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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 five patent family members in thirty-five countries.

The generic ingredient in SEGLENTIS is celecoxib; tramadol hydrochloride. There are twenty-six drug master file entries for this compound. One supplier is listed 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 April 19, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for SEGLENTIS

International Patents:	105
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	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:

10,245,276

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.

Pharmacology for SEGLENTIS

Drug Class	Nonsteroidal Anti-inflammatory Drug Opioid Agonist
Mechanism of Action	Cyclooxygenase Inhibitors Full Opioid Agonists

US Patents and Regulatory Information for SEGLENTIS

SEGLENTIS is protected by seven US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 10,245,276.

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
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

Hong Kong

Hungary

India

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Poland

Portugal

Russian Federation

San Marino

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
New Zealand	603457	Pharmaceutical compositions of co-crystals of tramadol and coxibs
Portugal	2575778
San Marino	T201300048	Cocristalli di tramadol e inibitori della cox-2
Russian Federation	2012120088	СОКРИСТАЛЛЫ ТРАМАДОЛА И КОКСИБОВ
Slovenia	2349238
China	102186465	Co-crystals of tramadol and nsaids

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

SEGLENTIS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SEGLENTIS

Introduction to SEGLENTIS

SEGLENTIS is a proprietary product developed by ESTEVE, a pharmaceutical company, and it is a combination of celecoxib and tramadol hydrochloride. This drug is specifically indicated for the management of acute pain in adults.

Market Approval and Launch

SEGLENTIS received U.S. FDA approval in October 2021, marking a significant milestone in its market entry. This approval was a result of thorough clinical trials and regulatory reviews, highlighting the drug's efficacy and safety profile for acute pain management[4].

Market Segment and Positioning

SEGLENTIS falls under the category of compound medications within the analgesics market. This segment is expected to show the fastest growth over the forecast period due to the increasing adoption of combination drugs, which offer high effectiveness with minimal side effects[4].

Target Market and Indications

The primary target market for SEGLENTIS includes patients experiencing acute pain. This can encompass a variety of pain conditions, including post-operative pain, traumatic injuries, and other acute pain scenarios. The drug's indication for acute pain management positions it as a valuable option in both hospital and outpatient settings[4].

Competitive Landscape

The analgesics market, particularly the segment for acute pain management, is highly competitive. SEGLENTIS competes with other opioid and non-opioid analgesics, as well as other combination drugs. However, its unique formulation and FDA approval provide a competitive edge. Companies like Teva Pharmaceutical, Pfizer, and Abbott are key players in this market, and SEGLENTIS must navigate this competitive landscape to gain market share[3][4].

Financial Trajectory

While specific financial projections for SEGLENTIS alone are not detailed in the available sources, the overall analgesics market provides a context for its potential financial trajectory.

• Market Size and Growth: The global analgesics market is expected to grow significantly, with estimates suggesting it will reach USD 75.73 billion by 2032, growing at a CAGR of 5.39% from 2024 to 2032[1].
• Segment Growth: The compound medication segment, where SEGLENTIS is positioned, is anticipated to show rapid growth due to its effectiveness and minimal side effects. This segment's growth is expected to contribute significantly to the overall market expansion[4].

Revenue Potential

Given the approval and market positioning of SEGLENTIS, it is likely to capture a substantial share of the growing analgesics market. Here are some key points to consider:

• Market Share: As a newly approved drug, SEGLENTIS will aim to capture a significant share of the acute pain management market. The compound medication segment's growth rate suggests that SEGLENTIS could contribute substantially to ESTEVE's revenue[4].
• Sales Projections: While exact sales projections for SEGLENTIS are not available, the overall growth of the analgesics market and the specific segment it operates in indicate a promising financial outlook. The global pain management drugs market, which includes analgesics, is expected to reach USD 120.9 billion by 2033, growing at a CAGR of 4.2% from 2024 to 2033[3].

Distribution and Accessibility

SEGLENTIS is expected to be distributed through various channels, including hospital pharmacies, retail pharmacies, and potentially online pharmacies. The retail pharmacies segment, which dominated the analgesics market with a revenue share of 50.96% in 2022, is likely to be a key distribution channel for SEGLENTIS[4].

Challenges and Opportunities

Despite its promising market position, SEGLENTIS faces several challenges and opportunities:

• Regulatory Environment: The analgesics market is subject to stringent regulatory requirements, particularly in developed regions. Compliance with these regulations will be crucial for the continued market presence of SEGLENTIS[3].
• Competition from Non-Opioid Alternatives: The development of non-opioid alternatives could pose a challenge to SEGLENTIS. However, its unique formulation and FDA approval provide a competitive edge in the market[2].

Key Takeaways

• Approval and Launch: SEGLENTIS received FDA approval in October 2021 for acute pain management.
• Market Segment: It operates in the compound medication segment, which is expected to grow rapidly.
• Financial Outlook: The drug is poised to capture a significant share of the growing analgesics market.
• Distribution: It will be distributed through hospital pharmacies, retail pharmacies, and potentially online pharmacies.
• Challenges: It faces challenges from regulatory environments and competition from non-opioid alternatives.

FAQs

Q: What is SEGLENTIS, and what is it used for? A: SEGLENTIS is a proprietary product combining celecoxib and tramadol hydrochloride, approved for the management of acute pain in adults.

Q: When did SEGLENTIS receive FDA approval? A: SEGLENTIS received U.S. FDA approval in October 2021.

Q: Which market segment does SEGLENTIS operate in? A: SEGLENTIS operates in the compound medication segment of the analgesics market.

Q: What are the key distribution channels for SEGLENTIS? A: The key distribution channels include hospital pharmacies, retail pharmacies, and potentially online pharmacies.

Q: What challenges might SEGLENTIS face in the market? A: SEGLENTIS may face challenges from stringent regulatory requirements and competition from non-opioid alternatives.

Sources

1. Analgesics Market Size, Share & Global Growth Analysis 2031 - SNS Insider
2. Opioids Market Size To Reach Around USD 26.78 Billion By 2034 - Precedence Research
3. Pain Management Drugs Market Size | CAGR Of 4.2% - Market.US
4. Analgesics Market Size, Share And Growth Report, 2030 - Grand View Research
5. Form 10-K for Heron Therapeutics INC DE filed 03/12/2024 - Heron Therapeutics INC