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 RISING on August 28^th, 2012.

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

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
Portugal	1200065
Slovenia	1200065
World Intellectual Property Organization (WIPO)	0110407
El Salvador	2001000138	COMPOSICION DE OVULOS INTRAVAGINALES DE CLINDAMICINA

Supplementary Protection Certificates for CLEOCIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	2013/044	Ireland		PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
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	2013C/060	Belgium		PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
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

CLEOCIN (clindamycin) Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

What is CLEOCIN and how is it used in the market?

CLEOCIN is a branded name for clindamycin, an antibiotic. In practice, its market is driven by:

• Bacterial indications where clinicians choose lincosamides, often after resistance and guideline constraints across common alternatives
• Formulation mix (oral vs topical vs injectable) that determines prescriber workflow, payer coverage, and channel profitability

The brand competes primarily against generic clindamycin products in most developed markets and against broader antibiotic classes (penicillins, cephalosporins, macrolides, etc.) in therapeutic positioning.

How has the patent and exclusivity position shaped commercialization?

CLEOCIN’s financial trajectory is fundamentally constrained by the fact that clindamycin’s core IP is long expired and the market is dominated by generics.

Key implications for brand economics:

• Price compression: branded pricing loses to low-cost generics once exclusivity ends.
• Share dilution: branded demand becomes a small residual driven by prescriber familiarity, contracts, and specific formulation availability.
• Marketing leverage shift: value accrues more from distribution and channel arrangements than from IP moat.

What market dynamics govern demand for CLEOCIN?

Therapy mix and guideline-driven prescribing

Clindamycin demand correlates with:

• Infectious disease prescribing volumes (skin/soft tissue, dental, anaerobic coverage use cases)
• Antibiotic stewardship: scrutiny around broad-spectrum use can shift volume toward or away from clindamycin depending on local guidance
• Sensitivity to resistance patterns: clindamycin remains used where organism susceptibility is preserved

Channel dynamics

• Generic penetration tends to keep transaction prices low across payers.
• Hospital procurement often favors contracted suppliers for injectable or inpatient-relevant formulations.
• Retail formularies influence oral and topical market share and net revenue, especially when generic alternatives are tiered low.

Competitive set

CLEOCIN’s competitive landscape is shaped by:

• Generic clindamycin as the near-substitute for most indications
• Other antibiotic classes for specific clinical pathways (broad-spectrum alternatives can gain share when guidelines shift)

What is the financial trajectory (market value signals and revenue drivers)?

Public, line-item brand financials for CLEOCIN as a standalone product are not consistently disclosed in a way that supports an auditable year-by-year model. The correct way to map financial trajectory using observable market signals is through three measurable forces that dominate branded antibiotics after exclusivity ends:

1. Net price decline and margin contraction

   • Branded-to-generic conversion drives a step-down in realized price and gross margin.
   • Even when unit volumes hold up, net revenue typically falls because reimbursement and wholesaler pricing converge to generic benchmarks.

2. Share erosion and SKU-level flattening

   • Brands often retain only partial share in certain formats.
   • Demand becomes more formulation-dependent than brand-dependent because prescribers select based on product form, dosing convenience, and formulary status.

3. Residual revenue depends on contracting and formulation availability

   • For injectables or specialty preparations, supply contracts can sustain some revenue.
   • For retail forms, generic ubiquity generally caps upside.

Where do market economics show the biggest pressure points?

Wholesale acquisition cost vs realized net price

In mature generic markets, the key financial variable is not list price but:

• payer rebates
• channel contracting terms
• inventory and supply pricing at wholesaler and provider levels

CLEOCIN’s branded economics are pressured by:

• generic price undercutting
• tier placement on formularies
• substitution at the pharmacy counter and hospital pharmacy

Inventory and supply chain normalization

Once product ecosystems become generic-led:

• lead times and supply certainty can matter more than brand marketing
• gross-to-net spreads narrow or become more volatile based on supplier competition

How does regulation and safety impact demand and pricing power?

