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Generated: September 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022574

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NDA 022574 describes SAFYRAL, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SAFYRAL profile page.

The generic ingredient in SAFYRAL is drospirenone; ethinyl estradiol; levomefolate calcium. There are ten drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol; levomefolate calcium profile page.

Summary for NDA: 022574

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:4
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 022574

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SAFYRAL
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL 022574 NDA AUTHORIZED GENERIC Sandoz Inc 0781-4103 0781-4103-52 3 BLISTER PACK in 1 PACKAGE (0781-4103-52) > 1 KIT in 1 BLISTER PACK (0781-4103-15)
SAFYRAL
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL 022574 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-403 50419-403-00 90 BLISTER PACK in 1 PACKAGE (50419-403-00) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG,N/A;0.03MG,N/A;0.451MG,0.451MG
Approval Date:Dec 16, 2010TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Apr 17, 2020Product Flag?Substance Flag?YDelist Request?
Patent:► SubscribePatent Expiration:Dec 20, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Mar 3, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:PREVENTION OF PREGNANCY

Expired Orange Book Patents for NDA: 022574

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
SAFYRAL
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022574-001Dec 16, 2010► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Covington
Cipla
Express Scripts
Cerilliant
McKinsey
AstraZeneca
Fish and Richardson
QuintilesIMS
Accenture
Healthtrust

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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