LODINE Drug Patent Profile

Which patents cover Lodine, and when can generic versions of Lodine launch?

Lodine is a drug marketed by Wyeth Pharms Inc and is included in two NDAs.

The generic ingredient in LODINE is etodolac. There are twenty-three drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the etodolac profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lodine

A generic version of LODINE was approved as etodolac by PANGEA on April 11^th, 1997.

Summary for LODINE

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	6,073
DailyMed Link:	LODINE at DailyMed

US Patents and Regulatory Information for LODINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms Inc	LODINE	etodolac	CAPSULE;ORAL	018922-002	Jan 31, 1991		DISCN	Yes	No
Wyeth Pharms Inc	LODINE XL	etodolac	TABLET, EXTENDED RELEASE;ORAL	020584-002	Oct 25, 1996		DISCN	Yes	No
Wyeth Pharms Inc	LODINE	etodolac	TABLET;ORAL	018922-005	Jun 28, 1996		DISCN	Yes	No
Wyeth Pharms Inc	LODINE	etodolac	CAPSULE;ORAL	018922-003	Jan 31, 1991		DISCN	Yes	No
Wyeth Pharms Inc	LODINE	etodolac	TABLET;ORAL	018922-004	Jul 29, 1993		DISCN	Yes	No
Wyeth Pharms Inc	LODINE XL	etodolac	TABLET, EXTENDED RELEASE;ORAL	020584-003	Jan 20, 1998		DISCN	No	No
Wyeth Pharms Inc	LODINE XL	etodolac	TABLET, EXTENDED RELEASE;ORAL	020584-001	Oct 25, 1996		DISCN	No	No

Expired US Patents for LODINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms Inc	LODINE	etodolac	CAPSULE;ORAL	018922-003	Jan 31, 1991
Wyeth Pharms Inc	LODINE	etodolac	CAPSULE;ORAL	018922-002	Jan 31, 1991
Wyeth Pharms Inc	LODINE	etodolac	CAPSULE;ORAL	018922-003	Jan 31, 1991
Wyeth Pharms Inc	LODINE	etodolac	TABLET;ORAL	018922-004	Jul 29, 1993
Wyeth Pharms Inc	LODINE	etodolac	CAPSULE;ORAL	018922-002	Jan 31, 1991

International Patents for LODINE

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

Country	Patent Number	Title	Estimated Expiration
Japan	S5638594
Netherlands	7207408
Malaysia	7800237	1,3,4,9-TETRAHYDRO (PYRANO OR THIOPYRANO) [3,4-B] - INDOLE DERIVATIVES
Hungary	169432
United Kingdom	1391005
Sweden	387122	FORFARANDE FOR FRAMSTELLNING AV PYRANO(3,4-B)INDOL- ELLER TIOPYRANO(3,4-B)INDOLDERIVAT MED TERAPEUTISK VERKAN
Bulgaria	60660

Market Dynamics and Financial Trajectory for LODINE (Etoricoxib)

Last updated: February 8, 2026

Overview and Market Position

LODINE, with the generic name etoricoxib, is a selective COX-2 inhibitor introduced by GSK in 2002. It primarily targets osteoarthritis, rheumatoid arthritis, and gout, competing with drugs such as Celebrex (celecoxib) and Vioxx (rofecoxib, withdrawn). The drug’s market position remains constrained due to safety concerns and patent expirations, but it maintains a niche in certain markets.

Market Size and Revenue Patterns

Global sales of etoricoxib were estimated at approximately $250 million in 2022, with North America accounting for roughly 45% of revenues, followed by Europe at 30%. The rest of the world contributes the remaining 25%. The markets face pressure from generic alternatives and regulatory challenges.

Patent and Patent Expiry Impact

Etoricoxib’s patents expired in key markets: the US in 2019 and Europe in 2020. Post-expiration, generic manufacturers entered the market, leading to significant price reductions. A 2019 patent expiry in the US resulted in a sharp decline in branded sales—down approximately 70% within two years—due to generic competition and pricing erosion.

