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Last Updated: December 22, 2024

Clindamycin palmitate hydrochloride - Generic Drug Details


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What are the generic sources for clindamycin palmitate hydrochloride and what is the scope of freedom to operate?

Clindamycin palmitate hydrochloride is the generic ingredient in two branded drugs marketed by Pfizer, Pharmacia And Upjohn, Amneal Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Heritage Pharms Inc, Padagis Us, and Rising, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for clindamycin palmitate hydrochloride. Nine suppliers are listed for this compound.

Summary for clindamycin palmitate hydrochloride
US Patents:0
Tradenames:2
Applicants:8
NDAs:9
Drug Master File Entries: 8
Finished Product Suppliers / Packagers: 9
Raw Ingredient (Bulk) Api Vendors: 69
Patent Applications: 684
What excipients (inactive ingredients) are in clindamycin palmitate hydrochloride?clindamycin palmitate hydrochloride excipients list
DailyMed Link:clindamycin palmitate hydrochloride at DailyMed
Pharmacology for clindamycin palmitate hydrochloride

US Patents and Regulatory Information for clindamycin palmitate hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd CLINDAMYCIN PALMITATE HYDROCHLORIDE clindamycin palmitate hydrochloride FOR SOLUTION;ORAL 202409-001 Apr 30, 2013 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx CLINDAMYCIN PALMITATE HYDROCHLORIDE clindamycin palmitate hydrochloride FOR SOLUTION;ORAL 206958-001 May 5, 2017 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pfizer CLEOCIN clindamycin palmitate hydrochloride FOR SOLUTION;ORAL 062644-001 Apr 7, 1986 AA RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Padagis Us CLINDAMYCIN PALMITATE HYDROCHLORIDE clindamycin palmitate hydrochloride FOR SOLUTION;ORAL 090902-001 Jul 7, 2010 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rising CLINDAMYCIN PALMITATE HYDROCHLORIDE clindamycin palmitate hydrochloride FOR SOLUTION;ORAL 203063-001 May 25, 2016 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Clindamycin palmitate hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Clindamycin Palmitate Hydrochloride

Market Size and Forecast

The market for Clindamycin Hydrochloride, which includes Clindamycin Palmitate Hydrochloride, has been experiencing significant growth. As of 2023, the Clindamycin Hydrochloride market was valued at USD 1.59 billion and is projected to reach USD 2.5 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.16% during the forecast period of 2024-2031[1].

In a more immediate forecast, the market is expected to grow from $1.68 billion in 2023 to $1.82 billion in 2024 at a CAGR of 8.5%, and further to $2.54 billion by 2028 at a CAGR of 8.6%[3].

Market Drivers

Several factors are driving the growth of the Clindamycin Palmitate Hydrochloride market:

Enhanced Healthcare Facilities

Improvements in healthcare facilities and services, especially in emerging economies, are increasing access to effective treatment options, thereby boosting the demand for medications like Clindamycin Palmitate Hydrochloride[1].

Research and Development

Continuous research and development efforts by pharmaceutical companies to expand the use of Clindamycin Palmitate Hydrochloride, including in combination therapies or new formulations, are driving market growth[1].

Regulatory Approvals

Timely approvals from regulatory authorities for new formulations or indications create new market opportunities and increase sales[1].

Growing Geriatric Population

The increasing elderly population, who are more susceptible to infections, drives higher demand for effective antibiotic treatments like Clindamycin Palmitate Hydrochloride[1].

Increased Prescription Rates

Physicians’ growing knowledge of Clindamycin’s efficacy and safety profile leads to an increase in prescriptions, driving market growth[1].

Market Entry of Generic Drugs

The introduction of generic versions of Clindamycin Palmitate Hydrochloride increases competition and makes treatments more affordable, thereby increasing market penetration[1].

Online Pharmacy Platforms

The rise in online pharmacies and e-commerce platforms for pharmaceuticals enhances distribution and accessibility, positively impacting the market[1].

Market Restraints

Despite the growth drivers, there are several challenges that the Clindamycin Palmitate Hydrochloride market faces:

Regulatory Challenges

Stringent regulations regarding the approval and marketing of antibiotics can slow down the entry of new products or formulations into the market. Compliance with these regulations can be time-consuming and costly[1].

Resistance Development

The increasing prevalence of antibiotic resistance poses a significant threat to the effectiveness of Clindamycin Palmitate Hydrochloride, potentially limiting its use in clinical settings and resulting in reduced demand[1].

Market Competition

The presence of various other antibiotics can restrict the market share of Clindamycin Palmitate Hydrochloride. Other alternatives may be preferred due to better efficacy, lower side effects, or cost advantages[1].

Cost and Pricing Pressures

Shifts in patient population needs and changes in demographic profiles or disease patterns can influence the demand for Clindamycin Palmitate Hydrochloride. For instance, changing rates of bacterial infections or shifts towards more chronic disease management may reduce the necessity for certain antibiotics[1].

Market Segmentation

The Clindamycin Hydrochloride market, including Clindamycin Palmitate Hydrochloride, is segmented based on several criteria:

Formulation Type

The market is segmented into oral, external use, and intravenous injection formulations. Each formulation type has its own set of applications and patient populations[3].

