CLINDAMYCIN PHOSPHATE; TRETINOIN - Generic Drug Details

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

Clindamycin phosphate; tretinoin is the generic ingredient in three branded drugs marketed by Actavis Mid Atlantic, Encube, Solaris Pharma Corp, Almirall, and Bausch, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Six suppliers are listed for this compound.

Summary for CLINDAMYCIN PHOSPHATE; TRETINOIN

US Patents:	0
Tradenames:	3
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	6
Clinical Trials:	9
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLINDAMYCIN PHOSPHATE; TRETINOIN
DailyMed Link:	CLINDAMYCIN PHOSPHATE; TRETINOIN at DailyMed

Recent Clinical Trials for CLINDAMYCIN PHOSPHATE; TRETINOIN

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

Sponsor	Phase
Alphacait, LLC	Phase 2
Haining Health-Coming Biotech Co., Ltd.	Phase 2
Zeichner, Joshua, M.D.	Phase 4

See all CLINDAMYCIN PHOSPHATE; TRETINOIN clinical trials

Pharmacology for CLINDAMYCIN PHOSPHATE; TRETINOIN

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

Anatomical Therapeutic Chemical (ATC) Classes for CLINDAMYCIN PHOSPHATE; TRETINOIN

D10AD	Retinoids for topical use in acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

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

L01XF	Retinoids for cancer treatment
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for CLINDAMYCIN PHOSPHATE; TRETINOIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZIANA	Gel	clindamycin phosphate; tretinoin	1.2%/0.025%	050802	1	2010-12-17

US Patents and Regulatory Information for CLINDAMYCIN PHOSPHATE; TRETINOIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Almirall	VELTIN	clindamycin phosphate; tretinoin	GEL;TOPICAL	050803-001	Jul 16, 2010	AB2	RX	Yes	Yes
Bausch	ZIANA	clindamycin phosphate; tretinoin	GEL;TOPICAL	050802-001	Nov 7, 2006	AB1	RX	Yes	Yes
Actavis Mid Atlantic	CLINDAMYCIN PHOSPHATE AND TRETINOIN	clindamycin phosphate; tretinoin	GEL;TOPICAL	202564-001	Jun 12, 2015	AB1	RX	No	No
Solaris Pharma Corp	CLINDAMYCIN PHOSPHATE AND TRETINOIN	clindamycin phosphate; tretinoin	GEL;TOPICAL	212845-001	Feb 10, 2022	AB2	RX	No	No
Encube	CLINDAMYCIN PHOSPHATE AND TRETINOIN	clindamycin phosphate; tretinoin	GEL;TOPICAL	216943-001	Sep 1, 2023	AB2	RX	No	No

Expired US Patents for CLINDAMYCIN PHOSPHATE; TRETINOIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	VELTIN	clindamycin phosphate; tretinoin	GEL;TOPICAL	050803-001	Jul 16, 2010	5,690,923
Bausch	ZIANA	clindamycin phosphate; tretinoin	GEL;TOPICAL	050802-001	Nov 7, 2006	RE41134
Bausch	ZIANA	clindamycin phosphate; tretinoin	GEL;TOPICAL	050802-001	Nov 7, 2006	6,387,383
Bausch	ZIANA	clindamycin phosphate; tretinoin	GEL;TOPICAL	050802-001	Nov 7, 2006	5,721,275

CLINDAMYCIN PHOSPHATE; TRETINOIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Clindamycin Phosphate; Tretinoin

Introduction

Clindamycin phosphate and tretinoin, when combined, form a potent topical treatment for acne vulgaris. This combination therapy has been gaining significant traction in the dermatological market due to its efficacy and safety profile. Here, we delve into the market dynamics and financial trajectory of this drug combination.

Market Size and Growth

The market for clindamycin phosphate topical formulations, including the combination with tretinoin, is experiencing robust growth. As of 2023, the global clindamycin phosphate topical market was valued at $0.94 billion and is projected to reach $1.07 billion in 2024, growing at a compound annual growth rate (CAGR) of 14.7%[1].

By 2028, the market is expected to expand to $1.86 billion, maintaining a CAGR of 14.8%[1]. This rapid growth is driven by several factors, including the increasing incidence of bacterial skin infections, rising antibiotic resistance, and growing awareness of skin health and hygiene.

Key Drivers of Growth

Rising Incidence of Skin Infections

The surge in skin infections, such as acne and cellulitis, is a significant driver of the market. Environmental pollution and poor hygiene practices contribute to the increasing prevalence of these infections, thereby boosting the demand for effective topical treatments like clindamycin phosphate and tretinoin[1].

Antibiotic Resistance

The growing issue of antibiotic resistance among bacterial strains, such as Staphylococcus aureus, has heightened the need for potent and effective antibiotics. Clindamycin phosphate remains effective against certain resistant strains, making it a preferred choice in dermatological treatments[1].

Dermatological Innovations

Advancements in dermatological drug innovation and the development of more efficient topical formulations are also driving market growth. The combination of clindamycin phosphate with tretinoin, for instance, enhances the comedolytic efficacy of tretinoin and provides a dual-action treatment for acne[2].

