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Last Updated: May 29, 2020

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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 patent protection?

Drospirenone; ethinyl estradiol is the generic ingredient in sixteen branded drugs marketed by Allied, Barr, Glenmark Pharms Ltd, Hetero Labs Ltd, Jubilant Cadista, Mylan Labs Ltd, Watson Labs, Sun Pharm, Aurobindo Pharma Ltd, Xiromed, Novast Labs, Lupin Ltd, Bayer Hlthcare, Accord Hlthcare, Apotex, Mayne Pharma, and Watson Labs Inc, and is included in thirty-three 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 seventy-three patent family members in forty-two countries.

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

Recent Clinical Trials for drospirenone; ethinyl estradiol

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of California, San FranciscoPhase 4
American University of Beirut Medical CenterPhase 2/Phase 3
Navy General Hospital, BeijingN/A

See all drospirenone; ethinyl estradiol clinical trials

Recent Litigation for drospirenone; ethinyl estradiol

Identify potential future generic entrants

District Court Litigation
Case NameDate
Teva Women's Health, Inc. v. Famy Care Ltd.2014-12-05
Bayer Schering Pharma AG v. Mylan Pharmaceuticals Inc.2011-04-19
BRAINTREE LABORATORIES, INC. v. LUPIN ATLANTIS HOLDINGS SA2011-03-09

See all drospirenone; ethinyl estradiol litigation

Synonyms for drospirenone; ethinyl estradiol
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(
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)phen
5a,7a-Dimethyl-1,1a,5,5a,5b,6,7,7a,8a,9,9a,9b,9c,9d-tetradecahydrospiro[cyclopropa[4,5]cyclopenta[1,2-a]cyclopropa[l]phenanthrene-8,2'-oxolane]-3,5'(4H)-dione--19-norpregna-1(10),2,4-trien-20-yne-3,17
BAY 86-5300
DR1021
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
DTXSID80936898
EE20/DRSP
Ethinylestradiol mixture with drospirenone
Ethinylestradiol-drospirenone mixt
Gianvi
Loryna
LS-181813
Nikki
Ocella
Petibelle
SCHEMBL8464101
Syeda
Vestura
Yasmin 28
YAZ
Yaz-28
Z 30.595
Zarah
Paragraph IV (Patent) Challenges for DROSPIRENONE; ETHINYL ESTRADIOL
Tradename Dosage Ingredient NDA Submissiondate
YAZ TABLET;ORAL drospirenone; ethinyl estradiol 021676 2006-09-29
YASMIN TABLET;ORAL-28 drospirenone; ethinyl estradiol 021098 2005-01-07

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
Glenmark Pharms Ltd DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL-28 204848-001 Mar 25, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm KYRA drospirenone; ethinyl estradiol TABLET;ORAL 202318-001 Jul 23, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Hetero Labs Ltd DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL 211944-001 Mar 22, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Watson Labs DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL 078833-001 Nov 28, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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   Start Trial   Start Trial
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006   Start Trial   Start Trial
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006   Start Trial   Start Trial
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006   Start Trial   Start Trial
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for drospirenone; ethinyl estradiol

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1380301 2009C/007 Belgium   Start Trial PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1380301 CA 2009 00017 Denmark   Start Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1214076 49/2008 Austria   Start Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
0398460 SPC/GB04/032 United Kingdom   Start Trial PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
1380301 SPC019/2009 Ireland   Start Trial SPC019/2009: 20091119, EXPIRES: 20220628
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Mallinckrodt
Dow
McKinsey
McKesson
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 verification 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.