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 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 ALMAJECT on July 24^th, 1987.

Summary for CLINDESSE

International Patents:	22
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	1
Patent Applications:	2,414
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
Japan	2001511773
Israel	192565
Australia	2006332519	Medicament for topical use
Japan	2007505927
China	1852690	Medicament conveying system

Supplementary Protection Certificates for CLINDESSE

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	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	C01304992/01	Switzerland		PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992	92401	Luxembourg		PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
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

CLINDESSE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Clindesse

Introduction

Clindesse, a clindamycin phosphate vaginal cream, is a significant player in the women's health pharmaceutical market, particularly in the treatment of bacterial vaginosis (BV). Here, we will delve into the market dynamics and financial trajectory of Clindesse, highlighting its key milestones, market performance, and the company's strategic moves.

Market Need and Competition

Bacterial vaginosis is the most common vaginal infection in women of childbearing age, creating a substantial market need for effective treatments. Clindesse, as the first and only single-dose therapy approved for BV in non-pregnant women, fills this need effectively[4].

Competitive Landscape

The market for BV treatments includes various formulations of clindamycin and other antibiotics. However, Clindesse's single-dose regimen sets it apart from competitors, offering convenience and compliance advantages[5].

Product Availability and Milestones

Launch and Reintroduction

Clindesse was initially launched and later reintroduced to the market. In 2013, Ther-Rx Corporation announced the availability of Clindesse, marking a significant milestone for the company alongside the reintroduction of Gynazole-1®, another anti-infective product[4].

Clinical Efficacy

Clinical studies have demonstrated Clindesse's efficacy in treating BV, showing similar cure rates to a 7-day regimen of clindamycin vaginal cream. This efficacy, combined with its single-dose convenience, has contributed to its market acceptance[5].

Financial Performance

Revenue Contribution

Clindesse, along with Gynazole-1®, has been a revenue driver for Ther-Rx Corporation. In fiscal 2008, these products helped solidify market leadership in key women’s health categories, contributing to the company's overall revenue growth[1].

Revenue Growth and Market Share

The success of Clindesse has been part of Ther-Rx's broader strategy to expand its product portfolio and increase market share. The company reported significant revenue growth, with net revenues from its specialty generics business, including Clindesse, increasing substantially during fiscal 2008[1].

Company Strategy and Expansion

Ther-Rx and K-V Pharmaceutical Company

Ther-Rx, as a subsidiary of K-V Pharmaceutical Company, has focused on women's health products. The availability of Clindesse and Gynazole-1® has been crucial in this segment, supporting the company's growth and market leadership[4].

Future Growth Prospects

The company has outlined several growth drivers, including continued revenue contribution from existing products like Clindesse, additional acquisition opportunities, and the introduction of new products. These strategies are expected to sustain and enhance the company's financial performance[1].

Market Impact and Customer Acceptance

Customer Acceptance

Clindesse has been well-received by both healthcare providers and patients due to its single-dose regimen and proven efficacy. This acceptance has translated into strong market performance and customer loyalty[4].

Market Share

The product's unique selling proposition has helped it capture a significant market share in the BV treatment segment. As of the last available data, Clindesse has treated over 2.2 million women, underscoring its market impact[4].

Challenges and Opportunities

Regulatory Environment

The pharmaceutical industry is heavily regulated, and products like Clindesse must navigate FDA approvals and compliance. However, the existing safety profile of clindamycin phosphate and the 505(b)(2) pathway can facilitate future approvals and expansions[3].

Market Expansion

There are opportunities for Clindesse to expand into new markets and indications. The company's focus on women's health and its existing product portfolio position it well for further growth in adjacent categories[1].

Key Takeaways

• Market Need: Clindesse addresses the significant market need for effective BV treatments.
• Competitive Advantage: Its single-dose regimen sets it apart from competitors.
• Financial Performance: Clindesse has contributed significantly to Ther-Rx's revenue growth and market leadership.
• Company Strategy: Continued focus on women's health products and expansion into new markets and indications.
• Customer Acceptance: Strong acceptance due to its efficacy and convenience.

FAQs

What is Clindesse used for?

Clindesse is used for the treatment of bacterial vaginosis (BV) in non-pregnant women. It is the first and only single-dose therapy approved for this condition[4].

How effective is Clindesse in treating BV?

Clinical studies have shown that Clindesse has similar cure rates to a 7-day regimen of clindamycin vaginal cream, making it an effective treatment option[5].

Who manufactures Clindesse?

Clindesse is manufactured by Ther-Rx Corporation, a subsidiary of K-V Pharmaceutical Company[4].

What sets Clindesse apart from other BV treatments?

Clindesse's single-dose regimen makes it more convenient and compliant compared to other treatments that require multiple doses over several days[5].

How has Clindesse impacted the financial performance of Ther-Rx Corporation?

Clindesse has been a significant revenue driver for Ther-Rx, contributing to the company's revenue growth and market leadership in women’s health categories[1].

Sources

1. Annual Reports: "Aligning Today's Strategy" - Annual Reports.
2. Perrigo Investor Day: "Corporate Overview 2011 Investor Day".
3. DARÉ BIOSCIENCE, INC.: "Annual Reports".
4. PR Newswire: "Ther-Rx Corporation Announces the Availability of Clindesse".
5. FDA Label: "Highlights of Prescribing Information".