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High Barrier ANDA

In 1984, the US Congress passed the Hatch-Waxman Act, or the Drug Price Competition and Patent Term Restoration Act, that created a regulatory review pathway for generic drugs. Since then, the US FDA can use safety and therapeutic efficacy data previously reviewed and approved pharmaceutical product (original brand-name product or brand-name drugs) to approve a generic drug with bioequivalence to the originally developed brand-name drug.
When an applicant submits an abbreviated new drug application (ANDA), a reference drug patent listed in the Orange Book shall be taken as verification and describe a class of the patent of a product within the application. The following diagram illustrates certification for reference drug patents listed in the Orange Book when generic drug applicants submit an abbreviated new drug application (ANDA) to the FDA.

Orange Book

Handa engages superior integration of the following competitive advantages:
● Innovative Formulation Design and Development
Handa possesses the formulation and R&D capacity. In addition, Handa has the expertise in the development of analytical and validation methods.
● Patent Analysis and Legal Strategy
Handa is well experienced in fully analyzing the patent claims for each compound and in designing subsequent legal strategy.
● Design of Bioequivalent (BE) and Pharmacokinetic (PK) Clinical Studies
Handa is experienced in designing and executing cost-effective BE clinical studies under US FDA guidelines to demonstrate generic products are bioequivalent to branded products.
● Regulatory Affairs
Since Handa has filed several ANDAs with US FDA, we are well experienced in preparing and drafting ANDA application documents.