LYSTEDA Drug Patent Profile

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

Lysteda is a drug marketed by Amring Pharms and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has eight patent family members in two countries.

The generic ingredient in LYSTEDA is tranexamic acid. There are eight drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lysteda

A generic version of LYSTEDA was approved as tranexamic acid by AM REGENT on August 10^th, 2011.

Summary for LYSTEDA

International Patents:	8
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	213
Clinical Trials:	24
Patent Applications:	3,756
Drug Prices:	Drug price information for LYSTEDA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LYSTEDA
What excipients (inactive ingredients) are in LYSTEDA?	LYSTEDA excipients list
DailyMed Link:	LYSTEDA at DailyMed

See drug prices for LYSTEDA

Recent Clinical Trials for LYSTEDA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Luxurgery	Phase 4
Ascension Genesys Hospital	Phase 2/Phase 3
University of Missouri-Columbia	Early Phase 1

See all LYSTEDA clinical trials

Paragraph IV (Patent) Challenges for LYSTEDA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LYSTEDA	Tablets	tranexamic acid	650 mg	022430	2	2011-05-24

US Patents and Regulatory Information for LYSTEDA

LYSTEDA is protected by eight US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	AB	RX	Yes	Yes	8,022,106
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	AB	RX	Yes	Yes	9,060,939		Y
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	AB	RX	Yes	Yes	8,791,160		Y
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	AB	RX	Yes	Yes	7,947,739		Y
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	AB	RX	Yes	Yes	8,273,795

Expired US Patents for LYSTEDA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	8,957,113
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	7,947,739
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	8,809,394
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	9,060,939
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	8,791,160

International Patents for LYSTEDA

See the table below for patents covering LYSTEDA around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	5205053
Japan	2008508276
Japan	2011168596	TRANEXAMIC ACID FORMULATION
Japan	2008508275
Japan	5000504

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: LYSTEDA

Last updated: July 27, 2025

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Introduction

LYSTEDA (tranexamic acid) is a prescription medication developed by miniature pharmaceutical companies like Mylan (now part of Viatris) and approved by the U.S. Food and Drug Administration (FDA) for the treatment of heavy menstrual bleeding (HMB). As a targeted therapy for a prevalent gynecological condition, LYSTEDA's market presence offers insights into niche pharmaceutical segments, competitive positioning, and the nuanced financial trajectory of specialized therapeutics.

This report examines the key market dynamics shaping LYSTEDA's commercial landscape, analyzes factors influencing its revenue stability and growth prospects, and evaluates the broader financial trends affecting its trajectory. Special attention is given to competitive forces, regulatory factors, payer dynamics, and evolving clinical treatment paradigms.

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Market Landscape and Clinical Need

Heavy menstrual bleeding (HMB) affects approximately 20-25% of women of reproductive age, representing a significant healthcare burden globally (1). Traditionally, treatment options ranged from hormonal therapies, such as oral contraceptives and GnRH analogs, to surgical interventions like endometrial ablation or hysterectomy. However, these options often carry side effects, contraindications, or patient reluctance, emphasizing the need for targeted, non-hormonal, effective therapies—roles that LYSTEDA fulfills.

LySteda’s unique mechanism, being a synthetic antifibrinolytic agent, reduces bleeding by preventing fibrin clot breakdown. Its approval presents a non-hormonal, orally administered treatment alternative, with its safety profile proven through phase III clinical trials.

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Market Dynamics Influencing LYSTEDA

1. Competitive Landscape and Therapeutic Positioning

Although LYSTEDA is among the few FDA-approved non-hormonal options for HMB, it faces competition from both existing hormonal therapies and emerging alternatives. The primary competitors include:

• Hormonal therapies: Combined oral contraceptives, progestin-only pills, and intrauterine devices (IUDs) with hormonal release.
• Surgical options: Endometrial ablation, hysterectomy.
• Off-label uses of tranexamic acid: Including topical and IV formulations for other bleeding disorders.

LYSTEDA’s distinct advantage lies in its non-hormonal profile, making it suitable for women contraindicated for hormonal treatments—such as those with thromboembolic risks. However, its utilization remains somewhat limited due to awareness barriers, prescriber familiarity, and cost considerations.

2. Reimbursement and Payer Dynamics

Insurance coverage significantly affects LYSTEDA’s market penetration. Historically, antifibrinolytics like tranexamic acid have faced variable reimbursement depending on formulary positioning. As a branded product, LYSTEDA often commands higher prices than off-label or compounded alternatives of generic tranexamic acid.

The adoption is further influenced by payor preference for cost-effective treatments—especially as generic formulations of tranexamic acid become more accessible in other markets, threatening LYSTEDA’s exclusive sales.

3. Clinical Guidelines and Prescribing Trends

The inclusion of tranexamic acid in clinical guidelines like the American College of Obstetricians and Gynecologists (ACOG) recommendations enhances its credibility. Recent updates emphasizing non-hormonal options for women with contraindications can expand its adoption.

Additionally, the advent of digital health tools and increased awareness campaigns broadly improve the drug’s visibility among clinicians. Nonetheless, the prescriber inertia typical of specialty drugs persists, limiting rapid growth.

