Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Colorcon
Moodys
Harvard Business School
Merck
McKinsey

Last Updated: October 19, 2019

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Regulatory Exclusivity: MISCELLANEOUS

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Drugs with Miscellaneous Regulatory Exclusivity

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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Exclusivity Expiration Patented / Exclusive Use
Glaxo Grp England INCRUSE ELLIPTA umeclidinium bromide POWDER;INHALATION 205382-001 Apr 30, 2014 RX Yes Yes   Start Trial UPDATES TO THE CLINICAL TRIALS SECTION OF THE LABELING TO INCLUDE RESULTS OF STUDIES PERFORMED TO EVALUATE THE BENEFIT OF ADDING INCRUSE ELLIPTA TO PATIENTS WHO ARE ON BACKGROUND THERAPY WITH BREO ELLIPTA AND ADVAIR DISKUS
Janssen Prods OLYSIO simeprevir sodium CAPSULE;ORAL 205123-001 Nov 22, 2013 DISCN Yes No   Start Trial UPDATES TO LABELING WITH RESULTS TO THE TIGER CLINICAL TRIAL
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-004 Aug 26, 2015 RX Yes Yes   Start Trial INFORMATION ADDED TO CLINICAL STUDIES SECTION OF THE LABELING REGARDING INITIAL COMBINATION THERAPY OF EMPAGLIFLOZIN WITH METFORMIN
Boehringer Ingelheim JARDIANCE empagliflozin TABLET;ORAL 204629-002 Aug 1, 2014 RX Yes Yes   Start Trial INFORMATION ADDED TO CLINICAL STUDIES SECTION OF THE LABELING REGARDING INITIAL COMBINATION THERAPY OF EMPAGLIFLOZIN WITH METFORMIN
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-001 Aug 26, 2015 RX Yes No   Start Trial INFORMATION ADDED TO CLINICAL STUDIES SECTION OF THE LABELING REGARDING INITIAL COMBINATION THERAPY OF EMPAGLIFLOZIN WITH METFORMIN
>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
McKesson
Merck
Johnson and Johnson
Mallinckrodt
Dow

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