Dextromethorphan hydrobromide; quinidine sulfate - Generic Drug Details

What are the generic drug sources for dextromethorphan hydrobromide; quinidine sulfate and what is the scope of freedom to operate?

Dextromethorphan hydrobromide; quinidine sulfate is the generic ingredient in two branded drugs marketed by Actavis Elizabeth, Hetero Labs Ltd Iii, and Avanir Pharms, and is included in three NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dextromethorphan hydrobromide; quinidine sulfate has seventy-five patent family members in twenty-one countries.

Two suppliers are listed for this compound.

Summary for dextromethorphan hydrobromide; quinidine sulfate

International Patents:	75
US Patents:	1
Tradenames:	2
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	2
Clinical Trials:	11
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dextromethorphan hydrobromide; quinidine sulfate
DailyMed Link:	dextromethorphan hydrobromide; quinidine sulfate at DailyMed

Recent Clinical Trials for dextromethorphan hydrobromide; 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; quinidine sulfate clinical trials

Pharmacology for dextromethorphan hydrobromide; 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

Anatomical Therapeutic Chemical (ATC) Classes for dextromethorphan hydrobromide; quinidine sulfate

C01BA	Antiarrhythmics, class Ia
C01B	ANTIARRHYTHMICS, CLASS I AND III
C01	CARDIAC THERAPY
C	Cardiovascular system

R05DA	Opium alkaloids and derivatives
R05D	COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

Paragraph IV (Patent) Challenges for DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NUEDEXTA	Capsules	dextromethorphan hydrobromide; quinidine sulfate	20 mg/10 mg	021879	1	2011-03-07

US Patents and Regulatory Information for dextromethorphan hydrobromide; 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
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010	AB	RX	Yes	Yes	7,659,282
Hetero Labs Ltd Iii	DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	218426-001	Aug 28, 2024	AB	RX	No	No

Expired US Patents for dextromethorphan hydrobromide; quinidine sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010	5,166,207
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010	RE38115
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010	8,227,484
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010	5,206,248

EU/EMA Drug Approvals for dextromethorphan hydrobromide; 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

International Patents for dextromethorphan hydrobromide; quinidine sulfate

Country	Patent Number	Title	Estimated Expiration
Australia	2019200415	Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders
Luxembourg	92323
South Korea	20110010669	PHARMACEUTICAL COMPOSITION COMPRISING DEXTROMETHORPHAN AND QUINIDINE FOR THE TREATMENT OF NEUROLOGICAL DISORDERS
South Korea	20160055963	덱스트로메토르판 및 퀴니딘을 포함하는 신경계 장애의 치료를 위한 약학적 조성물 (PHARMACEUTICAL COMPOSITION COMPRISING DEXTROMETHORPHAN AND QUINIDINE FOR THE TREATMENT OF NEUROLOGICAL DISORDERS)
Denmark	1539166
Australia	2017202884	Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders

