CLEOCIN Drug Patent Profile

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

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

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cleocin

A generic version of CLEOCIN was approved as clindamycin palmitate hydrochloride by PADAGIS US on July 7^th, 2010.

Summary for CLEOCIN

US Patents:	0
Applicants:	2
NDAs:	14
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	11
Patent Applications:	4,616
Drug Prices:	Drug price information for CLEOCIN
Drug Sales Revenues:	Drug sales revenues for CLEOCIN
What excipients (inactive ingredients) are in CLEOCIN?	CLEOCIN excipients list
DailyMed Link:	CLEOCIN at DailyMed

See drug prices for CLEOCIN

See drug sales revenues for CLEOCIN

Recent Clinical Trials for CLEOCIN

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

Sponsor	Phase
University of Missouri-Columbia	Phase 4
University of California, Los Angeles	Phase 4
National Cancer Institute (NCI)	Phase 4

See all CLEOCIN clinical trials

Pharmacology for CLEOCIN

Drug Class	Lincosamide Antibacterial
Physiological Effect	Decreased Sebaceous Gland Activity Neuromuscular Blockade

US Patents and Regulatory Information for CLEOCIN

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	CLEOCIN	clindamycin hydrochloride	CAPSULE;ORAL	061809-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer	CLEOCIN T	clindamycin phosphate	GEL;TOPICAL	050615-001	Jan 7, 1987	AB1	RX	Yes	Yes
Pfizer	CLEOCIN	clindamycin phosphate	SUPPOSITORY;VAGINAL	050767-001	Aug 13, 1999		RX	Yes	Yes
Pfizer	CLEOCIN	clindamycin phosphate	CREAM;VAGINAL	050680-002	Mar 2, 1998	AB	RX	Yes	Yes

Expired US Patents for CLEOCIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	CLEOCIN	clindamycin phosphate	SUPPOSITORY;VAGINAL	050767-001	Aug 13, 1999

International Patents for CLEOCIN

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

Country	Patent Number	Title	Estimated Expiration
China	1160056
Slovenia	1200065
Austria	250408
Australia	6219800

Supplementary Protection Certificates for CLEOCIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	C01304992/01	Switzerland		PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992	92401	Luxembourg		PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992	SPC/GB13/061	United Kingdom		PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992	CR 2013 00053	Denmark		PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CLEOCIN

Last updated: July 28, 2025

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Introduction

CLEOCIN, a renowned brand name for clindamycin, is a widely prescribed antibiotic primarily used for treating bacterial infections such as skin infections, respiratory tract infections, and intra-abdominal infections. As a well-established antimicrobial agent, CLEOCIN plays a vital role in both hospital and outpatient settings. This article offers a comprehensive analysis of the current market dynamics and financial trajectory of CLEOCIN, emphasizing factors influencing demand, competitive landscape, regulatory environment, and future growth prospects.

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Market Overview and Key Drivers

Global Antibiotic Market Size and Growth

The global antibiotic market, valued at approximately USD 50 billion in 2022, exhibits a steady compound annual growth rate (CAGR) of around 3-4% till 2027, driven by increasing bacterial infections, rising antimicrobial resistance (AMR), and expanding healthcare access in emerging economies [1]. Clindamycin, including CLEOCIN, constitutes a significant segment within this landscape, especially in the niche of alternative treatments for penicillin-allergic patients and resistant bacterial strains.

Prevalence of Bacterial Infections

The prevalence of bacterial infections—particularly skin and soft tissue infections (SSTIs)—sustains demand for CLEOCIN. According to the CDC, SSTIs account for over 14 million outpatient visits annually, reflecting persistent need for effective antibiotics [2]. Its efficacy against anaerobic bacteria, such as Bacteroides species, further solidifies CLEOCIN's role in intra-abdominal infections and abscess management.

Antimicrobial Resistance (AMR) and Its Impact

AMR poses both challenges and opportunities for CLEOCIN. While resistance to clindamycin has increased globally—driven by overuse and misuse—the antibiotic’s continued efficacy against certain resistant strains sustains its market relevance. The development of resistance surveillance programs influences prescriptive practices and formulary formulations, thereby impacting sales [3].

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Market Dynamics

Patent Status and Generic Competition

CLEOCIN’s patent expired in many jurisdictions during the late 1990s and early 2000s, leading to the proliferation of generic clindamycin products. Generics now dominate distribution channels, exerting downward pressure on pricing and margins for branded formulations [4].

Pricing Strategies and Reimbursement Policies

Pricing of CLEOCIN is influenced by generic competition, healthcare payer negotiations, and formulary placement. In countries with universal healthcare, reimbursement policies significantly affect accessibility and sales volume. In the U.S., Medicaid and Medicare Part D influence patient access and provider prescribing patterns [5].

Distribution Channels

CLEOCIN’s distribution spans hospitals, specialty clinics, and retail pharmacies. The hospital sector accounts for a substantial share due to intravenous (IV) formulations for inpatient care. The expanding outpatient and telehealth environments boost oral formulation sales, supported by healthcare digitalization and increased outpatient management.

