EVOCLIN Drug Patent Profile

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

Evoclin is a drug marketed by Norvium Bioscience and is included in one NDA. There are two patents protecting this drug.

This drug has thirty patent family members in fifteen countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Evoclin

A generic version of EVOCLIN was approved as clindamycin phosphate by ALMAJECT on July 24^th, 1987.

Summary for EVOCLIN

International Patents:	30
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	57
Drug Prices:	Drug price information for EVOCLIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EVOCLIN
What excipients (inactive ingredients) are in EVOCLIN?	EVOCLIN excipients list
DailyMed Link:	EVOCLIN at DailyMed

See drug prices for EVOCLIN

US Patents and Regulatory Information for EVOCLIN

EVOCLIN is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norvium Bioscience	EVOCLIN	clindamycin phosphate	AEROSOL, FOAM;TOPICAL	050801-001	Oct 22, 2004		DISCN	Yes	No	7,374,747		Y
Norvium Bioscience	EVOCLIN	clindamycin phosphate	AEROSOL, FOAM;TOPICAL	050801-001	Oct 22, 2004		DISCN	Yes	No	7,141,237		Y

Expired US Patents for EVOCLIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Norvium Bioscience	EVOCLIN	clindamycin phosphate	AEROSOL, FOAM;TOPICAL	050801-001	Oct 22, 2004	7,141,237
Norvium Bioscience	EVOCLIN	clindamycin phosphate	AEROSOL, FOAM;TOPICAL	050801-001	Oct 22, 2004	7,374,747

International Patents for EVOCLIN

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

Country	Patent Number	Title	Estimated Expiration
Spain	2637956
Australia	2009235974	Clindamycin Phosphate Foam
Taiwan	I355267
Canada	2513773	MOUSSE DE PHOSPHATE DE CLINDAMYCINE (CLINDAMYCIN PHOSPHATE FOAM)
Brazil	PI0406905	Espuma de fosfato de clindamicina
Eurasian Patent Organization	200501169	ПЕНА НА ОСНОВЕ ФОСФАТА КЛИНДАМИЦИНА

Supplementary Protection Certificates for EVOCLIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	2013/044	Ireland		PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992	122013000081	Germany		PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
1304992	C01304992/01	Switzerland		PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992	92401	Luxembourg		PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992	PA2013025,C1304992	Lithuania		PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
1304992	SPC/GB13/061	United Kingdom		PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624

EVOCLIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Evoclin

Introduction

Evoclin, a topical antibiotic, is part of the broader pharmaceutical market that is driven by various dynamics, including innovation, regulatory environments, and financial considerations. To understand the market dynamics and financial trajectory of Evoclin, it is essential to delve into the broader pharmaceutical industry trends and the specific factors influencing its market performance.

Pharmaceutical Market Overview

The global pharmaceutical market, excluding vaccines, is projected to reach $2,030 billion by 2027, growing at a compound annual growth rate (CAGR) of approximately 7% from 2022 to 2027[1].

Drivers of Market Growth

Several factors drive the growth of the pharmaceutical market, including:

Innovative New Products

The launch of innovative new products, such as novel therapies, is a significant driver of market growth. In developed markets like the EU4 (France, Germany, Italy, Spain) and the UK, premium-priced innovative drugs are expected to drive market value growth[1].

R&D Spending and Regulatory Approvals

High R&D spending and robust approvals in regions like the US support the entry of innovative drugs, fostering market growth. The US is expected to post a CAGR of 7-8% from 2022 to 2027, although major patent expiries and generic/biosimilar competition will impact growth[1].

Financial Ecosystem of Pharmaceutical R&D

The development and launch of drugs like Evoclin are influenced by the financial ecosystem of pharmaceutical R&D. Here are some key points:

Expected Financial Return

A drug’s expected financial return determines whether it is developed up to launch. This return is driven by factors such as commercial potential, investment cost, availability of capital, and the potential for scientific and medical advancement[3].

Investment and Funding

Early research is often funded by public-sector and not-for-profit organizations, while private investment, particularly from venture capital (VC), is crucial for overcoming the ‘translation gap’ and bringing a drug to market. Big biopharma plays a significant role in financing late-stage clinical development phases[3].

