CLINDAMYCIN PHOSPHATE - Generic Drug Details

What are the generic sources for clindamycin phosphate and what is the scope of patent protection?

Clindamycin phosphate is the generic ingredient in eighteen branded drugs marketed by Glenmark Pharms Ltd, Padagis Israel, Taro, Norvium Bioscience, Pfizer, Fougera Pharms, Padagis Us, Bausch, Alembic, Amneal, Encube, Quagen, Solaris Pharma Corp, Sun Pharma Canada, Zydus Lifesciences, Organon Llc, Pharmacia And Upjohn, Abraxis Pharm, Almaject, Bedford, Bristol Myers Squibb, Fresenius Kabi Usa, Hikma, Igi Labs Inc, Loch, Marsam Pharms Llc, Rising, Sagent Pharms Inc, Solopak, Teva Parenteral, Watson Labs, Baxter Hlthcare Corp, Sandoz Inc, Abbott Labs, Baxter Hlthcare, Boca Pharma Llc, Carnegie, Chartwell Rx, Encube Ethicals, Fougera Pharms Inc, G And W Labs Inc, Novast Labs, Pai Holdings Pharm, Ph Health, Taro Pharm Inds, Vintage Pharms, Xttrium Labs Inc, Epic Pharma Llc, Actavis Mid Atlantic, and Almirall, and is included in ninety-two NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Clindamycin phosphate has thirty-five patent family members in twenty-one countries.

There are twenty-five drug master file entries for clindamycin phosphate. Thirty-six suppliers are listed for this compound.

Summary for CLINDAMYCIN PHOSPHATE

International Patents:	35
US Patents:	3
Tradenames:	18
Applicants:	50
NDAs:	92
Drug Master File Entries:	25
Finished Product Suppliers / Packagers:	36
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	31
Patent Applications:	4,409
Drug Prices:	Drug price trends for CLINDAMYCIN PHOSPHATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLINDAMYCIN PHOSPHATE
What excipients (inactive ingredients) are in CLINDAMYCIN PHOSPHATE?	CLINDAMYCIN PHOSPHATE excipients list
DailyMed Link:	CLINDAMYCIN PHOSPHATE at DailyMed

See drug prices for CLINDAMYCIN PHOSPHATE

Recent Clinical Trials for CLINDAMYCIN PHOSPHATE

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

Sponsor	Phase
Sun Pharmaceutical Industries, Inc.	PHASE1
Daré Bioscience, Inc.	Phase 1
Memorial Sloan Kettering Cancer Center	Phase 2

See all CLINDAMYCIN PHOSPHATE clinical trials

Pharmacology for CLINDAMYCIN PHOSPHATE

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

Anatomical Therapeutic Chemical (ATC) Classes for CLINDAMYCIN PHOSPHATE

D10AF	Antiinfectives for treatment of acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

G01AA	Antibiotics
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

J01FF	Lincosamides
J01F	MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for CLINDAMYCIN PHOSPHATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CLINDESSE	Vaginal Cream	clindamycin phosphate	2%	050793	1	2015-02-05

US Patents and Regulatory Information for CLINDAMYCIN PHOSPHATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	clindamycin phosphate	INJECTABLE;INJECTION	203048-002	Apr 4, 2013	AP	RX	No	No
Baxter Hlthcare Corp	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	clindamycin phosphate	INJECTABLE;INJECTION	208084-002	Jun 28, 2017	AP	RX	No	No
Bausch	ZIANA	clindamycin phosphate; tretinoin	GEL;TOPICAL	050802-001	Nov 7, 2006	AB1	RX	Yes	Yes
Amneal	CLINDAMYCIN PHOSPHATE	clindamycin phosphate	GEL;TOPICAL	215219-001	Nov 3, 2022		DISCN	No	No
Watson Labs	CLINDAMYCIN PHOSPHATE	clindamycin phosphate	INJECTABLE;INJECTION	062900-001	Jun 8, 1988		DISCN	No	No

