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Last Updated: March 11, 2025

CLINDAMYCIN PHOSPHATE - Generic Drug Details


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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 two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Clindamycin phosphate has thirty-four patent family members in twenty-one countries.

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

Drug Prices for CLINDAMYCIN PHOSPHATE

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Recent Clinical Trials for CLINDAMYCIN PHOSPHATE

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

SponsorPhase
Daré Bioscience, Inc.Phase 1
Memorial Sloan Kettering Cancer CenterPhase 2
Daré Bioscience, Inc.Phase 3

See all CLINDAMYCIN PHOSPHATE clinical trials

Pharmacology for CLINDAMYCIN PHOSPHATE
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
Norvium Bioscience EVOCLIN clindamycin phosphate AEROSOL, FOAM;TOPICAL 050801-001 Oct 22, 2004 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hikma CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% clindamycin phosphate INJECTABLE;INJECTION 214401-001 Apr 5, 2023 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Pharmacia And Upjohn CLEOCIN PHOSPHATE clindamycin phosphate INJECTABLE;INJECTION 061839-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for CLINDAMYCIN PHOSPHATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Norvium Bioscience EVOCLIN clindamycin phosphate AEROSOL, FOAM;TOPICAL 050801-001 Oct 22, 2004 ⤷  Try for Free ⤷  Try for Free
Bausch CLINDAGEL clindamycin phosphate GEL;TOPICAL 050782-001 Nov 27, 2000 ⤷  Try for Free ⤷  Try for Free
Padagis Us CLINDESSE clindamycin phosphate CREAM;VAGINAL 050793-001 Nov 30, 2004 ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for CLINDAMYCIN PHOSPHATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992 PA2013025,C1304992 Lithuania ⤷  Try for Free 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 SPC/GB13/061 United Kingdom ⤷  Try for Free PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992 CR 2013 00053 Denmark ⤷  Try for Free PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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].

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.