CLINDESSE Drug Patent Profile

When do Clindesse patents expire, 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-six 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	9,789,057		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	5,266,329
Padagis Us	CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793-001	Nov 30, 2004	5,993,856
Padagis Us	CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793-001	Nov 30, 2004	6,899,890

International Patents for CLINDESSE

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

Country	Patent Number	Title	Estimated Expiration
Canada	2540129	SYSTEME PHARMACEUTIQUE D'ADMINISTRATION (PHARMACEUTICAL DELIVERY SYSTEM)
Japan	2519029
Eurasian Patent Organization	200870154	ЛЕКАРСТВЕННОЕ СРЕДСТВО ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ
South Korea	20030076159	생체결합성 약물전달체계 (Bioadhesive drug delivery system)

Supplementary Protection Certificates for CLINDESSE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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	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

Market Dynamics and Financial Trajectory for Clindesse

Last updated: February 20, 2026

What is Clindesse and its current market position?

Clindesse is a topical formulation of clindamycin phosphate, approved by the FDA for the treatment of bacterial vaginosis (BV). Its formulation is available as a vaginal cream, delivering targeted antimicrobial therapy with minimal systemic absorption. Clindesse gained regulatory approval in 1994 and is marketed primarily by Perrigo Company and other generics manufacturers.

Currently, the brand faces competition from other topical and oral antibiotics for BV, including metronidazole and alternative clindamycin formulations. Its presence in the US market is established, with additional sales driven by existing prescriptions and off-label uses.

What are the key market drivers impacting Clindesse?

Demographic factors

• Prevalence of bacterial vaginosis: BV affects approximately 29% of women aged 14-49 in the US, representing a large patient base. The condition is recurrent, with over 50% experiencing recurrence within a year.
• Reproductive age women: As BV impacts women predominantly in reproductive years, the demand for topical treatments remains steady.

Therapeutic landscape

• Competition from Paxil: Oral metronidazole is a first-line therapy, with high prescribing volume.
• Increased awareness: Growing focus on women's health fosters ongoing demand, but also heightened competition.

Regulatory and reimbursement environment

• FDA approvals: Clindesse's status remains stable, though newer formulations of clindamycin and alternative agents have entered the market.
• Reimbursement: Insurance coverage is solid for BV treatments, but formularies favor newer, often more convenient options.

Pricing dynamics

• Average wholesale price (AWP): Clindesse's AWP ranges between $150-$200 per treatment course.
• Generic competition: Generics reduce costs, but brand loyalty persists in some segments, providing some pricing power.

How do market and competitive trends influence Clindesse’s financial trajectory?

Factor	Impact	Market Data
Price erosion	Genric entry reduces prices by up to 50%.	Generic clindamycin vaginal cream sales account for 60% of volume in BV treatments.
Prescribing trends	Shift toward oral therapy impacts topical sales	Oral metronidazole prescriptions represent over 80 million annually in the US.
Recurrent infections	Lead to repeated prescriptions	Over 80% of BV cases recur within 12 months, sustaining repeat demand.
New entrants	Entry of novel formulations	Compounds like secnidazole and probiotic therapies pose future threats.

Revenue forecasts

• Current annual sales estimate: $50 million in the US.
• Short-term projection (next 2 years): Decline by 10-15% driven by pricing pressure and competition.
• Long-term outlook (5 years): Potential stabilization if repositioned or integrated within combination therapies, with estimated revenues of $35-$40 million annually.

What are the investment considerations?

• Targeted niche: Clindesse’s topical delivery grants advantages in minimizing systemic side effects.
• Patent and exclusivity: No recent patent protections; dominance depends on formulary placements and provider preference.
• Market share risks: Losses to oral therapies and newer agents threaten sustained sales.
• Opportunities: Label expansion for other infectious or gynecological indications could mitigate declines.

Summary of Financial Timeline

Year	Revenue Estimate	Key Factors	Comments
2023	$50 million	Steady demand, competitive pricing	Decline underway due to generics
2024	$45 million	Continued generic erosion	Slight market share loss
2025	$40 million	Market stabilization	Potential for niche growth
2027	$35-$40 million	Market adaptation	Possible new indications or formulations

Key Takeaways

• Clindesse revenue remains tied to BV prevalence and prescribing habits.
• Market share declines are driven by generics, oral alternatives, and emerging therapies.
• Pricing pressure impacts profitability, though niche positioning supports some resilience.
• Future growth depends on label expansion and strategic repositioning.
• The drug’s financial viability benefits from recurrent infection patterns and steady demand.

FAQs

1. What factors are most likely to influence Clindesse's market share?
   Generic competition, the rise of oral therapies, and new treatment modalities directly impact market share.

2. Is Clindesse likely to see regulatory changes that affect its sales?
   No significant upcoming regulatory changes are forecasted; however, label expansion or new indications could influence sales.

3. What are the key competitors in the BV treatment market?
   Oral metronidazole, oral tinidazole, and other topical clindamycin formulations.

4. Could patent protections or exclusivity extensions benefit Clindesse?
   No recent patent protections are available; exclusivity depends on formulation and regulatory strategies.

5. What opportunities exist for increasing Clindesse’s market volume?
   Expanding indications, improving formulation convenience, or integrating into combination therapies.

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References

[1] Centers for Disease Control and Prevention. (2022). Bacterial Vaginosis. CDC.
[2] Perrigo Company. (2023). Clindesse Prescribing Information.
[3] IMS Health (2021). National Prescription Audit.
[4] American Society for Microbiology. (2019). Trends in BV treatment.
[5] FDA (2022). Drug approvals and labeling updates.