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Last Updated: December 12, 2025

CLEOCIN T Drug Patent Profile


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Which patents cover Cleocin T, and what generic alternatives are available?

Cleocin T is a drug marketed by Pfizer and Pharmacia And Upjohn and is included in four NDAs.

The generic ingredient in CLEOCIN T is clindamycin phosphate. There are fifty-five drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.

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  • What is the 5 year forecast for CLEOCIN T?
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Summary for CLEOCIN T
Drug patent expirations by year for CLEOCIN T
Drug Prices for CLEOCIN T

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Recent Clinical Trials for CLEOCIN T

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SponsorPhase
University of Missouri-ColumbiaPhase 4
University of California, Los AngelesPhase 4
Roswell Park Cancer InstitutePhase 4

See all CLEOCIN T clinical trials

Pharmacology for CLEOCIN T

US Patents and Regulatory Information for CLEOCIN T

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer CLEOCIN T clindamycin phosphate GEL;TOPICAL 050615-001 Jan 7, 1987 AB1 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pharmacia And Upjohn CLEOCIN T clindamycin phosphate SOLUTION;TOPICAL 062363-001 Feb 8, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pfizer CLEOCIN T clindamycin phosphate LOTION;TOPICAL 050600-001 May 31, 1989 AB RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pfizer CLEOCIN T clindamycin phosphate SOLUTION;TOPICAL 050537-001 Approved Prior to Jan 1, 1982 DISCN Yes 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

Last updated: July 29, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: CLEOCIN T

Introduction

CLEOCIN T, a trademarked formulation containing the active ingredient clindamycin, is a broad-spectrum antibiotic primarily indicated for bacterial infections such as skin infections, respiratory tract infections, and intra-abdominal infections. As a derivative of lincomycin, clindamycin has a well-established market presence due to its efficacy against anaerobic bacteria and certain Gram-positive pathogens. Examining the market dynamics and financial pathway of CLEOCIN T involves assessing its clinical positioning, competitive landscape, regulatory considerations, and economic factors influencing its global sales trajectory.

Market Overview and Clinical Positioning

CLEOCIN T has gained recognition in both hospital and outpatient settings. Its primary appeal lies in its bacteriostatic activity, effectiveness in treating resistant strains, and safety profile. Its application covers indications such as skin and soft tissue infections, streptococcal pharyngitis, and dental infections, positioning it in a competitive antibiotic space that faces mounting pressure from antibiotic stewardship initiatives.

Despite broad clinical utility, the antibiotic market is increasingly scrutinized due to rising antimicrobial resistance (AMR), regulatory challenges, and the global push to curb unnecessary antibiotic prescriptions. These factors shape the demand dynamics for CLEOCIN T, both curtailing and fostering its sales depending on regional practices and the evolution of resistant strains.

Competitive Landscape

The landscape features several generic clindamycin formulations and alternative antibiotics such as metronidazole, doxycycline, and newer agents like linezolid. Brand-name presence, such as CLEOCIN T, often relies on established efficacy, formulation, and healthcare provider familiarity. However, generic competition pressures margins, particularly in developed markets where patent protections may have lapsed, and generic manufacturing is widespread.

New antibiotic development is limited due to economic disincentives and the complexity of bringing novel therapies to market. Consequently, brands like CLEOCIN T must navigate the challenge of maintaining market share amidst a proliferation of generics and shifting prescribing patterns emphasizing narrow-spectrum and targeted therapies.

Regulatory and Patents Landscape

CLEOCIN T’s original patents, pertaining to formulation and specific uses, have likely expired or are nearing expiration, opening pathways for generic manufacturers. Regulatory authorities worldwide enforce strict guidelines on antibiotic use, with some regions implementing stewardship protocols that restrict certain indications.

In some markets, regulatory bodies have granted orphan drug status or exclusivity periods in specific indications, temporarily shielding demand. Yet, overall, patent expirations tend to lead to a precipitous decline in branded sales, replaced by lower-cost generics, thereby impacting revenue projections significantly.

Epidemiological and Market Demand Drivers

Growing prevalence of bacterial infections, antibiotic resistance patterns, and surgical procedures increase demand for antibiotics like clindamycin. The rising incidence of skin infections, especially MRSA-related cases, supports sustained demand. However, the push for antibiotic stewardship and restrictions against overuse have tempered growth projections.

