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Last Updated: January 20, 2021

DrugPatentWatch Database Preview

Drospirenone - Generic Drug Details

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What are the generic drug 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-five 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

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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
Bayer Hlthcare YASMIN drospirenone; ethinyl estradiol TABLET;ORAL-28 021098-001 May 11, 2001 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Watson Labs Inc DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 203593-001 Oct 11, 2016 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
>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   Start Trial PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
2588114 19/2020 Austria   Start Trial PRODUCT NAME: DROSPIRENON; NAT. REGISTRATION NO/DATE: 139227 20191206; FIRST REGISTRATION: DK 31332 (MITTEILUNG) 20191022
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:

McKinsey
McKesson
Dow
Baxter
Johnson and Johnson
Boehringer Ingelheim

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