ARESTIN Drug Patent Profile

Which patents cover Arestin, and what generic alternatives are available?

Arestin is a drug marketed by Orapharma and is included in one NDA.

The generic ingredient in ARESTIN is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Arestin

A generic version of ARESTIN was approved as minocycline hydrochloride by WATSON LABS on December 30^th, 1991.

Summary for ARESTIN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	7
Patent Applications:	2,938
Drug Prices:	Drug price information for ARESTIN
What excipients (inactive ingredients) are in ARESTIN?	ARESTIN excipients list
DailyMed Link:	ARESTIN at DailyMed

See drug prices for ARESTIN

Recent Clinical Trials for ARESTIN

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

Sponsor	Phase
University of Minnesota - Clinical and Translational Science Institute	Phase 4
University of Minnesota	Phase 4
Bausch Health Companies, INC.	Phase 4

See all ARESTIN clinical trials

Pharmacology for ARESTIN

Drug Class	Tetracycline-class Drug
Physiological Effect	Decreased Prothrombin Activity

US Patents and Regulatory Information for ARESTIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Orapharma	ARESTIN	minocycline hydrochloride	POWDER, EXTENDED RELEASE;DENTAL	050781-001	Feb 16, 2001		RX	Yes	Yes

Expired US Patents for ARESTIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orapharma	ARESTIN	minocycline hydrochloride	POWDER, EXTENDED RELEASE;DENTAL	050781-001	Feb 16, 2001
Orapharma	ARESTIN	minocycline hydrochloride	POWDER, EXTENDED RELEASE;DENTAL	050781-001	Feb 16, 2001

International Patents for ARESTIN

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

Country	Patent Number	Title	Estimated Expiration
Spain	2427272
Australia	2009201777	Dispensing apparatus and cartridge
European Patent Office	2263596	Distributeur et cartouche (Dispensing apparatus and cartridge)
Portugal	2263596

ARESTIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Arestin

Introduction to Arestin

Arestin, a subgingival sustained-release product containing minocycline hydrochloride, is a key player in the periodontal therapeutics market. It is used to treat moderate to advanced chronic periodontitis and is applied directly into the periodontal pockets following scaling and root planing (SRP)[2].

Market Segmentation and Positioning

The global periodontal therapeutics market, in which Arestin is a significant component, is segmented by drug type and distribution channel. Arestin falls under the local antibiotics segment, which is expected to account for a significant share of the market. Other segments include systemic antibiotics and various distribution channels such as hospital pharmacies, retail pharmacies, drug stores, and e-commerce platforms[1][4].

Market Drivers

Several factors drive the demand for Arestin and the broader periodontal therapeutics market:

• Rise in Periodontitis Cases: The increasing number of reported cases of periodontitis globally is a major driver. Periodontitis is a chronic bacterial infection of the gums and bone supporting the teeth, and Arestin is an effective treatment option[1].
• Prevalence of Diabetes: There is a strong link between diabetes and periodontal diseases, making diabetic patients more susceptible to periodontitis. The rising prevalence of diabetes contributes to the demand for periodontal therapeutics like Arestin[1].
• Global Geriatric Population: The increasing geriatric population is another significant driver, as older adults are more prone to periodontal diseases due to decreased immune response and other health issues[1].
• Awareness About Oral Health: Growing awareness about oral health and the importance of preventive and therapeutic measures also boosts the market for Arestin[1].

Clinical Efficacy and Studies

Clinical studies have demonstrated the efficacy of Arestin in treating periodontitis. For instance, a study involving 368 and 380 subjects showed that patients treated with Arestin in addition to SRP had statistically significant reductions in probing pocket depth compared to those treated with SRP alone or SRP plus a vehicle. This indicates that Arestin enhances the effectiveness of SRP procedures[2].

Another study conducted by the University of Minnesota School of Dentistry found that Arestin decreased certain key pathogens in periodontal disease when applied correctly after SRP. This further supports its clinical utility[5].

