CLINDAMYCIN PHOSPHATE - Generic Drug Details

What are the generic drug sources for clindamycin phosphate and what is the scope of patent protection?

Clindamycin phosphate is the generic ingredient in eighteen branded drugs marketed by Glenmark Pharms Ltd, Padagis Israel, Taro, Norvium Bioscience, Pfizer, Fougera Pharms, Padagis Us, Bausch, Alembic, Amneal, Encube, Quagen, Solaris Pharma Corp, Zydus Lifesciences, Organon Llc, Pharmacia And Upjohn, Abraxis Pharm, Almaject, Bedford, Bristol Myers Squibb, Fresenius Kabi Usa, Hikma, Igi Labs Inc, Loch, Marsam Pharms Llc, Rising, Sagent Pharms Inc, Solopak, Teva Parenteral, Watson Labs, Baxter Hlthcare Corp, Sandoz Inc, Abbott Labs, Baxter Hlthcare, Boca Pharma Llc, Chartwell Rx, Encube Ethicals, Endo Operations, Fougera Pharms Inc, G And W Labs Inc, Novast Labs, Pai Holdings Pharm, Taro Pharm Inds, Vintage Pharms, Xttrium Labs Inc, Epic Pharma Llc, Actavis Mid Atlantic, and Almirall, and is included in ninety-one NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Clindamycin phosphate has sixty-four patent family members in twenty-five countries.

There are twenty-five drug master file entries for clindamycin phosphate. Thirty suppliers are listed for this compound.

Summary for CLINDAMYCIN PHOSPHATE

International Patents:	64
US Patents:	4
Tradenames:	18
Applicants:	48
NDAs:	91
Drug Master File Entries:	25
Finished Product Suppliers / Packagers:	30
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	30
Patent Applications:	3,692
Drug Prices:	Drug price trends for CLINDAMYCIN PHOSPHATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLINDAMYCIN PHOSPHATE
What excipients (inactive ingredients) are in CLINDAMYCIN PHOSPHATE?	CLINDAMYCIN PHOSPHATE excipients list
DailyMed Link:	CLINDAMYCIN PHOSPHATE at DailyMed

See drug prices for CLINDAMYCIN PHOSPHATE

Recent Clinical Trials for CLINDAMYCIN PHOSPHATE

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

Sponsor	Phase
Daré Bioscience, Inc.	Phase 1
Memorial Sloan Kettering Cancer Center	Phase 2
Daré Bioscience, Inc.	Phase 3

See all CLINDAMYCIN PHOSPHATE clinical trials

Pharmacology for CLINDAMYCIN PHOSPHATE

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

Anatomical Therapeutic Chemical (ATC) Classes for CLINDAMYCIN PHOSPHATE

D10AF	Antiinfectives for treatment of acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

G01AA	Antibiotics
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

J01FF	Lincosamides
J01F	MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for CLINDAMYCIN PHOSPHATE

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 CLINDAMYCIN PHOSPHATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	CLEOCIN	clindamycin phosphate	CREAM;VAGINAL	050680-001	Aug 11, 1992		DISCN	No	No
G And W Labs Inc	CLINDAMYCIN PHOSPHATE	clindamycin phosphate	SOLUTION;TOPICAL	062811-001	Sep 1, 1988		DISCN	No	No
Almaject	CLINDAMYCIN PHOSPHATE	clindamycin phosphate	INJECTABLE;INJECTION	062801-001	Jul 24, 1987		DISCN	No	No
Watson Labs	CLINDAMYCIN PHOSPHATE	clindamycin phosphate	INJECTABLE;INJECTION	062900-001	Jun 8, 1988		DISCN	No	No
Pai Holdings Pharm	CLINDAMYCIN PHOSPHATE	clindamycin phosphate	SOLUTION;TOPICAL	206945-001	Dec 30, 2016		DISCN	No	No
Hikma	CLINDAMYCIN PHOSPHATE	clindamycin phosphate	INJECTABLE;INJECTION	063068-001	Aug 28, 1989		DISCN	No	No
Abraxis Pharm	CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%	clindamycin phosphate	INJECTABLE;INJECTION	050635-001	Dec 22, 1989		RX	Yes	Yes

