DROSPIRENONE - Generic Drug Details

What are the generic drug sources for drospirenone and what is the scope of freedom to operate?

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

See drug sales revenues for DROSPIRENONE

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

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
		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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Pharms Ltd	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL-28	204848-001	Mar 25, 2016	AB	RX	No	No
Exeltis Usa Inc	DROSPIRENONE	drospirenone	TABLET, CHEWABLE;ORAL	216285-001	Jun 29, 2022		DISCN	Yes	No			Y
Lupin Ltd	DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	205947-001	Jun 13, 2018	AB	RX	No	No
Exeltis Usa Inc	SLYND	drospirenone	TABLET;ORAL	211367-001	May 23, 2019		RX	Yes	Yes
Hlthcare	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL	203291-001	Jul 18, 2017	AB	RX	No	No
Xiromed	SYEDA	drospirenone; ethinyl estradiol	TABLET;ORAL-28	090114-001	Mar 28, 2011	AB	RX	No	No

International Patents for DROSPIRENONE

Country	Patent Number	Title	Estimated Expiration
Norway	2020015
Slovenia	3632448
South Korea	102539030
Peru	20161410	COMPOSICION FARMACEUTICA QUE COMPRENDE DROSPIRENONA Y KIT ANTICONCEPTIVO
Chile	2012003685	Kit farmaceutico que comprende una o mas unidades de envasado que comprenden 21 a 28 unidades de dosificacion activas diarias en que cada una comprende por lo menos 2 mg de drosperidona, sin estrogernos; uso del kit y de una composicion farmaceutica que comprende drosperidona para preparar un medicamento util como anticonceptivo.
Guatemala	201200336	COMPOSICIÒN FARMACÈUTICA QUE COMPRENDE DROSPIRENONA Y KIT ANTICONCEPTIVO

Supplementary Protection Certificates for DROSPIRENONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2588114	122021000065	Germany		PRODUCT NAME: DROSPIRENON; NAT. REGISTRATION NO/DATE: 7002248.00.00 20210426; FIRST REGISTRATION: DK 61678 20191016
3632448	CA 2022 00016	Denmark		PRODUCT NAME: DROSPIRENON; NAT. REG. NO/DATE: 61678 20191016; FIRST REG. NO/DATE: DK 61678 20191016
2588114	2020C/518	Belgium		PRODUCT NAME: DROSPIRENON; AUTHORISATION NUMBER AND DATE: BE548284 20191107
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
3632448	C202230031	Spain		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	LUC00266	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401