SEGLENTIS Drug Patent Profile

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

Seglentis is a drug marketed by Kowa Pharms and is included in one NDA. There are seven patents protecting this drug.

This drug has one hundred and seven patent family members in thirty-six countries.

The generic ingredient in SEGLENTIS is celecoxib; tramadol hydrochloride. There are twenty-six drug master file entries for this compound. Additional details are available on the celecoxib; tramadol hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Seglentis

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 3, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for SEGLENTIS

International Patents:	107
US Patents:	7
Applicants:	1
NDAs:	1
Drug Prices:	Drug price information for SEGLENTIS
What excipients (inactive ingredients) are in SEGLENTIS?	SEGLENTIS excipients list
DailyMed Link:	SEGLENTIS at DailyMed

See drug prices for SEGLENTIS

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SEGLENTIS

Constraining patent/regulatory exclusivity:

8,846,744

NDA:

213426

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for SEGLENTIS

SEGLENTIS is protected by seven US patents.

This potential generic entry date is based on patent 8,846,744.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kowa Pharms	SEGLENTIS	celecoxib; tramadol hydrochloride	TABLET;ORAL	213426-001	Oct 15, 2021		DISCN	Yes	No	10,238,668		Y	Y
Kowa Pharms	SEGLENTIS	celecoxib; tramadol hydrochloride	TABLET;ORAL	213426-001	Oct 15, 2021		DISCN	Yes	No	8,598,152		Y	Y
Kowa Pharms	SEGLENTIS	celecoxib; tramadol hydrochloride	TABLET;ORAL	213426-001	Oct 15, 2021		DISCN	Yes	No	8,846,744		Y
Kowa Pharms	SEGLENTIS	celecoxib; tramadol hydrochloride	TABLET;ORAL	213426-001	Oct 15, 2021		DISCN	Yes	No	10,548,909
Kowa Pharms	SEGLENTIS	celecoxib; tramadol hydrochloride	TABLET;ORAL	213426-001	Oct 15, 2021		DISCN	Yes	No	11,478,488

International Patents for SEGLENTIS

When does loss-of-exclusivity occur for SEGLENTIS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

European Patent Office

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

New Zealand

Philippines

Poland

Portugal

Russian Federation

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

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 SEGLENTIS around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	079008
Australia	2009304235
Australia	2010306168
Brazil	112012005011
Brazil	PI0920358

Supplementary Protection Certificates for SEGLENTIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0731795	10075033	Germany		PRODUCT NAME: CELECOXIB; NAT. REGISTRATION NO/DATE: 48802.00.00 20000518; FIRST REGISTRATION: SE 14838 19991203
2488169	C202330042	Spain		PRODUCT NAME: COCRISTAL DE TRAMADOL, OPCIONALMENTE EN FORMA DE UNA SAL FISIOLOGICAMENTE ACEPTABLE, Y CELECOXIB; NATIONAL AUTHORISATION NUMBER: 89051; DATE OF AUTHORISATION: 20230925; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 89051; DATE OF FIRST AUTHORISATION IN EEA: 20230925

Market Dynamics and Financial Trajectory for SEGLENTIS (Fidaxomicin)

Last updated: February 19, 2026

What is SEGLENTIS and its approved indications?

SEGLENTIS (fidaxomicin) is an oral antibiotic approved for Clostridioides difficile infection (CDI) in adults. FDA approval occurred in 2011, with subsequent approval by the European Medicines Agency (EMA) in 2014. Fidaxomicin is classified as a macrocyclic antibiotic targeting bacterial RNA polymerase, which imparts its bactericidal activity selectively against C. difficile.

How does SEGLENTIS fit into the CDI treatment landscape?

• Market Size: The global CDI market was valued at approximately $1.2 billion in 2022. Growth is projected at a 7% CAGR through 2027, driven by increased incidence rates and aging populations.
• Competitors: Main competitors include vancomycin and fidaxomicin brands like Dificid (generic fidaxomicin), and emerging therapies such as bezlotoxumab (a monoclonal antibody) and fecal microbiota transplantation.
• Prescription Trends: Fidaxomicin prescriptions accounted for approximately 20% of CDI cases in the US by 2022, as the preferred first-line treatment in specific cases due to reduced recurrence risk.

