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Serving leading biopharmaceutical companies globally:

Mallinckrodt
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Harvard Business School
Moodys

Last Updated: July 5, 2020

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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
Epi Hlth RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552-001 Jan 18, 2017 RX Yes Yes   Start Trial NEW PRODUCT
Teva Pharm ARMONAIR RESPICLICK fluticasone propionate POWDER;INHALATION 208798-003 Jan 27, 2017 DISCN Yes No   Start Trial NEW PRODUCT
Teva Pharm AIRDUO RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-003 Jan 27, 2017 RX Yes Yes   Start Trial NEW PRODUCT
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-001 Oct 28, 2010 AB 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:

Merck
Colorcon
Express Scripts
Johnson and Johnson
Harvard Business School
McKinsey

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