INDOCIN Drug Patent Profile

Which patents cover Indocin, and what generic alternatives are available?

Indocin is a drug marketed by Zyla Life Sciences, Recordati Rare, and Zyla. and is included in five NDAs.

The generic ingredient in INDOCIN is indomethacin sodium. There are fifteen drug master file entries for this compound. Additional details are available on the indomethacin sodium profile page.

Summary for INDOCIN

US Patents:	0
Applicants:	3
NDAs:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	22
Patent Applications:	3,964
Drug Prices:	Drug price information for INDOCIN
What excipients (inactive ingredients) are in INDOCIN?	INDOCIN excipients list
DailyMed Link:	INDOCIN at DailyMed

See drug prices for INDOCIN

See drug sales revenues for INDOCIN

Recent Clinical Trials for INDOCIN

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

Sponsor	Phase
Johns Hopkins University	Phase 3
MetroHealth Medical Center	Early Phase 1
National Cancer Institute (NCI)	Phase 2

See all INDOCIN clinical trials

Pharmacology for INDOCIN

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

US Patents and Regulatory Information for INDOCIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zyla Life Sciences	INDOCIN	indomethacin	CAPSULE;ORAL	016059-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Zyla Life Sciences	INDOCIN	indomethacin	SUPPOSITORY;RECTAL	017814-001	Aug 13, 1984		DISCN	Yes	No
Zyla Life Sciences	INDOCIN	indomethacin	CAPSULE;ORAL	016059-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Recordati Rare	INDOCIN	indomethacin sodium	INJECTABLE;INJECTION	018878-001	Jan 30, 1985		DISCN	Yes	No

Expired US Patents for INDOCIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Zyla Life Sciences	INDOCIN	indomethacin	SUPPOSITORY;RECTAL	017814-001	Aug 13, 1984
Zyla Life Sciences	INDOCIN	indomethacin	SUPPOSITORY;RECTAL	017814-001	Aug 13, 1984

International Patents for INDOCIN

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

Country	Patent Number	Title	Estimated Expiration
Ireland	36932
Norway	137880
Kenya	2610	IMPROVED INDOMETHACIN SUPPOSITORIES
South Africa	7207134

Market Dynamics and Financial Trajectory for INDOCIN (Indomethacin)

Last updated: July 28, 2025

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Overview of INDOCIN (Indomethacin)

Indomethacin, marketed under the brand name INDOCIN, is a non-steroidal anti-inflammatory drug (NSAID) primarily prescribed for the management of acute gouty arthritis, osteoarthritis, rheumatoid arthritis, and other inflammatory conditions. Since its introduction in the 1960s, indomethacin has established a significant presence within the anti-inflammatory pharmaceutical landscape, characterized by a mature market with expanding indications and patient populations.

Market Dynamics

1. Competitive Landscape and Market Penetration

The pharmaceutical market for NSAIDs is highly competitive, dominated by well-established players like Pfizer (Indocin), Merck, and Novartis. INDOCIN’s patent expiration in numerous jurisdictions has led to the proliferation of generic alternatives, intensifying price competition and affecting revenue streams for branded formulations.

Despite generics occupying a substantial market share, INDOCIN maintains relevance due to its established efficacy and clinician familiarity. Its prescription base is bolstered in segments requiring potent anti-inflammatory action, notably for severe gout or rheumatoid conditions where safety profiles of newer agents are scrutinized.

2. Regulatory Environment and Approval Trends

Regulatory agencies, such as the FDA and EMA, rigorously evaluate NSAID safety profiles, particularly regarding cardiovascular risk, gastrointestinal bleeding, and renal toxicity. Evolving safety guidelines influence prescribing behaviors, potentially shifting market share towards newer, potentially safer NSAIDs or alternative therapies, like biologics for rheumatoid arthritis.

Furthermore, ongoing regulatory complexities in certain jurisdictions may restrict or limit indications, impacting market growth. However, approval of new formulations—such as topical or extended-release versions—can rejuvenate market interest.

3. Demographic and Epidemiological Trends

The aging global population and rising prevalence of chronic inflammatory diseases drive demand for NSAIDs like INDOCIN. According to WHO projections, the elderly demographic (65+) is expanding, increasing the burden of osteoarthritis and gout, thereby supporting sustained demand.

In addition, increased awareness and diagnosis rates for gout and rheumatoid arthritis bolster prescribing rates, especially in developed markets where access to healthcare is high.

4. Pharmacoeconomic Factors

Cost-effectiveness remains a key determinant in NSAID prescribing patterns. Generics have significantly lowered treatment costs, influencing both prescribing habits and insurance coverage policies. High out-of-pocket costs for branded INDOCIN can restrict market penetration, especially in emerging markets.

Moreover, the rising adoption of biosimilars and newer anti-inflammatory agents with improved safety profiles may influence the economic landscape. Comparative cost analyses favoring generics continue to dominate, although safety concerns may warrant alternative therapies, creating nuanced market dynamics.

