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Last Updated: September 29, 2020

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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-one 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
University of California, San FranciscoPhase 4
Quotient SciencesPhase 1
Janssen Sciences Ireland UCPhase 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
Jubilant Cadista DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL-28 210017-001 Sep 10, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Jubilant Cadista DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL 209423-001 Dec 22, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd LO-ZUMANDIMINE drospirenone; ethinyl estradiol TABLET;ORAL 209632-001 Feb 27, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Barr DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL 078515-001 Mar 30, 2009 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

Supplementary Protection Certificates for drospirenone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
2588114 CA 2020 00023 Denmark   Start Trial PRODUCT NAME: DROSPIRENON; NAT. REG. NO/DATE: 61678 20191016; FIRST REG. NO/DATE: DK 61678 20191016
1214076 C01214076/01 Switzerland   Start Trial PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
0398460 04C0022 France   Start Trial PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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Harvard Business School
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McKesson

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