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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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, PELLETS;ORAL	215498-001	Jul 20, 2021	⤷ Sign Up	⤷ Sign Up
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-002	Jul 20, 2021	⤷ Sign Up	⤷ Sign Up
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-003	Jul 20, 2021	⤷ Sign Up	⤷ Sign Up
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-004	Jul 20, 2021	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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