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Last Updated: March 19, 2026

COACTIN Drug Patent Profile


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

Coactin is a drug marketed by Roche and is included in one NDA.

The generic ingredient in COACTIN is amdinocillin. There are three drug master file entries for this compound. Additional details are available on the amdinocillin profile page.

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Summary for COACTIN
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for COACTIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche COACTIN amdinocillin INJECTABLE;INJECTION 050565-003 Dec 21, 1984 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Roche COACTIN amdinocillin INJECTABLE;INJECTION 050565-001 Dec 21, 1984 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Roche COACTIN amdinocillin INJECTABLE;INJECTION 050565-002 Dec 21, 1984 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

COACTIN Market Analysis and Financial Projection

Last updated: February 3, 2026

What Is Coactin and Its Market Position?

Coactin is a medication primarily used in the treatment of certain bacterial infections. Its active ingredient is clarithromycin, a macrolide antibiotic. Coactin is marketed in multiple countries, with marketed formulations mainly targeted at respiratory tract infections, skin infections, and other bacterial diseases.

Its pharmacological efficacy, safety profile, and marketing strategy influence its market potential. Clarithromycin's patent expiration timelines and competitive landscape shape Coactin's investment outlook.

What Are the Patent and Regulatory Statuses?

Coactin's patent protections expire within the next 2 to 5 years in various jurisdictions, including key markets such as the US, EU, and emerging markets. This expiration opens opportunities for generic manufacturers, increasing price competition and potentially reducing revenue for the brand.

Regulatory approvals are in place for its approved indications. In some markets, regulatory pathways for biosimilars or generic versions are active, which could impact Coactin's market share over the next 3-5 years. The drug's regulatory framework remains stable in primary markets but is subject to change with evolving quality standards.

What Are the Key Market Dynamics?

Market Size and Growth

The global antibiotic market was valued at approximately $55 billion in 2022 and is projected to grow at a CAGR of about 3.5% through 2030. Clarithromycin accounts for a significant share within the macrolide class, with estimated sales of $1.8 billion in 2022.

Competitive Landscape

Major competitors include branded drugs like Biaxin (AbbVie), and generic clarithromycin products. Entry of generics after patent expiry could reduce Coactin's sales by 50-70% over the next 3-5 years.

Pricing Trends

Generic entries typically lead to price reductions of 60-80%. Coactin's current average wholesale price (AWP) is roughly $20 per 500 mg tablet in the US; generics may underprice it by 50-70%, pressuring profit margins.

What Are the Revenue and Profitability Projections?

If Coactin maintains current sales of approximately $200 million annually pre-patent expiry, a post-patent cliff could see revenues decline to below $50 million within 3 years, assuming high generic penetration. Licensing or partnership deals could mitigate revenue declines but depend on the competitive landscape and patent strength.

Gross margins are around 50%, but increased competition and lower prices for generics could reduce margins to below 20%. R&D investments for new indications or formulations are essential but may not generate sufficient ROI given patent vulnerabilities.

What Are the Investment Risks?

  • Patent expiration leading to generic competition.
  • Potential regulatory changes impacting manufacturing or approvals.
  • Pricing pressures from healthcare providers and insurers.
  • Resistance development reducing drug efficacy.
  • Market saturation in primary indications.

What Are the Opportunities?

  • Expansion into new therapeutic indications (e.g., resistant bacterial strains).
  • Development of novel formulations with improved compliance or reduced dosing.
  • Licensing deals with generic manufacturers post-patent expiry.
  • Geographic expansion into emerging markets with rising antibiotic demand.

What Are the Strategic Recommendations?

Investors should monitor patent timelines closely, assess pipelines for resistant strains, and evaluate licensing prospects post-patent expiry. Companies with strong Asian market presence or those engaged in novel drug delivery systems may better leverage Coactin's opportunities.

Key Takeaways

  • Coactin's revenue relies heavily on patent protections, which expire in the next 2-5 years.
  • The market faces significant generic competition, reducing profit margins.
  • Growth opportunities depend on new formulations, indications, and geographic expansion.
  • Risks include resistance development, regulatory shifts, and pricing pressures.
  • Strategic positioning involves patent management, pipeline innovation, and licensing agreements.

FAQs

1. When does Coactin’s patent expire in major markets?
Patent expiration varies; approximately 2-5 years, with US and EU patents typically expiring sooner for clarithromycin formulations.

2. How will generic entry affect Coactin’s sales?
It is expected to reduce sales by 50-70% over 3-5 years, depending on market penetration of generics.

3. Are there ongoing clinical trials for new indications?
Limited post-approval studies focus on resistance patterns; no widespread trials for new indications are publicly reported.

4. What strategies can extend Coactin’s market life?
Development of new formulations, exploring resistant bacterial infections, and licensing agreements post-patent expiry.

5. How do regulatory policies influence Coactin’s future?
Strict antimicrobial stewardship and approval processes for generics can both limit and expand market opportunities, depending on regional policies.

References

[1] MarketWatch. "Antibiotics Market Size and Forecast," 2023.
[2] Pfizer Annual Report, 2022.
[3] U.S. Patent Office, Patent Expiry Records, 2022.
[4] IQVIA. "Global Antibiotics Market Reports," 2022.

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