Expired US Patents for CLINDAMYCIN PHOSPHATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Padagis Us	CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793-001	Nov 30, 2004	6,899,890
Norvium Bioscience	EVOCLIN	clindamycin phosphate	AEROSOL, FOAM;TOPICAL	050801-001	Oct 22, 2004	7,141,237
Pfizer	CLEOCIN	clindamycin phosphate	SUPPOSITORY;VAGINAL	050767-001	Aug 13, 1999	6,495,157
Bausch	CLINDAGEL	clindamycin phosphate	GEL;TOPICAL	050782-001	Nov 27, 2000	6,387,383
Padagis Us	CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793-001	Nov 30, 2004	5,993,856

International Patents for CLINDAMYCIN PHOSPHATE

Country	Patent Number	Title	Estimated Expiration
Mexico	390004
World Intellectual Property Organization (WIPO)	2005027807
Portugal	3324938
Mexico	2018000800
Japan	2007505927

Supplementary Protection Certificates for CLINDAMYCIN PHOSPHATE

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	122013000081	Germany		PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
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
1304992	2013/044	Ireland		PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322

Market Dynamics and Financial Trajectory for Clindamycin Phosphate

Last updated: July 27, 2025

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Introduction

Clindamycin phosphate remains a critical component in the antimicrobial arsenal, especially for treating skin and soft tissue infections, respiratory infections, and anaerobic bacterial infections. As antibiotic resistance escalates and regulatory landscapes evolve, understanding the market dynamics and financial trajectory for clindamycin phosphate is vital for stakeholders including pharmaceutical manufacturers, investors, and healthcare providers.

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Market Overview and Key Drivers

Global Market Size and Growth Trends

The global antibiotic market, valued at approximately USD 45 billion in 2022, is projected to expand at a compound annual growth rate (CAGR) of 3.5% through 2030 [1]. Clindamycin phosphate accounts for a significant segment within this space, attributed to its broad-spectrum activity, especially against anaerobic bacteria and certain protozoa.

In developed regions such as North America and Europe, increased prescribing of clindamycin phosphate aligns with rising incidences of skin infections, bacterial pneumonia, and obstetric infections. Meanwhile, emerging markets in Asia-Pacific witness growth due to increasing healthcare infrastructure and antimicrobial demand [2].

Therapeutic Demand and Prescribing Trends

The demand for clindamycin phosphate is driven by:

• Antibiotic Resistance Awareness: Rising resistance among Gram-positive bacteria to alternative antibiotics enhances clindamycin phosphate's role, particularly in MRSA (Methicillin-resistant Staphylococcus aureus) infections [3].
• Formulation Advancements: Availability of both topical and oral formulations increases its versatility, appealing to diverse clinical needs.
• Regulatory Approvals and Indications: Expanding approved indications, including off-label uses, contribute to market growth.

Impact of Antibiotic Stewardship and Resistance

Antibiotic stewardship programs globally aim to optimize antimicrobial use, which, while reducing unnecessary prescriptions, may constrain growth rates. Notably, clindamycin’s association with Clostridioides difficile infections imposes caution among prescribers, impacting demand patterns [4].

Competitive Landscape

Clindamycin phosphate faces competition from other antibiotics such as doxycycline, vancomycin, and linezolid, particularly in the treatment of resistant bacterial strains. The emergence of newer agents with improved safety profiles and reduced resistance potential could influence market share.

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Regulatory and Patent Dynamics

Patent Status and Generic Entry

Clindamycin phosphate’s patent protection generally expired in the late 1990s or early 2000s, resulting in widespread generic proliferation. The reduced patent barriers have driven pricing pressures, compressing profit margins but broadening access and prescription volumes.

Regulatory Approvals and Label Expansion

Regulatory agencies like the FDA and EMA continue to review and approve new formulations or indications for clindamycin phosphate. For instance, topical forms for acne vulgaris have Therapeutic Area approvals that enhance market penetration.

