Tag: Hatch-Waxman Act

8 Jan

Written by :
Zachary Kent

Categories :
Medications

First Generic vs Authorized Generic: How Market Entry Timing Changes Everything

First Generic vs Authorized Generic: How Market Entry Timing Changes Everything

First generics and authorized generics may look the same, but their timing and origin change everything. Learn how brand companies use authorized generics to undercut independent generic manufacturers and limit price savings.

3 Jan

Written by :
Zachary Kent

Categories :
Medications

How Brand Manufacturers Produce Their Own Generic Versions

How Brand Manufacturers Produce Their Own Generic Versions

Brand manufacturers create authorized generics-identical copies of their own drugs-to retain market share after patents expire. Learn how they're made, why they cost more than regular generics, and what this means for your prescriptions.

28 Dec

Written by :
Zachary Kent

Categories :
Medications

ANDA Process: Legal Requirements for Generic Drug Approval in the U.S.

ANDA Process: Legal Requirements for Generic Drug Approval in the U.S.

Learn the legal requirements for generic drug approval in the U.S. through the FDA's ANDA process, including bioequivalence standards, patent rules, manufacturing guidelines, and key challenges manufacturers face.