CLINDAGEL Drug Patent Profile

When do Clindagel patents expire, and what generic alternatives are available?

Clindagel is a drug marketed by Bausch and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Clindagel

A generic version of CLINDAGEL was approved as clindamycin phosphate by ALMAJECT on July 24^th, 1987.

Summary for CLINDAGEL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	1
Patent Applications:	2,414
Drug Prices:	Drug price information for CLINDAGEL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLINDAGEL
What excipients (inactive ingredients) are in CLINDAGEL?	CLINDAGEL excipients list
DailyMed Link:	CLINDAGEL at DailyMed

See drug prices for CLINDAGEL

See drug sales revenues for CLINDAGEL

Recent Clinical Trials for CLINDAGEL

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

Sponsor	Phase
Stiefel, a GSK Company	Phase 1
GlaxoSmithKline	Phase 1

See all CLINDAGEL clinical trials

Pharmacology for CLINDAGEL

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

US Patents and Regulatory Information for CLINDAGEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	CLINDAGEL	clindamycin phosphate	GEL;TOPICAL	050782-001	Nov 27, 2000	AB2	RX	Yes	Yes

Expired US Patents for CLINDAGEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	CLINDAGEL	clindamycin phosphate	GEL;TOPICAL	050782-001	Nov 27, 2000	6,387,383

International Patents for CLINDAGEL

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20030057526
Spain	2437321
Brazil	0113247
European Patent Office	2052714	Systemes de gel topiques destines au traitement des troubles de la peau (Topical gel delivery systems for treating skin disorders)
Australia	7900201
Portugal	1304992

Supplementary Protection Certificates for CLINDAGEL

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	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	92401	Luxembourg		PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992	1390049-3	Sweden		PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
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	474	Finland

CLINDAGEL Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Clindamycin Hydrochloride (CLINDAGEL)

Introduction to Clindamycin Hydrochloride

Clindamycin hydrochloride, often marketed under the brand name CLINDAGEL among others, is a potent antibiotic used to treat various bacterial infections. It is particularly effective against anaerobic bacteria and is widely used in treating skin and soft tissue infections, acne, and other conditions.

Market Size and Growth

The clindamycin hydrochloride market has been experiencing robust growth in recent years. As of 2023, the market size was valued at $1.68 billion and is projected to increase to $1.82 billion in 2024, with a compound annual growth rate (CAGR) of 8.5%[1].

By 2028, the market is expected to reach $2.54 billion, maintaining a CAGR of 8.6%. This strong growth is driven by several factors, including advancements in pharmaceutical formulations, increasing demand for targeted antibiotics with fewer side effects, and the growing prevalence of antibiotic-resistant infections globally[1].

Key Drivers of Market Growth

Increasing Prevalence of Bacterial Infections

The rising incidence of bacterial infections, particularly skin and soft tissue infections, is a significant driver of the clindamycin hydrochloride market. Factors such as heightened pollution, hormonal fluctuations, and lifestyle-related stress contribute to the increasing prevalence of skin infections and acne, for which clindamycin hydrochloride is often prescribed[1].

Advancements in Pharmaceutical Formulations

Advancements in pharmaceutical formulations and delivery methods are enhancing the efficacy and safety of clindamycin hydrochloride. This includes the development of combination therapies involving clindamycin and other antibiotics to combat complex infections more effectively[4].

Expansion in Emerging Markets

The growth of healthcare infrastructure and the increasing incidence of bacterial infections in emerging markets such as Asia Pacific and Latin America are fueling the demand for clindamycin hydrochloride. Governments and healthcare organizations in these regions are prioritizing access to essential antibiotics, which includes clindamycin phosphate injections and topical formulations[4].

Rising Antibiotic Resistance

The increasing prevalence of antibiotic-resistant bacteria is driving the demand for effective treatments like clindamycin hydrochloride, which remains potent against certain resistant strains. This trend underscores the importance of clindamycin in the global fight against antibiotic resistance[4].

Market Segments

Topical Formulations

The clindamycin phosphate topical market is a significant segment, valued at $279.56 million in 2024 and projected to grow to $407.92 million by 2032 at a CAGR of 6.50%. This market includes products such as gels, topical solutions, and foams, which are widely used for treating acne and other skin infections[3].

