Bupropion hydrochloride; dextromethorphan hydrobromide - Generic Drug Details

What are the generic sources for bupropion hydrochloride; dextromethorphan hydrobromide and what is the scope of patent protection?

Bupropion hydrochloride; dextromethorphan hydrobromide is the generic ingredient in one branded drug marketed by Axsome and is included in one NDA. There are one hundred and twenty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bupropion hydrochloride; dextromethorphan hydrobromide has one hundred and ninety-five patent family members in thirty-two countries.

One supplier is listed for this compound.

Summary for bupropion hydrochloride; dextromethorphan hydrobromide

International Patents:	195
US Patents:	120
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
DailyMed Link:	bupropion hydrochloride; dextromethorphan hydrobromide at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for bupropion hydrochloride; dextromethorphan hydrobromide

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.

Recent Clinical Trials for bupropion hydrochloride; dextromethorphan hydrobromide

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

Sponsor	Phase
Medical University of South Carolina	Phase 1

See all bupropion hydrochloride; dextromethorphan hydrobromide clinical trials

Pharmacology for bupropion hydrochloride; dextromethorphan hydrobromide

Drug Class	Aminoketone Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of Action	Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists
Physiological Effect	Increased Dopamine Activity Increased Norepinephrine Activity

Anatomical Therapeutic Chemical (ATC) Classes for bupropion hydrochloride; dextromethorphan hydrobromide

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous 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 BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AUVELITY	Extended-release Tablet	bupropion hydrochloride; dextromethorphan hydrobromide	45 mg/105 mg	215430	1	2022-12-22

US Patents and Regulatory Information for bupropion hydrochloride; dextromethorphan hydrobromide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes

International Patents for bupropion hydrochloride; dextromethorphan hydrobromide

Country	Patent Number	Title	Estimated Expiration
South Korea	20180136003	에리트로히드록시부프로피온을 이용한 약물의 혈장 농도의 조절 방법 (METHODS OF MODULATING DRUG PLASMA LEVELS USING ERYTHROHYDROXYBUPROPION)
Canada	3154845	COMPOSITIONS ET METHODES COMPRENANT DU BUPROPION OU DES COMPOSES CONNEXES ET DU DEXTROMETHORPHANE (COMPOSITIONS AND METHODS COMPRISING BUPROPION OR RELATED COMPOUNDS AND DEXTROMETHORPHAN)
Australia	2024205858	DOSAGE FORMS AND METHODS FOR ENANTIOMERICALLY ENRICHED OR PURE BUPROPION
South Korea	20230075531	거울상이성질체적으로 농후한 또는 순수한 부프로피온을 위한 투여 형태 및 방법 (DOSAGE FORMS AND METHODS FOR ENANTIOMERICALLY ENRICHED OR PURE BUPROPION)

Supplementary Protection Certificates for bupropion hydrochloride; dextromethorphan hydrobromide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	C 2017 047	Romania		PRODUCT NAME: COMBINATIE DE NALTREXONA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA, IN PARTICULAR CLORHIDRAT DE NALTREXONA SI BUPROPION SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA, IN PARTICULAR CLORHIDRAT DE BUPROPION; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF NATIONAL AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326
2316456	2017/059	Ireland		PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150326
0656775	28/2000	Austria		PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
2316456	17C1058	France		PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330

Bupropion hydrochloride; dextromethorphan hydrobromide Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Bupropion Hydrochloride and Dextromethorphan Hydrobromide

Introduction to Bupropion and Dextromethorphan

Bupropion hydrochloride and dextromethorphan hydrobromide, combined in the drug Auvelity, have recently gained significant attention for their therapeutic applications, particularly in treating major depressive disorder (MDD) and other conditions. This article delves into the market dynamics and financial trajectory of this drug combination.

Market Size and Growth

The global dextromethorphan market, which includes the combination of bupropion and dextromethorphan, is projected to experience steady growth. The market is expected to register a Compound Annual Growth Rate (CAGR) of 4.1% to 4.8% over the forecast period from 2023 to 2030[1][3][4].

Current Market Size

As of 2022, the global dextromethorphan market was valued at approximately USD 487.25 million. It is anticipated to reach USD 587.31 million by 2030[3].

Forecasted Growth

The growth is driven by increasing cases of respiratory conditions such as the common cold, flu, bronchitis, and allergies, which heighten the demand for cough suppressants like dextromethorphan. Additionally, the approval of new formulations, such as Auvelity for MDD, further boosts market expansion[1][3].

Key Drivers of Market Growth

Increasing Prevalence of Cough-Related Conditions

The rising prevalence of respiratory conditions is a significant driver. For instance, flu affects around 8.0% of the United States population annually, leading to a high demand for cough medications[1].

Growing Consumer Awareness and Self-Medication

Increased access to healthcare information has led to greater consumer awareness and a shift towards self-medication. This trend is particularly evident in the over-the-counter (OTC) segment, which dominates the dextromethorphan market[3].

