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Last Updated: June 12, 2021

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Drospirenone - Generic Drug Details

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What are the generic sources for drospirenone and what is the scope of patent protection?

Drospirenone is the generic ingredient in eighteen branded drugs marketed by Exeltis Usa Inc, Bayer Hlthcare, 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, Apotex, Mayne Pharma, Naari Pte Ltd, and Watson Labs Inc, and is included in thirty-five NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Drospirenone has forty-seven patent family members in twenty-seven countries.

There are eleven drug master file entries for drospirenone. One supplier is listed for this compound.

Drug Prices for drospirenone

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Drug Sales Revenue Trends for drospirenone

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Recent Clinical Trials for drospirenone

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

SponsorPhase
Inonu UniversityN/A
University of California, San FranciscoPhase 4
Quotient SciencesPhase 1

See all drospirenone clinical trials

Pharmacology for drospirenone
Drug ClassProgestin

US Patents and Regulatory Information for drospirenone

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   Get Started Free   Get Started Free Y   Get Started Free
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006 AB RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Bayer Hlthcare SAFYRAL drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022574-001 Dec 16, 2010 AB RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Lupin Ltd TYDEMY drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 205948-001 Dec 12, 2017 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Hetero Labs Ltd DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL-28 213034-001 Jan 24, 2020 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Watson Labs DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL 078833-001 Nov 28, 2011 AB RX No No   Get Started Free   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for drospirenone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1214076 C01214076/01 Switzerland   Get Started Free PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
2588114 19/2020 Austria   Get Started Free PRODUCT NAME: DROSPIRENON; NAT. REGISTRATION NO/DATE: 139227 20191206; FIRST REGISTRATION: DK 31332 (MITTEILUNG) 20191022
0398460 04C0022 France   Get Started Free PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
2588114 CA 2020 00023 Denmark   Get Started Free PRODUCT NAME: DROSPIRENON; NAT. REG. NO/DATE: 61678 20191016; FIRST REG. NO/DATE: DK 61678 20191016
0398460 SPC/GB04/032 United Kingdom   Get Started Free PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
2588114 2020C/518 Belgium   Get Started Free PRODUCT NAME: DROSPIRENON; AUTHORISATION NUMBER AND DATE: BE548284 20191107
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Baxter
Harvard Business School
Mallinckrodt
McKesson

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