Injection Formulations

The global clindamycin phosphate injection market was valued at $451.67 million in 2023 and is expected to grow to $743.86 million by 2032, with a CAGR of 5.7%. This segment is driven by the growing adoption of these injections in emerging markets and the expansion of healthcare infrastructure[4].

Financial Performance and Trends

Revenue Growth

The revenue growth of clindamycin hydrochloride is substantial, driven by its increasing adoption in various therapeutic areas. For instance, the market size is expected to grow from $1.68 billion in 2023 to $2.54 billion by 2028, indicating a robust financial trajectory[1].

Strategic Partnerships and Acquisitions

Companies in the clindamycin hydrochloride market are focusing on strategic partnerships and acquisitions to expand their product portfolios and enhance their distribution networks. This strategy helps in accessing new markets and strengthening their competitive position[4].

Research and Development

Investments in research and development are crucial for innovating and improving product formulations. Companies are working on developing combination therapies and enhancing the efficacy of clindamycin hydrochloride to address emerging antibiotic resistance issues[4].

Regional Market Dynamics

Asia Pacific

The Asia Pacific region is experiencing rapid growth in the clindamycin phosphate market, driven by the increasing prevalence of bacterial infections and the expanding healthcare infrastructure in countries like China, India, and Southeast Asia. This region is benefiting from increased investment in healthcare and pharmaceutical industries, making it a key area for future market expansion[4].

North America

North America has the largest share of the global clindamycin phosphate injection market. The region's advanced healthcare infrastructure and high demand for effective antibacterial treatments contribute to its significant market share[4].

Consumer and Healthcare Trends

Shift Towards Homecare Settings

There is a growing trend towards outpatient and homecare settings for administering antibiotics, supported by advancements in portable infusion technology. This shift is expected to further drive the demand for clindamycin hydrochloride in various formulations[4].

Personalized Medicine

The emphasis on personalized medicine and tailored antibiotic treatments is increasing. This trend is expected to drive the demand for clindamycin hydrochloride, as healthcare professionals seek more targeted and effective treatments for bacterial infections[1].

Key Takeaways

• Robust Market Growth: The clindamycin hydrochloride market is expected to grow significantly, from $1.68 billion in 2023 to $2.54 billion by 2028.
• Driving Factors: Increasing prevalence of bacterial infections, advancements in pharmaceutical formulations, and expansion in emerging markets are key drivers.
• Market Segments: Topical and injection formulations are significant segments, with the topical market projected to reach $407.92 million by 2032.
• Regional Growth: Asia Pacific is a key region for future market expansion due to its growing healthcare infrastructure and increasing demand for antibiotics.
• Strategic Trends: Companies are focusing on strategic partnerships, research and development, and expanding their product portfolios to maintain market competitiveness.

FAQs

What is the projected market size of clindamycin hydrochloride by 2028?

The clindamycin hydrochloride market is expected to reach $2.54 billion by 2028[1].

What is the CAGR of the clindamycin phosphate topical market from 2024 to 2032?

The clindamycin phosphate topical market is expected to exhibit a CAGR of 6.50% from 2024 to 2032[3].

Which regions are driving the growth of the clindamycin phosphate injection market?

Emerging markets such as Asia Pacific and Latin America are driving the growth of the clindamycin phosphate injection market due to expanding healthcare infrastructure and increasing incidence of bacterial infections[4].

What are the key trends in the clindamycin hydrochloride market?

Key trends include the rising prevalence of antibiotic-resistant bacteria, expansion in emerging markets, development of combination therapies, and a shift towards homecare settings[4].

How is the emphasis on personalized medicine affecting the clindamycin hydrochloride market?

The emphasis on personalized medicine is driving the demand for more targeted and effective treatments, which includes clindamycin hydrochloride, as healthcare professionals seek tailored antibiotic treatments[1].

Sources

1. GII Research: Clindamycin Hydrochloride Global Market Report 2024.
2. Mallinckrodt plc: Reports Fourth Quarter and Fiscal Year 2023.
3. The Market Intelligence: Clindamycin Phosphate Topical Market Growth, Size, Share, Trend.
4. Polaris Market Research: Clindamycin Phosphate Injection Market Growth Report, 2032.