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McKinsey
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Daiichi Sankyo
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Generated: April 25, 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 fourteen branded drugs marketed by Barr, Glenmark Pharms Ltd, Jubilant Cadista, Mylan Labs Ltd, PII, Watson Labs, Aurobindo Pharma Ltd, 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-seven 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. Fifteen suppliers are listed for this compound.
Summary for drospirenone; ethinyl estradiol
Synonyms for drospirenone; ethinyl estradiol
(1R,2R,4R,10R,11S,14S,15S,16S,18S,19S)-10,14-DIMETHYLSPIRO[HEXACYCLO[9.8.0.0(2),?.0?,(1)?.0(1)?,(1)?.0(1)?,(1)?]NONADECANE-15,2'-OXOLAN]-5-ENE-5',7-DIONE; (1S,10R,11S,14R,15S)-14-ETHYNYL-15-METHYLTETRACYCLO[8.7.0.0(2),?.0(1)(
164017-31-6
19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17alpha)-, mixt. with (2'S,6R,7R,8R,9S,10R,13S,14S,15S,16S)-3',4',6,7,8,9,10,11,12,13,14,15,16,20,21-hexadecahydro-10,13-dimethylspiro(17H-dicyclopropa(6,7:15,16)cyclopenta(a)ph
19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol,(17alpha)-,mixt.w/(2'S,6R,7R,8R,9S,10R,13S,14S,15S,16S)-3',4',6,7,8,9,10,11,12,13,14,15,16,20,21-hexadecahydro-10,13-dimethylspiro(17H-dicyclopropa(6,7:15,16)cyclopenta(a)phenanth
AC1L3VT1
BAY 86-5300
Drospirenone & Ethinyl Estradiol
drospirenone and ethinyl estradiol combination
Drospirenone mixture with Ethinyl estradiol
Drospirenone mixture with Ethinylestradiol
Drospirenone-ethinylestradiol mixt
Drospirenone(DRSP)
Drospirenone/Ethinyl Estradiol
EE20/DRSP
Ethinylestradiol mixture with drospirenone
Ethinylestradiol-drospirenone mixt
Gianvi
Loryna
LS-181813
Nikki
Ocella
Petibelle
PL047789
SCHEMBL8464101
Syeda
Vestura
Yasmin 28
YAZ
Yaz-28
Z 30.595
Zarah

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 SAFYRAL drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022574-001 Dec 16, 2010 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Aurobindo Pharma Ltd LO-ZUMANDIMINE drospirenone; ethinyl estradiol TABLET;ORAL 209632-001 Feb 27, 2018 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Bayer Hlthcare YASMIN drospirenone; ethinyl estradiol TABLET;ORAL-28 021098-001 May 11, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
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 ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for drospirenone; ethinyl estradiol

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0022 France ➤ Try a Free Trial PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
2009 00017 Denmark ➤ Try a Free Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
C/GB04/032 United Kingdom ➤ Try a Free Trial PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
C019/2009 Ireland ➤ Try a Free Trial SPC019/2009: 20091119, EXPIRES: 20220628
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Healthtrust
AstraZeneca
Harvard Business School
Colorcon
Citi
Boehringer Ingelheim
Julphar
Queensland Health

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