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. Forty 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:	258
Clinical Trials:	24
Patent Applications:	3,510
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
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	AB	RX	Yes	Yes			Y
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	AB	RX	Yes	Yes			Y

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
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009

International Patents for LYSTEDA

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

Country	Patent Number	Title	Estimated Expiration
Japan	5000504
Japan	2014193878	TRANEXAMIC ACID FORMULATIONS
Japan	2011168596	TRANEXAMIC ACID FORMULATION

Market Dynamics and Financial Trajectory for LYSTEDA

Introduction to LYSTEDA

LYSTEDA, also known as tranexamic acid, is a first-in-class, non-hormonal therapy specifically indicated for the treatment of women with cyclic heavy menstrual bleeding (HMB). Here, we will delve into the market dynamics and financial trajectory of this drug.

Historical Acquisition and Ownership

LYSTEDA has undergone significant changes in ownership, reflecting its strategic importance in the pharmaceutical market. Initially, Ferring Pharmaceuticals acquired the global rights to LYSTEDA from Xanodyne Pharmaceuticals, Inc. in 2010, expanding Ferring's Women’s Health product portfolio[2].

In December 2020, Amring Pharmaceuticals Inc. acquired the global rights to LYSTEDA from Ferring International Center S.A., further solidifying Amring's position in the treatment of HMB[1][5].

Market Position and Expansion

The acquisition by Amring has significantly strengthened its market position in the treatment of HMB. Amring had already been marketing the authorized generic version of LYSTEDA in the USA since March 14, 2016. With the global rights, Amring is now poised to expand product opportunities in markets outside of the USA[1][5].

Global Reach

LYSTEDA's market reach extends beyond the U.S., with potential expansion into other regions. Ferring initially planned to market LYSTEDA in the U.S. and evaluate opportunities in other markets, a strategy that Amring is likely to continue and expand upon[2].

Market Drivers

Several factors drive the demand for LYSTEDA and the broader anti-fibrinolytic drugs market:

Increasing Prevalence of HMB

Heavy menstrual bleeding affects a significant number of women, with estimates suggesting up to 22 million women in the U.S. alone suffer from HMB. This prevalence ensures a steady demand for effective treatments like LYSTEDA[2].

Growing Adoption in Other Indications

Beyond HMB, anti-fibrinolytic drugs like LYSTEDA are increasingly used in oral bleeding treatments and for conditions such as platelet dysfunctions, Von Willebrand disease, and hemophilia. This broader adoption is expected to bolster market growth[4].

Road Accidents and Trauma

The rising frequency of road accidents and trauma, which often result in severe bleeding, also drives the demand for anti-fibrinolytic drugs. This trend is particularly significant in regions like North America[4].

Financial Trajectory

Revenue Growth

The acquisition of LYSTEDA by Amring is expected to bring long-term value to patients and customers, translating into revenue growth. The global anti-fibrinolytic drugs market, which includes LYSTEDA, is projected to grow at a CAGR of 5% between 2024 and 2032[4].

Market Size and Share

The anti-fibrinolytic drugs market, driven by the increasing use of drugs like LYSTEDA, is substantial. North America has been a significant market for these drugs, and this dominance is expected to continue due to the rising numbers of severe road accidents and trauma[4].

R&D Investments

Growing investments in healthcare R&D, particularly in hemophilia products, are also expected to influence the demand for LYSTEDA and similar drugs. These investments are likely to enhance the product's efficacy and expand its indications, further driving market growth[4].

Competitive Landscape

The market for anti-fibrinolytic drugs, including LYSTEDA, is competitive with several key players. Amring's acquisition of LYSTEDA positions it as a market leader in the treatment of HMB, competing with other pharmaceutical companies that offer similar or complementary products[1][4].

Regional Market Dynamics

North America

North America has been a significant market for anti-fibrinolytic drugs due to the high incidence of road accidents and trauma. This region is expected to continue driving the market for LYSTEDA and other similar drugs[4].

Europe, Asia Pacific, and Latin America

These regions are also crucial for the anti-fibrinolytic drugs market. The growing healthcare sector in emerging regions and increasing investments in R&D are expected to augment the market growth in these areas[4].

Patient and Market Impact

Patient Benefits

LYSTEDA offers significant benefits to patients by providing an effective, non-hormonal treatment for HMB. This improves the quality of life for women suffering from this condition and reduces the need for more invasive treatments[2].

Market Value

The acquisition and continued marketing of LYSTEDA by Amring are expected to bring long-term value to both patients and the company. This is reflected in Amring's commitment to expanding product opportunities and securing its position as a market leader in HMB treatment[1][5].

Future Outlook

Growth Projections

The global anti-fibrinolytic drugs market, including LYSTEDA, is projected to grow at a CAGR of 5% between 2024 and 2032. This growth is driven by increasing demand for effective treatments for HMB, road accidents, and other conditions requiring anti-fibrinolytic drugs[4].

Strategic Expansion

Amring's acquisition of LYSTEDA is part of a broader strategy to expand its product portfolio and market reach. This strategic move is expected to enhance Amring's financial performance and market position in the coming years[1][5].

Key Takeaways

• LYSTEDA is a first-in-class, non-hormonal therapy for cyclic heavy menstrual bleeding (HMB).
• The drug has undergone significant ownership changes, with Amring Pharmaceuticals Inc. currently holding the global rights.
• The market for LYSTEDA is driven by the increasing prevalence of HMB, growing adoption in other indications, and rising road accidents and trauma.
• The global anti-fibrinolytic drugs market, including LYSTEDA, is projected to grow at a CAGR of 5% between 2024 and 2032.
• Amring's acquisition is expected to bring long-term value to patients and the company, solidifying its market position.

FAQs

What is LYSTEDA used for?

LYSTEDA, or tranexamic acid, is used specifically for the treatment of women with cyclic heavy menstrual bleeding (HMB).

Who currently owns the global rights to LYSTEDA?

Amring Pharmaceuticals Inc. currently owns the global rights to LYSTEDA, having acquired them from Ferring International Center S.A. in December 2020.

What are the key drivers of the anti-fibrinolytic drugs market?

The key drivers include the increasing prevalence of HMB, growing adoption in other indications such as oral bleeding treatments, and the rising frequency of road accidents and trauma.

How is the market for LYSTEDA expected to grow?

The global anti-fibrinolytic drugs market, including LYSTEDA, is projected to grow at a CAGR of 5% between 2024 and 2032.

What regions are significant for the anti-fibrinolytic drugs market?

North America, Europe, the Asia Pacific, Latin America, and the Middle East and Africa are the significant markets for anti-fibrinolytic drugs.

Sources

1. Amring Pharmaceuticals Inc. Acquires LYSTEDA® - BioSpace
2. Ferring acquires LYSTEDA™ from Xanodyne Pharmaceuticals, Inc. - Ferring
3. EXPRESS SCRIPTS CANADA - DRuG TRenD RePoRT - Express Scripts Canada
4. Anti-fibrinolytic Drugs Market Share, Trends 2024-2032 - Expert Market Research
5. Amring Pharmaceuticals Inc. Acquires LYSTEDA® - Business Wire

Last updated: 2024-12-17