Clindamycin hydrochloride - Generic Drug Details

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

Clindamycin hydrochloride is the generic ingredient in three branded drugs marketed by Pharmacia And Upjohn, Pfizer, Aurobindo Pharma, Chartwell Molecular, Cosette, Epic Pharma Llc, Glenmark Pharms Ltd, Micro Labs, Norvium Bioscience, Sun Pharm Inds Ltd, Teva, Watson Labs, and Zydus Pharms Usa, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for clindamycin hydrochloride

US Patents:	0
Tradenames:	3
Applicants:	13
NDAs:	14
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	37
Raw Ingredient (Bulk) Api Vendors:	145
Clinical Trials:	231
Patent Applications:	3,431
What excipients (inactive ingredients) are in clindamycin hydrochloride?	clindamycin hydrochloride excipients list
DailyMed Link:	clindamycin hydrochloride at DailyMed

Recent Clinical Trials for clindamycin hydrochloride

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

Sponsor	Phase
Cairo University	Phase 4
Janssen Research & Development, LLC	Phase 2
Frieder Schaumburg	Phase 4

See all clindamycin hydrochloride clinical trials

Pharmacology for clindamycin hydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for clindamycin hydrochloride

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

US Patents and Regulatory Information for clindamycin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Pharms Ltd	CLINDAMYCIN HYDROCHLORIDE	clindamycin hydrochloride	CAPSULE;ORAL	216957-001	Mar 10, 2023	AB	RX	No	No
Epic Pharma Llc	CLINDAMYCIN HYDROCHLORIDE	clindamycin hydrochloride	CAPSULE;ORAL	065194-002	Mar 22, 2004	AB	RX	No	No
Pfizer	CLEOCIN HYDROCHLORIDE	clindamycin hydrochloride	CAPSULE;ORAL	050162-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Norvium Bioscience	CLINDAMYCIN HYDROCHLORIDE	clindamycin hydrochloride	CAPSULE;ORAL	091225-001	May 31, 2011		DISCN	No	No
Epic Pharma Llc	CLINDAMYCIN HYDROCHLORIDE	clindamycin hydrochloride	CAPSULE;ORAL	065194-001	Mar 22, 2004	AB	RX	No	No
Teva	CLINDAMYCIN HYDROCHLORIDE	clindamycin hydrochloride	CAPSULE;ORAL	063027-001	Sep 20, 1989		DISCN	No	No

Clindamycin hydrochloride Market Analysis and Financial Projection Experimental

Clindamycin Hydrochloride Market Dynamics and Financial Trajectory

Market Overview

The clindamycin hydrochloride market has been experiencing robust growth in recent years, driven by several key factors. Here’s a detailed look at the market dynamics and financial trajectory of this antibiotic.

Market Size and Growth

The clindamycin hydrochloride market has seen significant expansion, with its size expected to grow from $1.68 billion in 2023 to $1.82 billion in 2024, at a compound annual growth rate (CAGR) of 8.5%[1][3][5].

Forecasted Growth

Looking ahead, the market is projected to continue its strong growth, reaching $2.54 billion by 2028 at a CAGR of 8.6%. This forecasted growth is attributed to several factors, including advances in pharmaceutical formulations and delivery methods, increasing demand for targeted antibiotics with fewer side effects, and rising investment in healthcare infrastructure and medication access[1][3][4].

Drivers of the Market

Increasing Prevalence of Bacterial Infections

The rising prevalence of bacterial infections, particularly those resistant to other antibiotics, has significantly driven the demand for clindamycin hydrochloride. Its effectiveness against resistant strains makes it a preferred choice among healthcare professionals[1][3][5].

Growing Adoption in Surgical Prophylaxis

Clindamycin hydrochloride is increasingly used in surgical prophylaxis due to its broad-spectrum antibacterial properties, which help in preventing post-surgical infections. This growing adoption is a key driver of the market[1][3].

Rising Awareness and Diagnosis of Skin and Soft Tissue Infections

Heightened awareness and improved diagnosis of skin and soft tissue infections have led to an increased use of clindamycin hydrochloride. The drug's antibacterial properties make it effective in treating these conditions[1][3].

Increasing Prevalence of Skin Infections and Acne

The growing incidence of skin infections and acne, driven by factors such as pollution, hormonal changes, and lifestyle-related stress, is another significant driver. For instance, in the UK, between February 2021 and January 2022, Clinical Commissioning Groups prescribed 1.52 million topical acne treatments valued at £22.67 million ($29.33 million)[1][3].

