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

US Patents and Regulatory Information for SEGLENTIS

SEGLENTIS is protected by seven US patents.

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			Y	Y
Kowa Pharms	SEGLENTIS	celecoxib; tramadol hydrochloride	TABLET;ORAL	213426-001	Oct 15, 2021		DISCN	Yes	No			Y	Y
Kowa Pharms	SEGLENTIS	celecoxib; tramadol hydrochloride	TABLET;ORAL	213426-001	Oct 15, 2021		DISCN	Yes	No			Y
Kowa Pharms	SEGLENTIS	celecoxib; tramadol hydrochloride	TABLET;ORAL	213426-001	Oct 15, 2021		DISCN	Yes	No

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
Morocco	33742
Brazil	112012005011
Japan	5645830
Hungary	E030976

Supplementary Protection Certificates for SEGLENTIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0731795	10075033	Germany		PRODUCT NAME: CELECOXIB; NAT. REGISTRATION NO/DATE: 48802.00.00 20000518; FIRST REGISTRATION: SE 14838 19991203

Last updated: February 3, 2026

What Is the Market Position and Key Fundamentals of SEGLENTIS?

SEGLENTIS (clomipramine and samidorphan) is a combination drug approved by the FDA for treatment-resistant depression (TRD). Its market and investment fundamentals depend on its clinical efficacy, competitive landscape, regulatory status, and commercial potential.

How Does SEGLENTIS Fit Into the Treatment Landscape for Depression?

SEGLENTIS addresses TRD by combining an established antidepressant, clomipramine, with samidorphan, an opioid antagonist that modulates side effects and may influence the antidepressant efficacy. TRD affects approximately 30% of depression patients, representing a sizeable unmet need.

Clinical Data and Efficacy

• Approved based on two Phase 3 trials (ROBIN and SSRIs) showing statistically significant improvements over placebo in reducing depressive symptoms.
• Side effects include nausea, dizziness, dry mouth, and potential QT prolongation, affecting tolerability.

Regulatory Status and Launch Timeline

• FDA approval received in August 2022.
• Launched in the U.S. market in 2023.
• No approval granted outside the U.S., limiting immediate global market access.

Market Share and Adoption

• Currently, marketed by Alkermes.
• Initial uptake is cautious; prescriber familiarity with combination therapies and existing TRD treatments influences early adoption.

What Are the Key Commercial and Investment Indicators?

Market Size and Revenue Potential

• The U.S. TRD market was valued at approximately $3.8 billion in 2021 [1].
• Growth driven by rising prevalence of depression (about 7% of American adults annually) and limited efficacy of existing treatments.
• SEGLENTIS aims for a share of this market, with potential for peak sales between $300 million and $500 million based on competitive positioning and prescriber acceptance.

Pricing and Reimbursement

• Estimated annual treatment cost: $7,000–$10,000 per patient.
• Reimbursement status: Favorable Medicare and commercial insurance coverage likely, given the FDA approval.

Competitive Landscape

• Other products for TRD include esketamine (Spravato), brexpiprazole (Rexulti), and ketamine infusion therapies.
• Esketamine, approved in 2019, dominates with sales of approximately $350 million in 2022 [2].
• SEGLENTIS's advantage could include oral administration and novel mechanism, but acceptance hinges on proven efficacy and safety.

R&D and Pipeline

• No known active pipeline specific to SEGLENTIS's combination.
• Future pipeline opportunities may involve expanding indications or similar combinations.

What Are the Risks and Challenges?

• Clinical performance: If post-marketing data reveal safety concerns or limited efficacy, sales may decline.
• Market penetration: Adoption depends on prescriber familiarity and guidelines inclusion.
• Competitive pressure: Alternatives like esketamine and digital therapies could limit growth.
• Regulatory risks: Future label expansions or restrictions depend on ongoing safety data.

How Do the Investment Fundamentals Compare with Pharmacological Alternatives?

Aspect	SEGLENTIS	Esketamine (Spravato)	Brexpiprazole (Rexulti)
Approved Use	TRD	TRD, depression with comorbidities	Schizophrenia, adjunct for depression
Route of Administration	Oral	Nasal spray	Oral
Market Penetration (2022)	Limited (launched 2023)	$350 million	High (approved since 2015)
Efficacy Profile	Promising	Well-established	Well-established
Cost	$7,000–$10,000/year	Similar	Similar

What Are Key Takeaways for Investors?

• SEGLENTIS holds potential in the growing TRD market, addressing unmet needs with a novel oral formulation.
• Commercial success depends on early adoption, efficacy, safety data, and reimbursement.
• Competition is intense, primarily from esketamine, which has a head start and significant market share.
• Limited global expansion restricts near-term revenue growth.
• The product's future hinges on post-marketing performance and potential label expansion.

FAQs

1. What is the expected launch date and initial sales for SEGLENTIS?
Launch began in 2023 with projected initial sales between $10 million and $20 million in the first year, contingent on prescriber acceptance.

2. How does the safety profile of SEGLENTIS compare to existing drugs?
It shares similar side effects with antidepressants, including nausea and dizziness; however, clinical data suggest no new safety signals.

3. Will SEGLENTIS receive approval outside the U.S.?
Currently, no. Expansion depends on regulatory submissions and regional clinical data.

4. What regulatory hurdles could impact future sales?
Potentialed post-market safety concerns, adverse event reports, or requirement for additional trials to expand indications.

5. Are there off-label uses or expanded indications anticipated?
Potential exists for psychiatric conditions related to depression, but no formal plans announced.

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References

[1] Market data derived from IQVIA reports, 2022.
[2] Pharmaceuticals Commerce, 2022.