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TUXARIN ER Drug Patent Profile

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

Tuxarin Er is a drug marketed by Mainpointe and is included in one NDA. There are two patents protecting this drug.

The generic ingredient in TUXARIN ER is chlorpheniramine maleate; codeine phosphate. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the chlorpheniramine maleate; codeine phosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Tuxarin Er

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 3, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TUXARIN ER

US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
DailyMed Link:	TUXARIN ER at DailyMed

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

NDA:

206323

Dosage:

TABLET, EXTENDED RELEASE;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.

Pharmacology for TUXARIN ER

Drug Class	Histamine-1 Receptor Antagonist Opioid Agonist
Mechanism of Action	Full Opioid Agonists Histamine H1 Receptor Antagonists

US Patents and Regulatory Information for TUXARIN ER

TUXARIN ER is protected by two 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
Mainpointe	TUXARIN ER	chlorpheniramine maleate; codeine phosphate	TABLET, EXTENDED RELEASE;ORAL	206323-001	Jun 22, 2015		RX	No	No
Mainpointe	TUXARIN ER	chlorpheniramine maleate; codeine phosphate	TABLET, EXTENDED RELEASE;ORAL	206323-001	Jun 22, 2015		RX	No	No			Y

Expired US Patents for TUXARIN ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mainpointe	TUXARIN ER	chlorpheniramine maleate; codeine phosphate	TABLET, EXTENDED RELEASE;ORAL	206323-001	Jun 22, 2015
Mainpointe	TUXARIN ER	chlorpheniramine maleate; codeine phosphate	TABLET, EXTENDED RELEASE;ORAL	206323-001	Jun 22, 2015

International Patents for TUXARIN ER

See the table below for patents covering TUXARIN ER around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	03068186
Canada	2365536	COMPOSITIONS ET PROCEDES POUR L'ADMINISTRATION AMELIOREE D'AGENTS THERAPEUTIQUES HYDROPHOBES (COMPOSITIONS AND METHODS FOR IMPROVED DELIVERY OF HYDROPHOBIC THERAPEUTIC AGENTS)
Australia	2002243387
Canada	2526616	COMPOSITIONS PHARMACEUTIQUES ET FORMES POSOLOGIQUES POUR L'ADMINISTRATION DE MEDICAMENTS HYDROPHOBES (PHARMACEUTICAL COMPOSITIONS AND DOSAGE FORMS FOR ADMINISTRATION OF HYDROPHOBIC DRUGS)

TUXARIN ER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TUXARIN ER

Introduction

TUXARIN ER, a Schedule III controlled prescription drug, contains codeine phosphate and chlorpheniramine maleate, and is used for the treatment of cough and other respiratory symptoms. Understanding the market dynamics and financial trajectory of TUXARIN ER involves analyzing various factors, including prescription trends, regulatory impacts, and competitive market forces.

Prescription Trends and Patient Demographics

Overall Prescription Trends

The prescription landscape for controlled substances, including TUXARIN ER, has seen significant changes over the past decade. For instance, the COVID-19 pandemic had a profound impact on prescription dispensations. There was a steep decline in the number of prescriptions dispensed immediately after the U.S. began to recommend COVID-19 restrictions, but by October 2020, dispensing rebounded to pre-pandemic levels and subsequently saw a high year-over-year increase between 2021 and 2022[1][4].

Patient Demographics

Patient demographics play a crucial role in understanding the market for TUXARIN ER. The number of prescriptions for stimulants and other controlled substances has increased across various age groups, with notable increases among the 31-40 and 71-80 age groups. However, TUXARIN ER, being a cough medication, may have different demographic trends. Generally, cough medications are prescribed across a wide age range, but the elderly and pediatric populations are particularly vulnerable to respiratory issues and may be key demographics for TUXARIN ER[4].

Regulatory Environment

Controlled Substance Regulations

TUXARIN ER, as a Schedule III controlled substance, is subject to strict regulations. The DEA and FDA impose various restrictions on the prescribing and dispensing of such drugs to mitigate abuse and dependency risks. For example, the concomitant use of opioids, including codeine in TUXARIN ER, with benzodiazepines or other CNS depressants is contraindicated due to the risk of profound sedation and respiratory depression[5].

Impact of Regulatory Changes

Regulatory changes can significantly impact the market dynamics of controlled substances. Stricter regulations on refills and co-prescribing with other controlled substances can influence prescriber behavior. For instance, the proportion of stimulant prescriptions with a co-prescription of an opioid medication decreased from 17% in 2012 to 7% in 2022, indicating a shift in prescribing practices due to regulatory pressures[1].

