CLEOCIN Drug Patent Profile

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

Cleocin is a drug marketed by Pharmacia And Upjohn and Pfizer and is included in fourteen NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cleocin

A generic version of CLEOCIN was approved as clindamycin palmitate hydrochloride by PADAGIS US on July 7^th, 2010.

Summary for CLEOCIN

US Patents:	0
Applicants:	2
NDAs:	14
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	11
Patent Applications:	3,147
Drug Prices:	Drug price information for CLEOCIN
Drug Sales Revenues:	Drug sales revenues for CLEOCIN
What excipients (inactive ingredients) are in CLEOCIN?	CLEOCIN excipients list
DailyMed Link:	CLEOCIN at DailyMed

See drug prices for CLEOCIN

See drug sales revenues for CLEOCIN

Recent Clinical Trials for CLEOCIN

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

Sponsor	Phase
University of Missouri-Columbia	Phase 4
University of California, Los Angeles	Phase 4
Roswell Park Cancer Institute	Phase 4

See all CLEOCIN clinical trials

Pharmacology for CLEOCIN

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

US Patents and Regulatory Information for CLEOCIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmacia And Upjohn	CLEOCIN	clindamycin hydrochloride	CAPSULE;ORAL	061809-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer	CLEOCIN T	clindamycin phosphate	GEL;TOPICAL	050615-001	Jan 7, 1987	AB1	RX	Yes	Yes
Pfizer	CLEOCIN	clindamycin phosphate	SUPPOSITORY;VAGINAL	050767-001	Aug 13, 1999		RX	Yes	Yes

Expired US Patents for CLEOCIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	CLEOCIN	clindamycin phosphate	SUPPOSITORY;VAGINAL	050767-001	Aug 13, 1999	6,495,157

International Patents for CLEOCIN

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

Country	Patent Number	Title	Estimated Expiration
Honduras	2000000166	COMPOSICION DE OVULOS INTRAVAGINALES DE CLINDAMICINA
Hong Kong	1047538
Australia	768907

Supplementary Protection Certificates for CLEOCIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	2013/044	Ireland		PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: 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

CLEOCIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Clindamycin (CLEOCIN)

Introduction to Clindamycin

Clindamycin, marketed under the brand name CLEOCIN, is a potent antibiotic used to treat various bacterial infections, including skin and soft tissue infections, anaerobic infections, and as a prophylactic in surgical procedures. The drug is available in several formulations, including topical and oral forms.

Market Size and Forecast

The clindamycin market is experiencing robust growth across its various formulations.

Clindamycin Hydrochloride Market

The clindamycin hydrochloride market was valued at $1.68 billion in 2023 and is projected to reach $1.82 billion in 2024, growing at a CAGR of 8.5%[3][4][5]. By 2028, the market is expected to expand to $2.54 billion, maintaining a CAGR of 8.6% during the forecast period. This growth is driven by the increasing prevalence of bacterial infections, the rising use of clindamycin in treating anaerobic infections, and its growing adoption in surgical prophylaxis.

Clindamycin Phosphate Topical Market

The clindamycin phosphate topical market was valued at $1.51 billion in 2023 and is projected to reach $4.07 billion by 2031, growing at a CAGR of 8.92% during the forecast period of 2024-2031. This significant growth is attributed to increasing access to healthcare, rising disposable incomes, and the growing acceptance of dermatological treatments[1].

Key Drivers of Market Growth

Increasing Prevalence of Bacterial Infections

The rising incidence of bacterial infections, including skin and soft tissue infections, is a major driver of the clindamycin market. Healthcare professionals increasingly recommend clindamycin due to its effectiveness against resistant bacterial strains[3][4][5].

Advances in Pharmaceutical Formulations

Advancements in pharmaceutical formulations and delivery methods are enhancing the efficacy and safety of clindamycin. This includes the development of targeted antibiotics with fewer side effects, which is driving demand for clindamycin-based treatments[3][4][5].

Growing Demand for Dermatological Treatments

The increasing societal acceptance of dermatological interventions as part of overall health and wellness is boosting the demand for topical agents like clindamycin phosphate. This trend is particularly pronounced in regions with improving healthcare access and rising disposable incomes[1].

Expansion in Emerging Markets

The use of clindamycin is expanding in emerging markets, driven by growing healthcare investments and increasing awareness of dermatological and other bacterial infections. Regions such as the Asia-Pacific, particularly countries like India and China, are experiencing rapid growth due to these factors[1][3].

