ZIANA Drug Patent Profile

When do Ziana patents expire, and what generic alternatives are available?

Ziana is a drug marketed by Bausch and is included in one NDA.

The generic ingredient in ZIANA is clindamycin phosphate; tretinoin. There are fifty-five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the clindamycin phosphate; tretinoin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ziana

A generic version of ZIANA was approved as clindamycin phosphate; tretinoin by ACTAVIS MID ATLANTIC on June 12^th, 2015.

Summary for ZIANA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	4
Patent Applications:	11
Drug Prices:	Drug price information for ZIANA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZIANA
What excipients (inactive ingredients) are in ZIANA?	ZIANA excipients list
DailyMed Link:	ZIANA at DailyMed

See drug prices for ZIANA

Pharmacology for ZIANA

Drug Class	Lincosamide Antibacterial Retinoid
Physiological Effect	Decreased Sebaceous Gland Activity

Paragraph IV (Patent) Challenges for ZIANA

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 ZIANA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	ZIANA	clindamycin phosphate; tretinoin	GEL;TOPICAL	050802-001	Nov 7, 2006	AB1	RX	Yes	Yes

Expired US Patents for ZIANA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	ZIANA	clindamycin phosphate; tretinoin	GEL;TOPICAL	050802-001	Nov 7, 2006
Bausch	ZIANA	clindamycin phosphate; tretinoin	GEL;TOPICAL	050802-001	Nov 7, 2006
Bausch	ZIANA	clindamycin phosphate; tretinoin	GEL;TOPICAL	050802-001	Nov 7, 2006

International Patents for ZIANA

See the table below for patents covering ZIANA around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2417646	SYSTEME DE DISTRIBUTION D'UN GEL TOPIQUE (TOPICAL GEL DELIVERY SYSTEM)
Cyprus	1114646
Brazil	0113247
Portugal	1304992
China	1460013

Supplementary Protection Certificates for ZIANA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	92401	Luxembourg		PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992	132013902214376	Italy		PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718
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	2013/044	Ireland		PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322

ZIANA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: ZIANA

Introduction

ZIANA, a topical acne treatment, is a combination therapy that includes clindamycin and tretinoin, produced by Medicis, now part of Galderma. To understand the market dynamics and financial trajectory of ZIANA, it is essential to delve into the broader acne drugs market, as well as specific trends and factors influencing this product.

Global Acne Drugs Market Overview

The global acne drugs market has been experiencing steady growth, driven by factors such as an increase in acne prevalence, rising population, strong economic growth, and increased healthcare expenditure. The market is expected to grow from $5.84 billion in 2023 to $6.11 billion in 2024 at a CAGR of 4.6%, and further to $7.3 billion by 2028 at a CAGR of 4.5%[1].

Market Segmentation

The acne drugs market is segmented by type, therapeutic class, and end user. ZIANA falls under the category of combination therapies, which are gaining popularity due to their efficacy in treating acne.

By Type

• Inflammatory Acne Drugs: These include products like ZIANA, which target the inflammatory aspects of acne.
• Non-Inflammatory Acne Drugs: These focus on non-inflammatory acne types[1].

By Therapeutic Class

• Retinoids: Include tretinoin, a key component of ZIANA.
• Antibiotics: Include clindamycin, another key component of ZIANA.
• Salicylic Acid and Benzoyl Peroxide: Other common therapeutic classes[4].

By End User

• Hospitals & Clinics
• Pharmacies & Drug Stores
• Ambulatory Surgical Centers: ZIANA is typically prescribed and dispensed through these channels[4].

Combination Therapies

Combination therapies like ZIANA (clindamycin and tretinoin) are increasingly popular due to their synergistic effects in treating acne. Other examples include Epiduo, Acanya, and Benzamycin. These products offer a comprehensive approach to acne treatment, addressing multiple aspects of the condition simultaneously[4].

