Patents & Exclusivities: The Blueprint for US Market Entry
About Course
Patents & Exclusivities: The Blueprint for US Market Entry is a focused online course that clarify the complex intellectual property landscape governing drug approval in the United States.
In the high-stakes world of US drug development, technical success in the lab is only half the battle; understanding the rules of the road for market entry is what ensures a product’s commercial viability.
This course provides a strategic roadmap through the intersection of Intellectual Property and FDA regulations. You will gain a clear, actionable understanding of:
- How patent and exclusivity work in USA?
- What are the types of FDA filings?
- How 505 (b) (2) filing strategy work?
- How NCE-1 filing strategy work?
- How 30 months stay works?
- How first-to-file 180 days exclusivity work?
Who Should Enroll:
- Intellectual Property Executives
- Regulatory Affairs Specialists
- Business Development Professionals
- Formulation Development Scientists
Whether you are a scientist or a regulatory professional planning a submission timeline, this course provides the blueprint needed to navigate the hurdles of the US market with confidence and precision.
Course Content
Module I
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The Hatch-Waxman Act
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Patents and Exclusivities in US Pharma Market
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Types of Patent Certifications
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Pre Assessment-1
Module II
Module III
Earn a certificate
Add this certificate to your resume to demonstrate your skills & increase your chances of getting noticed.
Student Ratings & Reviews
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