Regional Dynamics

Asia-Pacific Region

The Asia-Pacific region is a significant growth area for clindamycin, driven by rising rates of acne, a burgeoning youth population, and improving healthcare access. Countries like India and China are key markets, with growing disposable incomes and changing lifestyles contributing to higher product uptake[1].

Middle East and Africa

In the Middle East and Africa, the market landscape is diverse, with regulatory challenges impacting market accessibility. However, increasing healthcare investments and growing awareness of dermatological issues present opportunities for growth in these regions[1].

Trends Shaping the Market

Combination Therapies

There is a shift towards combination therapies that include clindamycin, which is expected to enhance treatment outcomes and drive market growth[3][4][5].

Clindamycin-Based Topical Formulations

The development of clindamycin-based topical formulations is on the rise, catering to the growing demand for effective dermatological treatments. This trend is particularly relevant in the context of acne and other skin conditions[1][3].

Strategic Partnerships and Acquisitions

Companies are engaging in strategic partnerships and acquisitions to expand their market presence. For example, Eris Lifesciences Limited acquired Oaknet Healthcare to penetrate the dermatology and cosmetology sectors, enhancing its product offerings and market reach[2].

Expansion into Veterinary Medicine

Clindamycin is also finding increasing applications in veterinary medicine, which is another growth avenue for the market[3][4][5].

Personalized Medicine

There is a growing emphasis on personalized medicine and tailored antibiotic treatments, which is expected to further drive the demand for clindamycin and other targeted antibiotics[3][4][5].

Challenges and Opportunities

Regulatory Challenges

Regulatory challenges, particularly in regions like the Middle East and Africa, can impact market accessibility. However, these challenges also present opportunities for companies that can navigate these regulatory landscapes effectively[1].

Impact of Global Events

Global events such as the COVID-19 pandemic and the Russian-Ukraine war have had various impacts on supply chains and consumption patterns. These events highlight the need for robust supply chain management and adaptability in the pharmaceutical industry[2].

Financial Trajectory

The financial trajectory of the clindamycin market is characterized by strong and consistent growth. Here are some key financial metrics:

• Clindamycin Hydrochloride Market: Expected to grow from $1.68 billion in 2023 to $2.54 billion by 2028 at a CAGR of 8.6%[3][4][5].
• Clindamycin Phosphate Topical Market: Expected to grow from $1.51 billion in 2023 to $4.07 billion by 2031 at a CAGR of 8.92%[1].

Key Takeaways

• The clindamycin market is driven by the increasing prevalence of bacterial infections and the growing acceptance of dermatological treatments.
• Advances in pharmaceutical formulations and delivery methods are enhancing the market.
• Emerging markets, particularly in the Asia-Pacific region, are experiencing rapid growth.
• Strategic partnerships, acquisitions, and the expansion into veterinary medicine are key trends.
• Regulatory challenges and global events present both obstacles and opportunities.

FAQs

Q: What is the projected growth rate of the clindamycin hydrochloride market? A: The clindamycin hydrochloride market is expected to grow at a CAGR of 8.6% from 2023 to 2028[3][4][5].

Q: What are the key drivers of the clindamycin phosphate topical market? A: The key drivers include increasing access to healthcare, rising disposable incomes, and the growing acceptance of dermatological treatments[1].

Q: How is the Asia-Pacific region contributing to the growth of the clindamycin market? A: The Asia-Pacific region is experiencing rapid growth due to rising rates of acne, a burgeoning youth population, and improving healthcare access in countries like India and China[1].

Q: What trends are shaping the future of the clindamycin market? A: Trends include a shift towards combination therapies, growth in clindamycin-based topical formulations, strategic partnerships and acquisitions, expansion into veterinary medicine, and a growing emphasis on personalized medicine[3][4][5].

Q: How do regulatory challenges impact the clindamycin market? A: Regulatory challenges, particularly in regions like the Middle East and Africa, can impact market accessibility but also present opportunities for companies that can navigate these regulatory landscapes effectively[1].

Sources

1. Verified Market Research: Clindamycin Phosphate Topical Market Size, Share And Forecast[1].
2. GII Research: Clindamycin Hydrochloride Global Market Report 2024[2].
3. The Business Research Company: Clindamycin Hydrochloride Global Market Report 2024[3].
4. The Business Research Company: Global Clindamycin Hydrochloride Market Size Forecast 2024 - 2033[4].
5. EINPresswire: Global Clindamycin Hydrochloride Market Set For 8.6 % Growth, Reaching $2.54 Billion By 2028[5].