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Serving leading biopharmaceutical companies globally:

AstraZeneca
Farmers Insurance
Julphar
McKinsey
US Department of Justice
Colorcon
Queensland Health
Deloitte
Baxter
Cantor Fitzgerald

Generated: February 19, 2018

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 twelve branded drugs marketed by Barr, Cyndea Pharma, Glenmark Pharms Ltd, Mylan Labs Ltd, PII, Watson Labs, Labs Leon Farma, Novast Labs Ltd, Lupin Ltd, Bayer Hlthcare, Accord Hlthcare, Apotex Inc, Mayne Pharma, and Watson Labs Inc, and is included in twenty-five NDAs. There are five 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 sixty-five patent family members in forty-two countries.

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

US Patents and Regulatory Information 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
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 AB RX No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novast Labs Ltd MELAMISA drospirenone; ethinyl estradiol TABLET;ORAL 202016-001 Jan 26, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Labs Ltd DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL-28 202131-001 May 4, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lupin Ltd NIKKI drospirenone; ethinyl estradiol TABLET;ORAL 201661-001 May 27, 2014 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bayer Hlthcare SAFYRAL drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022574-001 Dec 16, 2010 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novast Labs Ltd YAELA drospirenone; ethinyl estradiol TABLET;ORAL-28 202015-001 Nov 19, 2014 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Glenmark Pharms Ltd DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL 204296-001 Aug 17, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Glenmark Pharms Ltd DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL-28 204848-001 Mar 25, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for drospirenone; ethinyl estradiol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare YASMIN drospirenone; ethinyl estradiol TABLET;ORAL-28 021098-001 May 11, 2001 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare YASMIN drospirenone; ethinyl estradiol TABLET;ORAL-28 021098-001 May 11, 2001 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
7,569,557 Compositions of estrogen-cyclodextrin complexes ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for drospirenone; ethinyl estradiol

Supplementary Protection Certificates for drospirenone; ethinyl estradiol

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1214076/01 Switzerland ➤ Sign Up PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
C/GB04/032 United Kingdom ➤ Sign Up PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
2009 00017 Denmark ➤ Sign Up PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
C019/2009 Ireland ➤ Sign Up SPC019/2009: 20091119, EXPIRES: 20220628
49/2008 Austria ➤ Sign Up PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
C0022 France ➤ Sign Up PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Cantor Fitzgerald
Colorcon
QuintilesIMS
Cerilliant
Fish and Richardson
Johnson and Johnson
Merck
Teva

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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