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Last Updated: December 22, 2024

SYNALAR Drug Patent Profile


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Which patents cover Synalar, and when can generic versions of Synalar launch?

Synalar is a drug marketed by Medimetriks Pharms and is included in four NDAs.

The generic ingredient in SYNALAR is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Synalar

A generic version of SYNALAR was approved as fluocinolone acetonide by TARO on April 27th, 1982.

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Summary for SYNALAR
Drug patent expirations by year for SYNALAR
Drug Prices for SYNALAR

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Recent Clinical Trials for SYNALAR

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

SponsorPhase
Noah Rosenberg, MDPhase 4
LEO PharmaPhase 1

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Pharmacology for SYNALAR

US Patents and Regulatory Information for SYNALAR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Medimetriks Pharms SYNALAR fluocinolone acetonide CREAM;TOPICAL 012787-004 Approved Prior to Jan 1, 1982 AT RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Medimetriks Pharms SYNALAR fluocinolone acetonide OINTMENT;TOPICAL 013960-001 Approved Prior to Jan 1, 1982 AT RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Medimetriks Pharms SYNALAR fluocinolone acetonide CREAM;TOPICAL 012787-002 Approved Prior to Jan 1, 1982 AT RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Medimetriks Pharms SYNALAR fluocinolone acetonide CREAM;TOPICAL 012787-005 Approved Prior to Jan 1, 1982 AT RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Medimetriks Pharms SYNALAR-HP fluocinolone acetonide CREAM;TOPICAL 016161-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Medimetriks Pharms SYNALAR fluocinolone acetonide SOLUTION;TOPICAL 015296-001 Approved Prior to Jan 1, 1982 AT RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

SYNALAR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SYNALAR

Introduction

SYNALAR, a topical steroid containing fluocinolone acetonide, is used to treat a variety of inflammatory, pruritic, and allergic skin disorders. To understand its market dynamics and financial trajectory, we need to delve into several key areas, including market trends, competition, regulatory environment, and the broader pharmaceutical industry context.

Pharmaceutical Market Overview

The global pharmaceutical market is projected to reach $1.15 trillion by 2024 and exceed $1.4 trillion by 2028, driven by the increasing global burden of chronic diseases[3].

SYNALAR's Therapeutic Area

SYNALAR falls under the dermatology segment, which is a significant part of the pharmaceutical market. Dermatological conditions are prevalent, and the demand for effective treatments is high. The market for dermatological drugs is growing, with a focus on innovative and effective treatments for skin conditions.

Market Share and Competition

In the dermatology segment, SYNALAR competes with other topical corticosteroids. The market is dominated by both multinational corporations (MNCs) and local/regional companies. For instance, in the Middle East and Africa (MEA) region, MNCs account for 63% of the market share, but local companies are growing faster, taking away market share from MNCs[1].

Key Competitors

  • Generic and Branded Competitors: SYNALAR faces competition from both generic and branded versions of fluocinolone acetonide. Generic competitors can significantly impact the market share and pricing of branded products.
  • Other Topical Steroids: Other potent topical corticosteroids, such as those from companies like Novartis and GSK, also compete in the same therapeutic area.

Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of any pharmaceutical product. SYNALAR, as a well-established drug, has extensive clinical experience and is regulated under standard pharmaceutical guidelines.

Approval and Exclusivity

  • SYNALAR has been on the market for a long time, which means it has lost its patent exclusivity. This allows generic versions to enter the market, potentially reducing the sales of the branded product.
  • Regulatory hurdles, such as stricter safety and efficacy standards, can impact the development and marketing of new formulations or indications for SYNALAR[3].

Financial Performance

The financial performance of SYNALAR can be influenced by several factors:

Sales and Revenue

  • As a mature product, SYNALAR's sales are likely stable but may face decline due to generic competition. The MEA pharmaceutical market, for example, saw significant growth in retail channels, but established products like SYNALAR might experience slower growth rates compared to newer entrants[1].

Cost of Production and Distribution

  • The cost of producing and distributing SYNALAR affects its profitability. Factors such as raw material costs, manufacturing efficiency, and distribution channels can impact the bottom line.