Regulatory Challenges and Potential Restrictions

Concerns over antibiotic resistance and C. difficile risks may lead to restrictions or updated prescribing guidelines, potentially limiting market growth.

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Financial Trajectory and Revenue Projections

Historical Revenue and Market Share

Major pharma companies producing clindamycin phosphate, such as Pfizer, Actavis, and Glenmark, have historically realized steady revenues from their formulations. Generics dominate supply, driving downward price margins but ensuring volume-based profitability.

Forecasted Revenue Trends

Analysts project a moderate CAGR of 2-4% for clindamycin phosphate over the next five years, primarily driven by expanding global healthcare access and a steady prevalence of bacterial infections requiring therapy [5].

Pricing Dynamics

Pricing pressures due to generic competition are expected to persist, emphasizing cost-efficiency and volume sales over premium pricing. Innovation in formulation, such as liposomal or long-acting preps, may offer premium opportunities.

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Innovative Developments and Future Opportunities

Emerging research into combination therapies and novel delivery systems may revitalize clindamycin phosphate usage. For example:

• Nanotechnology-based formulations: Improve bioavailability and reduce resistance development.
• Combination regimens: Pairing with other antimicrobials to enhance efficacy and resist resistance.

Long-term investment prospects hinge on regulatory acceptance of such innovations and their ability to demonstrate safety and economic advantages.

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Market Challenges and Risks

• Antibiotic Resistance: Escalating resistance reduces clinical efficacy, compelling the market to pivot toward alternative agents.
• Regulatory and Stewardship Pressures: Stricter guidelines may curtail prescriptions and limit reimbursement.
• Pricing Pressures: Intense generic competition compresses profit margins, especially in mature markets.

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Conclusion

The financial trajectory and market dynamics for clindamycin phosphate depict a landscape characterized by steady demand, influenced heavily by resistance trends, regulatory actions, and innovation trajectories. While near-term growth may stabilize due to generic competition and stewardship efforts, opportunities for value-added formulations and expanded indications offer avenues for sustained revenue streams.

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Key Takeaways

• The global clindamycin phosphate market is mature with steady demand, primarily driven by infections resistant to other antibiotics.
• Patent expiration and generic proliferation exert downward pressure on prices but increase accessibility and prescribing volumes.
• Resistance development and stewardship initiatives could constrain growth but also stimulate innovation in formulations.
• Emerging technologies such as nanocarrier systems could provide differentiation and new revenue opportunities.
• Strategic focus on optimizing formulations, expanding indications, and navigating regulatory landscapes remains essential for long-term financial success.

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FAQs

1. How does antibiotic resistance impact the market for clindamycin phosphate?
Resistance reduces its clinical efficacy, leading to decreased prescribing and revenue, especially if resistance rates exceed therapeutic thresholds.

2. What are the primary competitors to clindamycin phosphate in the antimicrobial market?
Doxycycline, vancomycin, linezolid, and newer agents like dalbavancin compete in similar indications, influencing market share.

3. How do regulatory trends influence the future of clindamycin phosphate?
Stricter guidelines to curb resistance may limit use, while approvals for new formulations or indications could expand its market.

4. What innovative developments could enhance the market prospects for clindamycin phosphate?
Nanotechnology-based delivery systems and combination therapies may improve efficacy, safety profiles, and resistance management.

5. How do regional differences affect market dynamics?
Developing markets show increased growth potential due to rising healthcare access, whereas mature markets face pricing pressures and stewardship limitations.

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References

1. Grand View Research. (2022). Antibiotics Market Size & Trends.
2. IQVIA. (2022). Global Antimicrobial Market Insights.
3. CDC. (2021). Antibiotic Resistance Threats in the United States.
4. FDA. (2022). Clindamycin Use and C. difficile Risk.
5. EvaluatePharma. (2023). 5-Year Forecasts for Antibiotics and Antimicrobials.