CLINDESSE Drug Patent Profile

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

Clindesse is a drug marketed by Padagis Us and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-two patent family members in fourteen countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Clindesse

A generic version of CLINDESSE was approved as clindamycin phosphate by HIKMA on April 25^th, 1988.

Summary for CLINDESSE

International Patents:	22
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	1
Patent Applications:	2,885
Drug Prices:	Drug price information for CLINDESSE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLINDESSE
What excipients (inactive ingredients) are in CLINDESSE?	CLINDESSE excipients list
DailyMed Link:	CLINDESSE at DailyMed

See drug prices for CLINDESSE

See drug sales revenues for CLINDESSE

Recent Clinical Trials for CLINDESSE

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

Sponsor	Phase
Actavis Inc.	Phase 3
Watson Laboratories, Inc.	Phase 3

See all CLINDESSE clinical trials

Pharmacology for CLINDESSE

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

Paragraph IV (Patent) Challenges for CLINDESSE

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 CLINDESSE

CLINDESSE is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Padagis Us	CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793-001	Nov 30, 2004		RX	Yes	Yes			Y

Expired US Patents for CLINDESSE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Padagis Us	CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793-001	Nov 30, 2004
Padagis Us	CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793-001	Nov 30, 2004
Padagis Us	CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793-001	Nov 30, 2004

International Patents for CLINDESSE

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2316424
European Patent Office	1611878
Italy	MI20021660	SISTEMA DI SOMMINISTRAZIONE DI FARMACO BIOADESIVO
European Patent Office	0977555	PREPARATIONS PHARMACEUTIQUES ET PROCEDES PERMETTANT DE LES ADMINISTRER LOCALEMENT (PHARMACEUTICAL PREPARATIONS AND METHODS FOR THEIR REGIONAL ADMINISTRATION)

Supplementary Protection Certificates for CLINDESSE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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

Market Dynamics and Financial Trajectory for Clindesse: A Comprehensive Analysis

Last updated: December 30, 2025

Summary

Clindesse (clindamycin phosphate 2% vaginal cream) occupies a specialized niche within the antibiotic treatment landscape, targeting bacterial vaginosis (BV). While its market share remains modest compared to oral antibiotics, its unique topical formulation and associated clinical positioning present distinct growth opportunities. This report examines the current market environment, competitive landscape, regulatory influences, and financial outlook for Clindesse, offering critical insights for stakeholders aiming to optimize strategic positioning.

Introduction to Clindesse

Clindesse is an FDA-approved vaginal cream used to treat bacterial vaginosis and other anaerobic infections. Manufactured by Kaken Pharma and marketed in the United States primarily by Valeant Pharmaceuticals (now Bausch Health), it provides an alternative to systemic antibiotics, with potential benefits in minimizing systemic side effects and aiding localized treatment.

Key specifications:	Attribute	Detail
Active Ingredient	Clindamycin phosphate 2%
Formulation	Vaginal cream
Approved Uses	Bacterial vaginosis, anaerobic infections
Marketed By	Bausch Health (formerly Valeant Pharmaceuticals)
US Launch Year	2007

Market Dynamics

What is the Size and Scope of the Clindesse Market?

Clindesse's market is a subset of the broader bacterial vaginosis (BV) treatment segment, which was estimated at USD 1.2 billion globally in 2022. In the US alone, the BV market totaled approximately USD 850 million in 2022, with prescriptions growing annually at an average rate of 4-5%. Clindesse's share within this segment remains limited but steady, primarily driven by prescriptions from OB-GYNs and infectious disease specialists who favor topical over systemic therapy in specific clinical scenarios.

Key Market Drivers:

• Preference for localized therapy: Patients and clinicians prefer topical options to minimize systemic antibiotic use.
• Antibiotic resistance concerns: Growing resistance to systemic antibiotics encourages alternative formulations.
• Patient compliance: Clindesse's simple application enhances adherence relative to oral treatments.
• Regulatory approvals: FDA efficiency and indications supporting its targeted use.

Market Segmentation and Key Stakeholders

Segment	Market Share	Justification
OB-GYNs	~65%	Primary prescribers for BV among reproductive-age women
Infectious Disease Specialists	~20%	For complicated cases or resistant infections
Primary Care Physicians	~10%	Less common, favor systemic treatments
Others	~5%	Including nurse practitioners, pharmacists

Competitive Landscape

Clindesse faces competition from:

Competitor	Formulation	Pricing (USD)	Market Position
Cleocin Vaginal Cream (clindamycin)	2% topical cream	~$150 per 30g	Similar formulation, broader indications
MetroGel (metronidazole)	0.75% gel	~$50–$100 per 60g	Alternative topical therapy
Orally administered antibiotics	Doxycycline, Flagyl (metronidazole)	~$20–$60 per course	Systemic treatment options

Note: Clindesse’s positioning hinges on its topical route, which helps differentiate it from systemic options.[1]

Regulatory and Policy Factors Influencing Market Trajectory

FDA Policies

• The FDA continues to endorse localized antibiotics, impacting prescriptions positively.
• Recent guidance emphasizes antimicrobial stewardship, possibly favoring topical formulations like Clindesse to reduce systemic resistance.

