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Last Updated: March 4, 2024

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
Bayer Hlthcare MIRENA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 021225-001 Dec 6, 2000 RX Yes Yes ⤷  Try a Trial DOSING REGIMEN EXTENDING THE CONTRACEPTION USE FROM 5 YEARS TO UP TO 6 YEARS
Puma Biotech NERLYNX neratinib maleate TABLET;ORAL 208051-001 Jul 17, 2017 RX Yes Yes ⤷  Try a Trial NEW DOSING REGIMEN FOR THE PREVENTION AND MANAGEMENT OF NERATINIB‐ASSOCIATED DIARRHEA
Gilead Sciences Inc VEKLURY remdesivir POWDER;INTRAVENOUS 214787-001 Oct 22, 2020 RX Yes Yes ⤷  Try a Trial 3-DAY DOSING REGIMEN FOR THE TREATMENT OF COVID-19 IN ADULTS AND PEDIATRIC PATIENTS (>12 YEARS AND WEIGHING AT LEAST 40 KG) WITH POSITIVE RESULTS OF DIRECT SARS-COV-2 VIRAL TESTING, WHO ARE NOT HOSPITALIZED AND HAVE MILD-TO-MODERATE COVID-19, AND ARE AT HIGH RISK FOR PROGRESSION TO SEVERE COVID-19, INCLUDING HOSPITALIZATION OR DEATH
Gilead Sciences Inc VEKLURY remdesivir SOLUTION;INTRAVENOUS 214787-002 Oct 22, 2020 RX Yes Yes ⤷  Try a Trial 3-DAY DOSING REGIMEN FOR THE TREATMENT OF COVID-19 IN ADULTS AND PEDIATRIC PATIENTS (>12 YEARS AND WEIGHING AT LEAST 40 KG) WITH POSITIVE RESULTS OF DIRECT SARS-COV-2 VIRAL TESTING, WHO ARE NOT HOSPITALIZED AND HAVE MILD-TO-MODERATE COVID-19, AND ARE AT HIGH RISK FOR PROGRESSION TO SEVERE COVID-19, INCLUDING HOSPITALIZATION OR DEATH
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Exclusivity Expiration >Patented / Exclusive Use

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