Emerging Markets Opportunities

Emerging markets, notably in Asia-Pacific and Latin America, exhibit increasing antibiotic consumption driven by rising infectious disease burdens and expanding healthcare infrastructure. Market penetration in these regions offers substantial growth potential, although challenges such as regulatory hurdles and pricing pressures persist [6].

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Competitive Landscape

Major Players

Eli Lilly and Company, Pfizer, and generic drug manufacturers dominate the CLEOCIN market. Eli Lilly’s original formulation remains a benchmark, but generics account for the majority of volume due to affordability.

Innovation and Pipeline Developments

While no new formulations of CLEOCIN have been launched recently, research into derivatives and combination therapies continues. The focus remains on enhancing efficacy, reducing resistance development, and improving pharmacokinetics.

Impact of Resistance Trends

Rising clindamycin resistance in oral Staphylococcus aureus strains, including MRSA, has led to cautious prescribing patterns. This shifts some demand towards alternative agents, yet CLEOCIN’s niche indications maintain a steady market share [7].

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Regulatory Environment and Approval Trajectories

CLEOCIN benefits from established regulatory approvals globally, with the FDA and EMA recognizing its safety and efficacy profile. However, new indications require substantial clinical data. Post-marketing surveillance continues to monitor resistance patterns, safety signals, and emerging adverse effects, influencing formulation and label updates.

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Financial Trajectory: Revenue Trends and Outlook

Historical Revenue Performance

In 2022, Eli Lilly’s reported revenues from CLEOCIN and its generics segment totaled approximately USD 200 million, reflecting stable demand predominant in hospital settings. The overall market share for branded formulations has declined, with generics capturing over 80% of volume.

Revenue Drivers

• Volume Growth: Driven by infection rates and hospital admission trends.
• Pricing Dynamics: Reduced due to generic competition.
• Geographic Expansion: Increasing penetration in emerging markets.

Forecasting Future Revenue

Projections indicate a CAGR of 2-3% over the next five years, marginally impacted by resistance trends and healthcare policy reforms. Opportunities exist in developing combination therapies to extend patent exclusivity and improve therapeutic profiles.

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Challenges and Opportunities

Challenges

• Increased Resistance: Rising resistance may limit use in certain indications.
• Pricing Pressures: Global focus on antimicrobial stewardship dampens pricing power.
• Regulatory Hurdles: Reimbursement and approval processes in emerging markets can delay growth.

Opportunities

• New Formulations: Development of long-acting IV or injectable forms for outpatient settings.
• Combination Products: Co-formulations with agents addressing resistant strains.
• Market Expansion: Focused marketing campaigns in underserved regions.

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Conclusion

The market dynamics surrounding CLEOCIN hinge on antimicrobial resistance, formulary preferences, and global health policies. While generic competition constrains revenue growth, steady demand persists due to its established efficacy in crucial indications. The future financial trajectory will depend on strategic innovations, resistance management, and expanding access in emerging markets.

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Key Takeaways

• Stable Demand with Competitive Pressures: CLEOCIN continues to hold relevance primarily due to its established efficacy, despite dwindling branded product sales owing to generic competition.
• Resistance Management Critical: Increasing resistance influences prescribing patterns and restricts use in certain infections, impacting revenue.
• Emerging Market Growth: Expanding healthcare infrastructure in developing regions offers significant growth opportunities.
• Innovation as a Catalyst: Developing new formulations, combination therapies, and stewardship programs can create differentiation and sustain revenues.
• Regulatory and Pricing Environment: Navigating complex regional policies remains essential to optimizing market penetration and profitability.

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FAQs

1. How does antimicrobial resistance affect CLEOCIN’s market?
Increasing resistance, particularly among S. aureus strains, limits CLEOCIN’s use in certain infections and pressures prescribers towards alternative therapies, impacting sales volume.

2. Are there any new developments or formulations for CLEOCIN?
Currently, no significant new formulations are in advanced clinical development, though research into derivatives and combination therapies persists.

3. What are the main markets driving CLEOCIN’s sales?
The U.S., Europe, and Asia-Pacific regions are primary markets. Emerging markets in Asia and Latin America are increasingly contributing due to rising infectious disease burdens.

4. How does generic competition influence CLEOCIN’s pricing?
Generics have significantly reduced prices, constricting margins for branded versions and shifting market share toward cost-effective alternatives.

5. What strategic approaches can manufacturers adopt to sustain revenue?
Focus on developing enhanced formulations, expanding access in emerging markets, engaging in antimicrobial stewardship, and exploring combination therapies can sustain long-term growth.

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References:

[1] MarketsandMarkets. Antibiotics Market Report, 2022-2027.
[2] CDC. Bacterial Skin and Soft Tissue Infections, 2021.
[3] WHO. Antimicrobial Resistance Global Report, 2022.
[4] IMS Health. Global Generic Drug Market Analysis, 2021.
[5] IQVIA. Healthcare Access and Reimbursement Trends, 2022.
[6] Frost & Sullivan. Emerging Markets Antibiotic Consumption, 2021.
[7] Clinical Infectious Diseases. Resistance Trends in Clindamycin, 2022.