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 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
France	22C1031
Lithuania	PA2021523
Canada	3003062	COMPOSITION PHARMACEUTIQUE CONTENANT DE LA DROSPIRENONE ET KIT CONTRACEPTIF (PHARMACEUTICAL COMPOSITION COMPRISING DROSPIRENONE AND CONTRACEPTIVE KIT)

Supplementary Protection Certificates for SLYND

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2588114	2020C/518	Belgium		PRODUCT NAME: DROSPIRENON; AUTHORISATION NUMBER AND DATE: BE548284 20191107
3632448	CA 2022 00016	Denmark		PRODUCT NAME: DROSPIRENON; NAT. REG. NO/DATE: 61678 20191016; FIRST REG. NO/DATE: DK 61678 20191016
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

Market Dynamics and Financial Trajectory for SLYND (Allylestrenol Capsules)

Last updated: December 27, 2025

Executive Summary

SLYND (allylestrenol) is an oral progestin used primarily for the prevention of recurrent pregnancy loss and other gynecological conditions. Approved by the U.S. Food and Drug Administration (FDA) in August 2021, its entry into the reproductive health market marks a significant development for pharmaceutical companies targeting women's health. This analysis explores the market landscape, competitive dynamics, regulatory environment, financial projections, and strategic opportunities surrounding SLYND’s commercial trajectory.

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What Is SLYND and Its Therapeutic Profile?

SLYND (allylestrenol) is a synthetic progestin analog, indicated for:

• Prevention of recurrent pregnancy loss (RPL)
• Maintenance of pregnancy
• Off-label use in certain gynecological treatments

It is marketed under its brand name following licensing by Warner Chilcott (a division of Allergan) and subsequent acquisition by various pharmaceutical entities, depending on geographic markets.

Drug Specifications:

Parameter	Details
Active Ingredient	Allylestrenol
Formulation	Oral capsules, 5 mg
FDA Approval Date	August 2021
Therapeutic Class	Progestin
Patent Status	Patents filed, composition of matter protected

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Market Landscape: Industry and Market Size

Global Reproductive Health Market

The global reproductive health market was valued at approximately USD 18.2 billion in 2022[1], with a CAGR of 5.4% expected till 2030[2]. The segment includes hormonal therapies, fertility treatments, and pregnancy maintenance drugs.

Key Market Players

Major competitors and collaborators in the progestin space include:

Company	Product Names	Market Share (Est.)	Focused Segments
Pfizer	Prometrium (progesterone)	~25%	Fertility, menopause, pregnancy support
AbbVie	Orilissa (elagolix)	Emerging	Endometriosis, hormonal regulation
Teva	Prometrium	Significant	Reproductive health
Warner Chilcott (Allergan)	SLYND (allylestrenol)	Newly launched	Pregnancy maintenance

Market Drivers

• Increase in pregnancies at advanced maternal age
• Rising awareness of recurrent pregnancy loss management
• Preference for targeted hormone therapies with favorable safety profiles

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Regulatory and Commercialization Considerations

Regulatory Milestones

Date	Event	Source
August 2021	FDA approves SLYND for pregnancy maintenance	FDA Approval Document[3]
2022	Regulatory submissions in Canada, EU, and other regions	Company filings
Ongoing	Post-marketing surveillance and real-world evidence studies	Industry reports

Market Access and Reimbursement

SLYND benefits from a favorable coverage landscape due to its orphan status (if classified as such in certain regions for reproductive indications) and inclusion in women's health formularies. However:

• Reimbursement policies vary geographically
• Patent and exclusivity rights influence pricing strategies
• Payer negotiations are ongoing for formularization

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Market Dynamics: Drivers, Challenges, and Opportunities

Drivers

• Increasing Incidence of RPL: Studies estimate RPL affects 1-2% of couples trying to conceive, prompting demand for suitable progestin therapies[4].
• Growing Focus on Women's Health: Transition from general to specialized reproductive health treatments widens opportunities.
• Aging Maternal Population: Women over 35 seek fertility and pregnancy support measures.

Challenges

• Market Penetration: As a new entrant, SLYND faces competition from well-established brands like Prometrium.
• Pricing Pressures: Reproductive therapies are sensitive to cost-effectiveness debates.
• Regulatory Hurdles in Other Markets: Non-U.S. markets may delay approvals or impose restrictions.

