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Serving leading biopharmaceutical companies globally:

McKesson
Harvard Business School
Johnson and Johnson
Baxter
Boehringer Ingelheim
Moodys

Last Updated: October 23, 2019

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Regulatory Exclusivity: NEW PRODUCT

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Drugs with New Product Regulatory Exclusivity

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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Exclusivity Expiration Patented / Exclusive Use
Septodont Holding ORAVERSE phentolamine mesylate INJECTABLE;INJECTION 022159-001 May 9, 2008 RX Yes Yes   Start Trial NEW PATIENT POPULATION
Sun Pharma Global BROMSITE bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 206911-001 Apr 8, 2016 RX Yes Yes   Start Trial NEW PRODUCT
Avedro Inc PHOTREXA VISCOUS IN DEXTRAN 20% riboflavin 5'-phosphate sodium SOLUTION/DROPS;OPHTHALMIC 203324-002 Apr 15, 2016 RX Yes Yes   Start Trial NEW PRODUCT
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Exclusivity Expiration >Patented / Exclusive Use

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Serving leading biopharmaceutical companies globally:

Express Scripts
McKinsey
Baxter
Colorcon
AstraZeneca
Boehringer Ingelheim

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