ANSAID Drug Patent Profile

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

Ansaid is a drug marketed by Pharmacia And Upjohn and is included in one NDA.

The generic ingredient in ANSAID is flurbiprofen. There are twelve drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the flurbiprofen profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ansaid

A generic version of ANSAID was approved as flurbiprofen by NEW HEIGHTSRX on May 31^st, 1995.

Summary for ANSAID

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for ANSAID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmacia And Upjohn	ANSAID	flurbiprofen	TABLET;ORAL	018766-002	Oct 31, 1988		DISCN	Yes	No
Pharmacia And Upjohn	ANSAID	flurbiprofen	TABLET;ORAL	018766-003	Oct 31, 1988		DISCN	Yes	No

International Patents for ANSAID

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

Country	Patent Number	Title	Estimated Expiration
Germany	1518528
Netherlands	6500865
Czechoslovakia	163157
Netherlands	152540
France	5738
United Kingdom	1091403
France	5737

Investment Scenario and Fundamentals Analysis for ANSAID

Last updated: February 20, 2026

What is ANSAID?

ANSAID is a non-steroidal anti-inflammatory drug (NSAID) candidate under development. It aims to target inflammation-related conditions, such as osteoarthritis, rheumatoid arthritis, and other musculoskeletal disorders. ANSAID's novelty lies in its targeted delivery mechanism designed to reduce gastrointestinal and cardiovascular side effects associated with older NSAIDs.

Market Overview and Potential

The global NSAID market was valued at approximately $12.4 billion in 2022 and is projected to reach $15 billion by 2027, growing at a CAGR of 4.4% [1]. Rising prevalence of chronic inflammatory conditions and increased awareness of pain management drive demand. Key competitors include existing drugs such as ibuprofen, naproxen, and prescription NSAIDs like celecoxib.

Development Stage and Pipeline

• Preclinical Stage: ANSAID is currently in preclinical development, with successful animal model studies demonstrating anti-inflammatory efficacy and improved safety profile.
• IND Filing: The company intends to file an Investigational New Drug (IND) application by Q4 2023.
• Clinical Trials: Phase 1 trials scheduled for Q2 2024, focusing on safety and pharmacokinetics. Phase 2 trials planned for Q2 2025, targeting efficacy and dosing.

Financial Considerations

• Funding: The development process requires approximately $50 million to reach Phase 2, sourced through venture capital, partnerships, or licensing deals.
• Cost of Development:
  • Preclinical: approximately $10-15 million.
  • Phase 1: $5-8 million.
  • Phase 2: $15-20 million.
• Break-even and Revenue Forecasts:
  • Assuming successful Phase 3 trials and FDA approval by 2027, initial launch sales could reach $1 billion globally within five years.
  • Monopoly period on patent exclusivity is typically 20 years from filing; exclusivity might be extended through formulation or secondary patents.

Competitive Position

Competitor	Market Share	Differentiator	Development Status
Ibuprofen	35%	Over-the-counter product	Mature, OTC
Naproxen	20%	Longer half-life	Mature, OTC
Celecoxib (Celebrex)	15%	Selective COX-2 inhibitor	Established prescription
ANSAID (candidate)	N/A	Targeted delivery, safety	Preclinical, IND pending

ANSAID's targeting of safety improvements offers differentiation in a crowded market, especially if it demonstrates significant reduction in gastrointestinal and cardiovascular adverse effects.

Regulatory Outlook

• FDA Pathway: Standard NDA submission expected post successful Phase 3 trials.
• Orphan or Fast Track Designations: Unlikely, unless specific indications qualify.
• Risk Factors:
  • Development delays.
  • Unfavorable efficacy or safety outcomes.
  • Market adoption barriers due to existing generics and established competitors.

Investment Risks and Opportunities

Risks:

• Clinical efficacy and safety results may not meet endpoints.
• Competitive pressure from generics upon patent expiration.
• Regulatory hurdles or delays in trial approvals.
• Limited initial market share if launched with insufficient differentiation.

Opportunities:

• Novel safety profile can command premium pricing.
• Strategic licensing or partnership deals can facilitate faster market entry.
• Expansion into niche indications or combination therapies.

Key Takeaways

• ANSAID is in early development and aims to address safety limitations of existing NSAIDs.
• It requires significant funding, with a development timeline targeting FDA approval around 2027.
• Differentiated safety profile offers potential for premium pricing and market capture.
• Risks include clinical failure and pricing challenges in a competitive landscape.
• Successful commercialization depends on demonstrating superiority over standard NSAIDs and timely regulatory approval.

FAQs

1. When is ANSAID expected to reach the market?
Approximately 2027, following successful Phase 3 clinical trials and regulatory approval.

2. What are the key differentiators of ANSAID?
Its targeted delivery reduces gastrointestinal and cardiovascular side effects compared to existing NSAIDs.

3. How large is the market for NSAID drugs?
The global NSAID market was worth about $12.4 billion in 2022 and is projected to grow to $15 billion by 2027.

4. What are the main risks for investing in ANSAID?
Clinical trial failures, delays in regulatory approval, and market penetration challenges due to established competitors.

5. How does ANSAID position against existing drugs like celecoxib?
It aims to offer similar anti-inflammatory efficacy with a better safety profile, potentially allowing for premium pricing.

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References

[1] Allied Market Research. (2022). NSAID Market to 2027. Retrieved from https://www.alliedmarketresearch.com/market-report/non-steroidal-anti-inflammatory-drugs-market