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Generated: September 26, 2017

DrugPatentWatch Database Preview

Drospirenone; ethinyl estradiol - Generic Drug Details

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What are the generic sources for drospirenone; ethinyl estradiol and what is the scope of drospirenone; ethinyl estradiol patent protection?

Drospirenone; ethinyl estradiol
is the generic ingredient in eleven branded drugs marketed by Sandoz, Barr, Novast Labs Ltd, Mylan Labs Ltd, Watson Labs, Accord Hlthcare, Glenmark Pharms Ltd, Lupin Ltd, Bayer Hlthcare, Apotex Inc, Mayne Pharma, PII, and Watson Labs Inc, and is included in twenty-three NDAs. There are seven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Drospirenone; ethinyl estradiol has one hundred and ninety-five patent family members in forty-three countries.

There are ten drug master file entries for drospirenone; ethinyl estradiol. Fifteen suppliers are listed for this compound.

Summary for Generic Name: drospirenone; ethinyl estradiol

Tradenames:11
Patents:7
Applicants:13
NDAs:23
Drug Master File Entries: see list10
Suppliers / Packagers: see list15
Bulk Api Vendors: see list4
Clinical Trials: see list720
Patent Applications: see list4
Drug Prices:see low prices
DailyMed Link:drospirenone; ethinyl estradiol at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Barr
DROSPIRENONE AND ETHINYL ESTRADIOL
drospirenone; ethinyl estradiol
TABLET;ORAL-28077527-001May 9, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
YAZ
drospirenone; ethinyl estradiol
TABLET;ORAL021676-001Mar 16, 2006ABRXYesYes► Subscribe► Subscribe ► Subscribe
Lupin Ltd
DROSPIRENONE AND ETHINYL ESTRADIOL
drospirenone; ethinyl estradiol
TABLET;ORAL-28201663-001Dec 18, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
SAFYRAL
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022574-001Dec 16, 2010ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Glenmark Pharms Ltd
DROSPIRENONE AND ETHINYL ESTRADIOL
drospirenone; ethinyl estradiol
TABLET;ORAL-28204848-001Mar 25, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Watson Labs Inc
DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL203594-001Oct 11, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
LORYNA
drospirenone; ethinyl estradiol
TABLET;ORAL079221-001Mar 28, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Pii
DROSPIRENONE AND ETHINYL ESTRADIOL
drospirenone; ethinyl estradiol
TABLET;ORAL203291-001Jul 18, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
SYEDA
drospirenone; ethinyl estradiol
TABLET;ORAL-28090114-001Mar 28, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Labs Ltd
DROSPIRENONE AND ETHINYL ESTRADIOL
drospirenone; ethinyl estradiol
TABLET;ORAL202594-001Oct 22, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: drospirenone; ethinyl estradiol

Non-Orange Book Patents for Generic Ingredient: drospirenone; ethinyl estradiol

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,121,465 Process for production drospirenone and intermediate products of the process► Subscribe
7,569,557Compositions of estrogen-cyclodextrin complexes► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: drospirenone; ethinyl estradiol

Country Document Number Estimated Expiration
Austria420648► Subscribe
Yugoslavia51203► Subscribe
Norway332726► Subscribe
Spain2211580► Subscribe
Portugal1214076► Subscribe
New Zealand517845► Subscribe
Australia2005202046► Subscribe
Hong Kong1061968► Subscribe
Australia6589500► Subscribe
Hong Kong1055397► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: DROSPIRENONE; ETHINYL ESTRADIOL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2006009Lithuania► SubscribePRODUCT NAME: DROSPIRENONUM; NAT. REGISTRATION NO/DATE: LT/1/06/0520/001, 2006 07 10 LT/1/06/0520/002, 2006 07 10 LT/1/06/0520/003, 2006 07 10 LT/1/06/0520/004 20060710; FIRST REGISTRATION: RVG 31781 20050804
C019/2009Ireland► SubscribeSPC019/2009: 20091119, EXPIRES: 20220628
C/GB04/032United Kingdom► SubscribePRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
1214076/01Switzerland► SubscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
C0022France► SubscribePRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
2009 00017Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Cantor Fitzgerald
Cipla
QuintilesIMS
Argus Health
McKesson
Teva
Colorcon
Fuji
Express Scripts

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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