Pricing Strategies

  • Pricing is a critical factor in the pharmaceutical industry. SYNALAR's pricing strategy must balance profitability with market competition and regulatory pressures. In regions like the MEA, where local companies are growing rapidly, pricing strategies need to be competitive to maintain market share[1].

Investment Trends in Pharmaceutical R&D

The overall investment trends in pharmaceutical R&D can influence the financial trajectory of SYNALAR and similar products.

Declining ROI in R&D

  • The return on investment (ROI) for pharmaceutical R&D has been declining, raising concerns about the sustainability of current R&D models. This decline is partly due to increasing regulatory hurdles and shorter exclusivity periods[3].

Focus on High-Growth Areas

  • Pharmaceutical companies are increasingly focusing on high-growth areas such as oncology, diabetes, and cardiovascular diseases. While SYNALAR is not in these high-growth areas, its stability and established market position can still contribute to the overall financial health of the company[3].

Market Dynamics in Key Regions

The performance of SYNALAR can vary significantly across different regions due to local market dynamics.

Middle East and Africa (MEA)

  • In the MEA region, the pharmaceutical market is growing rapidly, with countries like Saudi Arabia, Egypt, and the UAE showing significant growth. However, the retail channel, which is dominant in these markets, saw varying growth rates, and institutional channels grew faster in some countries[1].

Other Regions

  • In other regions, such as Europe and North America, the market dynamics might be different due to varying regulatory environments, reimbursement policies, and competitive landscapes.

Consumer and Prescriber Preferences

Consumer and prescriber preferences play a crucial role in the market dynamics of SYNALAR.

Brand Loyalty

  • SYNALAR benefits from its long history and established brand reputation, which can lead to brand loyalty among both prescribers and consumers.

Generic Preference

  • However, the increasing acceptance and preference for generic drugs can erode the market share of branded products like SYNALAR.

Future Outlook

The future outlook for SYNALAR is influenced by several factors:

Innovation and New Indications

  • To maintain its market position, SYNALAR could benefit from new formulations, indications, or delivery systems. However, the high cost and risk associated with R&D make this a challenging strategy[3].

Market Expansion

  • Expanding into new markets, especially in regions with growing healthcare needs, could provide new revenue streams for SYNALAR.

Competitive Strategies

  • Competitive strategies such as pricing adjustments, marketing campaigns, and partnerships with healthcare providers can help SYNALAR maintain its market share.

Key Takeaways

  • SYNALAR operates in a competitive dermatology market with significant generic competition.
  • The product's financial trajectory is influenced by regulatory environments, market dynamics in various regions, and overall trends in pharmaceutical R&D.
  • To maintain its market position, SYNALAR needs to balance pricing strategies, invest in new formulations or indications, and expand into new markets.

FAQs

What is SYNALAR used for?

SYNALAR is used to treat a variety of inflammatory, pruritic, and allergic skin disorders.

How does SYNALAR compete in the market?

SYNALAR competes with other topical corticosteroids, both generic and branded, and faces competition from local and multinational pharmaceutical companies.

What are the key factors affecting SYNALAR's financial performance?

Key factors include sales and revenue, cost of production and distribution, pricing strategies, and the overall investment trends in pharmaceutical R&D.

How does the regulatory environment impact SYNALAR?

The regulatory environment affects SYNALAR through patent exclusivity, safety and efficacy standards, and approval processes, which can influence its market share and profitability.

What is the future outlook for SYNALAR?

The future outlook for SYNALAR depends on innovation, market expansion, and competitive strategies to maintain its market position in a competitive and evolving pharmaceutical landscape.

Sources

  1. Middle East & Africa Pharmaceutical Market Insights Report - IQVIA
  2. Quarterly Results | Synaptics Incorporated - Investor Relations (Not relevant to the topic)
  3. Investment Trends in Pharmaceutical Research and Development - DrugBank Blog
  4. SYNALAR (Fluocinolone Acetonide 0.025%) Cream 30g - Medicines.org.uk

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