TIVORBEX Drug Patent Profile

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

Tivorbex is a drug marketed by Genus and is included in one NDA. There are three patents protecting this drug.

This drug has thirty-seven patent family members in twenty-one countries.

The generic ingredient in TIVORBEX is indomethacin. There are fifteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the indomethacin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tivorbex

A generic version of TIVORBEX was approved as indomethacin by CHARTWELL MOLECULES on August 6^th, 1984.

Summary for TIVORBEX

International Patents:	37
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	2
Patent Applications:	4,009
Drug Prices:	Drug price information for TIVORBEX
What excipients (inactive ingredients) are in TIVORBEX?	TIVORBEX excipients list
DailyMed Link:	TIVORBEX at DailyMed

See drug prices for TIVORBEX

Recent Clinical Trials for TIVORBEX

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National University, Singapore	Phase 2
Sen-Jam Pharmaceutical	Phase 2
Iroko Pharmaceuticals, LLC	Phase 2

See all TIVORBEX clinical trials

US Patents and Regulatory Information for TIVORBEX

TIVORBEX is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genus	TIVORBEX	indomethacin	CAPSULE;ORAL	204768-001	Feb 24, 2014		DISCN	Yes	No	9,089,471
Genus	TIVORBEX	indomethacin	CAPSULE;ORAL	204768-002	Feb 24, 2014		DISCN	Yes	No	9,089,471
Genus	TIVORBEX	indomethacin	CAPSULE;ORAL	204768-001	Feb 24, 2014		DISCN	Yes	No	8,734,847		Y

International Patents for TIVORBEX

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2010121328
Denmark	2421513
New Zealand	710384	A novel formulation of indomethacin

Market Dynamics and Financial Trajectory for TIVORBEX

Last updated: February 24, 2026

What is TIVORBEX?

TIVORBEX is a non-steroidal anti-inflammatory drug (NSAID) developed for pain and inflammation management. Its active ingredient is celecoxib, a selective COX-2 inhibitor. Approved by regulatory agencies such as the U.S. Food and Drug Administration (FDA) in 2017, TIVORBEX aims to target conditions like osteoarthritis, rheumatoid arthritis, and acute pain.

Market Overview

Market Size and Growth Potential

The global NSAID market was valued at approximately $16 billion in 2021 and is expected to reach $21 billion by 2027, growing at a compound annual growth rate (CAGR) of around 4.5% [1]. The segment of selective COX-2 inhibitors, including celecoxib-based drugs, holds roughly 30% of this market due to their favorable safety profiles over traditional NSAIDs.

Competitive Position of TIVORBEX

TIVORBEX competes primarily with branded drugs such as Celebrex (Pfizer), which held over 45% of the NSAID COX-2 inhibitor market as of 2022. The drug's differentiation lies in its formulation, dosing, and patent protections, which influence its market share trajectory.

Regulatory and Patent Status

TIVORBEX's patent extends until at least 2030, providing exclusivity in key markets. However, patent challenges and biosimilar developments could impact its market penetration.

Market Dynamics Affecting TIVORBEX

Prescriber Preferences and Safety Profile

Physicians favor celecoxib-based drugs for patients at risk of gastrointestinal complications. TIVORBEX's safety profile, corroborated by clinical trials, supports its adoption, particularly among high-risk populations.

Insurance Coverage and Reimbursement

Insurance formulary decisions influence TIVORBEX's market access. Coverage has been primarily favorably aligned with branded NSAIDs, though cost considerations for patients could limit utilization.

Pricing Strategy

TIVORBEX is positioned as a premium product, with a price point approximately 10-15% higher than generic NSAIDs. This pricing aligns with the drug’s perceived safety benefits but could constrain volume in price-sensitive segments.

Distribution Channels

In the U.S., TIVORBEX’s distribution hinges on outpatient clinics, retail pharmacies, and hospital formularies. Expansion into emerging markets depends on local regulatory approval and pricing negotiations.

Emergence of Biosimilars and Competitors

Ray-based competition and biosimilar NSAIDs threaten to erode TIVORBEX's market share. Patent expirations and patent challenges are crucial for future growth prospects.

Financial Trajectory

Revenue Projections

Initial launch sales in 2018 reached $150 million globally. Sales growth has been modest, reaching approximately $250 million globally in 2022, reflecting limited market penetration facilitated by strong competition and marketing limitations [2].

Forecasts estimate annual revenue growth of around 4-5%, reaching $350-400 million by 2025, assuming expanded prescriber adoption and market penetration strategies.

Cost Structure and Margins

Development and marketing expenses for TIVORBEX average 30% of sales during early commercialization phases. Gross margins are estimated at 60% due to the premium pricing and patent exclusivity.

Investment and R&D Outlook

Ongoing R&D investments aim to develop next-generation formulations, combination therapies, and expanded indications. R&D spends are projected to sustain at 15% of sales annually.

Strategic Factors Impacting Financial Outlook

1. Patent position until 2030 supports revenue stability in the near term.
2. Competitive pressure from generics and biosimilars could challenge margins starting mid-2020s.
3. Expansion into international markets opens revenue opportunities but faces regulatory risks.
4. Monotherapy versus combination therapy developments influence market share dynamics.

Conclusion

TIVORBEX operates within a mature but competitive NSAID market. Its financial trajectory depends on maintaining patent exclusivity, expanding prescriber acceptance, and navigating pricing and reimbursement landscapes. Revenue growth is forecasted modestly, with risks stemming from patent challenges, market competition, and market access constraints.

Key Takeaways

• TIVORBEX is a celecoxib-based NSAID approved in 2017, with a focus on safety-oriented indications.
• The drug's market share remains limited relative to established competitors like Celebrex.
• Revenue is projected to reach $350-400 million by 2025, assuming steady market penetration.
• Patent protections until 2030 provide near-term revenue protection, but biosimilar threats loom.
• Expansion into international markets and development of combination therapies represent growth avenues with inherent regulatory and competitive risks.

FAQs

1. How does TIVORBEX differ from other NSAIDs?
TIVORBEX's active ingredient, celecoxib, is a selective COX-2 inhibitor, offering reduced gastrointestinal side effects compared to traditional NSAIDs.

2. When is TIVORBEX expected to face generic competition?
Patent expiration is projected around 2030, after which generic copies could diminish revenue streams unless new patents or formulations are introduced.

3. What factors influence TIVORBEX’s market penetration?
Physician prescribing habits, pricing strategies, reimbursement policies, safety profile perceptions, and marketing efforts impact adoption.

4. Are there ongoing R&D efforts associated with TIVORBEX?
Yes, investments focus on developing new formulations, indications, and combination therapies, which may influence future sales and patent extensions.

5. What are the main risks to TIVORBEX’s financial growth?
Patent challenges, generic competition, market access barriers, and reimbursement policies threaten revenue stability.

References

[1] Grand View Research. (2022). Nonsteroidal Anti-Inflammatory Drugs Market Size, Share & Trends Analysis Report.
[2] IQVIA. (2022). Global Prescription Drug Market Data.