Regional disparities exist: North America and Europe exhibit mature markets with stable but declining branded sales due to generics. In contrast, emerging markets such as India, China, and Latin America present growth opportunities fueled by increasing healthcare infrastructure, rising bacterial infection rates, and less stringent regulations.

Economic Factors and Revenue Trajectory

The financial outlook for CLEOCIN T hinges on several key factors:

  • Generic Competition: Once patent protections lapse, price erosion ensues. Price reductions typically range from 30% to 80%, depending on market and entry of generics.

  • Market Penetration: In developed regions, market saturation and stewardship programs slow growth. In emerging markets, expanding access and improving healthcare infrastructure provide opportunities for volume growth.

  • Pricing Strategies: Pharmaceutical companies adopt tiered pricing and patient assistance programs to sustain revenue streams while navigating regulatory and reimbursement frameworks.

  • Manufacturing and Supply Chain: Cost control in production, driven by scale efficiencies and outsourcing, influences profit margins.

Analysts project a decline in CLEOCIN T’s global sales in the next five years, driven by patent expiry and generic competition, with a potential stabilization or modest growth in emerging markets.

Future Outlook and Market Opportunities

  1. Formulation Innovations: Developing new formulations such as long-acting injectables or combination therapies could bolster demand and mitigate generic erosion.

  2. Stewardship and Precision Use: Incorporating rapid diagnostics and stewardship programs may create niche markets for targeted use, maintaining premium pricing in select indications.

  3. Regulatory Favorability: Strategic registrations and expanded indications could preserve market relevance, especially in regions with unmet needs for effective anaerobic coverage.

  4. Biotech and Biosimilar Competition: The emergence of biosimilars and novel antibiotics, especially against resistant strains, threatens the long-term market share of established drugs like CLEOCIN T.

Risks and Challenges

The primary threats include antimicrobial resistance reducing clinical utility, regulatory restrictions curbing use, and market saturation with generic clindamycin products. Additionally, pharmaceutical companies managing CLEOCIN T must contend with decreasing margins post-patent expiry and shifts toward newer, cost-effective therapies.

Conclusion

The market dynamics for CLEOCIN T typify those of a mature antibiotic, characterized by initial growth, subsequent patent-driven revenues, and eventual decline due to generic competition. While current sales are stabilizing in some regions, the overall financial trajectory forecasts a gradual decline, accentuated by regulatory, economic, and microbiological challenges. Strategic focus on formulations, indications, and regional expansion may sustain modest growth in the evolving landscape.


Key Takeaways

  • CLEOCIN T’s global sales are primarily driven by its efficacy against specific bacterial infections and regional healthcare infrastructure.
  • Patent expirations and generic competition significantly pressure revenue streams, especially in developed markets.
  • Emerging markets offer growth potential, with increasing infection prevalence and less stringent regulation.
  • Innovation in formulations and targeted use could create niche opportunities and prolong market relevance.
  • Long-term success depends on balancing regulatory constraints, antimicrobial resistance concerns, and evolving healthcare practices.

FAQs

1. What are the main indications for CLEOCIN T?
CLEOCIN T is primarily used to treat bacterial infections including skin and soft tissue infections, respiratory infections, intra-abdominal infections, and dental infections caused by susceptible bacteria.

2. How does antimicrobial resistance impact CLEOCIN T’s market?
Resistance, especially among anaerobes and Gram-positive bacteria, limits clinical utility, prompting stricter prescribing guidelines and reducing overall demand in some markets.

3. What is the impact of patent expiry on CLEOCIN T sales?
Patent expiry leads to increased generic competition, often causing a significant decline in branded sales and pressure on profit margins.

4. Are there new formulations or combinations of CLEOCIN T under development?
While existing evidence suggests minimal recent innovation specifically for CLEOCIN T, pharmaceutical companies explore combination therapies and extended-release formulations to enhance clinical use and market longevity.

5. Which regions present growth opportunities for CLEOCIN T?
Emerging markets like China, India, and Latin America offer growth potential due to expanding healthcare infrastructure, increasing infection rates, and less stringent regulatory environments.


Sources
[1] World Health Organization. Antimicrobial resistance. 2022.
[2] MarketWatch. Global antibiotics market report. 2022.
[3] Clinical pharmacology guidelines and prescribing data. 2023.
[4] FDA and EMA regulatory frameworks for antibiotics. 2022.
[5] Industry analyses on patent expirations and generic drug competition. 2022.

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