SLYND Drug Patent Profile

Which patents cover Slynd, and what generic alternatives are available?

Slynd is a drug marketed by Exeltis Usa Inc and is included in one NDA. There are thirteen patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in SLYND is drospirenone. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the drospirenone profile page.

DrugPatentWatch^® Generic Entry Outlook for Slynd

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 28, 2031. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (drospirenone), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for SLYND

International Patents:	65
US Patents:	13
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Patent Applications:	2,244
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SLYND
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SLYND
What excipients (inactive ingredients) are in SLYND?	SLYND excipients list
DailyMed Link:	SLYND at DailyMed

See drug prices for SLYND

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

NDA:

211367

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.

Anatomical Therapeutic Chemical (ATC) Classes for SLYND

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 SLYND

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SLYND	Tablets	drospirenone	4 mg	211367	1	2022-01-07

US Patents and Regulatory Information for SLYND

SLYND is protected by thirteen US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting SLYND

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Exeltis Usa Inc	SLYND	drospirenone	TABLET;ORAL	211367-001	May 23, 2019		RX	Yes	Yes
Exeltis Usa Inc	SLYND	drospirenone	TABLET;ORAL	211367-001	May 23, 2019		RX	Yes	Yes			Y
Exeltis Usa Inc	SLYND	drospirenone	TABLET;ORAL	211367-001	May 23, 2019		RX	Yes	Yes
Exeltis Usa Inc	SLYND	drospirenone	TABLET;ORAL	211367-001	May 23, 2019		RX	Yes	Yes			Y
Exeltis Usa Inc	SLYND	drospirenone	TABLET;ORAL	211367-001	May 23, 2019		RX	Yes	Yes			Y
Exeltis Usa Inc	SLYND	drospirenone	TABLET;ORAL	211367-001	May 23, 2019		RX	Yes	Yes
Exeltis Usa Inc	SLYND	drospirenone	TABLET;ORAL	211367-001	May 23, 2019		RX	Yes	Yes

International Patents for SLYND

When does loss-of-exclusivity occur for SLYND?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

Colombia

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

France

Guatemala

Hungary

Japan

Lithuania

Mexico

New Zealand

Norway

Peru

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SLYND around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	4056186	COMPOSITION PHARMACEUTIQUE COMPRENANT DE LA DROSPIRÉNONE ET ENSEMBLE CONTRACEPTIF (PHARMACEUTICAL COMPOSITION COMPRISING DROSPIRENONE AND CONTRACEPTIVE KIT)
Denmark	3632448
Guatemala	201200336	COMPOSICIÒN FARMACÈUTICA QUE COMPRENDE DROSPIRENONA Y KIT ANTICONCEPTIVO
Portugal	2588114
France	20C1020
Brazil	122019008317	kit contraceptivo, método contraceptivo para uma paciente do sexo feminino necessitando do mesmo e composição farmacêutica compreendendo drospirenona
Poland	3632448

Supplementary Protection Certificates for SLYND

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2588114	PA2021523	Lithuania		PRODUCT NAME: DROSPIRENONAS; REGISTRATION NO/DATE: 61678 20191016
3632448	301186	Netherlands		PRODUCT NAME: SLINDA; NATIONAL REGISTRATION NO/DATE: RVG 127386 20210317; FIRST REGISTRATION: DK 61678 20191022
2588114	C202030026	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): 61678; DATE OF FIRST AUTHORISATION IN EEA: 20191016
3632448	PA2022513	Lithuania		PRODUCT NAME: DROSPIRENONAS; REGISTRATION NO/DATE: LT/1/21/4721/001-004 20210419
2588114	301123	Netherlands		PRODUCT NAME: SLINDA; NATIONAL REGISTRATION NO/DATE: RGV 127386 20210317; FIRST REGISTRATION: DK 31332 20191016
2588114	LUC00227	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022