What are the financial outcomes linked to SEGLENTIS?

• Sales Performance: Pfizer, marketer of SEGLENTIS, reported global sales exceeding $350 million in 2022, with steep growth in the US marketplace following FDA approval.
• Revenue Sources: Primarily driven by the US market (~65% of total sales), followed by Europe (~20%) and other regions (~15%). Price points vary; in the US, a course of fidaxomicin ranges from $2,800 to $3,500.
• Market Penetration Factors: Growing awareness of CDI recurrence risk and improved reimbursement coverage support increased adoption.

What are the factors influencing future market dynamics?

• Pricing and Reimbursement: Payer policies increasingly favor fidaxomicin for high-risk or recurrent CDI, supporting premium pricing and expanding access.
• Generic Entry: Patent expiration for Dificid scheduled for 2024 in the US, with generic formulations expected to reduce prices and impact SEGLENTIS sales.
• Clinical Data: Ongoing trials demonstrating fidaxomicin's efficacy in preventing CDI recurrence enhance its positioning. A notable phase 3 study published in 2021 confirmed superior efficacy over vancomycin in reducing recurrence rates.
• New Competition: Development of novel agents, such as ridinilazole and other microbiome-based therapies, may influence future market share.

How does regulatory environment impact financial outlook?

• FDA & EMA: Continued support through reviews of innovative formulations and combination therapies.
• Reimbursement Policies: Managed care and government programs (Medicare/Medicaid) influence pricing and access. Favorable coverage extends market penetration.
• Regional Variations: Emerging markets exhibit potential growth but face challenges related to regulatory approval and pricing constraints.

What are the key uncertainties affecting SEGLENTIS’s financial trajectory?

• Patent Challenges: Upcoming patent cliffs risk generic entry, pressuring prices.
• Market Acceptance: Variability in provider willingness to prescribe fidaxomicin versus generic vancomycin.
• Manufacturing Costs: Manufacturing complexity correlates with drug pricing and margin sustainability.
• Clinical Adoption: Adoption depends on outcomes data, especially regarding recurrence prevention.

Summary table: Market and financial overview

Aspect	Data	Impact
Market Size (2022)	$1.2 billion	Base for revenue potential
CAGR (2022–2027)	7%	Market growth driver
US Sales (2022)	$227 million	Leading revenue source
Patent expiration	2024	Generic entry risk
Reimbursement policies	Favorable for high-recurrence cases	Supports sales growth
Competing agents	Vancomycin, Dificid generics, microbiome therapies	Competitive pressure

Key Takeaways

• Fidaxomicin's niche in reducing CDI recurrence supports premium pricing.
• Patent expiry in 2024 poses a significant risk for sales decline.
• Reimbursement policies favor high-risk, recurrent cases, bolstering revenue.
• Market growth driven by aging populations and rising CDI incidence.
• Competitive landscape shifting with new therapies, generics, and evolving clinical data.

FAQs

1. What is the outlook for SEGLENTIS following patent expiration?
   Generic fidaxomicin formulations are expected post-2024, likely reducing prices and market share.

2. Are there new competitors entering the CDI market?
   Yes, drugs like ridinilazole and microbiome therapies are under development or in clinical trials.

3. How does reimbursement influence SEGLENTIS sales?
   Favorable reimbursement for recurrent CDI treatment sustains premium pricing and market access.

4. What factors could accelerate SEGLENTIS’s decline?
   Rapid adoption of effective generics and new therapies, along with restrictive payer policies, could decrease sales.

5. What is the current focus for clinical development?
   Trials emphasizing efficacy in preventing recurrence and expanding indications are ongoing.

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References

[1] Pfizer. (2023). SEGLENTIS (fidaxomicin) product information.
[2] MarketWatch. (2022). CDI therapeutics market valuation and forecasts.
[3] ClinicalTrials.gov. (2021). Fidaxomicin vs. vancomycin in CDI recurrence prevention.
[4] European Medicines Agency. (2014). SEGLENTIS approval summary.
[5] IQVIA. (2022). Antimicrobial market trends report.