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Last Updated: September 16, 2021

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Regulatory Exclusivity Expiring in 2021


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Drugs with Regulatory Exclusivity Expiring in 2021

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Exclusivity Expiration Patented / Exclusive Use
Novartis Pharms Corp ENTRESTO sacubitril; valsartan TABLET;ORAL 207620-001 Jul 7, 2015 RX Yes No ⤷  Free Forever Trial PEDIATRIC EXCLUSIVITY
Novartis Pharms Corp ENTRESTO sacubitril; valsartan TABLET;ORAL 207620-002 Jul 7, 2015 RX Yes No ⤷  Free Forever Trial PEDIATRIC EXCLUSIVITY
Novartis Pharms Corp ENTRESTO sacubitril; valsartan TABLET;ORAL 207620-003 Jul 7, 2015 RX Yes Yes ⤷  Free Forever Trial PEDIATRIC EXCLUSIVITY
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-001 May 29, 2013 RX Yes No ⤷  Free Forever Trial TRAMETINIB IN COMBO WITH DABRAFENIB FOR TX. OF PTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST. THIS INDICATION IS BASED ON THE DEMONSTRATION OF DURABLE RESPONSE RATE
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-002 May 29, 2013 DISCN Yes No ⤷  Free Forever Trial TRAMETINIB IN COMBO WITH DABRAFENIB FOR TX. OF PTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST. THIS INDICATION IS BASED ON THE DEMONSTRATION OF DURABLE RESPONSE RATE
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-003 May 29, 2013 RX Yes Yes ⤷  Free Forever Trial TRAMETINIB IN COMBO WITH DABRAFENIB FOR TX. OF PTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST. THIS INDICATION IS BASED ON THE DEMONSTRATION OF DURABLE RESPONSE RATE
>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:

McKesson
Merck
Dow
Harvard Business School
Boehringer Ingelheim
Moodys

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