Restraints of the Market

Side Effects and Resistance

Despite its effectiveness, clindamycin hydrochloride can have side effects such as gastrointestinal issues and the potential for antibiotic resistance. These factors can act as restraints to the market growth[1][3].

Regulatory Challenges

Regulatory hurdles and stringent approval processes can also slow down the market growth. Pharmaceutical companies must navigate these challenges to bring new formulations and products to the market[1][3].

Market Segmentation

By Type

The clindamycin hydrochloride market is segmented by type into oral, external use, and intravenous injection. Each segment has its own growth trajectory based on the specific applications and patient needs[1].

• Oral: This segment includes capsules and oral suspensions, which are widely used for treating various bacterial infections.
• External Use: Topical formulations such as gels and creams are used for skin infections and acne.
• Intravenous Injection: Used in severe infections requiring immediate and potent antibacterial action.

By Indication

The market is also segmented by indication, including treatment of acne, bacterial infections, bone and joint infections, and other infectious diseases. The growth in each segment is driven by the specific needs and prevalence of these conditions[1].

Trends in the Market

Shift Towards Combination Therapies

There is a growing trend towards using clindamycin hydrochloride in combination therapies to enhance its effectiveness and reduce the risk of resistance. This approach is becoming more common in treating complex infections[1][3].

Growth in Topical Formulations

The development of clindamycin-based topical formulations is on the rise, driven by the increasing prevalence of skin infections and acne. These formulations offer targeted treatment with fewer systemic side effects[1][3].

Strategic Partnerships and Acquisitions

Companies are engaging in strategic partnerships and acquisitions to expand their market presence and develop new products. For example, Glenmark Pharmaceuticals received final approval from the US FDA for its generic version of clindamycin hydrochloride capsules in March 2023[1].

Expansion in Veterinary Medicine

Clindamycin hydrochloride is also being increasingly used in veterinary medicine, treating bacterial infections in animals. This expansion into new markets is contributing to the overall growth of the market[1][3].

Personalized Medicine

There is a growing emphasis on personalized medicine and tailored antibiotic treatments. This trend is expected to drive the development of more targeted and effective clindamycin hydrochloride formulations[1][3].

Financial Trajectory

The financial trajectory of the clindamycin hydrochloride market is positive, with significant growth expected over the next few years. Here are some key financial highlights:

• Current Market Size: $1.68 billion in 2023[1][3][5].
• Projected Market Size: $1.82 billion in 2024 and $2.54 billion by 2028[1][3][5].
• CAGR: 8.5% from 2023 to 2024 and 8.6% from 2024 to 2028[1][3][5].

Key Takeaways

• The clindamycin hydrochloride market is driven by the increasing prevalence of bacterial infections, growing adoption in surgical prophylaxis, and rising awareness of skin and soft tissue infections.
• The market is expected to grow significantly, reaching $2.54 billion by 2028.
• Key trends include a shift towards combination therapies, growth in topical formulations, strategic partnerships, expansion into veterinary medicine, and a focus on personalized medicine.
• Despite growth, the market faces restraints such as side effects and regulatory challenges.

FAQs

Q: What is the current market size of clindamycin hydrochloride?

A: The current market size of clindamycin hydrochloride is $1.68 billion in 2023[1][3][5].

Q: What is the projected growth rate of the clindamycin hydrochloride market?

A: The market is expected to grow at a CAGR of 8.5% from 2023 to 2024 and 8.6% from 2024 to 2028[1][3][5].

Q: What are the main drivers of the clindamycin hydrochloride market?

A: The main drivers include the increasing prevalence of bacterial infections, growing adoption in surgical prophylaxis, rising awareness of skin and soft tissue infections, and the growing prevalence of skin infections and acne[1][3].

Q: What are some of the key trends in the clindamycin hydrochloride market?

A: Key trends include a shift towards combination therapies, growth in topical formulations, strategic partnerships, expansion into veterinary medicine, and a focus on personalized medicine[1][3].

Q: Which companies are major players in the clindamycin hydrochloride market?

A: Major companies include those like Glenmark Pharmaceuticals, which have received approvals for generic versions of clindamycin hydrochloride capsules and are expanding their market presence through strategic partnerships and acquisitions[1].

Sources

1. The Business Research Company: Clindamycin Hydrochloride Global Market Report 2024
2. EIN Presswire: Global Clindamycin Hydrochloride Market Set For 8.6 % Growth ...
3. GII Research: Clindamycin Hydrochloride Global Market Report 2024
4. Market Research Intellect: Clindamycin Hydrochloride Market Size, Scope And Forecast Report
5. MarketResearch.com: Clindamycin Hydrochloride Global Market Report 2024