Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Harvard Business School
McKesson
Dow
Mallinckrodt
Express Scripts

Last Updated: September 25, 2022

Details for New Drug Application (NDA): 208224


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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 five 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-one 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:5
Formulation / Manufacturing:see details
Pharmacology for NDA: 208224
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 50419-424-01 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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INTRAUTERINE DEVICE;INTRAUTERINEStrength19.5MG
Approval Date:Sep 16, 2016TE:RLD:Yes
Patent:See Plans and PricingPatent Expiration:Sep 16, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD OF POSITIONING AN INTRAUTERINE SYSTEM (IUS) BY DETERMINING A DEPTH OF THE UTERUS, HOLDING AN INSERTER HANDLE WITH ONE HAND, INSERTING THE IUS INTO THE UTERUS, AND RETRACTING A SLIDER ON THE HANDLE TO RELEASE THE IUS INTO THE UTERUS
Patent:See Plans and PricingPatent Expiration:Apr 1, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:See Plans and PricingPatent Expiration:Nov 13, 2023Product Flag?YSubstance Flag?Delist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
Express Scripts
Moodys
Johnson and Johnson
Medtronic
Baxter

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 verification 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.