Details for New Drug Application (NDA): 206333

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NDA 206333 describes KYBELLA, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There are sixteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the KYBELLA profile page.

The generic ingredient in KYBELLA is deoxycholic acid. There are thirty-three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the deoxycholic acid profile page.

Summary for 206333

Tradename:	KYBELLA
Applicant:	Abbvie
Ingredient:	deoxycholic acid
Patents:	16

Pharmacology for NDA: 206333

Physiological Effect	Decreased Cell Membrane Integrity

Medical Subject Heading (MeSH) Categories for 206333

Cholagogues and Choleretics

Suppliers and Packaging for NDA: 206333

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333	NDA	Kythera Biopharmaceuticals Inc.	61168-101	61168-101-03	2 VIAL, GLASS in 1 CARTON (61168-101-03) / 2 mL in 1 VIAL, GLASS
KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333	NDA	Kythera Biopharmaceuticals Inc.	61168-101	61168-101-04	4 VIAL, GLASS in 1 CARTON (61168-101-04) / 2 mL in 1 VIAL, GLASS (61168-101-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	20MG/2ML (10MG/ML)
Approval Date:	Apr 29, 2015	TE:	AP	RLD:	Yes
Patent:	⤷ Get Started Free	Patent Expiration:	Mar 2, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Get Started Free	Patent Expiration:	Feb 17, 2032	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	IMPROVEMENT IN THE APPEARANCE OF MODERATE TO SEVERE CONVEXITY OR FULLNESS ASSOCIATED WITH SUBMENTAL FAT IN ADULTS BY MEANS OF REDUCING SUBMENTAL FAT VOLUME AS DESCRIBED IN THE APPROVED LABELING
Patent:	⤷ Get Started Free	Patent Expiration:	Dec 10, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD FOR REDUCTION OF SUBMENTAL FAT

Expired US Patents for NDA 206333

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	⤷ Get Started Free	⤷ Get Started Free
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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