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Last Updated: September 23, 2021

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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
Bausch LUZU luliconazole CREAM;TOPICAL 204153-001 Nov 14, 2013 RX Yes Yes ⤷  Try it Free NEW PATIENT POPULATION
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-003 Dec 7, 2011 AB RX Yes No ⤷  Try it Free NEW PATIENT POPULATION
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-001 Oct 28, 2010 AB RX Yes Yes ⤷  Try it Free NEW PATIENT POPULATION
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013 AB RX Yes No ⤷  Try it Free NEW PATIENT POPULATION
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-002 Oct 28, 2010 AB RX Yes No ⤷  Try it Free NEW PATIENT POPULATION
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-003 Mar 22, 2018 RX Yes No ⤷  Try it Free 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:

Boehringer Ingelheim
AstraZeneca
Moodys
McKinsey
Dow
Johnson and Johnson

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