Financial Trajectory

Revenue and Sales

The financial trajectory of TUXARIN ER is influenced by several factors, including prescription volumes, pricing strategies, and competition. While specific financial data for TUXARIN ER is not provided, the overall trend in the prescription drug market suggests that controlled substances continue to generate significant revenue. The increase in prescription volumes for controlled substances, despite regulatory challenges, indicates a stable to growing revenue stream for such medications[1][4].

Pricing and Cost Considerations

Pricing regulations and cost considerations are critical in the pharmaceutical market. In regulated markets, price constraints can affect the profitability of pharmaceutical companies. For example, in France, price regulation led to modest savings and increased consumer surplus, but it also shifted consumption towards branded drugs at the expense of generics[3].

Telemedicine and Access

The COVID-19 pandemic accelerated the use of telemedicine, which has had a lasting impact on how prescriptions are managed. For TUXARIN ER, the increased use of telemedicine could enhance access to the medication, particularly for patients in remote or underserved areas. However, this also introduces new challenges in terms of monitoring and managing potential abuse[1][4].

Competitive Landscape

Market Competition

The market for cough medications is competitive, with various branded and generic options available. TUXARIN ER competes with other codeine-based and non-codeine-based cough medications. The preference for branded drugs over generics, as seen in other markets, could influence the market share of TUXARIN ER. However, the unique formulation and therapeutic benefits of TUXARIN ER could help it maintain a competitive edge[3].

Brand Loyalty and Physician Preferences

Physician preferences and brand loyalty are significant factors in the pharmaceutical market. Psychiatrists and pediatricians are among the top prescribers of controlled substances, and their preferences can drive market trends. For TUXARIN ER, building strong relationships with healthcare providers and demonstrating clinical efficacy can be crucial in maintaining market share[4].

Impact of External Factors

Economic and Social Factors

Economic and social factors, such as healthcare policy changes and public health crises, can significantly impact the market for TUXARIN ER. For instance, the COVID-19 pandemic highlighted the importance of telemedicine and remote healthcare services, which could continue to shape the prescription drug market in the future[1][4].

Technological Advancements

Technological advancements in healthcare, including electronic health records and prescription management systems, can streamline the prescribing and dispensing process for TUXARIN ER. These advancements can improve patient compliance and reduce the risk of abuse by enhancing monitoring capabilities[1].

Key Takeaways

• Regulatory Compliance: TUXARIN ER must navigate strict regulations as a Schedule III controlled substance.
• Prescription Trends: The COVID-19 pandemic and telemedicine have significantly impacted prescription dispensations.
• Patient Demographics: Understanding the demographics of patients prescribed TUXARIN ER is crucial for marketing and sales strategies.
• Financial Trajectory: Revenue is influenced by prescription volumes, pricing strategies, and competition.
• Competitive Landscape: TUXARIN ER competes in a crowded market with both branded and generic options.
• External Factors: Economic, social, and technological factors can shape the market dynamics.

FAQs

What are the key ingredients in TUXARIN ER?

TUXARIN ER contains codeine phosphate and chlorpheniramine maleate.

What are the primary uses of TUXARIN ER?

TUXARIN ER is used for the treatment of cough and other respiratory symptoms.

What are the risks associated with TUXARIN ER?

TUXARIN ER carries risks such as respiratory depression, drug dependence, and interactions with other CNS depressants.

How has the COVID-19 pandemic affected the prescription of TUXARIN ER?

The pandemic led to a temporary decline in prescriptions but saw a rebound and subsequent increase in dispensations by the end of 2020.

What role does telemedicine play in the prescription and management of TUXARIN ER?

Telemedicine has increased access to TUXARIN ER, especially during the pandemic, but also introduces challenges in monitoring and managing potential abuse.

Sources

1. IQVIA Report on Stimulant Trends from 2012 - 2022. U.S. Department of Justice, Drug Enforcement Administration.
2. Competitive Effects of Federal and State Opioid Restrictions. National Bureau of Economic Research.
3. Identifying Industry Margins with Price Constraints: Structural Estimation on Pharmaceuticals. Toulouse School of Economics.
4. IQVIA Report on Stimulant Trends from 2012 - 2021. U.S. Department of Justice, Drug Enforcement Administration.
5. TUXARIN ER Label. U.S. Food and Drug Administration.