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Last Updated: October 24, 2020

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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
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013 AB RX Yes No   Start Trial NEW PATIENT POPULATION
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-001 Oct 28, 2010 AB RX Yes Yes   Start Trial NEW PATIENT POPULATION
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes   Start Trial NEW PATIENT POPULATION
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-002 Oct 28, 2010 AB RX Yes No   Start Trial NEW PATIENT POPULATION
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 RX Yes Yes   Start Trial NEW PATIENT POPULATION
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-003 Dec 7, 2011 AB RX Yes No   Start Trial NEW PATIENT POPULATION
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 RX Yes No   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:

Colorcon
Harvard Business School
Medtronic
Mallinckrodt
Baxter
Merck

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