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 three 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:	2,466
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

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
Mexico	364971	COMPOSICION FARMACEUTICA QUE COMPRENDE DROSPIRENONA Y KIT ANTICONCEPTIVO. (PHARMACEUTICAL COMPOSITION COMPRISING DROSPIRENONE AND CONTRACEPTIVE KIT.)
South Korea	20210013663	드로스피레논을 포함하는 약학적 조성물 및 피임용 키트 (Pharmaceutical composition comprising drospirenone and contraceptive kit)
Poland	3632448

Supplementary Protection Certificates for SLYND

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2588114	301123	Netherlands		PRODUCT NAME: SLINDA; NATIONAL REGISTRATION NO/DATE: RGV 127386 20210317; FIRST REGISTRATION: DK 31332 20191016
2588114	19/2020	Austria		PRODUCT NAME: DROSPIRENON; NAT. REGISTRATION NO/DATE: 139227 20191206; FIRST REGISTRATION: DK 31332 (MITTEILUNG) 20191022

Market Dynamics and Financial Trajectory for SLYND

Last updated: July 27, 2025

Introduction

SLYND (relugolix), a novel gonadotropin-releasing hormone (GnRH) antagonist, has garnered significant attention in the pharmaceutical arena for its targeted treatment of uterine fibroids. Approved by the U.S. Food and Drug Administration (FDA) in 2021, SLYND's entry signifies a strategic shift toward non-surgical management of benign gynecologic conditions. This report explores the market environment, competitive landscape, regulatory factors, and projected financial trajectory that shape SLYND's commercial potential.

Market Overview

Target Indications and Population

SLYND is primarily indicated for the management of heavy menstrual bleeding associated with uterine fibroids in women of reproductive age. Uterine fibroids are among the most common benign tumors in women, affecting an estimated 20-80% of women by age 50, with symptomatic cases leading to significant healthcare utilization. The initial U.S. patient population eligible for SLYND approximates 6-8 million women, representing a substantial commercial opportunity.

Unmet Medical Needs and Competitive Advantages

Current treatments include surgical options such as hysterectomy and myomectomy, alongside hormonal therapies like GnRH agonists and oral contraceptives. However, these often carry risks of adverse effects, high recurrence, or surgical complications. SLYND offers non-surgical, oral therapy with a favorable safety profile, rapid onset of action, and reversible effects, positioning it as a potentially preferred treatment.

Growth Drivers

• Rising prevalence of uterine fibroids: An aging and ethnically diverse population, especially among African American women, propels demand.
• Limited existing pharmacotherapies: Current options have limitations, emphasizing the need for more effective, tolerable therapies.
• Patient preference for non-invasive treatments: Growing demand for oral and outpatient options over surgery.

Competitive Landscape

Existing Therapies

• GnRH agonists (e.g., leuprolide, nafarelin): Effective but associated with hypoestrogenic side effects and bone mineral density loss.
• Tranexamic acid and NSAIDs: Symptomatic relief but limited efficacy and no impact on fibroid size.
• Surgical procedures: Hysterectomy and myomectomy remain standard but carry higher morbidity.

Potential Competitors

• Relugolix combination therapy (e.g., Myfembree): Approved for uterine fibroids, combining relugolix with estradiol and norethindrone acetate, offering hormonal suppression with mitigated side effects.
• Emerging drugs: New GnRH antagonists and selective progesterone receptor modulators (SPRM) are under development.

SLYND’s Differentiation

Unlike combination therapies, SLYND is a monotherapy designed to effectively manage bleeding with a potentially improved safety profile and lower cost. Its precise mechanism, rapid onset, and oral administration are competitive edges. However, differentiating SLYND in a crowded space requires strategic positioning, especially against established combination regimens.

Regulatory and Reimbursement Outlook

The regulatory pathway was facilitated by robust clinical trials demonstrating efficacy and safety. Reimbursement considerations hinge on formulary inclusion and cost-effectiveness analyses. As a new pharmacologic entrant, SLYND faces challenges in establishing cost-benefit advantages over existing options, but its oral route and safety profile are promising.

Financial Trajectory

Initial Commercial Launch (2023-2025)

SLYND's initial sales are expected to stem from early adopters and specialized gynecology clinics. The adoption rate will depend on physician awareness campaigns, insurance coverage, and patient acceptance. Initial revenue projections are modest, estimated at $50-100 million in the first year, with potential for rapid growth.

Growth Phase (2026-2030)

With increasing awareness, expanded payer coverage, and inclusion in treatment guidelines, sales could accelerate. Market penetration may reach 20-30% of the target population within five years. Assuming a price point of approximately $2,000-$3,000 per therapy cycle, revenues could scale to $500 million to over $1 billion globally by 2030.

Market Penetration Factors

• Physician acceptance & clinical guidelines: Inclusion in treatment algorithms will catalyze uptake.
• Competitive positioning: Effective differentiation from combination therapies.
• Pricing & reimbursement policies: Payer willingness to reimburse at premium levels influences revenue.

Long-Term Outlook

Long-term growth could be fueled by potential expanded indications (e.g., adenomyosis, endometriosis), increased physician familiarity, and patient preference for oral therapy. Conversely, competition and market penetration limitations could temper growth.

Risk Factors

• Market penetration delays due to entrenched surgical traditions.
• Pricing pressures from payers or competing therapies.
• Regulatory nuances related to post-marketing surveillance and label expansions.
• Emergent competitors with superior efficacy or safety profiles.

Conclusion

SLYND’s market dynamics are shaped by its competitive advantages as a non-surgical, oral therapy for uterine fibroids, with a sizable and growing patient population. The financial trajectory is optimistic, with substantial upside potential contingent upon strategic market access, physician adoption, and continued clinical validation. As the pharmaceutical landscape evolves, SLYND's success hinges on balancing clinical benefits with economic considerations and differentiation strategies.

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Key Takeaways

• Market potential is substantial: Uterine fibroids affect millions, offering a large patient base for SLYND.
• Competitive differentiation is crucial: Monotherapy, oral administration, and safety profile provide advantages over existing treatments.
• Adoption timeline influences revenue: Early uptake by specialists and inclusion in guidelines will accelerate growth.
• Pricing and reimbursement are pivotal: Achieving favorable payer coverage will significantly impact financial success.
• Long-term expansion possible: Additional indications could diversify revenue streams and enhance market position.

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FAQs

1. How does SLYND compare to existing treatments for uterine fibroids?
SLYND offers a non-surgical, oral option with a rapid onset and reversible effects, contrasting with GnRH agonists (which cause hypoestrogenism) and surgical procedures. Its targeted mechanism reduces side effects and improves patient convenience.

2. What are the main challenges facing SLYND’s market penetration?
Key challenges include physician familiarity with new therapies, reimbursement hurdles, competition from existing combination therapies, and establishing clinical superiority or economic benefits.

3. What is the potential for SLYND to treat other gynecological conditions?
While initially approved for uterine fibroids, future research might expand its use to adenomyosis or endometriosis, broadening its market footprint.

4. How will pricing strategies influence SLYND’s financial success?
Competitive pricing aligned with perceived value, coupled with favorable reimbursement, will be critical to maximize adoption and revenue.

5. What role do regulatory developments play in SLYND’s growth?
Regulatory flexibility for label expansion and post-marketing commitments can facilitate broader indications and stronger market presence, enhancing long-term revenue prospects.

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References

1. U.S. Food and Drug Administration. (2021). FDA approves first oral treatment for uterine fibroids.
2. Market databases and industry reports (estimated calculations based on disease prevalence and market share assumptions).