SLYND Drug Patent Profile

When do Slynd patents expire, and when can generic versions of Slynd launch?

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

This drug has sixty-nine patent family members in thirty-one 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 four 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 are two tentative approvals for the generic drug (drospirenone), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for SLYND

International Patents:	69
US Patents:	15
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Patent Applications:	2,678
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

Constraining patent/regulatory exclusivity:

10,987,364

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.

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 fifteen US patents.

This potential generic entry date is based on patent 10,987,364.

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

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	10,179,140
Exeltis Usa Inc	SLYND	drospirenone	TABLET;ORAL	211367-001	May 23, 2019		RX	Yes	Yes	11,951,213
Exeltis Usa Inc	SLYND	drospirenone	TABLET;ORAL	211367-001	May 23, 2019		RX	Yes	Yes	10,603,281
Exeltis Usa Inc	SLYND	drospirenone	TABLET;ORAL	211367-001	May 23, 2019		RX	Yes	Yes	11,291,632		Y
Exeltis Usa Inc	SLYND	drospirenone	TABLET;ORAL	211367-001	May 23, 2019		RX	Yes	Yes	11,478,487		Y
Exeltis Usa Inc	SLYND	drospirenone	TABLET;ORAL	211367-001	May 23, 2019		RX	Yes	Yes	12,280,151		Y

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

Philippines

Poland

Portugal

San Marino

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
Argentina	081670
Australia	2011273605
Brazil	112012033391
Brazil	122019008317
Canada	2803721
Canada	3003062

Supplementary Protection Certificates for SLYND

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0398460	SPC/GB04/032	United Kingdom		PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
0398460	04C0022	France		PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
2588114	CA 2020 00023	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

DrugChatter Q&A for SLYND

When will slynd have a generic?
Slynd does it help with irregular bleeding related to fibroids?
Can you bleed heavily on slynd?
When does slynd patent expire?
When does slynd go generic?