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:

Merck
Boehringer Ingelheim
Express Scripts
Harvard Business School
Mallinckrodt
Dow

Last Updated: October 17, 2019

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Regulatory Exclusivity: NEW DOSING SCHEDULE

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Drugs with New Dosing Schedule Regulatory Exclusivity

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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Exclusivity Expiration Patented / Exclusive Use
Allergan Sales Llc DALVANCE dalbavancin hydrochloride POWDER;INTRAVENOUS 021883-001 May 23, 2014 RX Yes Yes   Start Trial ADDITION OF A 1500MG-SINGLE-DOSE REGIMEN FOR THE TREATMENT OF ADULT PATIENTS WITH ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS (ABSSI)
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 RX Yes No   Start Trial UPDATED INFORMATION ADDED TO THE DOSAGE AND ADMINISTRATION SECTION OF THE LABELING PROVIDING DOSAGE RECOMMENDATIONS FOR INTERRUPTIONS AND DISCONTINUATION OF THERAPY
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013 RX Yes Yes   Start Trial DOSING INFORMATION ADDED TO THE LABELING PROVIDING INFORMATION ON TRANSITIONING FROM SUBCUTANEOUS OR INTRAVENOUS ROUTES OF ADMINISTRATION OF TREPROSTINIL
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-001 Dec 20, 2013 RX Yes No   Start Trial UPDATED INFORMATION ADDED TO THE DOSAGE AND ADMINISTRATION SECTION OF THE LABELING PROVIDING DOSAGE RECOMMENDATIONS FOR INTERRUPTIONS AND DISCONTINUATION OF THERAPY
>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:

Johnson and Johnson
Medtronic
Merck
Colorcon
Boehringer Ingelheim
Mallinckrodt

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