Key Players and Market Competition

The acne drugs market is dominated by major players such as Allergan, Galderma S.A., Valeant Pharmaceutical International Inc., Teva Pharmaceutical Industries Ltd., and Johnson & Johnson Services, Inc. Galderma, the producer of ZIANA, has a significant presence in the dermatology segment and continues to invest in innovative products and marketing strategies[4].

Financial Performance and Projections

While specific financial data for ZIANA is not readily available, the overall performance of the acne drugs market and Galderma's position within it provide insights into its financial trajectory.

Revenue Growth

The global acne market, which includes products like ZIANA, is expected to grow from $4.03 billion in 2020 to $4.61 billion by 2025 at a CAGR of 3.4%. This growth is driven by increasing demand for effective acne treatments and the rising prevalence of acne[4].

Market Share and Competitiveness

Galderma's strong portfolio in dermatology, including ZIANA, contributes significantly to its revenue. The company's focus on innovation, partnerships, and strategic marketing helps maintain its competitive edge in the market.

Trends and Innovations

Several trends are shaping the acne drugs market, including:

Narrow Spectrum Antibiotics

There is a growing interest in narrow spectrum antibiotics to reduce antibiotic resistance, which could impact the formulation and marketing of products like ZIANA[1].

Cannabis Products

The exploration of cannabis products, including cannabis oil, for acne treatment is another trend, though it is still in its early stages[1].

Social Media Marketing

Companies are increasingly using social media to market acne treatment products, which can enhance the visibility and appeal of products like ZIANA[1].

Regional Market Dynamics

The acne drugs market varies by region, with different segments showing different growth rates.

Asia-Pacific

This region is expected to see significant growth due to a large and growing population, increasing healthcare expenditure, and a rising teenage population with sedentary lifestyles[1].

North America

The North American market for topical prescription drugs for acne was estimated to be approximately $1.7 billion as of 2015, indicating a substantial market size for products like ZIANA[3].

Challenges and Restraints

Despite the growth potential, the acne drugs market faces several challenges, including:

Regulatory Hurdles

Stringent regulatory requirements and the need for bioequivalence studies can slow down the approval and launch of new products[3].

Competition

The market is highly competitive, with many established players and a constant influx of new products, which can make it challenging for any single product to dominate the market[4].

Key Takeaways

• Market Growth: The global acne drugs market is expected to grow steadily, driven by increasing demand and healthcare expenditure.
• Combination Therapies: Products like ZIANA are gaining popularity due to their efficacy in treating acne.
• Competitive Landscape: Galderma, the producer of ZIANA, is a major player in the dermatology segment with a strong portfolio and strategic marketing.
• Trends and Innovations: The market is influenced by trends such as narrow spectrum antibiotics, cannabis products, and social media marketing.
• Regional Dynamics: Different regions show varying growth rates, with Asia-Pacific expected to see significant growth.

FAQs

What is ZIANA used for?

ZIANA is a topical acne treatment that combines clindamycin and tretinoin to treat inflammatory acne.

Who produces ZIANA?

ZIANA is produced by Medicis, which is now part of Galderma.

What are the key components of ZIANA?

The key components of ZIANA are clindamycin (an antibiotic) and tretinoin (a retinoid).

How is the global acne drugs market expected to grow?

The global acne drugs market is expected to grow from $5.84 billion in 2023 to $7.3 billion by 2028 at a CAGR of 4.5%.

What trends are influencing the acne drugs market?

Trends include the use of narrow spectrum antibiotics, development of combination therapies, exploration of cannabis products, and the use of social media for marketing.

Sources

1. The Business Research Company: Global Acne Drugs Market Report 2024
2. Annual Reports: Valeant Annual Report 2010
3. SEC Filing: Sol-Gel Technologies Ltd
4. GlobeNewswire: Global Acne Market Report 2021-2025 & 2030
5. Mizuho Group: No Rosy Outlook for Early 2017; Landscape May Improve Later