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Last Updated: December 3, 2022

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 twenty branded drugs marketed by Exeltis Usa Inc, Mayne Pharma, Bayer Hlthcare, Barr, Glenmark Pharms Ltd, Hetero Labs, Hlthcare, Jubilant Cadista, Mylan Labs Ltd, Watson Labs, Sun Pharm, Aurobindo Pharma Ltd, Xiromed, Novast Labs, Lupin Ltd, Apotex, Naari Pte Ltd, and Watson Labs Inc, and is included in thirty-seven NDAs. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Drospirenone has sixty-two patent family members in twenty-nine 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
Insud PharmaPhase 3
Chemo ResearchPhase 3
Chemo ResearchPhase 4

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Paragraph IV (Patent) Challenges for DROSPIRENONE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SLYND Tablets drospirenone 4 mg 211367 1 2022-01-07

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
Lupin Ltd DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 205947-001 Jun 13, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bayer Hlthcare ANGELIQ drospirenone; estradiol TABLET;ORAL 021355-002 Sep 28, 2005 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Exeltis Usa Inc DROSPIRENONE drospirenone TABLET, CHEWABLE;ORAL 216285-001 Jun 29, 2022 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hetero Labs DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL 211944-001 Mar 22, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for drospirenone

Country Patent Number Title Estimated Expiration
Peru 20161410 COMPOSICION FARMACEUTICA QUE COMPRENDE DROSPIRENONA Y KIT ANTICONCEPTIVO See Plans and Pricing
European Patent Office 4056186 COMPOSITION PHARMACEUTIQUE COMPRENANT DE LA DROSPIRÉNONE ET ENSEMBLE CONTRACEPTIF (PHARMACEUTICAL COMPOSITION COMPRISING DROSPIRENONE AND CONTRACEPTIVE KIT) See Plans and Pricing
Norway 2020015 See Plans and Pricing
Brazil 112012033391 kit contraceptivo, método contraceptivo para uma paciente do sexo feminino necessitando do mesmo e composição farmacêutica compreendendo drospirenova. See Plans and Pricing
Guatemala 201200336 COMPOSICIÒN FARMACÈUTICA QUE COMPRENDE DROSPIRENONA Y KIT ANTICONCEPTIVO See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for drospirenone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2588114 CA 2020 00023 Denmark See Plans and Pricing PRODUCT NAME: DROSPIRENON; NAT. REG. NO/DATE: 61678 20191016; FIRST REG. NO/DATE: DK 61678 20191016
3632448 2022C/529 Belgium See Plans and Pricing PRODUCT NAME: DROSPIRENON; AUTHORISATION NUMBER AND DATE: BE548284 20191107
3632448 CA 2022 00016 Denmark See Plans and Pricing PRODUCT NAME: DROSPIRENON; NAT. REG. NO/DATE: 61678 20191016; FIRST REG. NO/DATE: DK 61678 20191016
3632448 PA2022513 Lithuania See Plans and Pricing PRODUCT NAME: DROSPIRENONAS; REGISTRATION NO/DATE: LT/1/21/4721/001-004 20210419
3632448 29/2022 Austria See Plans and Pricing PRODUCT NAME: DROSPIRENON; NAT. REGISTRATION NO/DATE: 139227 20191206; FIRST REGISTRATION: DK 31332 (MITTEILUNG) 20191022
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.