About NCE Grid
Welcome to the NCE Grid
Your Go-To Platform for Tracking NCE-1 & aBLA Filings
Stay ahead in generic drug development with the NCE Grid. It is a powerful platform designed to help you monitor, analyze, and stay tuned to the real-time filing information about the latest New Chemical Entity Minus 1 (NCE-1) and aBLA filings and data exclusivity expiries.
What is NCE-1 Date?
NCE-1 date is exactly one year before a new chemical entity (NCE) drug’s 5-year exclusivity period expires. It is the earliest date that generic drug companies can file an Abbreviated New Drug Application (ANDA) with paragraph IV to challenge the patents.
Data Exclusivity Expiry & Market Exclusivity Expiry
Data exclusivity expiry for biologics
It is the period during which biosimilar applications cannot be submitted to the FDA, effectively blocking biosimilar submissions for the first 4 years.
Market Exclusivity expiry for biologics
Market exclusivity is the period during which the FDA cannot approve any biosimilar to the reference biologic, giving the innovator product 12 years of protected time on the market without biosimilar competition.
Why use NCE Grid?
Real-Time Alerts
Stay updated on the latest NCE-1/aBLA filings
Comprehensive Database
Access detailed insights on the current NCE-1/aBLA filings
Competitive Intelligence
Track market trends, leading players, and projected sales impact
Accelerate Your Market Access
The NCE Grid helps you streamline regulatory planning, gain strategic insights, and make faster, more informed decisions — all through a single, easy-to-use dashboard.
Contact Us for more details.
