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.
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 Loss of Exclusivity (LOE) 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 |
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 | 70183-125-85 | 4 BOX in 1 CASE (70183-125-85) / 4 BLISTER PACK in 1 BOX (70183-125-22) / 21 TABLET in 1 BLISTER PACK |
| 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: | RX | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE | ||||
| Approval Date: | Feb 28, 2017 | TE: | RLD: | Yes | |||||
| 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: | ⤷ Try a Trial | Patent Expiration: | Dec 11, 2027 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 28, 2031 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | THE TREATMENT OF CARCINOID SYNDROME DIARRHEA IN COMBINATION WITH SOMATOSTATIN ANALOG (SSA) THERAPY IN ADULTS INADEQUATELY CONTROLLED BY SSA THERAPY | ||||||||
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