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Serving leading biopharmaceutical companies globally:

Medtronic
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US Army
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Federal Trade Commission
Healthtrust
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Generated: November 22, 2017

DrugPatentWatch Database Preview

Drospirenone; ethinyl estradiol - Generic Drug Details

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What are the generic drug 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 two hundred and twenty-one patent family members in forty-four countries and seven supplementary protection certificates in seven countries.

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

Summary for drospirenone; ethinyl estradiol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glenmark Pharms Ltd
DROSPIRENONE AND ETHINYL ESTRADIOL
drospirenone; ethinyl estradiol
TABLET;ORAL-28204848-001Mar 25, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Accord Hlthcare
DROSPIRENONE AND ETHINYL ESTRADIOL
drospirenone; ethinyl estradiol
TABLET;ORAL-28207245-001Nov 22, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Barr
DROSPIRENONE AND ETHINYL ESTRADIOL
drospirenone; ethinyl estradiol
TABLET;ORAL-28077527-001May 9, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Watson Labs
DROSPIRENONE AND ETHINYL ESTRADIOL
drospirenone; ethinyl estradiol
TABLET;ORAL078833-001Nov 28, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Barr
DROSPIRENONE AND ETHINYL ESTRADIOL
drospirenone; ethinyl estradiol
TABLET;ORAL078515-001Mar 30, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe
Mayne Pharma
DROSPIRENONE AND ETHINYL ESTRADIOL
drospirenone; ethinyl estradiol
TABLET;ORAL-28090081-001Sep 7, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Glenmark Pharms Ltd
DROSPIRENONE AND ETHINYL ESTRADIOL
drospirenone; ethinyl estradiol
TABLET;ORAL204296-001Aug 17, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Novast Labs Ltd
YAELA
drospirenone; ethinyl estradiol
TABLET;ORAL-28202015-001Nov 19, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
BEYAZ
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022532-001Sep 24, 2010ABRXNoNo► Subscribe► SubscribeY ► Subscribe
Watson Labs Inc
DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL203594-001Oct 11, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: drospirenone; ethinyl estradiol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
YASMIN
drospirenone; ethinyl estradiol
TABLET;ORAL-28021098-001May 11, 2001► Subscribe► Subscribe
Bayer Hlthcare
YAZ
drospirenone; ethinyl estradiol
TABLET;ORAL021676-001Mar 16, 2006► Subscribe► Subscribe
Bayer Hlthcare
YAZ
drospirenone; ethinyl estradiol
TABLET;ORAL021676-001Mar 16, 2006► Subscribe► Subscribe
Bayer Hlthcare
YAZ
drospirenone; ethinyl estradiol
TABLET;ORAL021676-001Mar 16, 2006► Subscribe► Subscribe
Bayer Hlthcare
YASMIN
drospirenone; ethinyl estradiol
TABLET;ORAL-28021098-001May 11, 2001► Subscribe► Subscribe
Bayer Hlthcare
YAZ
drospirenone; ethinyl estradiol
TABLET;ORAL021676-001Mar 16, 2006► Subscribe► Subscribe
Bayer Hlthcare
YAZ
drospirenone; ethinyl estradiol
TABLET;ORAL021676-001Mar 16, 2006► Subscribe► Subscribe
Bayer Hlthcare
YAZ
drospirenone; ethinyl estradiol
TABLET;ORAL021676-001Mar 16, 2006► Subscribe► Subscribe
Bayer Hlthcare
YAZ
drospirenone; ethinyl estradiol
TABLET;ORAL021676-001Mar 16, 2006► Subscribe► Subscribe
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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
7,569,557Compositions of estrogen-cyclodextrin complexes► Subscribe
6,121,465 Process for production drospirenone and intermediate products of the process► 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
Poland331530► Subscribe
Norway332726► Subscribe
Bulgaria102976► Subscribe
Japan2009102424► Subscribe
South Korea20090120015► Subscribe
Canada2756207► Subscribe
Denmark1632237► Subscribe
New Zealand526847► Subscribe
Portugal1598069► Subscribe
Cyprus1109252► 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
C0022France► SubscribePRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
1214076/01Switzerland► SubscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
2009 00017Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
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
49/2008Austria► SubscribePRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
C019/2009Ireland► SubscribeSPC019/2009: 20091119, EXPIRES: 20220628
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Healthtrust
Moodys
Harvard Business School
Mallinckrodt
Express Scripts
Queensland Health
Chubb
Chinese Patent Office
Merck
Julphar

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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