Route of Administration

The route of administration, such as oral, topical, or intravenous, influences the market dynamics. For example, oral formulations like Clindamycin Palmitate Hydrochloride are widely used for treating various infections[3].

Indication

Clindamycin Palmitate Hydrochloride is indicated for the treatment of acne, bacterial infections, bone and joint infections, and other infectious diseases. The increasing prevalence of skin infections and acne is a significant driver for this segment[3].

Geography

The market is geographically segmented into North America, Europe, Asia-Pacific, and the Middle East and Africa. Each region presents unique opportunities and challenges. For instance, the Asia-Pacific region exhibits significant growth potential due to rising awareness of healthcare and improving healthcare infrastructure[1].

Pharmacokinetics and Pharmacodynamics

Clindamycin Palmitate Hydrochloride is a water-soluble hydrochloride salt of the ester of clindamycin and palmitic acid. It targets the 50S subunit of bacterial ribosomes, inhibiting the growth and replication of anaerobic bacteria.

  • Peak Serum Concentrations: Pharmacokinetic studies show that Clindamycin Palmitate Hydrochloride reaches peak active serum concentrations rapidly, similar to Clindamycin Hydrochloride. In pediatric patients, mean peak serum concentrations range from 1.24 to 3.79 mcg/mL depending on the dose[2][5].
  • Elimination Half-Life: The average serum half-life is approximately two hours in pediatric patients and around 4 hours in elderly patients. This indicates that age does not significantly alter clindamycin pharmacokinetics, although there may be slight variations in elimination half-life[2][5].

Clinical Applications

Clindamycin Palmitate Hydrochloride is used in various clinical settings:

Anaerobic Bacterial Infections

It is specifically indicated for the treatment of anaerobic bacterial infections, which can occur in the skin, respiratory tract, and gastrointestinal tract[4].

Acne and Skin Infections

Its antibacterial properties make it effective in treating skin infections and acne, particularly in reducing bacterial growth that causes inflammation[3].

Surgical Prophylaxis

Clindamycin Palmitate Hydrochloride is also used in surgical prophylaxis to prevent infections during surgical procedures[3].

Future Trends

Several trends are expected to shape the market for Clindamycin Palmitate Hydrochloride in the future:

Combination Therapies

There is a growing trend towards combination therapies that include Clindamycin Palmitate Hydrochloride, which can enhance its efficacy and reduce the risk of antibiotic resistance[3].

Topical Formulations

The development of clindamycin-based topical formulations is expected to increase, driven by the growing prevalence of skin infections and acne[3].

Strategic Partnerships and Acquisitions

The market is likely to see increased strategic partnerships and acquisitions among pharmaceutical companies, which can expand the market presence of Clindamycin Palmitate Hydrochloride[3].

Veterinary Medicine

The use of Clindamycin Palmitate Hydrochloride in veterinary medicine is also expanding, adding another growth avenue for the market[3].

Personalized Medicine

There is a growing emphasis on personalized medicine and tailored antibiotic treatments, which could further drive the demand for Clindamycin Palmitate Hydrochloride[3].

Key Takeaways

  • The Clindamycin Hydrochloride market, including Clindamycin Palmitate Hydrochloride, is projected to grow significantly due to factors like enhanced healthcare facilities, research and development, and increasing geriatric population.
  • The market faces challenges such as regulatory hurdles, antibiotic resistance, and market competition.
  • Clindamycin Palmitate Hydrochloride is widely used for treating anaerobic bacterial infections, acne, and skin infections.
  • Future trends include a shift towards combination therapies, development of topical formulations, and increased use in veterinary medicine.

FAQs

Q: What is the projected market size for Clindamycin Hydrochloride by 2031? A: The Clindamycin Hydrochloride market is projected to reach USD 2.5 billion by 2031[1].

Q: What are the primary drivers of the Clindamycin Palmitate Hydrochloride market? A: The primary drivers include enhanced healthcare facilities, research and development, regulatory approvals, growing geriatric population, and increased prescription rates[1].

Q: What are the main indications for Clindamycin Palmitate Hydrochloride? A: The main indications include the treatment of anaerobic bacterial infections, acne, bacterial infections, bone and joint infections, and other infectious diseases[3].

Q: How does the pharmacokinetics of Clindamycin Palmitate Hydrochloride vary with age? A: Age alone does not significantly alter the pharmacokinetics of Clindamycin Palmitate Hydrochloride, although there may be slight variations in elimination half-life in elderly patients[2][5].

Q: What are the future trends expected to shape the Clindamycin Palmitate Hydrochloride market? A: Future trends include a shift towards combination therapies, development of topical formulations, strategic partnerships and acquisitions, expansion in veterinary medicine, and a growing emphasis on personalized medicine[3].

Sources

  1. Verified Market Research: Clindamycin Hydrochloride Market Size, Share And Forecast.
  2. Pfizer Medical Information: CLEOCIN® Pediatric (clindamycin) Clinical Pharmacology Patient.
  3. The Business Research Company: Clindamycin Hydrochloride Global Market Report 2024.
  4. Synapse by Patsnap: Clindamycin Palmitate Hydrochloride's R&D Progress.
  5. Pfizer Labeling: Clindamycin palmitate hydrochloride for oral solution, USP.

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