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DORAL Drug Patent Profile

When do Doral patents expire, and when can generic versions of Doral launch?

Doral is a drug marketed by Galt Pharms and is included in one NDA. There is one patent protecting this drug.

The generic ingredient in DORAL is quazepam. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the quazepam profile page.

DrugPatentWatch^® Generic Entry Outlook for Doral

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 3, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DORAL

US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Patent Applications:	3,599
What excipients (inactive ingredients) are in DORAL?	DORAL excipients list
DailyMed Link:	DORAL at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DORAL

NDA:

018708

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for DORAL

DORAL is protected by one US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-003	Feb 26, 1987		DISCN	No	No
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-001	Dec 27, 1985		RX	Yes	Yes

Expired US Patents for DORAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-001	Dec 27, 1985
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-003	Feb 26, 1987
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-001	Dec 27, 1985
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-001	Dec 27, 1985

International Patents for DORAL

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

Country	Patent Number	Title	Estimated Expiration
Spain	505951
Germany	2734070
Japan	H0443070
Yugoslavia	40088

DORAL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: DORAL

Introduction

DORAL, a brand name for the drug quazepam, is a benzodiazepine used primarily for the treatment of insomnia. To understand the market dynamics and financial trajectory of DORAL, it is essential to delve into various aspects of the pharmaceutical industry, including market trends, competitive landscape, and financial performance.

Market Overview

The pharmaceutical market, particularly for sleep aids and benzodiazepines, is influenced by several factors including regulatory environments, patient needs, and technological advancements.

Regulatory Environment

Regulatory changes and approvals significantly impact the market dynamics of pharmaceuticals. For instance, the FDA's stringent guidelines on the use of benzodiazepines due to their potential for abuse and dependence can affect the sales and prescription rates of drugs like DORAL[4].

Patient Needs and Preferences

The increasing awareness of sleep disorders and the need for effective treatments drive the demand for sleep aids. However, the preference for non-benzodiazepine alternatives due to their lower risk of dependency also influences the market share of DORAL.

Competitive Landscape

The sleep aid market is highly competitive, with various drugs and formulations available.

Competing Drugs

Drugs like zolpidem (Ambien) and eszopiclone (Lunesta) are prominent competitors in the sleep aid market. These drugs often have different mechanisms of action and side effect profiles, which can affect their market share relative to DORAL[3].

Formulation Advancements

Advancements in drug delivery, such as the development of subcutaneous and intravenous formulations, can also impact the competitive landscape. However, DORAL, being an oral medication, may face competition from drugs with more convenient or less invasive administration methods[1].

Financial Performance

The financial trajectory of DORAL can be analyzed through various financial metrics and industry trends.

Sales and Revenue

Historical data on DORAL's sales and revenue can provide insights into its market performance. However, specific financial data for DORAL is not readily available in the provided sources. Generally, the revenue of sleep aid medications can fluctuate based on prescription rates, competition, and regulatory changes.

Cost and Operating Expenses

The cost of sales, research and development expenses, and selling, general, and administrative expenses are crucial in determining the profitability of a drug. For example, the financial reports of other pharmaceutical companies show that R&D expenses and SG&A costs can significantly impact net income[2].

Case Study: Similar Pharmaceutical Financial Analysis

While specific financial data for DORAL is not available, analyzing the financial performance of similar pharmaceutical companies can provide valuable insights.

Questcor Pharmaceuticals

Questcor Pharmaceuticals, which produced H.P. Acthar Gel, saw significant increases in net sales driven by expanded usage in multiple therapeutic areas. This example illustrates how targeted marketing and expanded therapeutic uses can drive revenue growth[5].

Market Trends and Projections

The overall pharmaceutical market, including the segment for sleep aids, is subject to various trends and projections.

Generic Drug Market

The generic drug market, which could impact branded drugs like DORAL, is expected to grow due to patent expirations and increasing demand for affordable medications. This growth can lead to increased competition and potentially lower prices for branded drugs[4].

Injectable Drug Delivery Market

Although DORAL is an oral medication, the broader trend in the injectable drug delivery market indicates a shift towards more advanced and patient-friendly delivery methods. This trend could influence the development of future sleep aid medications[1].

Challenges and Opportunities

Several challenges and opportunities arise in the context of DORAL's market dynamics and financial trajectory.

Challenges

• Regulatory Scrutiny: Benzodiazepines face strict regulatory oversight due to their potential for abuse and dependency.
• Competition: The sleep aid market is highly competitive, with numerous alternatives available.
• Patient Safety: Ensuring patient safety while maintaining efficacy is a continuous challenge.

Opportunities

• Expanding Therapeutic Uses: Identifying new therapeutic uses for DORAL could expand its market.
• Marketing and Education: Targeted marketing and educational campaigns can increase prescription rates.
• Formulation Improvements: Developing new formulations or delivery methods could enhance patient compliance and comfort.

Key Takeaways

• The market dynamics for DORAL are influenced by regulatory environments, patient needs, and competitive landscapes.
• Financial performance is impacted by sales, operating expenses, and market trends.
• Understanding broader pharmaceutical trends, such as the growth of generic drugs and advancements in drug delivery, is crucial for strategic planning.
• Identifying new therapeutic uses and improving formulations can present opportunities for growth.

Frequently Asked Questions (FAQs)

1. What is DORAL used for? DORAL, or quazepam, is primarily used for the treatment of insomnia.

2. How does the regulatory environment affect DORAL? The FDA's stringent guidelines on benzodiazepines due to their potential for abuse and dependency can impact the sales and prescription rates of DORAL.

3. What are the main competitors of DORAL in the sleep aid market? Competitors include zolpidem (Ambien) and eszopiclone (Lunesta), among others.

4. How do advancements in drug delivery impact DORAL? Advancements in injectable and subcutaneous drug delivery methods can influence patient preferences and compliance, potentially affecting the market share of oral medications like DORAL.

5. What are the key financial metrics to consider for DORAL's financial trajectory? Key metrics include sales revenue, cost of sales, research and development expenses, and selling, general, and administrative expenses.

Sources:

1. Injectable Drug Delivery Market Size to Hit USD 1,630.73 Bn by 2033 - Biospace
2. Blueprint Medicines Reports Second Quarter 2024 Results and ... - Blueprint Medicines
3. Financial Analysis of Competitive Drugs with PharmaKB - Pharmaceutical KnowledgeBase
4. Generics 2030 - KPMG International
5. QUESTCOR PHARMACEUTICALS, INC. - Investor Relations