Expanding Healthcare Infrastructure

The expansion of healthcare infrastructure in emerging economies is another key factor. Regions such as Asia Pacific and Latin America are witnessing increased access to medical treatments, which is fueling the demand for clindamycin phosphate and other topical antibiotics[1][4].

Market Segmentation

The market for clindamycin phosphate topical formulations is segmented by formulation type, application, and end user.

Formulation Type

The market includes various formulations such as gels, creams, and lotions. The clindamycin phosphate and tretinoin gel formulation is particularly popular due to its stability and efficacy in treating moderate-to-severe acne[2].

Application

The primary application of this combination therapy is in the management of acne vulgaris, including moderate comedonal and mild-to-moderate papulopustular acne. It can also be used in combination with systemic antiacne therapies for more severe cases[2].

End User

The end users include dermatology clinics, hospitals, and retail pharmacies. The growing trend towards homecare settings for administering antibiotics is also contributing to the market's expansion[4].

Financial Trajectory

The financial trajectory of the clindamycin phosphate topical market is promising. Here are some key financial projections:

• Current Market Size: The market was valued at $0.94 billion in 2023 and is expected to reach $1.07 billion in 2024[1].
• Future Projections: By 2028, the market is projected to grow to $1.86 billion, with a CAGR of 14.8%[1].
• Long-Term Outlook: Another report suggests that the market could reach $4.07 billion by 2031, growing at a CAGR of 8.92% from 2024 to 2031[3].

Regional Analysis

The market is geographically segmented, with North America currently leading due to its sophisticated healthcare system and high incidence of bacterial infections. However, the Asia Pacific region is expected to witness substantial growth due to expanding healthcare infrastructure and rising infection rates[1][4].

Trends and Innovations

Several trends are shaping the market for clindamycin phosphate and tretinoin:

Combination Therapies

The adoption of clindamycin-based combination therapies is on the rise. These combinations enhance efficacy and help combat complex infections more effectively[1].

Antibiotic Stewardship

There is a growing focus on antibiotic stewardship to combat antibiotic resistance. This includes the responsible use of antibiotics like clindamycin phosphate to ensure their continued effectiveness[1].

Personalized Dermatological Treatments

A shift towards personalized dermatological treatments is also observed. This involves tailoring treatment plans to individual patient needs, which can include the use of clindamycin phosphate and tretinoin based on specific skin conditions and patient responses[1].

Safety and Efficacy

The safety and efficacy of clindamycin phosphate and tretinoin have been well-documented. The combination gel formulation has been shown to enhance the comedolytic efficacy of tretinoin while maintaining a good safety profile. Discontinuation rates due to adverse events are low, and the formulation is designed to minimize irritation[2].

"The addition of clindamycin to tretinoin enhances the comedolytic efficacy of tretinoin in moderate-to-severe acne of the face. The comedolytic activity of tretinoin and the anti-inflammatory efficacy of clindamycin accelerate resolution of all types of acne lesions without affecting the safety of both compounds."[2]

Regulatory Considerations

The FDA has provided guidance on the bioequivalence studies required for generic versions of clindamycin phosphate and tretinoin gel. These studies can be conducted either in vitro or in vivo, with specific criteria to ensure the bioequivalence of the generic product to the reference standard[5].

Key Takeaways

• The clindamycin phosphate topical market is growing rapidly, driven by increasing skin infections, antibiotic resistance, and advancements in dermatological treatments.
• The combination of clindamycin phosphate and tretinoin is highly effective and safe, making it a preferred treatment for acne vulgaris.
• The market is expected to reach $1.86 billion by 2028, with a CAGR of 14.8%.
• Regional growth is significant, especially in the Asia Pacific region due to expanding healthcare infrastructure.
• Trends include the adoption of combination therapies, antibiotic stewardship, and personalized dermatological treatments.

FAQs

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

Q: What is the projected growth rate of the clindamycin phosphate topical market? A: The market is projected to grow at a CAGR of 14.8% from 2023 to 2028[1].

Q: What are the main applications of clindamycin phosphate and tretinoin? A: The main applications are in the management of moderate comedonal and mild-to-moderate papulopustular acne, as well as in combination with systemic antiacne therapies for more severe cases[2].

Q: Which regions are expected to see significant growth in the clindamycin phosphate topical market? A: North America is currently leading, but the Asia Pacific region is expected to witness substantial growth due to expanding healthcare infrastructure and rising infection rates[1][4].

Q: What are the key trends shaping the market for clindamycin phosphate and tretinoin? A: Key trends include the adoption of combination therapies, focus on antibiotic stewardship, and a shift towards personalized dermatological treatments[1].

Sources:

1. The Business Research Company. Clindamycin Phosphate Topical Global Market Report 2024.
2. PubMed. Clindamycin phosphate/tretinoin gel formulation in the treatment of moderate-to-severe acne of the face.
3. Verified Market Research. Clindamycin Phosphate Topical Market Size, Share And Forecast.
4. Polaris Market Research. Clindamycin Phosphate Injection Market Growth Report, 2032.
5. FDA. Draft Guidance on Clindamycin Phosphate; Tretinoin Topical Gel.