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

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:	69
US Patents:	15
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Patent Applications:	2,185
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

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.

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
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			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

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
Norway	2020015
France	20C1020
Lithuania	PA2022513
South Korea	20170085604	드로스피레논을 포함하는 약학적 조성물 및 피임용 키트 (Pharmaceutical composition comprising drospirenone and contraceptive kit)
Ecuador	SP12012359	COMPOSICIÓN FARMACÉUTICA QUE COMPRENDE DROSPIRENONA Y KIT ANTICONCEPTIVO
Lithuania	PA2021523

Supplementary Protection Certificates for SLYND

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2588114	19/2020	Austria		PRODUCT NAME: DROSPIRENON; NAT. REGISTRATION NO/DATE: 139227 20191206; FIRST REGISTRATION: DK 31332 (MITTEILUNG) 20191022
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
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
3632448	2022C/529	Belgium		PRODUCT NAME: DROSPIRENON; AUTHORISATION NUMBER AND DATE: BE548284 20191107
3632448	LUC00266	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401
2588114	2020C/518	Belgium		PRODUCT NAME: DROSPIRENON; AUTHORISATION NUMBER AND DATE: BE548284 20191107

Market Dynamics and Financial Trajectory for SLYND

Introduction

SLYND, a progestin-only contraceptive pill containing drospirenone, has been a significant player in the global contraceptive drugs market since its approval by the FDA in May 2019. Here, we delve into the market dynamics and financial trajectory of SLYND, highlighting key factors influencing its growth and competitive position.

Market Size and Growth

The global contraceptive drugs market, within which SLYND operates, is projected to grow significantly. As of 2023, the global market size was valued at USD 18.57 billion and is expected to reach USD 37.22 billion by 2032, exhibiting a CAGR of 8.2% during the forecast period (2024-2032)[1].

Product Segment Performance

SLYND falls under the oral segment of contraceptive drugs, which dominates the market due to its higher adoption rates in both developed and developing countries. The oral segment's growth is driven by the clinical benefits of oral medicines over other contraceptive methods, such as injectables and patches, and the ease of administration and widespread availability of these products[1].

Distribution Channels

The retail pharmacy segment dominates the distribution channels for contraceptive drugs, including SLYND. This dominance is attributed to the growing demand for over-the-counter (OTC) contraceptive drugs and favorable regulatory policies in several countries, allowing birth control pills to be sold OTC. Online channels are also growing rapidly, offering discounts and wide availability, which further supports the market growth of SLYND[1].

Regional Market Performance

North America, particularly the U.S., is a significant market for SLYND. The region's high awareness about birth control pills, growing childbearing population, and increasing fertility rates contribute to its dominance. The U.S. contraceptive drugs market is projected to reach an estimated value of USD 12.06 billion by 2032[1].

Competitive Landscape

SLYND, developed by Exeltis USA Inc., faces competition from other major players in the contraceptive drugs market, such as Johnson & Johnson Services, Inc., AbbVie Inc., and Bayer AG. However, SLYND has experienced a notable 19% growth in market share since its introduction, making it a competitive entrant in the progestin-only pill (POP) market[4].

Generic Competition

In November 2022, the FDA tentatively approved Lupin’s generic version of SLYND, which could potentially impact the market share of the branded product. However, Exeltis USA Inc. has taken legal action against Lupin, alleging patent infringement, which may delay the full impact of generic competition[4].

Regulatory and Approval Landscape

SLYND was approved by the FDA on May 23, 2019, under New Drug Application (NDA) No. 211367. The approval process involved extensive clinical trials that established its safety and efficacy in preventing pregnancy. The drug is indicated for use by females of reproductive potential and is contraindicated in females with hepatic or renal impairment[3][4].

Clinical Benefits and Side Effects

SLYND works by inhibiting the gonadotropic hormones, thereby preventing ovulation. It is administered as one 4-mg tablet daily for 24 consecutive days, followed by four inert tablets. Common adverse reactions include acne, metrorrhagia, headache, breast pain, and weight increase. The drug also carries risks such as hyperkalemia in patients with renal impairment and bleeding irregularities[2][3].

Financial Impact

The financial trajectory of SLYND is closely tied to the overall growth of the contraceptive drugs market. With increasing consumer awareness and favorable regulatory environments, SLYND is poised to contribute significantly to the revenue growth of its parent company, Exeltis USA Inc. The 19% growth in market share since its introduction is a strong indicator of its financial performance and potential for future growth[4].

Strategic Collaborations and Market Strategies

Top market players, including Exeltis USA Inc., focus on strategic collaborations to gain a competitive advantage. These collaborations can involve partnerships with healthcare providers, public health programs, and other stakeholders to increase awareness and accessibility of contraceptive drugs like SLYND[1].

Public Health Initiatives and Awareness

Increasing focus on creating awareness through public programs and growing insurance coverage for contraceptive drugs are key drivers of the market. These initiatives, particularly in regions like Asia Pacific, where government efforts to expand access to contraceptive drugs are on the rise, will continue to support the growth of SLYND and similar products[1].

Conclusion

SLYND, as a product within the broader contraceptive drugs market, is experiencing significant growth driven by its clinical benefits, ease of administration, and favorable regulatory environment. Despite the potential impact of generic competition, SLYND's strong market performance and the overall growth trajectory of the contraceptive drugs market position it for continued success.

Key Takeaways

• Market Growth: The global contraceptive drugs market is projected to grow from USD 19.80 billion in 2024 to USD 37.22 billion by 2032.
• Product Segment: The oral segment, where SLYND belongs, dominates the market due to its clinical benefits and ease of administration.
• Distribution Channels: Retail pharmacies and online channels are key distribution segments driving the market.
• Regional Performance: North America, particularly the U.S., is a significant market for SLYND.
• Competitive Landscape: SLYND faces competition but has shown a 19% growth in market share since its introduction.
• Regulatory Landscape: Approved by the FDA in 2019, with ongoing legal actions against generic competitors.
• Clinical Benefits and Risks: Effective in preventing pregnancy but carries risks such as hyperkalemia and bleeding irregularities.

FAQs

Q1: What is SLYND, and how does it work? SLYND is a progestin-only contraceptive pill containing drospirenone, which works by inhibiting the gonadotropic hormones to prevent ovulation.

Q2: When was SLYND approved by the FDA? SLYND was approved by the FDA on May 23, 2019.

Q3: What are the common side effects of SLYND? Common side effects include acne, metrorrhagia, headache, breast pain, and weight increase.

Q4: How does the generic competition affect SLYND? The FDA's tentative approval of Lupin’s generic version of SLYND in November 2022 could impact its market share, but ongoing legal actions may delay the full impact of generic competition.

Q5: What are the key drivers of the market growth for SLYND? Key drivers include increasing consumer awareness, favorable regulatory policies, and growing insurance coverage for contraceptive drugs.

Sources

1. Fortune Business Insights - Contraceptive Drugs Market Size, Share | Global Report, 2032
2. FDA - SLYND (drospirenone) - accessdata.fda.gov
3. FDA - NDA 211367 Multi-disciplinary Review and Evaluation - FDA
4. United States District Court - in the united states district court - District of Delaware
5. Pharmaceuticals.gov.in - An Analysis on leveraging the patent cliff with drug sales worth USD ...

Last updated: 2024-12-16