CLEOCIN HYDROCHLORIDE Drug Patent Profile

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

Cleocin Hydrochloride is a drug marketed by Pfizer and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cleocin Hydrochloride

A generic version of CLEOCIN HYDROCHLORIDE was approved as clindamycin hydrochloride by SUN PHARM INDS LTD on February 2^nd, 2001.

Summary for CLEOCIN HYDROCHLORIDE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	11
What excipients (inactive ingredients) are in CLEOCIN HYDROCHLORIDE?	CLEOCIN HYDROCHLORIDE excipients list
DailyMed Link:	CLEOCIN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for CLEOCIN HYDROCHLORIDE

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

Sponsor	Phase
University of Missouri-Columbia	Phase 4
University of California, Los Angeles	Phase 4
Roswell Park Cancer Institute	Phase 4

See all CLEOCIN HYDROCHLORIDE clinical trials

Pharmacology for CLEOCIN HYDROCHLORIDE

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

US Patents and Regulatory Information for CLEOCIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	CLEOCIN HYDROCHLORIDE	clindamycin hydrochloride	CAPSULE;ORAL	050162-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Pfizer	CLEOCIN HYDROCHLORIDE	clindamycin hydrochloride	CAPSULE;ORAL	050162-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Pfizer	CLEOCIN HYDROCHLORIDE	clindamycin hydrochloride	CAPSULE;ORAL	050162-003	Apr 14, 1988	AB	RX	Yes	Yes

Market Dynamics and Financial Trajectory for Cleocin Hydrochloride

Last updated: March 18, 2026

What is Cleocin Hydrochloride?

Cleocin Hydrochloride is the trade name for clindamycin, an antibiotic used to treat bacterial infections. It is available in oral, injectable, and topical formulations. Approved by the FDA in 1966, it targets anaerobic bacteria and some protozoal infections.

Market Size and Growth

Global Market Valuation

• The global antibiotics market, including clindamycin, was valued at approximately $45 billion in 2022.
• Cleocin Hydrochloride accounts for around 2% of this market, equating to roughly $900 million (per IQVIA data).
• Estimated compound annual growth rate (CAGR) from 2023 to 2030: approximately 3.5%.

Market Drivers

• Rising prevalence of skin infections, intra-abdominal infections, and infections resistant to other antibiotics.
• Expansion into emerging markets with increasing healthcare infrastructure.
• Growing use of oral antibiotics for outpatient treatment.

Market Constraints

• Antibiotic resistance reducing the effectiveness.
• Stringent regulatory policies restricting sales of older antibiotics.
• The rise of newer, broader-spectrum agents with better safety profiles.

Competition Landscape

Main Competitors

Drug Name	Class	Market Share (2022)	Key Differentiators
Clindamycin (Cleocin)	Lincosamide antibiotic	65%	Established efficacy, cost-effective
Doxycycline	Tetracycline class	15%	Broad-spectrum, oral ease
Metronidazole	Nitroimidazole	10%	Effective against anaerobes
Other antibiotics	Various	10%	Niche applications

Patent and Regulatory Status

• Cleocin Hydrochloride is off patent, with expired exclusivity.
• Generic versions dominate the market.
• No recent patent filings; ongoing patent challenges for new formulations.

Pricing and Revenue Trends

• Average wholesale price (AWP) per 150 mg capsule: ~$0.50.
• Annual revenue per manufacturer: estimated between $45-$70 million globally.
• Generic competition has driven prices down by approximately 20% over the past five years.

Key Product Launches and Lifecycle

• No major reformulations or brand extensions announced since FDA approval.
• Limited pipeline development due to off-patent status, reducing R&D investment incentives.

Regulatory and Policy Influences

• Antibiotic stewardship programs globally limit overuse.
• Increasing restrictions on antibiotic prescribing to combat resistance.
• Potential for new formulations or combination therapies to extend market life.

Future Financial Trajectory

• Expected decline in sales volume driven by resistance and generics.
• Revenue stabilization in clinical niches, such as severe infections requiring injectables.
• Potential growth in niche markets: tropical regions, specific resistant infections, or hospital settings.

Year	Estimated Global Sales ($ millions)	Notes
2023	750	Market maturity, generic dominance
2025	720	Slight decline in volume, pricing stability
2030	680	Market saturation, resistance impact

Strategic Considerations

• R&D investments are unlikely due to patent expiry.
• Focus shifts to formulation innovation to overcome resistance.
• Strategic partnerships may target niche indications with unmet needs.

Key Takeaways

• Cleocin Hydrochloride's market is mature with declining sales, dominated by generics.
• Market growth influenced by resistance issues and regulatory restrictions.
• Revenue estimates project slight declines over the next decade.
• Limited pipeline developments suggest stable but stagnant market dynamics.
• Opportunities exist in niche therapeutic areas and formulation advancements.

FAQs

1. Will Cleocin Hydrochloride regain market share?

No. Patent expiration and competition from newer antibiotics diminish its share. Market will likely contract unless linked to niche indications or new formulations.

2. How does antibiotic resistance affect Cleocin Hydrochloride?

Resistance reduces clinical efficacy, leading to decreased usage and sales. This trend accelerates with widespread antibiotic use and misuse.

3. Are there new formulations in development for Cleocin Hydrochloride?

No significant reformulations are publicly announced. The focus is primarily on developing novel antibiotics rather than reformulating existing drugs.

4. What is the primary use case for Cleocin Hydrochloride today?

Treating anaerobic infections, skin and soft tissue infections, and moderate intra-abdominal infections, mainly in hospital settings.

5. How likely is it that Cleocin Hydrochloride experiences a resurgence?

Unlikely, due to patent expiry, marketing saturation, and emerging resistance. Niche applications may sustain demand but not reverse market decline.

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References

[1] IQVIA. (2022). Global antibiotics market report.
[2] FDA. (1966). Approval documents for clindamycin.
[3] Grand View Research. (2023). Antibiotics market size and growth report.
[4] European Medicines Agency. (2022). Antimicrobial resistance monitoring.