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Details for New Drug Application (NDA): 208794
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NDA 208794 describes XERMELO, which is a drug marketed by Tersera and is included in one NDA. There are five patents protecting this drug. Additional details are available on the XERMELO profile page.
The generic ingredient in XERMELO is telotristat etiprate. Additional details are available on the telotristat etiprate profile page.
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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