DROSPIRENONE - Generic Drug Details

✉ Email this page to a colleague

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, Lupin Ltd, Mayne Pharma, Bayer Hlthcare, Barr, Glenmark Pharms Ltd, Hetero Labs, Hlthcare, Jubilant Cadista, Watson Labs, Xiromed, Sun Pharm, Aurobindo Pharma Ltd, Novast Labs, Apotex, Dr Reddys Labs Sa, Naari Pte Ltd, and Watson Labs Inc, and is included in thirty-eight NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for DROSPIRENONE

International Patents:	66
US Patents:	22
Tradenames:	20
Applicants:	18
NDAs:	38
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	101
Patent Applications:	3,354
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

Recent Clinical Trials for DROSPIRENONE

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

Sponsor	Phase
McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 4
Eli Lilly and Company	Phase 1
Bristol-Myers Squibb	Phase 1

See all DROSPIRENONE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for DROSPIRENONE

G03AC	Progestogens
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Exeltis Usa Inc	DROSPIRENONE	drospirenone	TABLET, CHEWABLE;ORAL	216285-001	Jun 29, 2022		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Xiromed	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL	202594-001	Oct 22, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bayer Hlthcare	ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355-001	Feb 29, 2012		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Sun Pharm	KYRA	drospirenone; ethinyl estradiol	TABLET;ORAL	202318-001	Jul 23, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Canada	3003062	COMPOSITION PHARMACEUTIQUE CONTENANT DE LA DROSPIRENONE ET KIT CONTRACEPTIF (PHARMACEUTICAL COMPOSITION COMPRISING DROSPIRENONE AND CONTRACEPTIVE KIT)	⤷ Sign Up
Japan	5810159		⤷ Sign Up
Guatemala	201200336B	COMPOSICIÓN FARMACÉUTICA QUE COMPRENDE DROSPIRENONA Y KIT ANTICONCEPTIVO (SOLICITUD DIVISIONAL NO. 2)	⤷ Sign Up
Portugal	2588114		⤷ Sign Up
South Korea	102164693		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for DROSPIRENONE

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2588114	LUC00227	Luxembourg	⤷ Sign Up	PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022
3632448	2022C/529	Belgium	⤷ Sign Up	PRODUCT NAME: DROSPIRENON; AUTHORISATION NUMBER AND DATE: BE548284 20191107
3632448	122022000040	Germany	⤷ Sign Up	PRODUCT NAME: DROSPIRENON; NAT. REGISTRATION NO/DATE: 7002248.00.00 20210426; FIRST REGISTRATION: DAENEMARK 61678 20191016
1380301	2009C/007	Belgium	⤷ Sign Up	PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
3632448	LUC00266	Luxembourg	⤷ Sign Up	PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.