Clindamycin has a known safety profile relevant to antibiotic prescribing:

• Clostridioides difficile-associated risk is a clinical consideration that affects stewardship patterns.
• Safety warnings can limit demand elasticity, particularly in outpatient settings where alternative therapies exist.

In practical terms:

• stewardship scrutiny shifts prescribing toward narrower or guideline-preferred options when available
• it reduces the brand’s ability to sustain premium pricing versus generics

What does the competitive and brand landscape imply for investment-style outlook?

CLEOCIN’s investment profile is shaped by the classic post-exclusivity reality:

• Low incremental pricing power
• Limited growth potential at the brand level without a differentiated formulation, new indication, or substantial managed-care advantage
• Revenue stability risk depends on contracting outcomes and generic market dynamics, not on new IP

For financial forecasting, the dominant question becomes whether a brand retains:

• defensible formulary placement in one or more key SKUs
• contracting advantages in institutional channels
• differentiated delivery characteristics versus the generic set

What product-format economics matter most for CLEOCIN?

Even without proprietary disclosure, the market structure of clindamycin antibiotics implies that financial trajectory differs by format:

CLEOCIN format (typical)	Primary demand driver	Main financial outcome post-generic entry
Oral	Retail prescription volume + formulary tiers	Net price compression, share thinning
Topical	Dermatology/skin infections use patterns	Lower brand premium, residual share
Injectable	Hospital/institution procurement + acute use	Contracted supply pricing can cap downside but limits upside

This SKU-level structure means that a brand’s financial trajectory tends to be uneven: one format can stabilize net revenue while others erode.

How does the US market specifically shape CLEOCIN’s financial path?

In the US, generic substitution rules and payer formulary design tend to drive:

• rapid uptake of generics for clindamycin across oral and many topical categories
• institutional switching via pharmacy and therapeutics committees

Net result:

• the branded product’s economic trajectory typically shows long-run decline after exclusivity and then “plateau” driven by residual prescribing and contract-held channels.

Is CLEOCIN still a material brand revenue driver?

For mature antibiotic brands under generic pressure, the usual pattern is:

• CLEOCIN becomes smaller in relative importance within the company’s portfolio
• its financial contribution becomes focused on maintenance of specific contracts and use-case niches rather than growth

This is consistent with how major branded antibiotic franchises behave after clindamycin-like molecules exit exclusivity.

Key Takeaways

• CLEOCIN is structurally constrained by long-expired clindamycin exclusivity dynamics, with generics determining price and volume.
• Financial trajectory is dominated by net price compression and formulation-specific residual share, not by IP-driven expansion.
• Market dynamics hinge on antibiotic stewardship, guideline positioning, and formulary contracting, with safety considerations limiting pricing power.
• Outlook is channel-driven: stability depends on institutional and payer placement for specific SKUs, while upside is limited without meaningful differentiation.

FAQs

1) What drives CLEOCIN demand more: clinical need or pricing?

Clinical need drives baseline demand; pricing and formulary tiering determine realized net revenue and branded share once generics dominate.

2) Why does the brand typically underperform after generic entry?

Generic substitution and reimbursement convergence reduce the brand premium, compressing net prices and shifting volume toward the lowest contracted or tiered options.

3) Which CLEOCIN formats tend to be most defensible?

Formats tied to institutional procurement and contract-managed supply can retain more stability than retail-dependent formats under generic substitution pressure.

4) How does C. difficile risk affect prescribing patterns?

Safety risk is reflected in stewardship and guideline adherence, which can limit broader use when alternatives exist, reducing demand elasticity.

5) What is the practical meaning for forecasting CLEOCIN revenues?

Forecasting should center on contracting outcomes, formulary placement, and expected generic price levels rather than assuming IP-led growth.

References

[1] FDA. Drugs@FDA: CLEOCIN (clindamycin) drug label information and approvals. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] DailyMed. CLEOCIN (clindamycin) prescribing information and safety information. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/
[3] GlobalData. Clindamycin market and competitive landscape coverage (antibiotics category dynamics). GlobalData Pharmaceuticals. https://www.globaldata.com/