent to Boniva. However, generic medications are allowed to have different inactive ingredients than the brand-name medication. This might include fillers, dyes, or other ingredients that may cause problems for people with allergies or sensitivities.

Generic boniva approved for osteoporosis

(HealthDay) -- The first generic versions of the once-monthly osteoporosis drug Boniva (ibandronate) have been approved by the U.S. Food and Drug Administration. Osteoporosis, characterized by a thinning of the bones, is the most common type of bone disease, the agency said in a news release Monday. More common in postmenopausal women, it increases the risk of fracture, especially of the hip, spine and wrist.

More than 40 million people in the United States have the disease or are at significant risk for it, the FDA said. Approvals to produce generic Boniva have been granted to: Apotex Inc., Orchid Healthcare and Mylan Pharmaceuticals. Generic drugs are medically equivalent to the brand-name versions and are subject to the same quality standards, the agency said.

Has a generic version of Boniva been approved?

A generic version of Boniva has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available.The following products are equivalent to Boniva and have been approved by the FDA. 

Generic boniva injection

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