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Last Updated: October 26, 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
Akcea Theraps TEGSEDI inotersen sodium SOLUTION;SUBCUTANEOUS 211172-001 Oct 5, 2018 RX Yes Yes   Start Trial   Start Trial Y
Akcea Theraps TEGSEDI inotersen sodium SOLUTION;SUBCUTANEOUS 211172-001 Oct 5, 2018 RX Yes Yes   Start Trial   Start Trial Y
Akcea Theraps TEGSEDI inotersen sodium SOLUTION;SUBCUTANEOUS 211172-001 Oct 5, 2018 RX Yes Yes   Start Trial   Start Trial TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN AMYLOIDOSIS
Radius Health Inc TYMLOS abaloparatide SOLUTION;SUBCUTANEOUS 208743-001 Apr 28, 2017 RX Yes Yes   Start Trial   Start Trial METHOD OF TREATING POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE.
Janssen Biotech BALVERSA erdafitinib TABLET;ORAL 212018-003 Apr 12, 2019 RX Yes Yes   Start Trial   Start Trial TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA THAT HAS SUSCEPTIBLE FGFR3 OR FGFR2 GENETIC ALTERATIONS AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY
Janssen Biotech BALVERSA erdafitinib TABLET;ORAL 212018-002 Apr 12, 2019 RX Yes No   Start Trial   Start Trial TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA THAT HAS SUSCEPTIBLE FGFR3 OR FGFR2 GENETIC ALTERATIONS AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY
Janssen Biotech BALVERSA erdafitinib TABLET;ORAL 212018-001 Apr 12, 2019 RX Yes No   Start Trial   Start Trial TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA THAT HAS SUSCEPTIBLE FGFR3 OR FGFR2 GENETIC ALTERATIONS AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY
>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:

Dow
Medtronic
Colorcon
McKesson
Express Scripts
Johnson and Johnson

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