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Pharma: Regulatory Milestones Tracker

GlobalData’s Regulatory Milestones Tracker provides a comprehensive and analytical view of constraining patent/drug expiry for marketed & pipeline drugs in the US, Europe, Japan, and China. Our database provides insight into regulatory designations such as Orphan Drug status, several Accelerated Approval Pathways, exclusivity data, and GlobalData also tracks Prescription Drug User Fee Act (PDUFA) date and Para IV filings, ensuring competitive analysis of entire landscape.

We track over 60,000+ sources as part of our curated secondary research program.

Data Characteristics

Launch Year: 2015
Historical Start Date: Drug Expiry: 1995; Review Designations: 1984
Data Coverage: Drug Expiry: 8,083 Drugs; Review Designations: 5,076
Regional Coverage: Europe/Middle East/Africa; Asia Pacific; North America
Country Coverage: Drug Expiry: 3 (US, Europe & Japan); Review Designations: 5 (US, Europe, United Kingdom, China & Japan)
Company Coverage: Drug Expiry: 3,312; Review Designations: 2,717
Total Companies with Tickers: Drug Expiry: 1,090; Review Designations: 830
Collection Time: Daily
Delivery Methods: API, Cloud


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