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Last Updated: September 25, 2020

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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Parapro Llc NATROBA spinosad SUSPENSION;TOPICAL 022408-001 Jan 18, 2011 RX Yes Yes   Start Trial   Start Trial Y TOPICAL TREATMENT OF HEAD LICE INFESTATION IN PATIENTS FOUR (4) YEARS OF AGE AND OLDER
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-003 Jun 27, 2006 AP RX Yes Yes   Start Trial   Start Trial Y
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-002 Mar 16, 2005 AP RX Yes Yes   Start Trial   Start Trial Y
Nabriva XENLETA lefamulin acetate SOLUTION;INTRAVENOUS 211673-001 Aug 19, 2019 RX Yes Yes   Start Trial   Start Trial Y Y TREATMENT OF ADULTS WITH COMMUNITY-ACQUIRED BACTERIAL PNEUMONIA CAUSED BY SUSCEPTIBLE MICROORGANISMS
Sucampo Pharma Llc RESCULA unoprostone isopropyl SOLUTION/DROPS;OPHTHALMIC 021214-001 Aug 3, 2000 DISCN Yes No   Start Trial   Start Trial THE LONG TERM TREATMENT OF PROPHYLACTIC MANAGEMENT OF OCULAR HYPERTENSION AND GLAUCOMA
Nabriva XENLETA lefamulin acetate TABLET;ORAL 211672-001 Aug 19, 2019 RX Yes Yes   Start Trial   Start Trial Y Y TREATMENT OF ADULTS WITH COMMUNITY-ACQUIRED BACTERIAL PNEUMONIA CAUSED BY SUSCEPTIBLE MICROORGANISMS
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use

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Serving leading biopharmaceutical companies globally:

Harvard Business School
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