Details for New Drug Application (NDA): 021225

✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions

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 are four patents 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-nine suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.

Summary for 021225

Tradename:	MIRENA
Applicant:	Bayer Hlthcare
Ingredient:	levonorgestrel
Patents:	4
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021225

Physiological Effect	Inhibit Ovum Fertilization

Medical Subject Heading (MeSH) Categories for 021225

Contraceptive Agents, Female
Contraceptives, Oral, Synthetic

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.	50419-423	50419-423-01	1 INTRAUTERINE DEVICE in 1 CARTON (50419-423-01)
MIRENA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	021225	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-423	50419-423-08	1 INTRAUTERINE DEVICE in 1 CARTON (50419-423-08)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INTRAUTERINE DEVICE;INTRAUTERINE			Strength	52MG
Approval Date:	Dec 6, 2000	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Aug 20, 2023
Regulatory Exclusivity Use:	DOSING REGIMEN EXTENDING THE CONTRACEPTION USE FROM 5 YEARS TO UP TO 6 YEARS
Patent:	⤷ Try a Trial	Patent Expiration:	Sep 16, 2029	Product 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:	⤷ Try a Trial	Patent Expiration:	Apr 1, 2031	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 021225

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	MIRENA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	021225-001	Dec 6, 2000	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

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.