Expired US Patents for CLINDAMYCIN PHOSPHATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Padagis Us	CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793-001	Nov 30, 2004	6,899,890
Norvium Bioscience	EVOCLIN	clindamycin phosphate	AEROSOL, FOAM;TOPICAL	050801-001	Oct 22, 2004	7,141,237
Padagis Us	CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793-001	Nov 30, 2004	5,993,856
Bausch	CLINDAGEL	clindamycin phosphate	GEL;TOPICAL	050782-001	Nov 27, 2000	6,387,383
Padagis Us	CLINDESSE	clindamycin phosphate	CREAM;VAGINAL	050793-001	Nov 30, 2004	5,266,329
Pfizer	CLEOCIN	clindamycin phosphate	SUPPOSITORY;VAGINAL	050767-001	Aug 13, 1999	6,495,157
Norvium Bioscience	EVOCLIN	clindamycin phosphate	AEROSOL, FOAM;TOPICAL	050801-001	Oct 22, 2004	7,374,747

International Patents for CLINDAMYCIN PHOSPHATE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2289512	Mousse pharmaceutique (Pharmaceutical foam)
Argentina	047108	FORMULACION FARMACEUTICA PARA TRATAR AFECCIONES VAGINALES EN HUMANOS, COMPOSICION PARA TRATAR UNA INFECCION VAGINAL Y METODO PARA TRATAR DICHA INFECCION VAGINAL
Japan	4828404
World Intellectual Property Organization (WIPO)	2017015232
World Intellectual Property Organization (WIPO)	2004064833
Serbia	20050557	KLINDAMICIN FOSFAT U OBLIKU PENE (CLINDAMYCIN PHOSPHATE FOAM)
Canada	2635992	MEDICAMENT UTILISE PAR VOIE TOPIQUE (MEDICAMENT FOR TOPICAL USE)

Supplementary Protection Certificates for CLINDAMYCIN PHOSPHATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
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	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

CLINDAMYCIN PHOSPHATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Clindamycin Phosphate

Introduction

Clindamycin phosphate, an antibiotic used to treat various bacterial skin infections, is experiencing significant growth in the global market. This article delves into the market dynamics, financial trajectory, and key factors influencing the clindamycin phosphate market.

Market Size and Growth

The clindamycin phosphate topical market is projected to undergo substantial growth. As of 2023, the market size was valued at $0.94 billion, and it is expected to increase to $1.07 billion in 2024, reflecting a compound annual growth rate (CAGR) of 14.7%[3].

By 2028, the market is anticipated to reach $1.86 billion, maintaining a CAGR of 14.8% during the forecast period. This rapid growth is driven by several key factors, including the rising incidence of bacterial skin infections such as acne and cellulitis, and the increasing antibiotic resistance among bacterial strains like Staphylococcus aureus[1][3].

Drivers of Growth

Rising Incidence of Bacterial Skin Infections

The escalating cases of bacterial skin infections are a primary driver of the market's growth. Conditions like acne and cellulitis are becoming more prevalent, leading to a higher demand for effective topical treatments[1][3].

Increasing Antibiotic Resistance

The growing issue of antibiotic resistance among bacterial strains is another significant factor. Clindamycin phosphate remains effective against certain resistant strains, making it a preferred treatment option[3].

Growing Awareness of Skin Health and Hygiene

There is an increasing awareness of skin health and hygiene, particularly in developing regions. This heightened consciousness is driving the demand for topical antibiotics like clindamycin phosphate[3].

Advancements in Dermatological Treatments

The use of clindamycin phosphate in dermatological treatments is on the rise. Innovations in topical formulations and the development of combination therapies are further boosting the market[3].

Regional Market Dynamics

North America

North America is currently the leading region in the clindamycin phosphate market, driven by its sophisticated healthcare system, high incidence of bacterial infections, and the presence of significant pharmaceutical companies. The region's well-established healthcare infrastructure and investments in research and development have facilitated widespread use of clindamycin phosphate[4].

Asia Pacific

The Asia Pacific region is expected to witness substantial growth due to the expanding healthcare infrastructure and rising prevalence of bacterial infections in countries like China, India, and Southeast Asian nations. The growing population and improving access to healthcare services are key factors driving this growth[4].

Europe and Latin America

Europe and Latin America are also notable regions, with Europe maintaining a stable market presence and Latin America experiencing growth due to improving healthcare facilities and rising infection rates[4].

Key Trends

Adoption of Combination Therapies

There is a growing trend towards the adoption of clindamycin-based combination therapies to enhance efficacy and combat complex infections. Research into these combination therapies is on the rise, contributing to market growth[3].

Development of Efficient Topical Formulations

The development of more efficient topical formulations is another trend. Companies are investing in research and development to innovate and improve product formulations, addressing emerging antibiotic resistance issues[3].