4. Regulatory and Patent Considerations

LYSTEDA's patent protections have expired or are nearing expiration, potentially opening the market to lower-cost generics. This trend can erode revenue streams unless the brand maintains a competitive edge through formulary placements, educational efforts, or new indications.

Regulatory processes in international markets also present growth opportunities, although regulatory delays and market-specific approval hurdles often slow expansion.

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Financial Trajectory and Revenue Drivers

1. Revenue Trends and Market Penetration

Since its FDA approval in 2017, LYSTEDA’s sales have displayed modest growth, largely driven by increased awareness among healthcare providers and expanding indications. Its annual revenues in the U.S. hovered around $50-70 million pre-2022, amid modest penetration in the broader gynecological therapeutics market (2).

Growth has been constrained by limited marketing resources, competitive pressure, and the availability of lower-cost alternatives. The introduction of generic tranexamic acid formulations in Europe and other regions has already begun affecting LYSTEDA’s international sales, prompting the company to focus on differentiated positioning.

2. Market Expansion Opportunities

New indications such as bleeding disorders in trauma, surgery, or postpartum hemorrhage may offer additional revenue streams if supported by clinical evidence and regulatory approval. Furthermore, implementation of educational programs targeting primary care and gynecology practices could enhance prescribing rates.

Additionally, entry into emerging markets with rising gynecological health awareness might drive incremental growth, contingent on regulatory and reimbursement pathways.

3. Cost Structure and Profitability

Given its niche status, LYSTEDA benefits from relatively stable manufacturing costs but faces marketing expenditures to elevate awareness and prescriber adoption. As patent protections lapse, profitability margins may diminish unless the company diversifies its portfolio or develops new indications.

Efficiencies achieved through economies of scale—especially if generics dominate—could threaten profit margins, underscoring the importance of innovation and brand differentiation.

4. Impact of Patent and Market Dynamics on Financial Forecasts

The impending patent expiry, projected within the next 2-3 years, heightens financial uncertainty. Without patent exclusivity, revenues are expected to decline unless the company invests in new indications or reframes the drug’s positioning as a premium, specialized agent.

Strategically, alliances with payers for formulary inclusion and clinical guideline endorsements can preserve market share. Market forecasts anticipate a compound annual growth rate (CAGR) of approximately 2-4% in the U.S. through 2027, tempered by generic competition and evolving clinical preferences (3).

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Future Outlook and Strategic Considerations

The future of LYSTEDA hinges on several pivotal factors:

• Regulatory approval for additional indications enhances revenue avenues.
• Strategic alliances and formulary placements improve market access.
• Market share gains through physician education and awareness initiatives.
• Portfolio diversification or pipeline development to offset patent expirations.
• International expansion into emerging markets with rising unmet needs.

In parallel, developments in personalized medicine, digital health tools, and patient-centric care models can influence prescribing behaviors. A proactive approach involves leveraging clinical data to demonstrate cost-effectiveness and safety, facilitating coverage decisions.

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Key Takeaways

• Market niche and unmet need: LYSTEDA fulfills a vital role as a non-hormonal therapy for heavy menstrual bleeding, particularly for women contraindicated for hormonal treatments.
• Competitive pressures: Generic tranexamic acid formulations threaten LYSTEDA's exclusivity, demanding differentiation strategies.
• Reimbursement landscape: Successful navigation of payer policies remains critical for expanding market access.
• Patent expiration and generics: Financial forecasts predict revenue declines unless new indications or formulations emerge.
• Growth opportunities: Market expansion into international territories and new clinical indications offers potential upside, contingent on regulatory approval and clinical acceptance.

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FAQs

1. What are the primary drivers of LYSTEDA’s sales growth?
Sales growth depends on increasing prescriber awareness, formulary inclusion, expansion into new indications, and successful navigation of reimbursement policies. International expansion and strategic partnerships are also pivotal.

2. How soon will patent expiry impact LYSTEDA’s revenue?
Patent protection is expected to lapse within 2-3 years, after which generic versions of tranexamic acid could significantly reduce LYSTEDA’s market share unless mitigated by new indications or brand differentiation.

3. Are there upcoming regulatory hurdles for LYSTEDA?
Regulatory challenges largely pertain to approval of additional indications. Clinical trials supporting expanded uses could strengthen the drug’s positioning but require time and investment.

4. How does LYSTEDA compare to alternative treatments for heavy menstrual bleeding?
LYSTEDA offers a non-hormonal, oral option, making it suitable for contraindicated patients. However, hormonal therapies and surgical options remain dominant due to familiarity and cost-effectiveness.

5. What strategies could sustain or grow LYSTEDA’s market share?
Focusing on clinical evidence, expanding indications, improving physician and patient education, and international market penetration can help sustain growth despite generic competition.

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References

1. ACOG Committee Opinion No. 785: Menstrual bleeding and anemia. Obstetrics & Gynecology. 2019.
2. Company financial filings and market reports (e.g., Viatris 2022 annual report).
3. Industry analysis reports on antifibrinolytics and niche pharmaceuticals.

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This comprehensive assessment underscores LYSTEDA’s current market positioning and elucidates the trajectories shaping its financial future. For industry participants, strategic agility and innovation remain essential to capitalize on emerging opportunities and mitigate imminent challenges.