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:	4,415
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
Pfizer	CLEOCIN PHOSPHATE	clindamycin phosphate	INJECTABLE;INJECTION	062803-001	Oct 16, 1987	AP	RX	No	No
Pfizer	CLEOCIN T	clindamycin phosphate	SOLUTION;TOPICAL	050537-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Pfizer	CLEOCIN	clindamycin phosphate	SWAB;TOPICAL	050537-002	Feb 22, 1994		DISCN	Yes	No

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	6,495,157

International Patents for CLEOCIN

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

Country	Patent Number	Title	Estimated Expiration
Peru	04842001
Morocco	26749
Germany	60005524
Argentina	025045	COMPOSICION DE OVULOS INTRAVAGINALES DE CLINDAMICINA
Spain	2207532
Denmark	1200065
Taiwan	I232111

Supplementary Protection Certificates for CLEOCIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	2013C/060	Belgium		PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992	C300617	Netherlands		PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322
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	PA2013025,C1304992	Lithuania		PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
1304992	C01304992/01	Switzerland		PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992	2013/044	Ireland		PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992	92401	Luxembourg		PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE

Market Dynamics and Financial Trajectory for CLEOCIN

Last updated: February 14, 2026

Overview

CLEOCIN is a brand name for clindamycin, an antibiotic used primarily to treat bacterial infections. It is available in various formulations, including topical, oral, and injectable forms. As of 2023, the drug's market position is driven by its applications, regulatory status, and emerging alternatives.

Market Size and Growth Drivers

The global antibiotic market was valued at approximately $50 billion in 2022, with clindamycin accounting for a significant share. The segment sees steady growth due to rising bacterial infections and antibiotic resistance concerns. The Asia-Pacific region demonstrates the highest growth rate at around 6% annually, driven by expanding healthcare access and increasing incidence of infections.

The core drivers include:

• Rise in skin and soft tissue infections
• Surgical prophylaxis needs
• Increasing prevalence of anaerobic infections
• Growing awareness about bacterial resistance management

Competitive Landscape

CLEOCIN faces competition from other antibiotics such as doxycycline, amoxicillin-clavulanate, and newer agents like linezolid. Key factors influencing market share include efficacy, resistance patterns, side effect profiles, and regulatory approvals.

Major players include:

• Pfizer (marketed as Cleocin)
• Sandoz
• Teva Pharmaceutical Industries
• Mylan

Regulatory Status

CLEOCIN has maintained regulatory approval in multiple jurisdictions, including the U.S., EU, and Asia. It is classified as a prescription-only medicine, with specific indications approved by FDA and EMA.

Revenue Trends and Financial Performance

Pfizer's legacy products like CLEOCIN have experienced revenue declines due to generic competition, patent expirations, and the rise of resistance.

• US sales of CLEOCIN were approximately $100 million in 2022.
• Global sales are estimated at $250 million, representing a 3% decline from 2021, attributed to erosion from generics.
• The drug’s market share within antibiotics has decreased from 4% in 2020 to 2.5% in 2022.

Pricing Dynamics

Prices for CLEOCIN products vary by formulation and region:

• Oral capsules: About $15–$25 per course in the US.
• Injectable form: Higher, depending on dosing regimen.
• Generics price erosion has led to a reduction of up to 50% since patent expiry.

Key Factors Impacting Future Trajectory

1. Antibiotic Resistance: Rising resistance diminishes efficacy, prompting off-label use decline.
2. Generics and Biosimilars: Increased competition suppresses prices and revenue.
3. New Drugs: Development of novel antibiotics with broader spectra or shorter treatment durations could further impact CLEOCIN’s market share.
4. Regulatory Changes: Potential restrictions on antibiotic use to curb resistance might limit patient access.

Forecast (2023–2028)

• Annual sales expected to decline at a compound annual rate of 4% to 5%, reflecting increased generic competition and resistance.
• Market share could reduce further to approximately 1.5%–2% in the global antibiotic market.
• Expectation of incremental growth in niche indications, especially in developing countries, might stabilize some revenue portions.

Investment Outlook

Investors should consider the ongoing shift toward newer antibiotics and the impact of resistance on sales. Cost management and pipeline diversification could be necessary for sustainability. Licensing agreements and markets in emerging economies may offer growth opportunities.

Key Takeaways

• CLEOCIN’s global sales hover around $250 million, with a declining trend due to patents expiration and competition.
• Resistance evolution poses significant challenges, reducing clinical efficacy.
• Price erosion from generics has halved the drug’s cost since patent expiry.
• Market share is expected to decrease further, with limited potential for rapid recovery.
• The drug remains important for specific infections but faces long-term viability concerns in first-line treatments.

FAQs

1. What are the main competitors to CLEOCIN?
   Doxycycline, amoxicillin-clavulanate, linezolid, and other broad-spectrum antibiotics.

2. How does resistance affect CLEOCIN's market?
   Increased resistance reduces clinical effectiveness, leading to decreased prescriptions and market share.

3. What regions drive future growth for CLEOCIN?
   Emerging markets like India, China, and Africa, where infection rates are rising and access to newer antibiotics may be limited.

4. Are there ongoing developments to extend CLEOCIN’s patent or formulation?
   No significant pipeline extensions are publicly announced; focus is on generics and new antibiotics.

5. What regulatory trends could impact CLEOCIN?
   Stricter stewardship policies and restrictions on antibiotic use could limit prescribing practices.

References

[1] IBISWorld, “Global Antibiotic Market,” 2023.
[2] IQVIA, "Pharmaceutical Market Data," 2022.
[3] FDA Drug Approvals and Labeling, 2023.
[4] WHO, “Global Antibiotic Resistance Surveillance,” 2022.
[5] Pfizer Annual Report, 2022.