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Serving 500+ biopharmaceutical companies globally:

Baxter
Moodys
Mallinckrodt
Colorcon
Merck
McKesson
Medtronic
Chinese Patent Office
Daiichi Sankyo
Johnson and Johnson

Generated: June 24, 2017

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 two 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-eight suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.

Summary for NDA: 208224

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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

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 50419-424-01 1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-01)
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INTRAUTERINE DEVICE;INTRAUTERINEStrength19.5MG
Approval Date:Sep 16, 2016TE:RLD:Yes
Patent:7,252,839Patent Expiration:Nov 13, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:9,615,965Patent Expiration:Sep 16, 2029Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Sep 16, 2019
Regulatory Exclusivity Use:NEW PRODUCT


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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
US Army
Medtronic
Cerilliant
Julphar
McKesson
Moodys
Merck
Cantor Fitzgerald
Chinese Patent Office

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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