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Last Updated: May 20, 2022

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. It is available from two suppliers. There are five patents protecting this drug. Additional details are available on the XERMELO profile page.

The generic ingredient in XERMELO is telotristat etiprate. Two suppliers are listed for this compound. Additional details are available on the telotristat etiprate profile page.
Summary for 208794
Tradename:XERMELO
Applicant:Tersera
Ingredient:telotristat etiprate
Patents:5
DrugPatentWatch® Estimated 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
Suppliers and Packaging for NDA: 208794
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XERMELO telotristat etiprate TABLET;ORAL 208794 NDA Lexicon Pharmaceuticals, Inc. 70183-125 70183-125-84 4 BOX in 1 CASE (70183-125-84) > 7 BLISTER PACK in 1 BOX (70183-125-21) > 3 TABLET in 1 BLISTER PACK (70183-125-03)
XERMELO telotristat etiprate TABLET;ORAL 208794 NDA Lexicon Pharmaceuticals, Inc. 70183-125 70183-125-85 4 BOX in 1 CASE (70183-125-85) > 4 BLISTER PACK in 1 BOX (70183-125-22) > 21 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Feb 28, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 28, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Feb 28, 2024
Regulatory Exclusivity Use:TREATMENT OF CARCINOID SYNDROME DIARRHEA IN COMBINATION WITH SOMATOSTATIN ANALOG (SSA) THERAPY IN ADULTS INADEQUATELY CONTROLLED BY SSA THERAPY
Patent:See Plans and PricingPatent Expiration:Dec 11, 2027Product Flag?Substance Flag?YDelist Request?

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