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Last Updated: June 27, 2022

Regulatory Exclusivity: NEW INDICATION


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Drugs with New Indication Regulatory Exclusivity

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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Exclusivity Expiration Patented / Exclusive Use
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-001 Apr 25, 2016 RX Yes No See Plans and Pricing TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-002 Apr 25, 2016 RX Yes No See Plans and Pricing TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-003 Apr 25, 2016 RX Yes Yes See Plans and Pricing TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 RX Yes Yes See Plans and Pricing TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS, A SYMPTOM OF VULVAR AND VAGINAL ATROPHY, DUE TO MENOPAUSE
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-001 Sep 22, 2015 RX Yes No See Plans and Pricing TREATMENT OF ADULT PATIENTS WITH METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA PREVIOUSLY TREATED WITH AT LEAST TWO PRIOR LINES OF CHEMOTHERAPY, AND IF APPROPRIATE, HER2/NEU-TARGETED THERAPY
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 RX Yes Yes See Plans and Pricing TREATMENT OF ADULT PATIENTS WITH METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA PREVIOUSLY TREATED WITH AT LEAST TWO PRIOR LINES OF CHEMOTHERAPY, AND IF APPROPRIATE, HER2/NEU-TARGETED THERAPY
Astrazeneca Ab QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-001 Feb 27, 2017 RX Yes Yes See Plans and Pricing EXPANDED INDICATION FOR USE AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
>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
Colorcon
Harvard Business School
Mallinckrodt
Express Scripts
Johnson and Johnson

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