DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE Drug Patent Profile

Which patents cover Dextromethorphan Hydrobromide And Quinidine Sulfate, and when can generic versions of Dextromethorphan Hydrobromide And Quinidine Sulfate launch?

Dextromethorphan Hydrobromide And Quinidine Sulfate is a drug marketed by Actavis Elizabeth and Hetero Labs Ltd Iii and is included in two NDAs.

The generic ingredient in DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE is dextromethorphan hydrobromide; quinidine sulfate. There are twenty-three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; quinidine sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dextromethorphan Hydrobromide And Quinidine Sulfate

A generic version of DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE was approved as dextromethorphan hydrobromide; quinidine sulfate by ACTAVIS ELIZABETH on October 10^th, 2017.

Summary for DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	11
Patent Applications:	57
DailyMed Link:	DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE at DailyMed

Recent Clinical Trials for DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

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

Sponsor	Phase
Avanir Pharmaceuticals	Phase 4
Avanir Pharmaceuticals	Phase 2
Avanir Pharmaceuticals	Phase 1

See all DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE clinical trials

Pharmacology for DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

Drug Class	Antiarrhythmic Cytochrome P450 2D6 Inhibitor Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists

US Patents and Regulatory Information for DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Elizabeth	DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	202934-001	Oct 10, 2017	AB	RX	No	No
Hetero Labs Ltd Iii	DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	218426-001	Aug 28, 2024	AB	RX	No	No

EU/EMA Drug Approvals for DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Jenson Pharmaceutical Services Limited	Nuedexta	dextromethorphan hydrobromide, quinidine sulfate	EMEA/H/C/002560 Nuedexta is indicated for the symptomatic treatment of pseudobulbar affect (PBA) in adults. Efficacy has only been studied in patients with underlying amyotrophic lateral sclerosis or multiple sclerosis.	Withdrawn	no	no	no	2013-06-24

Market Dynamics and Financial Trajectory for Dextromethorphan Hydrobromide and Quinidine Sulfate (Nuedexta)

Introduction

Dextromethorphan hydrobromide and quinidine sulfate, marketed as Nuedexta, is a unique combination drug approved by the FDA for the treatment of pseudobulbar affect (PBA), a condition characterized by sudden, uncontrollable episodes of laughing or crying. Here, we delve into the market dynamics and financial trajectory of this drug.

Approval and Launch

Nuedexta was launched in the US in February 2011 by Avanir Pharmaceuticals, marking it as the world’s first and only approved treatment for PBA[2][4].

Clinical Efficacy

The drug's efficacy was established through the STAR trial, a double-blind, placebo-controlled study. This trial demonstrated that the combination of dextromethorphan (20 mg or 30 mg) and quinidine (10 mg) significantly reduced the frequency of PBA episodes compared to placebo. Patients in the dextromethorphan/quinidine 20 mg/10 mg group reported an 82% reduction in mean weekly episode frequency from baseline, compared to a 47% reduction in the placebo group[1].

Market Performance

Since its launch, Nuedexta has shown significant growth. In the twelve-month period from July 2013 to June 2014, sales of Nuedexta reached $94 million, representing a 50% increase over the prior year. This growth was driven by Avanir's robust sales organization and the drug's unique position in the market[2].

Acquisition and Market Expansion

In December 2014, Otsuka Pharmaceutical acquired Avanir Pharmaceuticals, further expanding Nuedexta's reach. This acquisition brought three distinct values to Otsuka: the established market presence of Nuedexta, a strong sales organization, and a promising pipeline of CNS indications[2].

Financial Trajectory

The financial performance of Nuedexta has been robust. The drug's sales have consistently increased, driven by its unique market position and the lack of alternative treatments for PBA. The acquisition by Otsuka has also contributed to its financial stability and growth potential.

Market Exclusivity

Avanir Pharmaceuticals successfully defended its patent for Nuedexta in an appeal, securing market exclusivity until 2026. This exclusivity has been crucial in maintaining the drug's market share and financial performance[4].

Competitive Landscape

Nuedexta remains the only FDA-approved product for the treatment of PBA, giving it a significant competitive advantage. However, the broader dextromethorphan market is competitive, with several major pharmaceutical companies such as AstraZeneca, Aurobindo Pharma, Glenmark Pharmaceuticals Ltd., Pfizer, and Sun Pharmaceutical operating in the space[3].

Regional Market Dynamics

The dextromethorphan market, including Nuedexta, is expected to see significant growth in regions like North America and the Asia Pacific. North America is anticipated to be a major market due to the high incidence of flu and cold cases, particularly among the geriatric population. The Asia Pacific region is also expected to grow, driven by increasing cases of coughs and colds and a shift towards self-medication[3].

Challenges and Opportunities

Despite its success, Nuedexta faces challenges such as potential side effects associated with dextromethorphan and quinidine. However, the ongoing innovation in formulations and the exploration of new indications, such as agitation associated with Alzheimer’s disease, present opportunities for further market expansion[1][3].

Pharmacoeconomic Impact

The economic impact of Nuedexta is significant, particularly given its unique position in the market. However, there is a lack of published pharmacoeconomic models for Nuedexta, making it challenging to compare its economic benefits directly with other treatments. The STAR trial provided robust data but did not include head-to-head comparisons with traditional agents, which would be necessary for a comprehensive pharmacoeconomic analysis[1].

Conclusion

Nuedexta has established itself as a critical treatment for pseudobulbar affect, with a strong market presence and financial trajectory. Its unique combination of dextromethorphan and quinidine, along with its market exclusivity until 2026, ensures continued growth. However, the broader dextromethorphan market faces challenges from side effects and competition, which need to be addressed to sustain long-term growth.

Key Takeaways

• Unique Market Position: Nuedexta is the only FDA-approved treatment for pseudobulbar affect.
• Clinical Efficacy: Significant reduction in PBA episodes demonstrated in the STAR trial.
• Financial Performance: Robust sales growth, with $94 million in sales from July 2013 to June 2014.
• Market Exclusivity: Secured until 2026, ensuring continued market dominance.
• Regional Growth: North America and Asia Pacific are key growth regions.
• Challenges and Opportunities: Side effects and new indications present both challenges and opportunities.

FAQs

What is Nuedexta used for?

Nuedexta is used for the treatment of pseudobulbar affect (PBA), a condition characterized by sudden, uncontrollable episodes of laughing or crying.

When was Nuedexta launched?

Nuedexta was launched in the US in February 2011 by Avanir Pharmaceuticals.

What is the unique mechanism of Nuedexta?

Nuedexta combines dextromethorphan hydrobromide and quinidine sulfate. Quinidine inhibits the rapid metabolism of dextromethorphan, increasing its bioavailability and therapeutic effect.

Who acquired Avanir Pharmaceuticals?

Otsuka Pharmaceutical acquired Avanir Pharmaceuticals in December 2014.

What is the market exclusivity period for Nuedexta?

Nuedexta has market exclusivity until 2026, following a successful patent appeal by Avanir Pharmaceuticals.

Sources

1. Dextromethorphan Hydrobromide and Quinidine Sulfate (Nuedexta) Drug Monograph. PBM.VA.GOV.
2. OTSUKA PHARMACEUTICAL TO ACQUIRE AVANIR. OTSUKA.CO.JP.
3. Dextromethorphan Market Size. Mordor Intelligence.
4. AVANIR Pharmaceuticals Prevails In NUEDEXTA Patent Appeal. BioSpace.
5. 021879Orig1s000 - accessdata.fda.gov. FDA.GOV.