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Deloitte
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Generated: December 19, 2018

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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 freedom to operate?

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, Lupin Ltd, Bayer Hlthcare, Accord Hlthcare, Apotex Inc, Mayne Pharma, and Watson Labs Inc, and is included in twenty-nine 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 eleven drug master file entries for drospirenone; ethinyl estradiol. Twenty suppliers are listed for this compound.

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 Y ➤ Try a Free Trial
Mylan Labs Ltd DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL 202594-001 Oct 22, 2015 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Watson Labs Inc DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 203594-001 Oct 11, 2016 AB RX No No ➤ 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
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 ➤ 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 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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Supplementary Protection Certificates for drospirenone; ethinyl estradiol

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
1214076/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
49/2008 Austria ➤ Try a Free Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Covington
Medtronic
Julphar
Fuji
McKesson
Moodys
Chubb
Teva

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