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Last Updated: April 24, 2024

Details for New Drug Application (NDA): 215498

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NDA 215498 describes BYLVAY, which is a drug marketed by Ipsen and is included in one NDA. It is available from two suppliers. There are eleven patents protecting this drug. Additional details are available on the BYLVAY profile page.

The generic ingredient in BYLVAY is odevixibat. Two suppliers are listed for this compound. Additional details are available on the odevixibat profile page.

Summary for 215498

Tradename:	BYLVAY
Applicant:	Ipsen
Ingredient:	odevixibat
Patents:	11

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 215498

Generic Entry Date for 215498^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial Dosage: CAPSULE, PELLETS;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: 215498

Mechanism of Action	Ileal Bile Acid Transporter Inhibitors

Suppliers and Packaging for NDA: 215498

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498	NDA	Ipsen Biopharmaceuticals, Inc.	15054-3301	15054-3301-1	1 BOTTLE in 1 CARTON (15054-3301-1) / 30 CAPSULE, COATED PELLETS in 1 BOTTLE
BYLVAY	odevixibat	CAPSULE;ORAL	215498	NDA	Ipsen Biopharmaceuticals, Inc.	15054-3301	15054-3301-1	1 BOTTLE in 1 CARTON (15054-3301-1) / 30 CAPSULE, COATED PELLETS in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, PELLETS;ORAL			Strength	0.2MG
Approval Date:	Jul 20, 2021	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jul 20, 2026
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:	Jun 13, 2026
Regulatory Exclusivity Use:	TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS)
Regulatory Exclusivity Expiration:	Jun 13, 2030
Regulatory Exclusivity Use:	TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS)

Expired US Patents for NDA 215498

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-002	Jul 20, 2021	⤷ Try a Trial	⤷ Try a Trial
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-001	Jul 20, 2021	⤷ Try a Trial	⤷ Try a Trial
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-003	Jul 20, 2021	⤷ Try a Trial	⤷ Try a Trial
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-004	Jul 20, 2021	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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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 verification 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.