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Generated: November 14, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208794

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NDA 208794 describes XERMELO, which is a drug marketed by Lexicon Pharms Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the XERMELO profile page.

The generic ingredient in XERMELO is telotristat etiprate. One supplier is listed for this compound. Additional details are available on the telotristat etiprate profile page.
Summary for 208794
Tradename:XERMELO
Applicant:Lexicon Pharms Inc
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
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)

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:➤ Sign UpPatent Expiration:Dec 11, 2027Product Flag?Substance Flag?YDelist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.