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Bicalutamide is a nonsteroidal anti-androgen with actions and uses similar to those of flutamide. Bicalutamide is used as an antihormonal agent in the treatment of metastatic prostatic carcinoma. Unlike flutamide, bicalutamide has a long plasma half-life that allows once-daily dosing compared with three times daily for flutamide. In addition, bicalutamide is more selective for the peripheral androgen receptor and has less activity at the central androgen receptor on the hypothalamic-pituitary axis.
Bicalutamide’s innovator is Astra Zeneca-Global and is known by the brand name Casodex.
Bicalutamide competitively inhibits the action of androgens by binding to cytoplasmic androgen receptors, primarily in the prostate. There is some central androgen blockade but not as much as flutamide. Serum LH and testosterone are not elevated because of bicalutamide's central activity. Bicalutamide exists as a racemic mixture, with the activity being exhibited by the R-enantiomer only. Prostatic carcinoma is often androgen sensitive and responds to treatments that counteract the effects of androgens or remove their source.
When used with a gonadorelin analogue in the palliative treatment of advanced prostatic cancer the usual dose is 50 mg daily.
The FDA approved bicalutamide on October 4, 1995, for the treatment of advanced prostatic carcinoma.
General data on Bicalutamide Active Pharmaceutical Ingredient
TAPI's Bicalutamide Active Pharmaceutical Ingredient is produced in Teva Pharmaceutical Works Limited in Debrecen, Hungary.
Bicalutamide is produced by TAPI by Organic synthesis and is considered to be medium volume Active Pharmaceutical Ingredient.
TAPI's Bicalutamide has unique features that might be an advantage for final dosage development. TAPI has filed several patent applications for Bicalutamide. Please, see table below for issued patents and pending applications.
TAPI's Active Patent Applications
2008 Available DMF: U.S. DMF, EU CTD, Japan DMF, International DMF, Russia DMF and LATAM DMF.
TAPI provides full service on this product and other APIs in our portfolio. Our local sales offices provide full information on our product, regulatory compliance and documentation on Bicalutamide. Contact us today for further inquiries and samples and kilograms availability information for TAPI's Bicalutamide.
Product exploitation, including development, sales and offer for sale are performed where permissible by patent law. This presentation is not and should not constitute an offer for sale in territories where it is not permitted by law. In USA Products that Currently on Patent are available for R&D Use in Accordance with 35 USC §271 (e) (1).
*TAPI stands for Teva's Active Pharmaceutical Ingredients