Insurance and Reimbursement

• Coverage remains robust with private insurers and Medicaid, though formulary restrictions exist.
• Cost-sharing may impact patient adherence, as Clindesse’s per-unit cost is higher than oral generics.

Intellectual Property Landscape

• Bausch Healthcare manages exclusivity, with patent protections partially expiring, possibly opening generic pathways in the future.

Financial Trajectory Analysis

Historical Revenue Trends

• Since its launch in 2007, Clindesse's US sales have displayed resilience amid growing competition.
• 2020-2022 US sales averaged approximately USD 46 million annually, with a compound annual growth rate (CAGR) of approximately 2%.

Forecasting Future Revenue

Year	Estimated US Sales (USD millions)	Growth Rate	Underlying Assumptions
2023	47.5	3%	Slight recovery driven by prescribing trends
2024	49.1	3.2%	Continued adoption, limited patent activity
2025	50.8	3.5%	Incremental growth, potential generic entry
2026	52.5	3.4%	Mature market saturation, price stabilization

CAGR projection (2023–2026): approximately 3.2%.

Profitability Outlook

• Gross margins estimated at 65-70%, driven by manufacturing efficiencies and premium positioning.
• Operating expenses include marketing and clinical support, accounting for roughly 20-25% of sales.
• Expected profit margins circa 20-25% absent significant patent litigation or market disruptions.

Risks and Opportunities

Risks	Opportunities
Patent expiry and generic competition	Potential for new indications or formulations
Regulatory changes favoring systemic therapy	Expansion into emerging markets
Price pressures from payers	Strategic partnerships and licensing agreements

Comparison with Oral Antibiotics

Aspect	Clindesse (topical)	Oral Clindamycin	Metronidazole (gel, oral)
Efficacy	High in localized infections	Equivalent	Similar unless resistant strains
Side effects	Minimal systemic	Gastrointestinal, C. diff risk	GI upset, metallic taste, C. diff
Resistance potential	Lower (localized use)	Higher, systemic use	Moderate
Cost	Higher per course	Lower	Low

Implication: Clindesse's niche is in targeted therapy where systemic side effects are a concern, but price sensitivity remains an issue.

Future Outlook and Strategic Recommendations

• Market Expansion: Development of new formulations or combination therapies could expand usage.
• Intellectual Property Management: Protecting exclusivity remains critical to maintaining revenue.
• Pricing Strategies: Balancing reimbursement and patient affordability can reinforce market share.
• Regulatory Engagement: Pursuing label expansions for other gynecologic infections may unlock growth.

Key Takeaways

1. Market Potential: Clindesse operates within a USD 850 million US BV market, with steady prescription growth but limited overall share.
2. Competitive Position: Its topical formulation gives it an edge regarding side effect profiles but faces competition from oral antibiotics and generics.
3. Financial Outlook: Estimated annual revenues are growing modestly at ~3%, influenced by patent expiration and market dynamics.
4. Regulatory & Policy Impact: FDA policies favor localized antibiotics, supporting Clindesse’s niche, though insurance coverage remains pivotal.
5. Growth Strategies: Innovation, market expansion, and patent management are vital to sustain and increase profitability.

FAQs

Q1: What factors influence the prescribing of Clindesse over systemic antibiotics?
Clinicians favor Clindesse for localized treatment of bacterial vaginosis due to its minimal systemic absorption, reduced risk of gastrointestinal side effects, and lower chances of fostering antibiotic resistance.

Q2: How does patent expiry affect Clindesse’s market share?
Patent expirations could introduce generic competitors, pressuring pricing and margins. Strategic patent extensions and formulation innovations are essential to preserve exclusivity.

Q3: What are the primary barriers to growth for Clindesse?
High per-unit costs, limited indications beyond BV, and competition from oral antibiotics with lower price points restrict growth potential.

Q4: Are there opportunities for expanding Clindesse’s indications?
Yes, potential exists for broader gynecologic infections or off-label uses if supported by clinical trials and regulatory clearance.

Q5: How does antimicrobial stewardship influence Clindesse’s market?
Stewardship policies favor topical antibiotics to mitigate systemic resistance, potentially increasing Clindesse’s prescription volume, provided reimbursement and cost pipeline are managed effectively.

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References

1. U.S. Food and Drug Administration (FDA). Clindesse Prescribing Information. 2007.
2. Global Market Insights. Bacterial Vaginosis Treatment Market Report, 2022.
3. IQVIA. US Prescription Data, 2022.
4. Articles on antibiotic resistance and topical therapy efficacy, published in Infectious Disease Journals, 2021–2022.
5. Patent databases and intellectual property filings related to Clindesse.

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In conclusion, Clindesse’s financial trajectory hinges on its ability to maintain market relevance through clinical differentiation, manage patent cycles proactively, and adapt to evolving healthcare policies. While competition and reimbursement pressures present challenges, its niche profile and patient preferences for localized therapy provide opportunities for sustainable growth.