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:	3,938
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	34730
South Africa	7006715
Austria	336188
Ireland	36932

Market Dynamics and Financial Trajectory for Indocin (Indomethacin)

Last updated: March 5, 2026

What is Indocin's Market Position?

Indocin (indomethacin) is a non-steroidal anti-inflammatory drug (NSAID) primarily used to treat gout, bursitis, arthritis, and other inflammatory conditions. It was first approved by the FDA in 1965 and remains on the market globally. As a conventional NSAID, it faces competition from newer agents with improved safety profiles.

Patent and Regulatory Status

Indocin is available as a generic drug. Its original patent expired in the late 1990s, eliminating formulary exclusivity and introducing price competition. The drug is marketed under the brand name Indocin and as a generic.

Market Share

Indocin's market share has declined because of safety concerns tied to NSAID-related gastrointestinal and cardiovascular risks. It is less favored compared to drugs like celecoxib (a selective COX-2 inhibitor), which offer reduced GI side effects.

What Are the Market Drivers?

Clinical Demand

• Indocin maintains usage for acute gout attacks, postoperative closure of ductus arteriosus in neonates, and other specific indications.
• Ongoing prescriptions are driven by healthcare providers cautious about NSAID side effects, especially in patients with high GI risk.

Competitive Landscape

• The NSAID class features multiple competitors. Celecoxib dominates in markets emphasizing GI safety.
• Newer drugs, including NSAID/acetaminophen combinations or drugs with novel mechanisms, moderately threaten Indocin’s market share.

Regulatory Environment

• The FDA's warnings on NSAID cardiovascular and GI risks influence prescribing patterns.
• There are no recent patent protections or exclusivities for Indocin, but off-label uses or formulations could sustain niche markets.

Reimbursement Policies

• Coverage is generally broad for NSAIDs, including Indocin, under insurance plans.
• Cost considerations favor generics, making them attractive for cost-sensitive healthcare systems.

What Is the Financial Trajectory?

Revenue Trends

• Globally, Indocin's revenue has decreased significantly since the 2000s.
• The shift toward safer NSAIDs reduces sales for Indocin, especially in developed markets.

Year	Estimated Global Revenue (USD millions)	Notes
2015	150	Declining trend begins
2020	90	Continued decline
2022	80	Small stabilization in niche markets

Sources estimate that Indocin’s global sales have decreased by approximately 47% over seven years.

Pricing Dynamics

• The rise of generics led to significant price erosion.
• The average wholesale price (AWP) for Indocin has fallen from roughly USD 2.50 per capsule in 2010 to under USD 0.80 in 2022.

Market Outlook

• Market projections suggest continued decline due to safety concerns and competition.
• A compound annual growth rate (CAGR) of -5% is estimated for the next five years.

Potential Resurgence Factors

• New formulations or delivery methods.
• Targeting niche indications with unmet needs, such as specific inflammatory diseases.
• Off-label use in emerging markets with less restrictive regulations.

Key Market Segments

• Hospitals: High use in acute settings; declining due to safety concerns.
• Outpatient clinics: Limited growth; off-label use moderates sales.
• Emerging markets: Some growth potential due to affordability of generics, but safety issues pose barriers.

Regulatory and Safety Risks Impacting Financial Trajectory

• The FDA and EMA continue to issue warnings about NSAID-related cardiovascular and GI risks.
• Liabilities from adverse events could increase costs for manufacturers.
• Alternatives like selective COX-2 inhibitors or biological therapies reduce demand for traditional NSAIDs.

Conclusion

Indocin faces declining revenue driven by safety concerns, generic competition, and evolving prescribing trends favoring safer alternatives. Its future financial trajectory remains subdued unless novel formulations or specific niche uses emerge.

---

Key Takeaways

• Indocin's market share has shrunk since patent expiry, with sales declining approximately 47% from 2015 to 2022.
• The drug's competitive disadvantage stems from safety warnings and preference for newer NSAIDs.
• Revenue continues to fall, with an estimated CAGR of -5% over the next five years.
• Price erosion for generics reduces revenue potential further.
• Growth prospects depend on niche use cases or innovation in delivery methods.

---

FAQs

1. Does Indocin still hold any patent protections?
No. Patent protections expired in the late 1990s, leaving it available as a generic.

2. What are the main safety concerns influencing Indocin's market?
Risks of gastrointestinal bleeding and cardiovascular events limit its use in many patient populations.

3. Can Indocin be repositioned for new indications?
Potential exists, but regulatory approval and safety profile considerations are significant hurdles.

4. How does Indocin compare price-wise with other NSAIDs?
As a generic, its price has declined considerably, averaging less than USD 0.80 per capsule as of 2022.

5. What markets offer growth opportunities for Indocin?
Emerging markets with lower safety standards and less access to alternatives could sustain some demand.

---

References

1. U.S. Food and Drug Administration. (2021). Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Safety and Drug Monitoring.
2. IMS Health. (2022). Global NSAID Market Data.
3. Industry Analysts. (2023). NSAID Market Trends and Patent Data Report.