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Last Updated: May 5, 2024

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 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
Bristol Myers Squibb Company (BMS)	Phase 1
Janssen Pharmaceutica N.V., Belgium	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
Hetero Labs	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL	211944-001	Mar 22, 2019	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lupin Ltd	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL-28	201663-001	Dec 18, 2012	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Labs Ltd	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL	202594-001	Oct 22, 2015	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
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Xiromed	LORYNA	drospirenone; ethinyl estradiol	TABLET;ORAL	079221-001	Mar 28, 2011	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
South Korea	20190073598	드로스피레논을 포함하는 약학적 조성물 및 피임용 키트 (Pharmaceutical composition comprising drospirenone and contraceptive kit)	⤷ Try a Trial
Guatemala	201200336B	COMPOSICIÓN FARMACÉUTICA QUE COMPRENDE DROSPIRENONA Y KIT ANTICONCEPTIVO (SOLICITUD DIVISIONAL NO. 2)	⤷ Try a Trial
Mexico	364971	COMPOSICION FARMACEUTICA QUE COMPRENDE DROSPIRENONA Y KIT ANTICONCEPTIVO. (PHARMACEUTICAL COMPOSITION COMPRISING DROSPIRENONE AND CONTRACEPTIVE KIT.)	⤷ Try a Trial
Portugal	2588114		⤷ Try a Trial
Hungary	E058176		⤷ Try a Trial
Hungary	S2000016		⤷ 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
2588114	C202030026	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): 61678; DATE OF FIRST AUTHORISATION IN EEA: 20191016
3632448	PA2022513	Lithuania	⤷ Try a Trial	PRODUCT NAME: DROSPIRENONAS; REGISTRATION NO/DATE: LT/1/21/4721/001-004 20210419
2588114	CA 2020 00023	Denmark	⤷ Try a Trial	PRODUCT NAME: DROSPIRENON; NAT. REG. NO/DATE: 61678 20191016; FIRST REG. NO/DATE: DK 61678 20191016
3632448	LUC00266	Luxembourg	⤷ Try a Trial	PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401
3632448	2022C/529	Belgium	⤷ Try a Trial	PRODUCT NAME: DROSPIRENON; AUTHORISATION NUMBER AND DATE: BE548284 20191107
3632448	22C1031	France	⤷ Try a Trial	PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 31332 20191016
>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.