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Last Updated: July 4, 2020

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Regulatory Exclusivity: NEW COMBINATION


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Drugs with New Combination Regulatory Exclusivity

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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Exclusivity Expiration Patented / Exclusive Use
Allergan DALVANCE dalbavancin hydrochloride POWDER;INTRAVENOUS 021883-001 May 23, 2014 RX Yes Yes   Start Trial NEW CHEMICAL ENTITY
Cubist Pharms Llc SIVEXTRO tedizolid phosphate TABLET;ORAL 205435-001 Jun 20, 2014 RX Yes Yes   Start Trial NEW CHEMICAL ENTITY
Cubist Pharms Llc SIVEXTRO tedizolid phosphate POWDER;INTRAVENOUS 205436-001 Jun 20, 2014 RX Yes Yes   Start Trial NEW CHEMICAL ENTITY
Melinta Therap ORBACTIV oritavancin diphosphate POWDER;INTRAVENOUS 206334-001 Aug 6, 2014 RX Yes Yes   Start Trial NEW CHEMICAL ENTITY
>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:

Dow
Mallinckrodt
Merck
AstraZeneca
Moodys
Baxter

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