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Last Updated: July 4, 2020

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Regulatory Exclusivity Expiring in 2023


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Drugs with Regulatory Exclusivity Expiring in 2023

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Exclusivity Expiration Patented / Exclusive Use
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes   Start Trial TREATMENT OF SPINAL MUSCULAR ATROPHY IN PEDIATRIC AND ADULT PATIENTS
Clovis Oncology Inc RUBRACA rucaparib camsylate TABLET;ORAL 209115-003 May 1, 2017 RX Yes No   Start Trial AS MONOTHERAPY FOR THE TREATMENT OF PATIENTS WITH DELETERIOUS BRCA MUTATION (GERMLINE AND/OR SOMATIC) ASSOCIATED ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH TWO OR MORE CHEMOTHERAPIES
Clovis Oncology Inc RUBRACA rucaparib camsylate TABLET;ORAL 209115-001 Dec 19, 2016 RX Yes No   Start Trial AS MONOTHERAPY FOR THE TREATMENT OF PATIENTS WITH DELETERIOUS BRCA MUTATION (GERMLINE AND/OR SOMATIC) ASSOCIATED ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH TWO OR MORE CHEMOTHERAPIES
Clovis Oncology Inc RUBRACA rucaparib camsylate TABLET;ORAL 209115-002 Dec 19, 2016 RX Yes Yes   Start Trial AS MONOTHERAPY FOR THE TREATMENT OF PATIENTS WITH DELETERIOUS BRCA MUTATION (GERMLINE AND/OR SOMATIC) ASSOCIATED ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH TWO OR MORE CHEMOTHERAPIES
Shire Dev Llc MOTEGRITY prucalopride succinate TABLET;ORAL 210166-002 Dec 14, 2018 RX Yes Yes   Start Trial NEW CHEMICAL ENTITY
Shire Dev Llc MOTEGRITY prucalopride succinate TABLET;ORAL 210166-001 Dec 14, 2018 RX Yes No   Start Trial NEW CHEMICAL ENTITY
>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:

Express Scripts
Moodys
Medtronic
McKinsey
Harvard Business School
Boehringer Ingelheim

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