The regulatory requirements for generic drugs include, but not limited to, same active ingredients, same dosage form, same route of administration, same strength, and same conditions of use compared to brand name drug product (RLD: reference listed drug).
In 1984, the Drug Price Competition and Patent Term Restoration Act (P.L. 98-417), was signed into law, which is now called “the Hatch-Waxman Act.” The Hatch-Waxman Act is intended to expedite and streamline FDA drug review and approvals for generic drugs including and patent litigation involving generic drugs.
According to the Hatch-Waxman Act, generic drug firms can file either one of two applications to obtain FDA approval of a generic drug: 1). An Abbreviated New Drug Application (ANDA); 2). 505(b)(2) Application. Under the Hatch-Waxman Act, there are certain market exclusivity periods for NDAs (non-patent based and patent based).
New chemical entity (NCE) exclusivity (5 years) is non-patent based. A generic drug firm is barred from filing an ANDA due to NCE exclusivity (5 years from the first NDA approval). However, a generic drug firm may file an ANDA with a Paragraph IV patent certification pursuant to the Hatch-Waxman Act, allowing a generic drug firm to challenge a brand name drug firm’s patent exclusivity for the RLD.
This seminar is intended to help industry better understand ANDA approval process pursuant to GDUFA. In particular, it is further intended to cover Paragraphs 1-4 certifications with major focus on Paragraph IV certifications.
At the end of this seminar, you should be able to understand regulatory requirements for ANDA filings with focus on paragraph IV (para IV) certifications.
Areas Covered in the Session :
- Laws and Regulations
- Hatch-Waxman Act
- Orange Book
- Regulatory Requirements for Generic ANDA and 505(b)2 Filings
- Patent-Based and Non-Patent Based Exclusivities
- Patent Certifications
- Paragraph IV Patent Certifications
- Reference Listed Drug (RLD)
- ANDAs Containing a Paragraph IV Certification
- Patent Litigations
- PASS-IT Recommendations: Best Practices
Who Will Benefit:
- Compliance Officers
- Regulatory Affairs
- Clinical Affairs
- Quality Assurance
- Anyone Interested in the FDA Drug Review and Approval Processes