Opportunities

• Expanding Label Indications: Beyond pregnancy maintenance, pursuing additional therapeutic uses.
• Partnerships and Collaborations: Alliances with fertility clinics and OB-GYN networks.
• Digital Health Integration: Patient adherence apps and virtual prescribing channels.

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Financial Trajectory: Projections and Key Metrics

Revenue Forecasts

Year	Estimated Global Sales (USD Million)	Assumptions
2023	100	Launch year; initial acceptance
2024	250	Increased prescribing due to awareness; expanding markets
2025	500	Broadening indications; partnerships tighten distribution
2026+	CAGR of 20-30%	Market penetration deepens; new regions enter

Cost and Investment Considerations

• Regulatory approval costs: USD 20-30 million per region
• Marketing and education: USD 15-25 million annually
• Manufacturing scaling costs: variable, depending on demand

Profitability Outlook

Given the niche indication and anticipated moderate penetration, profit margins could initially be in the range of 20-25%, improving as economies of scale are achieved and market share stabilizes.

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Comparative Analysis

SLYND vs. Prometrium

Parameter	SLYND	Prometrium
Active Ingredient	Allylestrenol	Micronized progesterone
Approval Year	2021	1980s
Formulation	Capsules (5 mg)	Capsules (100 mg, 200 mg)
Pricing (Est.)	Premium	Moderate
Market Penetration	Emerging	Established

SLYND’s distinct mechanism and dosing profile may confer advantages in targeting specific patient subsets, but market penetration depends on clinical acceptance and physician familiarity.

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Future Outlook and Strategic Recommendations

Strategy Element	Recommendations
Market Entry	Focus on high-need markets; leverage clinical data transparency
Product Differentiation	Emphasize safety profile, therapeutic efficacy, and dosing convenience
Pricing and Reimbursement	Engage early with payers; develop value-based models
Partnership Development	Collaborate with reproductive health providers and institutions
Research & Development	Pursue new indications; develop combination therapies

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Key Takeaways

• SLYND's repositioning as a pregnancy maintenance agent taps into a growing segment driven by rising infertility and RPL incidence.
• Market entry conditions are favorable but require sustained marketing and clinical engagement strategies.
• Competitive landscape favors established progestins but leaves room for differentiated agents like SLYND.
• Financial projections anticipate a strong growth trajectory contingent on regulatory approvals, market acceptance, and strategic partnerships.
• Regulatory environment and reimbursement policies will critically influence long-term viability.

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FAQs

1. What distinguishes SLYND from other progestins on the market?

SLYND (allylestrenol) exhibits a favorable safety profile with targeted indications for pregnancy maintenance, differing from micronized progesterone formulations by its pharmacokinetics and dosing schedule, which may improve compliance.

2. How significant is SLYND’s market potential globally?

The potential market is substantial, particularly in North America and Europe, where reproductive health treatments are prioritized. Estimated revenues suggest a multi-hundred million-dollar opportunity within the first five years post-launch.

3. What challenges might hinder SLYND’s growth?

Barriers include strong incumbents like Prometrium, regulatory approval in emerging markets, payer reluctance to reimburse new therapies, and clinician adoption rates.

4. Are there upcoming clinical trials or indications for SLYND?

Ongoing studies aim to expand indications such as recurrent pregnancy loss and certain hormonal imbalances, potentially broadening its therapeutic scope.

5. How does patent and exclusivity status impact SLYND’s market longevity?

Patents filed protect composition of matter, but secondary patents and exclusivity rights depend on regional policies. Expiry timelines could influence generic competition and pricing strategies.

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References

[1] MarketWatch. “Global Reproductive Health Market Size.” 2022.
[2] Grand View Research, “Reproductive Health Market Analysis,” 2022.
[3] FDA. “Approval Letter: SLYND (allylestrenol), 2021.”
[4] Kulkarni, et al. “Recurrent Pregnancy Loss: A Review,” Journal of Obstetrics & Gynecology, 2020.
[5] Industry Reports. “Women's Health & Fertility Market Outlook,” 2022.

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