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Last Updated: April 26, 2024

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, Dr Reddys Labs Sa, Naari Pte Ltd, and Watson Labs Inc, and is included in thirty-seven NDAs. There are eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Drospirenone has sixty-five patent family members in twenty-nine countries.

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

Summary for drospirenone

International Patents:	65
US Patents:	18
Tradenames:	20
Applicants:	19
NDAs:	37
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	98
Patent Applications:	3,354
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for drospirenone
Drug Sales Revenues:	Drug sales revenues for drospirenone
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for drospirenone
What excipients (inactive ingredients) are in drospirenone?	drospirenone excipients list
DailyMed Link:	drospirenone at DailyMed

See drug prices for drospirenone

Drug Sales Revenue Trends for drospirenone

See drug sales revenues for drospirenone

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for drospirenone

Generic Entry Date for drospirenone^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial Dosage: TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for drospirenone

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

Sponsor	Phase
University of Colorado, Denver	Phase 2
Janssen Pharmaceutica N.V., Belgium	Phase 1
Bristol Myers Squibb Company (BMS)	Phase 1

See all drospirenone clinical trials

Generic filers with tentative approvals for DROSPIRENONE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	4MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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 Trial	⤷ Try a Trial				⤷ Try a Trial
Lupin Ltd	TYDEMY	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	205948-001	Dec 12, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Hetero Labs	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL-28	213034-001	Jan 24, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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

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Country	Patent Number	Title	Estimated Expiration
Peru	20161410	COMPOSICION FARMACEUTICA QUE COMPRENDE DROSPIRENONA Y KIT ANTICONCEPTIVO	⤷ Try a Trial
South Korea	102539030		⤷ Try a Trial
Serbia	63027	FARMACEUTSKA KOMPOZICIJA KOJA OBUHVATA DROSPIRENON ZA UPOTREBU KAO KONTRACEPTIV (PHARMACEUTICAL COMPOSITION COMPRISING DROSPIRENONE FOR USE AS A CONTRACEPTIVE)	⤷ Try a Trial
European Patent Office	3632448	COMPOSITION PHARMACEUTIQUE COMPRENANT DE LA DROSPIRÉNONE ET ENSEMBLE CONTRACEPTIF (PHARMACEUTICAL COMPOSITION COMPRISING DROSPIRENONE AND CONTRACEPTIVE KIT)	⤷ Try a Trial
South Korea	20130048227	PHARMACEUTICAL COMPOSITION COMPRISING DROSPIRENONE AND CONTRACEPTIVE KIT	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for drospirenone

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0398460	SPC/GB04/032	United Kingdom	⤷ Try a 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	122021000065	Germany	⤷ Try a Trial	PRODUCT NAME: DROSPIRENON; NAT. REGISTRATION NO/DATE: 7002248.00.00 20210426; FIRST REGISTRATION: DK 61678 20191016
3632448	C202230031	Spain	⤷ Try a Trial	PRODUCT NAME: DROSPIRENONA; NATIONAL AUTHORISATION NUMBER: 84603-SE/H/1869/001/DC; DATE OF AUTHORISATION: 20191025; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SE/H/1809/001/DC; DATE OF FIRST AUTHORISATION IN EEA: 20191016
3632448	301186	Netherlands	⤷ Try a Trial	PRODUCT NAME: SLINDA; NATIONAL REGISTRATION NO/DATE: RVG 127386 20210317; FIRST REGISTRATION: DK 61678 20191022
3632448	CA 2022 00016	Denmark	⤷ Try a Trial	PRODUCT NAME: DROSPIRENON; NAT. REG. NO/DATE: 61678 20191016; FIRST REG. NO/DATE: DK 61678 20191016
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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