BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Deloitte
Colorcon
McKinsey
US Army
Medtronic
Covington
Farmers Insurance
Harvard Business School
Argus Health

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208224

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NDA 208224 describes KYLEENA, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the KYLEENA profile page.

The generic ingredient in KYLEENA is levonorgestrel. There are twenty drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.
Summary for 208224
Tradename:KYLEENA
Applicant:Bayer Hlthcare
Ingredient:levonorgestrel
Patents:3
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 208224
Ingredient-typeProgesterone Congeners
Physiological EffectInhibit Ovum Fertilization
Medical Subject Heading (MeSH) Categories for 208224
Suppliers and Packaging for NDA: 208224
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KYLEENA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 208224 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-424 50419-424-71 1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-71)
KYLEENA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 208224 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-424 50419-424-08 1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-08)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INTRAUTERINE DEVICE;INTRAUTERINEStrength19.5MG
Approval Date:Sep 16, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 16, 2019
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ SubscribePatent Expiration:Nov 13, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:➤ SubscribePatent Expiration:Sep 16, 2029Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

UBS
US Army
QuintilesIMS
Baxter
US Department of Justice
Citi
Cantor Fitzgerald
Chinese Patent Office
Queensland Health

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 verifification 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.

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