Market Dynamics for Evoclin

Competitive Landscape

Evoclin operates in a competitive landscape where market share is influenced by factors such as efficacy, convenience of dosing, and patient access. For example, in the treatment of Spinal Muscular Atrophy (SMA), new entrants with better long-term efficacy and convenience are gaining market traction against established treatments[4].

Pricing and Reimbursement

The pricing and reimbursement landscape is critical. Governments and private insurance companies’ willingness to pay for new drugs significantly influences the supply and distribution of novel drugs. Affordability issues can pressure the willingness to pay, affecting the development and launch of drugs[3].

Financial Trajectory

Revenue Growth

While specific financial data for Evoclin is not provided in the sources, we can draw parallels from similar pharmaceutical products. For instance, Evolus, a company in the aesthetics market, has shown significant revenue growth driven by strong customer adoption and market share gains. Evolus aims to reach $700 million in revenue by 2028, with a CAGR of 28%[5].

Operating Expenses and Profitability

Companies in the pharmaceutical sector often manage their financial trajectory by focusing on operating expenses and aiming for profitability. Evolus, for example, has demonstrated disciplined operating expense management and is on track to achieve profitability in 2025. Similar strategies could be applied to the financial management of Evoclin[5].

Key Factors Influencing Evoclin’s Market Performance

Regulatory Environment

Regulatory approvals and compliance are crucial for the launch and continued market presence of Evoclin. Changes in regulatory environments can significantly impact the drug’s market performance.

Market Access

Market access, influenced by pricing, reimbursement policies, and healthcare reforms, is vital for the drug’s success. Governments implementing measures to control rising pharmaceutical expenditure can affect the drug’s market growth[1].

Patient Needs and Preferences

The unmet needs of patients and their preferences for treatment options play a significant role. For instance, the convenience of dosing helped Evrysdi, a treatment for SMA, gain quick market traction[4].

Future Outlook

Growth Projections

The future outlook for Evoclin would depend on its ability to navigate the competitive landscape, secure favorable pricing and reimbursement, and meet patient needs effectively. Given the broader pharmaceutical market trends, innovative drugs with strong commercial potential are likely to drive growth.

Challenges and Opportunities

Challenges such as major patent expiries and subsequent generic/biosimilar competition, as well as affordability issues, need to be addressed. However, opportunities in emerging therapeutic areas and the growing demand for innovative treatments present a positive outlook for drugs like Evoclin.

Key Takeaways

• Innovative Products: The launch of innovative new products drives market growth in the pharmaceutical sector.
• Financial Ecosystem: The expected financial return, investment, and funding are critical for drug development and launch.
• Competitive Landscape: Market share is influenced by efficacy, convenience, and patient access.
• Regulatory Environment: Regulatory approvals and compliance are essential for market presence.
• Market Access: Pricing, reimbursement policies, and healthcare reforms impact market growth.
• Patient Needs: Unmet patient needs and preferences drive market success.

FAQs

Q: What drives the growth of the pharmaceutical market? A: The launch of innovative new products, high R&D spending, and robust approvals are significant drivers of market growth.

Q: How does the financial ecosystem influence drug development? A: The expected financial return, investment cost, availability of capital, and potential for scientific and medical advancement determine whether a drug is developed up to launch.

Q: What are the key factors influencing a drug's market performance? A: Regulatory environment, market access, patient needs, and competitive landscape are crucial factors.

Q: How do pricing and reimbursement policies affect the pharmaceutical market? A: Governments and private insurance companies’ willingness to pay for new drugs significantly influences the supply and distribution of novel drugs.

Q: What are the challenges and opportunities for drugs like Evoclin in the future? A: Challenges include patent expiries and affordability issues, while opportunities lie in emerging therapeutic areas and growing demand for innovative treatments.

Sources

1. IQVIA Quarterly Pharmaceutical Market Outlook - November 2023
2. Evolus Investor Presentation - June 2023
3. The Financial Ecosystem of Pharmaceutical R&D - RAND
4. Outclassed: The Battle for Therapeutic Market Share
5. Earnings call: Evolus reports record growth, targets $700M by 2028