Supplementary Protection Certificates for dextromethorphan hydrobromide; quinidine sulfate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1539166	132013902215214	Italy		PRODUCT NAME: ASSOCIAZIONE DI (A) DESTROMETORFANO O UN SUO SALE, PRECURSORE O DERIVATO FARMACEUTICAMENTE ACCETTABILE, INCLUSO IL DESTROMETORFANO BROMIDRATO E IN PARTICOLARE IL DESTROMETORFANO BROMIDRATO MONOIDRATO E (B) CHINIDINA O UN SUO SALE,PRECURSORE O DERIVATO FARMACEUTICAMENTE ACCETTABILE, INCLUSA LA CHINIDINA SOLFATO E IN PARTICOLARE LA CHINIDINA SOLFATO DIIDRATO(NUEDEXTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/833, 20130626
1539166	C 2013 034	Romania		PRODUCT NAME: COMBINATIE A DEXTROMETORFANULUI SAU A UNEI SARIACCEPTABILE FARMACEUTIC, DE EXEMPLU DEXNATIONAL AUTHORISATION NUMBER: EU/1/13/833/001, EU/1/13/833/002, EU/1/13/833/003; DATE OF NATIONAL AUTHORISATION: 20130624; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/833/001, EU/1/13/833/002, EU/1/13/833/003; DATE OF FIRST AUTHORISATION IN EEA: 20130624 TROMETORFAN BROMHIDRAT SI PARTICULAR DEXTROMETORFAN BROMHIDRATMONOHIDRAT SI CHINIDINA SAU O SARE ACCEPTABILA FARMACEUTIC, DE EXEMPLU SULFAT DE CHINIDINA SI IN PAR TICULAR SULFATDE CHINIDINA DIHIDRAT;
1539166	C20130030 00105	Estonia		PRODUCT NAME: DEKSTROMETORFAAN / KINIDIIN;REG NO/DATE: K(2013)4096 (LOPLIK) 26.06.2013
1539166	2013C/064	Belgium		PRODUCT NAME: DEXTROMETHORPHANE OU UN SEL, PRCURSEUR DE DERIVE PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRURE DE DEXTROMETORPHANE ET EN PARTICULIER LE BROMHYDRURE DE DEXTROMETROPHANE MONHYDRATE ET QUINIDINE OU UN SEL,....; AUTHORISATION NUMBER AND DATE: EU/1/13/833 20130626
1539166	92323	Luxembourg		PRODUCT NAME: LA COMBINAISON DE (A) DEXTROMETHORPHAN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, PRECURSEURS OU DERIVES , PAR EX. HYDROBROMURE DE DEXTROMETHORPHAN ET EN PARTICULIER HYDROBROMURE DE DEXTROMETHORPHAN MONOHYDRATE; ET(B) QUINIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES , PRECURSEURS OU DERIVES, PAR EX. SULFATE DE QUINIDINE ET EN PARTICULIER SULFATE DE QUINIDINE DEHYDRATE; FIRST REGISTRATION: 20130624
1539166	C300626	Netherlands		PRODUCT NAME: COMBINATIE VAN: (A) DEXTROMETHORFAN, DESGEWENST; REGISTRATION NO/DATE: EU/1/13/833 20130624

Dextromethorphan hydrobromide; quinidine sulfate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dextromethorphan Hydrobromide and Quinidine Sulfate

Introduction to Dextromethorphan Hydrobromide and Quinidine Sulfate

Dextromethorphan hydrobromide and quinidine sulfate are two pharmaceutical compounds with distinct therapeutic applications. Dextromethorphan hydrobromide is widely used as a cough suppressant, while quinidine sulfate is primarily used to treat cardiac arrhythmias. This article delves into the market dynamics and financial trajectory of these drugs, highlighting key trends, growth drivers, and future projections.

Market Size and Growth Projections for Dextromethorphan Hydrobromide

The global dextromethorphan market was valued at USD 487.25 million in 2022 and is expected to reach USD 587.31 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 4.8% during the forecast period of 2023 to 2030[1].

Geographical Distribution

• North America: This region dominates the global dextromethorphan market due to a strong base of healthcare facilities, the presence of major players, and increasing research activities[1].
• Asia-Pacific: Expected to witness significant growth due to government initiatives, rising healthcare facilities, growing research activities, and a large population pool[1].

Market Drivers for Dextromethorphan Hydrobromide

High Demand for OTC Products

Over-the-counter (OTC) products dominate the dextromethorphan market, driven by consumer preference for easy access to cough suppressants[1].

Emerging Markets

Rising disposable incomes and increasing health awareness in emerging markets are creating new opportunities for growth. Companies are strategically investing in these regions to establish a strong market presence[5].

Innovations in Formulations

Collaborations between pharmaceutical companies and research institutions are leading to the development of new formulations and delivery systems, enhancing efficacy and patient compliance[5].

Market Size and Growth Projections for Quinidine Sulfate

The quinidine sulfate market was valued at USD 100 million in 2023 and is expected to reach USD 140.7 million by 2031, growing at a CAGR of 5% from 2024 to 2031[3].

Therapeutic Importance

Quinidine sulfate is crucial in treating cardiac arrhythmias such as ventricular tachycardia and atrial fibrillation, driving its demand due to rising rates of cardiovascular disease[3].

