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Serving leading biopharmaceutical companies globally:

Dow
Harvard Business School
McKesson
Johnson and Johnson
AstraZeneca
Boehringer Ingelheim

Last Updated: October 19, 2019

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Regulatory Exclusivity: NEW PATIENT POPULATION

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Drugs with New Patient Population 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
Teva Branded Pharm PROAIR RESPICLICK albuterol sulfate POWDER, METERED;INHALATION 205636-001 Mar 31, 2015 RX Yes Yes   Start Trial NEW PATIENT POPULATION
Perrigo Pharma Intl ENTOCORT EC budesonide CAPSULE;ORAL 021324-001 Oct 2, 2001 AB RX Yes Yes   Start Trial NEW PATIENT POPULATION
Allergan Sales Llc TEFLARO ceftaroline fosamil POWDER;INTRAVENOUS 200327-001 Oct 29, 2010 RX Yes No   Start Trial NEW PATIENT POPULATION
Allergan Sales Llc TEFLARO ceftaroline fosamil POWDER;INTRAVENOUS 200327-002 Oct 29, 2010 RX Yes Yes   Start Trial NEW PATIENT POPULATION
>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:

Mallinckrodt
McKinsey
Moodys
Baxter
AstraZeneca
Express Scripts

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