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Generated: March 26, 2019

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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 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, 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 seventy patent family members in forty-two countries.

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

Synonyms for drospirenone; ethinyl estradiol
164017-31-6
AC1L3VT1
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
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

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
Mylan Labs Ltd DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL-28 202131-001 May 4, 2015 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Glenmark Pharms Ltd DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL-28 204848-001 Mar 25, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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
Labs Leon Farma LORYNA drospirenone; ethinyl estradiol TABLET;ORAL 079221-001 Mar 28, 2011 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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
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 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 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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1380301 2009C/007 Belgium ➤ Try a Free Trial PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
0398460 SPC/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
1380301 CA 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
1214076 SZ 49/2008 Austria ➤ Try a Free Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
1380301 SPC019/2009 Ireland ➤ Try a Free Trial SPC019/2009: 20091119, EXPIRES: 20220628
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
Federal Trade Commission
Farmers Insurance
Covington
Cipla

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