Glossary of Clinical Terms

ANDA : An abbreviated new drug application (ANDA) is a written application for a generic drug that is submitted to the FDA for review and potential approval of an existing licensed medication or approved drug.

The generic manufacturer filing an ANDA only needs to prove that their product is comparable to that of the innovator drug. After ANDA is approved, an associate individual could market the drug product to supply a secure, effective, and different product at a lower price than the proprietary drug. The FDA’s Approved Drug Products with Therapeutic Equivalence (Orange Book) list will consist of all approved drugs, both innovator and generic.

Why ANDA?

✅To reduce the pricing of a drug product
✅ In order to expedite the process of product development
✅To boost the bioavailability of the drug
✅To facilitate wider and faster access to generic drug products

ANDA Certificate Clauses:

1. Paragraph I: When a drug candidate’s patent is not submitted (no patent in the Orange Book). The FDA can quickly approve ANDA.
2. Paragraph II: Whenever the patent expires, the FDA can quickly approve the ANDA.
3. Paragraph III: The FDA can approve ANDA after the specific date that the drug’s patent is set to expire.
4. Paragraph IV: This is applicable when the patent is invalid or non-infringed by the generic applicant. Generic applicants can then file a notice to the patent holder.