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Details for New Drug Application (NDA): 208794
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The generic ingredient in XERMELO is telotristat etiprate. Additional details are available on the telotristat etiprate profile page.
Summary for 208794
Tradename: | XERMELO |
Applicant: | Tersera |
Ingredient: | telotristat etiprate |
Patents: | 5 |
Generic Entry Opportunity Date for 208794
Generic Entry Date for 208794*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 208794
Mechanism of Action | Tryptophan Hydroxylase Inhibitors |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE | ||||
Approval Date: | Feb 28, 2017 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Feb 28, 2022 | ||||||||
Regulatory Exclusivity Use: | |||||||||
Regulatory Exclusivity Expiration: | Feb 28, 2024 | ||||||||
Regulatory Exclusivity Use: | |||||||||
Patent: | Start Trial | Patent Expiration: | Dec 11, 2027 | Product Flag? | Substance Flag? | Y | Delist Request? |
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