Product Launches and Approvals

Recent approvals, such as the FDA approval of Auvelity in August 2022 for treating MDD, are expected to significantly impact market growth. Other ongoing clinical trials, like the study by Axsome Therapeutics for agitation linked with Alzheimer's disease, also indicate potential future growth[1][2].

Regional Market Analysis

North America

North America currently holds the largest market share due to a strong base of healthcare facilities, a high prevalence of respiratory conditions, and a significant presence of major pharmaceutical companies. For example, during the 2022 influenza season, Canada reported 16,126 laboratory-confirmed influenza detections, highlighting the region's demand for dextromethorphan[1].

Asia Pacific

The Asia Pacific region is expected to be the fastest-growing market. This growth is attributed to government initiatives promoting healthcare awareness, an increase in healthcare facilities, and a large population pool with growing demand for quality healthcare[1][3].

Competitive Landscape

The dextromethorphan market is slightly fragmented, with several notable companies operating globally and regionally. Key players include:

• AstraZeneca
• Aurobindo Pharma
• Glenmark Pharmaceuticals Ltd.
• Pfizer
• Sun Pharmaceutical
• Axsome Therapeutics

These companies are known for their significant market shares and innovative product launches[1][3][4].

Mechanism of Action and Therapeutic Applications

Dextromethorphan

Dextromethorphan acts as an uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist and a sigma-1 receptor agonist. This mechanism is crucial in its antidepressant and cough suppressant effects[2][5].

Bupropion

Bupropion is a norepinephrine and dopamine reuptake inhibitor (NDRI) and a CYP2D6 inhibitor, which enhances the bioavailability and duration of action of dextromethorphan. Together, they provide a synergistic effect in treating MDD[2][5].

Financial Implications

Market Value

The financial trajectory of the dextromethorphan market, including the bupropion and dextromethorphan combination, is positive. The market's projected growth from USD 487.25 million in 2022 to USD 587.31 million by 2030 indicates a robust financial outlook[3].

Cost and Accessibility

The cost of Auvelity, the drug combining bupropion and dextromethorphan, varies based on insurance plans and pharmacies. However, the availability of savings cards and coupons can make the medication more accessible to patients[5].

Challenges and Restraints

Side Effects

Despite the market growth, side effects associated with dextromethorphan drugs are a significant restraint. These side effects can limit the market expansion and necessitate careful monitoring and management[1].

Future Outlook

The future of the bupropion and dextromethorphan market looks promising, driven by increasing demand for effective treatments for MDD and respiratory conditions. Ongoing research and clinical trials are expected to introduce new therapeutic applications, further boosting market growth.

"The launch of dextromethorphan-based drugs is also expected to boost the market expansion. For instance, in September 2021, in India, Sun Pharmaceutical Industries launched a novel formulation in cough management, Chericof 12 (dextromethorphan hydrobromide 30 mg and chlorpheniramine maleate 4 mg)"[1].

Key Takeaways

• The global dextromethorphan market is expected to grow at a CAGR of 4.1% to 4.8% from 2023 to 2030.
• The market is driven by increasing cases of respiratory conditions and the launch of new formulations like Auvelity.
• North America holds the largest market share, while the Asia Pacific region is expected to be the fastest-growing market.
• Key players include AstraZeneca, Aurobindo Pharma, Glenmark Pharmaceuticals Ltd., Pfizer, and Sun Pharmaceutical.
• The combination of bupropion and dextromethorphan has a synergistic effect in treating MDD.

FAQs

What is the current market size of the dextromethorphan market?

The global dextromethorphan market was valued at approximately USD 487.25 million in 2022[3].

Who are the major players in the dextromethorphan market?

Major players include AstraZeneca, Aurobindo Pharma, Glenmark Pharmaceuticals Ltd., Pfizer, and Sun Pharmaceutical[1][3][4].

What is the fastest-growing region in the dextromethorphan market?

The Asia Pacific region is expected to be the fastest-growing market during the forecast period[1][3].

What are the key drivers of the dextromethorphan market growth?

Key drivers include the increasing prevalence of cough-related conditions, growing consumer awareness and self-medication, and product launches and approvals[1][3].

What are the potential challenges for the dextromethorphan market?

Side effects associated with dextromethorphan drugs are a significant restraint that could limit market expansion[1].

Sources

1. Mordor Intelligence: Dextromethorphan Market Size & Share Analysis - Growth Trends.
2. PubMed: Dextromethorphan/Bupropion: First Approval.
3. Data Bridge Market Research: Dextromethorphan Market Size, Scope, Growth, Value & Statistics.
4. GI Intelligence: Dextromethorphan - Market Share Analysis, Industry Trends.
5. Drugs.com: Bupropion and Dextromethorphan: Uses, Dosage, Side Effects.