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Generated: October 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206333

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NDA 206333 describes KYBELLA, which is a drug marketed by Kythera Biopharms and is included in one NDA. It is available from one supplier. There are fourteen 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:Kythera Biopharms
Ingredient:deoxycholic acid
Patents:14
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 206333
Generic Entry Date for 206333*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS

*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: 206333
Medical Subject Heading (MeSH) Categories for 206333
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 61168-101-04 4 VIAL, GLASS in 1 CARTON (61168-101-04) > 2 mL in 1 VIAL, GLASS (61168-101-01)
KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333 NDA Kythera Biopharmaceuticals Inc. 61168-101 61168-101-94 4 VIAL, GLASS in 1 CARTON (61168-101-94) > 2 mL in 1 VIAL, GLASS (61168-101-91)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength20MG/2ML (10MG/ML)
Approval Date:Apr 29, 2015TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Dec 10, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR REDUCTION OF SUBMENTAL FAT
Patent:➤ Try a Free TrialPatent Expiration:Dec 10, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR REDUCTION OF SUBMENTAL FAT
Patent:➤ Try a Free TrialPatent Expiration:Mar 2, 2030Product Flag?YSubstance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Deloitte
Dow
Citi
US Army
AstraZeneca
Cerilliant
Moodys
Accenture

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