Financial Trajectory

The periodontal therapeutics market, which includes Arestin, is expected to experience significant growth:

• Market Size and Growth Rate: The periodontal therapeutics market is anticipated to reach US$ 1.1 billion by 2027, expanding at a Compound Annual Growth Rate (CAGR) of 8.8% from 2019 to 2027[1].
• Revenue Forecast: The local antibiotics segment, where Arestin is categorized, is expected to account for a substantial share of the market revenue. For example, the global Arestin market revenue is forecasted to grow significantly over the forecast period[1].

Distribution Channels and Market Attractiveness

Arestin is distributed through various channels, including hospital pharmacies, retail pharmacies, drug stores, and e-commerce platforms. The market attractiveness analysis by distribution channel indicates that hospital pharmacies and retail pharmacies are key channels for Arestin, given their direct access to dental care providers and patients[1][4].

Competitive Landscape

The periodontal therapeutics market is competitive, with several key players. Arestin is manufactured by OraPharma, and other major players in the market include Den-Mat Holdings, LLC, Valeant Pharmaceuticals International, Inc., Dexcel Pharma, 3M Company, Oral Science, and Kaken Pharmaceutical Co., Ltd. The competitive landscape is characterized by market share analysis, company profiles, and strategic activities such as product launches, acquisitions, and partnerships[1][4].

Regional Analysis

The market for Arestin is analyzed across various regions, including North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. Each region has its own market dynamics, driven by local healthcare policies, awareness about oral health, and the prevalence of periodontal diseases. North America and Europe are significant markets due to high awareness and advanced healthcare infrastructure[1][4].

Challenges and Opportunities

While Arestin has a strong market position, there are challenges and opportunities to consider:

• Generic Competition: The entry of generic versions of antibiotics could impact the market share of branded products like Arestin. However, the complexity of manufacturing sustained-release formulations can act as a barrier to entry for generics[3].
• Innovative Strategies: Companies can focus on organic growth strategies such as product approvals, patents, and innovative marketing to maintain market share and expand their customer base[4].

Key Takeaways

• Arestin is a crucial product in the periodontal therapeutics market, driven by rising cases of periodontitis, diabetes prevalence, and an aging population.
• Clinical studies have demonstrated the efficacy of Arestin in reducing pocket depth and eliminating periodontic pathogens.
• The market is expected to grow significantly, with Arestin contributing substantially to the local antibiotics segment.
• Distribution through hospital pharmacies, retail pharmacies, and e-commerce platforms is key to its market success.
• The competitive landscape involves several major players, with strategies focusing on product innovation and market expansion.

FAQs

Q: What is Arestin used for? Arestin is used to treat moderate to advanced chronic periodontitis. It is applied directly into the periodontal pockets following scaling and root planing (SRP)[2].

Q: What are the key drivers of the periodontal therapeutics market? The key drivers include the rise in reported cases of periodontitis, increase in prevalence of diabetes, rise in global geriatric population, and surge in awareness about oral health[1].

Q: How effective is Arestin in clinical settings? Clinical studies have shown that Arestin significantly reduces probing pocket depth and eliminates certain key pathogens in periodontal disease when applied correctly after SRP[2][5].

Q: What is the expected market size and growth rate for the periodontal therapeutics market? The periodontal therapeutics market is expected to reach US$ 1.1 billion by 2027, expanding at a CAGR of 8.8% from 2019 to 2027[1].

Q: Who are the major players in the periodontal therapeutics market? Major players include Den-Mat Holdings, LLC, Valeant Pharmaceuticals International, Inc., Dexcel Pharma, 3M Company, Oral Science, Kaken Pharmaceutical Co., Ltd., and OraPharma, the manufacturer of Arestin[1][4].

Sources:

1. Transparency Market Research - Periodontal Therapeutics Market Analysis Report 2027
2. Drugs.com - Arestin: Package Insert / Prescribing Information
3. Federal Trade Commission - Generic Drug Industry Dynamics
4. The Insight Partners - Periodontal Therapeutics Market Developments by 2031
5. Dental Products Report - New Clinical Study Demonstrates ARESTIN Decreases Certain Periodontitis Pathogens