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Generated: June 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021225

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NDA 021225 describes MIRENA, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the MIRENA profile page.

The generic ingredient in MIRENA 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: 021225

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: 021225

Ingredient-typeProgesterone Congeners
Physiological EffectInhibit Ovum Fertilization

Suppliers and Packaging for NDA: 021225

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIRENA
levonorgestrel
INTRAUTERINE DEVICE;INTRAUTERINE 021225 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-421 50419-421-01 1 INTRAUTERINE DEVICE in 1 CARTON (50419-421-01)
MIRENA
levonorgestrel
INTRAUTERINE DEVICE;INTRAUTERINE 021225 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-423 50419-423-01 1 INTRAUTERINE DEVICE in 1 CARTON (50419-423-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INTRAUTERINE DEVICE;INTRAUTERINEStrength52MG
Approval Date:Dec 6, 2000TE:RLD:Yes
Patent:9,615,965Patent Expiration:Sep 16, 2029Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021225

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
MIRENA
levonorgestrel
INTRAUTERINE DEVICE;INTRAUTERINE021225-001Dec 6, 20005,785,053► Subscribe
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Serving 500+ biopharmaceutical companies globally:

US Army
Dow
Queensland Health
McKinsey
Healthtrust
Fish and Richardson
Argus Health
McKesson
Cipla
Accenture

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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