Focus on Antibiotic Stewardship

There is a heightened focus on antibiotic stewardship to combat resistance. This includes strategies to ensure the responsible use of antibiotics, which is crucial for the long-term effectiveness of clindamycin phosphate[3].

Shift Towards Personalized Dermatological Treatments

The market is also seeing a shift towards personalized dermatological treatments. This trend involves tailoring treatments to individual patient needs, which can enhance the effectiveness of clindamycin phosphate and other topical antibiotics[3].

Financial Trajectory

Current Market Value

As of 2023, the clindamycin phosphate topical market was valued at $0.94 billion. It is expected to grow to $1.07 billion in 2024 and reach $1.86 billion by 2028[1][3].

Compound Annual Growth Rate (CAGR)

The market is projected to maintain a CAGR of 14.8% from 2024 to 2028, indicating a robust financial trajectory driven by the factors mentioned above[1][3].

Investment and Research

Companies are investing heavily in research and development to innovate and improve clindamycin phosphate formulations. Strategic partnerships, acquisitions, and targeted marketing efforts in emerging economies are also crucial for capturing market share and meeting the increasing demand for effective antibacterial treatments[4].

Market Segmentation

The clindamycin phosphate market is segmented based on types, end-users, and regional segmentation. Understanding these segments is essential for companies to tailor their strategies and expand their market reach effectively[2][4].

Challenges and Opportunities

Antibiotic Resistance

One of the significant challenges is the ongoing issue of antibiotic resistance. However, this also presents an opportunity for the development of new and more effective formulations of clindamycin phosphate[3].

Regulatory Environment

The regulatory environment plays a crucial role in the market's growth. Compliance with regulations and obtaining necessary approvals are essential for the launch and distribution of clindamycin phosphate products[4].

Emerging Markets

Emerging markets, particularly in the Asia Pacific and Latin America, offer significant opportunities for growth. Expanding healthcare infrastructure and rising demand for effective antibiotics in these regions are key drivers of market expansion[4].

"Clindamycin phosphate remains effective against certain resistant strains, making it a preferred treatment option," - The Business Research Company[3].

Conclusion

The clindamycin phosphate market is poised for significant growth driven by the rising incidence of bacterial skin infections, increasing antibiotic resistance, and advancements in dermatological treatments. With a projected market size of $1.86 billion by 2028 and a CAGR of 14.8%, this market presents substantial opportunities for pharmaceutical companies and healthcare providers.

Key Takeaways

• Rapid Market Growth: The clindamycin phosphate topical market is expected to grow from $0.94 billion in 2023 to $1.86 billion by 2028.
• High CAGR: The market will maintain a CAGR of 14.8% during the forecast period.
• Key Drivers: Rising incidence of bacterial skin infections, increasing antibiotic resistance, and growing awareness of skin health.
• Regional Growth: North America leads the market, with significant growth expected in the Asia Pacific and Latin America.
• Trends: Adoption of combination therapies, development of efficient topical formulations, and a focus on antibiotic stewardship.

FAQs

Q1: What is the current market size of the clindamycin phosphate topical market? The current market size of the clindamycin phosphate topical market was valued at $0.94 billion in 2023[1][3].

Q2: What is the projected growth rate of the clindamycin phosphate topical market? The market is projected to grow at a compound annual growth rate (CAGR) of 14.8% from 2024 to 2028[1][3].

Q3: Which regions are expected to see significant growth in the clindamycin phosphate market? North America is currently the leading region, but the Asia Pacific and Latin America are expected to witness substantial growth due to expanding healthcare infrastructure and rising infection rates[4].

Q4: What are the key drivers of the clindamycin phosphate market growth? The key drivers include the rising incidence of bacterial skin infections, increasing antibiotic resistance, and growing awareness of skin health and hygiene[1][3].

Q5: Are there any trends in the market that could impact the future of clindamycin phosphate? Yes, trends such as the adoption of combination therapies, development of efficient topical formulations, and a focus on antibiotic stewardship are expected to influence the market's future growth[3].

Sources

1. The Business Research Company, "Global Clindamycin Phosphate Topical Market Set For 14.8% Growth, Reaching $1.86 Billion By 2028"[1].
2. Taiwan News, "Clindamycin Phosphate Market Segmentation Symphony"[2].
3. Global Industry Analysts Research, "Clindamycin Phosphate Topical Global Market Report 2024"[3].
4. Polaris Market Research, "Clindamycin Phosphate Injection Market Growth Report, 2032"[4].