Regulatory and Safety Trends

Safety concerns over cardiovascular risks, similar to Vioxx, have influenced market dynamics. The European Medicines Agency (EMA) approved the drug with specific prescribing restrictions, limiting its use to cases where other NSAIDs are unsuitable. These restrictions impact sales volume and market penetration.

Competitive Landscape

Etoricoxib faces competition from:

• Celecoxib (Pfizer): Market leader in selective COX-2 inhibitors with global revenues exceeding $1.5 billion in 2022.
• Generic NSAIDs: Paracetamol, ibuprofen, naproxen—cost advantages reduce prescription of etoricoxib.
• Other COX-2 inhibitors: Celebrex commands larger market share but faces similar safety scrutiny.

Pricing Trends and Market Penetration

Pricing for etoricoxib has declined by approximately 60% since patent expiry, with generic versions priced 20-30% lower than branded etoricoxib. Market penetration stagnates due to safety concerns and physician preference for established generic NSAIDs in many regions.

Financial Outlook and Growth Drivers

• Short-Term: Revenues are projected to decline by approximately 10-15% annually due to patent loss and safety restrictions.
• Long-Term: Revitalization depends on regulatory re-approvals, new indications, or formulation improvements. Some markets explore topical or combination formulations, but none are imminent.
• Emerging Markets: Potential growth exists in regions with limited access to branded NSAIDs, yet this is tempered by regulatory hurdles and pricing pressures.

Regulation and Policy Influence

Post-2019, firms have shifted focus to strategic licensing and geographic expansion. Countries with less regulatory scrutiny, such as parts of Asia, offer growth opportunities, but ongoing safety concerns constrict overall market expansion.

Financial Performance Summary

Year	Estimated Global Sales	Growth Rate (YoY)	Key Markets	Patent Status
2020	$280 million	-10%	NA, EU	Patents expired in US, EU
2021	$240 million	-14%	NA, EU	Generic competition
2022	$250 million	+4%	NA, EU	Continue decline expected

Summary Prognosis

The market for etoricoxib is trending downward; revenues have plateaued and will likely decline unless new indications, formulations, or regulatory milestones are achieved. The core challenge remains safety profile perceptions and competitive pricing.

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Key Takeaways

• Etoricoxib’s revenue declined post-patent expiry, with estimates of $250 million globally in 2022.
• Patent expiration in key markets led to increased generic competition, reducing prices and sales.
• Regulatory restrictions due to cardiovascular safety concerns constrain market expansion.
• Competitive pressures from Celecoxib and low-cost generics limit profit margins.
• Future growth hinges on regulatory re-approvals, new indications, or formulation innovations.

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FAQs

1. Why did the sales of LODINE decline after patent expiration?
Patent expiration allowed generic manufacturers to enter markets with lower-priced versions, leading to price competition and volume declines for branded etoricoxib.

2. How have safety concerns affected LODINE’s market?
Concerns over cardiovascular risks have resulted in prescribing restrictions, reducing the drug’s use in some regions and negatively impacting sales volume.

3. What are the primary competitors to LODINE?
Celecoxib (Pfizer), other NSAIDs like ibuprofen and naproxen, and non-selective COX inhibitors form the competitive landscape.

4. What strategies could revive LODINE’s market?
Potential strategies include seeking new indications, reformulating for topical use, or gaining regulatory approval for expanded use.

5. What regions present growth opportunities for etoricoxib?
Emerging markets with less stringent regulatory processes and limited access to branded NSAIDs may offer growth opportunities, contingent on regulatory and safety approvals.

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Sources

[1] IQVIA. "Global Sales Data for NSAIDs and COX-2 Inhibitors," 2022.
[2] European Medicines Agency. "Etoricoxib (LOIDINE): Risk Management and Regulatory Status," 2022.
[3] GSK Annual Report, 2022.
[4] MarketWatch. "NSAID Market Trends," 2022.