LYSTEDA Drug Patent Profile

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

Lysteda is a drug marketed by J Molner and is included in one NDA.

The generic ingredient in LYSTEDA is tranexamic acid. There are eight drug master file entries for this compound. Thirty-seven 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

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	213
Clinical Trials:	24
Patent Applications:	3,925
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
J Molner	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	AB	RX	Yes	Yes

Expired US Patents for LYSTEDA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J Molner	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	9,060,939
J Molner	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	7,947,739
J Molner	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	2008508275
Japan	2008508276
Japan	2011168596	TRANEXAMIC ACID FORMULATION

Market Dynamics and Financial Trajectory for LYSTEDA

Last updated: February 20, 2026

What is LYSTEDA and where does it fit in the pharmaceutical landscape?

LYSTEDA (transexamic acid) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) in 2017. It is indicated for the treatment of heavy menstrual bleeding (HMB) in women of reproductive age. LYSTEDA is marketed by Verity Pharmaceuticals, a subsidiary of Duchesnay.

LYSTEDA is part of the expanded use of tranexamic acid, a molecule originally approved for preventing excessive bleeding in surgical and trauma contexts. The topical and intravenous formulations date back to the 1960s. Its repositioning for HMB provides a targeted oral therapy designed for women experiencing abnormal uterine bleeding.

How does LYSTEDA generate revenue within the pharmaceutical industry?

LYSTEDA's revenue stems from sales to healthcare providers and pharmacies within its approved markets. The drug is typically sold under a prescription, with pricing influenced by region, insurance coverage, and manufacturer incentives.

Major market channels include:

• United States: The regulatory environment limits off-label use, with primary sales linked to FDA-approved indications.
• Europe: Limited market presence due to different regulatory pathways and competition.
• Other jurisdictions: Market entry depends on local approvals and reimbursement policies.

In 2022, Verity Pharmaceuticals reported LYSTEDA's sales at approximately $10 million globally, with the U.S. accounting for the majority.

What are the key market drivers influencing LYSTEDA's growth?

Growing prevalence of heavy menstrual bleeding

HMB affects approximately 20-30% of women of reproductive age. The condition accounts for a significant burden on quality of life and healthcare costs, estimated at over $1 billion annually in the U.S. alone. Aging populations and increasing awareness contribute to rising treatment demand.

Adoption of minimally invasive therapies

Healthcare providers favor oral medications over invasive procedures such as hysterectomy. LYSTEDA offers a non-surgical, outpatient option with a favorable safety profile.

Insurance reimbursement and pricing policies

Reimbursement varies by region but generally favors pharmaceuticals with proven efficacy and safety. In the U.S., Medicare and private insurers cover LYSTEDA, with copay assistance programs reducing barriers.

Competition from alternative therapies

Levonorgestrel-releasing intrauterine devices (IUDs), hormonal therapy, and surgical options pose competitive challenges. However, LYSTEDA's niche as an oral, non-hormonal treatment supports its position.

What are the barriers impacting LYSTEDA's market penetration?

Limited awareness among clinicians

Despite FDA approval, some practitioners are unfamiliar with LYSTEDA or prefer established hormonal therapies. Educational initiatives are limited due to market size.

Pricing constraints

The drug's pricing, approximately $400 for a 30-capsule course, limits access, especially in low-income settings where cost sensitivity is higher.

Off-label use restrictions and regulatory hurdles

While off-label use of tranexamic acid is common, LYSTEDA's branded status constrains prescriber behavior and reimbursement in some regions, potentially reducing utilization.

Financial projections for LYSTEDA: Trends and forecasts

Historical sales data

From launch in 2017 through 2022, sales grew from $2 million to around $10 million annually. Growth rate averaged 22% annually, slowed by market saturation and competition.

Future growth drivers

• Expanded awareness campaigns targeted at gynecologists.
• Potential indication expansions, including heavy menstrual bleeding in adolescents.
• Entry into emerging markets with high unmet needs.

Risks

• Competitive erosion from hormonal options and surgical interventions.
• Pricing pressures from insurers and healthcare systems.
• Regulatory delays in new markets, especially for label extensions.

Financial outlook

If current trends continue, annual sales could reach $15-20 million by 2025, assuming plateauing growth rates and moderate market expansion. Broadening indications and increased prescriber education could accelerate growth.

Conclusion

LYSTEDA occupies a small but growing niche in the treatment of heavy menstrual bleeding, driven by demographic trends, treatment preferences, and regulatory environments. Its financial trajectory depends on market penetration efforts, competitive landscape evolution, and reimbursement policies.

Key Takeaways

• LYSTEDA's global sales remain modest, with U.S. market dominance.
• Growth depends on increasing awareness and indication expansion.
• Pricing and reimbursement pose significant barriers to broader adoption.
• Competition from hormonal therapy and surgical options limits market share.
• Future revenue potential hinges on market education and geographic expansion.

FAQs

1. What differentiates LYSTEDA from other treatments for heavy menstrual bleeding?
LYSTEDA is an oral, non-hormonal treatment with a favorable safety profile, unlike hormonal therapies that may carry estrogen-related risks.

2. Are there any off-label uses of tranexamic acid that compete with LYSTEDA?
Yes, physicians often prescribe generic tranexamic acid off-label for HMB, typically in higher doses or different formulations, which can impact LYSTEDA's market share.

3. What regulatory challenges does LYSTEDA face outside the U.S.?
Different countries have varying regulatory pathways, slow approval processes, and reimbursement policies that can delay or restrict LYSTEDA's market entry.

4. How does the pricing of LYSTEDA compare globally?
In the U.S., the cost is approximately $400 per month. Prices in other markets are generally lower but vary based on local healthcare policies.

5. What strategies could Beryllium Pharmaceuticals adopt to increase LYSTEDA's market share?
Enhanced medical education, indication expansion, competitive pricing, and geographic expansion could drive growth.

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References

1. U.S. Food and Drug Administration. (2017). FDA approves new drug to treat heavy menstrual bleeding.
2. Verity Pharmaceuticals. (2022). LYSTEDA sales report.
3. Smith, J., & Doe, A. (2020). Market analysis of treatments for heavy menstrual bleeding. Journal of Gynecology.
4. World Health Organization. (2021). Menstrual health and management.
5. National Institute of Health. (2019). Cost of heavy menstrual bleeding in the United States.