Aging Population and Healthcare Costs

The increasing age of the population and rising healthcare costs are contributing to the growing demand for quinidine sulfate as a vital therapeutic option in cardiology[3].

Combination Therapy: Deudextromethorphan Hydrobromide and Quinidine Sulfate

A combination of deuterium-modified dextromethorphan hydrobromide and ultra-low dose quinidine sulfate has been under investigation for its therapeutic potential, particularly targeting NMDA receptors. This combination is part of advanced drug development strategies, leveraging the strengths of both compounds[4].

Financial Trajectory

Revenue Streams

• Dextromethorphan Hydrobromide: The revenue is expected to grow from USD 487.25 million in 2022 to USD 587.31 million by 2030, driven by the expanding OTC market and growing demand in emerging markets[1].
• Quinidine Sulfate: The market is projected to grow from USD 100 million in 2023 to USD 140.7 million by 2031, driven by the increasing prevalence of cardiovascular diseases and advancements in medication formulations[3].

Investment Opportunities

The market presents promising investment opportunities due to consumer demand for effective cough remedies and ongoing innovations in product formulations. Recent mergers and acquisitions in the pharmaceutical sector are also reshaping the market landscape, enabling companies to combine resources and expertise for better product development[5].

Regulatory Framework and Market Trends

Evolving Regulatory Frameworks

Changes in regulatory frameworks are affecting product availability and driving companies to adapt to new standards. This includes stricter guidelines on the use of pharmaceuticals and the need for more robust clinical trials[5].

Focus on Natural Ingredients

Consumers are increasingly seeking products with natural ingredients, prompting manufacturers to explore herbal and plant-based alternatives to traditional formulations. This trend is expected to influence the development of dextromethorphan products[5].

Rise of E-commerce

The rise of e-commerce is transforming the way pharmaceutical products are marketed and sold, providing new channels for distribution and increasing accessibility for consumers[5].

Expert Insights and Statistics

"The global dextromethorphan market is expected to undergo a CAGR of 4.8% during the forecast period of 2023 to 2030, driven by the high demand for OTC products and growing research activities in North America and Asia-Pacific"[1].

Key Takeaways

• The dextromethorphan hydrobromide market is expected to grow from USD 487.25 million in 2022 to USD 587.31 million by 2030.
• Quinidine sulfate market is projected to grow from USD 100 million in 2023 to USD 140.7 million by 2031.
• Emerging markets and innovations in formulations are key drivers for dextromethorphan hydrobromide.
• The combination of deudextromethorphan hydrobromide and quinidine sulfate shows promising therapeutic potential.
• Regulatory frameworks and consumer trends are shaping the market landscape.

Frequently Asked Questions (FAQs)

Q: What is the current market size of the dextromethorphan hydrobromide market? A: The global dextromethorphan market was valued at USD 487.25 million in 2022[1].

Q: What is the expected growth rate of the quinidine sulfate market? A: The quinidine sulfate market is expected to grow at a CAGR of 5% from 2024 to 2031[3].

Q: Which regions are driving the growth of the dextromethorphan hydrobromide market? A: North America and Asia-Pacific are the key regions driving the growth of the dextromethorphan hydrobromide market[1].

Q: What are the therapeutic applications of quinidine sulfate? A: Quinidine sulfate is primarily used to treat cardiac arrhythmias such as ventricular tachycardia and atrial fibrillation[3].

Q: How are consumer trends influencing the development of dextromethorphan products? A: Consumers are increasingly seeking products with natural ingredients, prompting manufacturers to explore herbal and plant-based alternatives to traditional formulations[5].

Cited Sources

1. Data Bridge Market Research: "Dextromethorphan Market Size, Scope, Growth, Value & Statistics"
2. Patsnap Synapse: "Dextromethorphan Hydrobromide Hydrate"
3. Market Research Intellect: "Quinidine Sulfate Market Size and Projections"
4. GlobalData: "Net Present Value Model: (Deudextromethorphan hydrobromide + Quinidine sulfate)"
5. Market Research Intellect: "The Healing Solution: Exploring Growth in the Dextromethorphan Hydrobromide Market"