Dosage forms comprising abiraterone acetate
AssigneeJanssen Pharmaceutica NV
InventorsJurgen Mensch, Urbain Alfons C. Delaet, Philip Erna H. Heyns, Claire Elisabeth Balmain
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AssigneeJanssen Pharmaceutica NV
InventorsJurgen Mensch, Urbain Alfons C. Delaet, Philip Erna H. Heyns, Claire Elisabeth Balmain
Estimating the term…
Disclosed are solid oral dosage forms comprising about 500 mg of abiraterone acetate; and a film coating that is positioned on an outer surface of said dosage form, wherein the dosage forms are bioequivalent to 250 mg ZYTIGA® abiraterone acetate dosage forms when administered orally on an equivalent dose basis. Also disclosed are approved drug products comprising 500 mg abiraterone acetate, as are methods of treatment, of reducing pill burden, and of providing pharmaceutical regimen that is bioequivalent to 250 mg ZYTIGA® abiraterone acetate dosage forms when administered orally on an equivalent dose basis.
A solid oral dosage form comprising about 500 mg of abiratirone acetate and having a dissolution profile characterized by one or more of features (a)-(f):
A solid oral dosage form comprising about 500 mg of abiratirone acetate and having a dissolution profile characterized by one or more of features (a)-(f):
A solid oral dosage form comprising:
A method of selling a drug product comprising abiraterone acetate, said method comprising selling such drug product, wherein a drug product label for a reference listed drug for such drug product includes instructions for treating non-metastatic castration resistant prostate cancer.
A method of offering for sale a drug product comprising abiraterone acetate, said method comprising offering for sale such drug product, wherein a drug product label for a reference listed drug for such drug product includes instructions for treating non-metastatic castration resistant prostate cancer.
A method of selling a drug product comprising abiraterone acetate, said method comprising selling such drug product, wherein the drug product label for a reference listed drug for such drug product comprises metastasis free survival data.
A method of offering for sale a drug product comprising abiraterone acetate, said method comprising offering for sale such drug product, wherein the drug product label for a reference listed drug for such drug product comprises metastasis free survival data.
An approved drug product comprising 500 mg abiraterone acetate.
Dependencies are inferred from the claim text.