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Financial Trajectory: Revenue and Growth Outlook

1. Revenue Trends and Market Share

Since the patent expiry of INDOCIN in many regions, the financial trajectory has shifted from revenue growth driven by patent-protected sales to stabilization or decline attributable to generic competition. For instance, in the U.S., INDOCIN’s revenue has plateaued, with a decline observed as physicians shift towards NSAIDs with improved safety profiles and adjunct therapies.

Global revenues for INDOCIN are estimated to be in the hundreds of millions USD annually, with marketplaces such as Europe, Asia, and Latin America providing substantial contributions, chiefly through generic formulations.

2. Impact of Patent Expiration and Generic Competition

Patent cliffs have historically caused revenue erosion in the pharmaceutical sector. For INDOCIN, generic competition has precipitated significant price reductions—sometimes by over 80%—dampening profit margins for branded manufacturers. NY Times reports indicate that in jurisdictions like India and China, generic versions dominate market share, further pressuring original formulations.

3. R&D and Lifecycle Management Strategies

Pharmaceutical companies adopting lifecycle management strategies—novel formulations, fixed-dose combinations, or topical applications—aim to extend INDOCIN’s market viability and mitigate revenue decline. For example, reformulating INDOCIN as a topical gel or producing sustained-release variants can open niche markets, especially in vulnerable patient populations, thereby maintaining or enhancing revenue streams.

4. Potential for New Indications and Off-Label Uses

Research into expanding INDOCIN’s therapeutic indications—such as for certain cancer-related pain or as part of combination therapies—could provide incremental revenue opportunities. Regulatory approvals for such off-label use could also influence its financial trajectory.

5. Market Forecast and Long-term Outlook

The forecast for INDOCIN’s revenue indicates a gradual decline due to generic erosion and safety concerns restricting usage. Nonetheless, emerging regional markets and niche indications, amplified by formulations with improved safety profiles, offer potential for moderated growth or stabilization over the next decade.

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Key Drivers Influencing Future Financial Performance

• Safety Profile Improvements: Development of formulations with reduced gastrointestinal and cardiovascular risks may bolster market share.

• Regulatory Environment: Stringent safety warnings could limit prescribing, whereas approvals for alternative indications could expand use.

• Market Expansion: Growing demand in emerging markets with improving healthcare access may offset declines elsewhere.

• Formulation Innovation: Extended-release and topical variants can create new revenue streams in targeted patient populations.

• Competitive Alternatives: Emergence of biologics and disease-modifying agents keep peak market share in check.

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Conclusion

The market dynamics for INDOCIN are shaped by intense generic competition, evolving safety considerations, and demographic trends favoring increased NSAID demand. Financial prospects hinge on strategic lifecycle management, formulation innovations, and expanding into underserved markets. While near-term revenue may face declines post-patent expiry, targeted strategies and new formulations can sustain its relevance within the anti-inflammatory pharmacopeia.

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Key Takeaways

• Market maturity and patent expiries have led to reduced revenues for INDOCIN, dominated now by generics.

• Safety concerns significantly influence prescribing patterns, creating both challenges and opportunities for innovative formulations.

• Growing elderly populations and increased prevalence of chronic inflammatory diseases support ongoing demand in specific segments.

• Lifecycle extension strategies, such as topical or sustained-release formulations, are crucial for maintaining financial viability.

• Emerging markets and niche indications offer pathways for growth amid competitive pressures.

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FAQs

1. How has patent expiration affected INDOCIN's market revenue?
Patent expirations have introduced generic competitors, leading to substantial price reductions and a decline in branded INDOCIN’s revenue, necessitating strategic reforms to sustain profitability.

2. What safety concerns are associated with INDOCIN, and how do they influence market dynamics?
INDOMETHACIN poses risks of gastrointestinal bleeding, cardiovascular events, and renal impairment, which can limit its use and prompt prescribers to consider alternative NSAIDs or therapies with improved safety profiles.

3. Are there new formulations of INDOCIN that could extend its market life?
Yes. Extended-release tablets and topical gels are being developed to reduce side effects and target specific patient groups, thereby creating new revenue opportunities.

4. In which regions does INDOCIN hold the highest market share currently?
Developed markets like North America and Europe see significant generic penetration, but emerging markets such as India and China still have notable prescription volumes, favoring low-cost formulations.

5. What is the outlook for INDOCIN in the next decade?
While its traditional market may contract due to safety concerns and generic competition, strategic formulation innovations and market expansions could preserve or slightly increase its usage in niche segments.

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References

1. [FDA Drug Database and Labeling Information]
2. WHO Global Health Observatories, Disease Prevalence Data
3. Industry reports on NSAID market trends (e.g., IQVIA, Pharmaprojects)
4. Patent and regulatory filings from respective jurisdictions
5. Market analyses from Bloomberg Intelligence and EvaluatePharma