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-five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bupropion hydrochloride; dextromethorphan hydrobromide has two hundred and forty-two patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for bupropion hydrochloride; dextromethorphan hydrobromide

International Patents:	242
US Patents:	125
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bupropion hydrochloride; dextromethorphan hydrobromide
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

International Patents for bupropion hydrochloride; dextromethorphan hydrobromide

Country	Patent Number	Title	Estimated Expiration
Australia	2024205858	DOSAGE FORMS AND METHODS FOR ENANTIOMERICALLY ENRICHED OR PURE BUPROPION
South Korea	102524253
Israel	297349	שימוש באריתרוהידרוקסיבופרופיון להעלאת רמת תרופות בפלאזמה (Methods of modulating drug plasma levels using erythrohydroxybupropion)

Supplementary Protection Certificates for bupropion hydrochloride; dextromethorphan hydrobromide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	C201730057	Spain		PRODUCT NAME: NALTREXONA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA, EN PARTICULAR CLORHIDRATO DE NALTREXONA, Y BUPROPION O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR CLORHIDRATO DE BUPROPION.; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326

Market Dynamics and Financial Trajectory for Bupropion Hydrochloride; Dextromethorphan Hydrobromide

Last updated: July 31, 2025

Introduction

Bupropion Hydrochloride and Dextromethorphan Hydrobromide are two prominent pharmaceutical compounds with distinct therapeutic applications. Bupropion, primarily used as an antidepressant and smoking cessation aid, has seen sustained growth due to evolving mental health awareness. Dextromethorphan, a widely used cough suppressant, remains integral to over-the-counter (OTC) cold remedies. This analysis examines the current market landscape, procurement trajectories, competitive forces, and future growth prospects for these compounds, providing key insights for stakeholders.

Overview of the Compounds

Bupropion Hydrochloride

Bupropion is an atypical antidepressant, classified as a norepinephrine-dopamine reuptake inhibitor (NDRI). It is marketed under various brand names, including Wellbutrin and Zyban, with applications extending into smoking cessation, depression, and ADHD. Its unique mechanism and favorable side effect profile have contributed to sustained demand (FDA approval in 1985; [1]).

Dextromethorphan Hydrobromide

Dextromethorphan (DXM) is a codeine analog that functions as an antitussive. Sold predominantly OTC, it is included in many multi-symptom cold and cough formulations. Its favorable safety profile, ease of production, and broad applicability underpin its widespread use ([2]).

Market Dynamics

Market Size and Growth Trends

Bupropion Hydrochloride

The global antidepressant market, estimated at over USD 15 billion in 2022 (Grand View Research), benefits significantly from the inclusion of bupropion. Rising mental health awareness, increased diagnosis of depression, and expanding smoking cessation programs catalyze growth. The global bupropion market was valued at approximately USD 1.4 billion in 2021, with a compound annual growth rate (CAGR) of about 6% projected through 2028 ([3]).

Emerging markets in Asia-Pacific and Latin America exhibit accelerated growth, driven by greater healthcare access and evolving regulatory landscapes. The shift toward generic formulations due to patent expirations further fuels market expansion.

Dextromethorphan Hydrobromide

The OTC cough suppressant segment, driven by Dextromethorphan, was valued at approximately USD 3.5 billion in 2022, with a CAGR of around 4.5%. The OTC availability, combined with a consistent demand during flu seasons and a broad consumer base, sustains stability. However, regulatory scrutiny over abuse potential and newer formulations affecting its market share are notable factors ([4]).

Regulatory Environment

Bupropion

Regulatory bodies such as the U.S. Food and Drug Administration (FDA) have maintained stringent approval processes for new formulations and indications. Patent protections and exclusivity rights continue to influence market dynamics, with several biosimilars entering the space post-patent expiration. Additionally, off-label use for weight loss and ADHD influences market expansion.

Dextromethorphan

While OTC status ensures accessibility, regulatory agencies have increased oversight over misuse and abuse, especially concerning recreational drug use. Restrictions and formulations combining DXM with other ingredients have evolved to mitigate abuse potential ([5]).

Competitive Landscape

Bupropion

Market competition comprises branded formulations (Wellbutrin, Zyban) and a proliferation of generics. Major pharmaceutical players include Teva, GlaxoSmithKline, and Mylan. Innovations such as extended-release formulations and combination therapies drive differentiation.

Dextromethorphan

Major OTC producers include Johnson & Johnson, Procter & Gamble, and GlaxoSmithKline. Market share is fragmented, with a high degree of over-the-counter availability. New formulations, including extended-release and combination drugs, aim to improve efficacy and safety profiles.

Pricing and Reimbursement Factors

Bupropion

Pricing varies widely; branded versions command premium prices, while generics offer significant cost benefits. Reimbursement policies in developed markets often favor prescribed formulations, influencing market uptake.

Dextromethorphan

Pricing remains low due to OTC sale and generic availability. Consumer purchasing patterns primarily drive revenue, with minimal reimbursement influence.

Financial Trajectory and Forecasting

Revenue Projections

Bupropion

Projected revenues for bupropion are expected to grow at a CAGR of approximately 5-6% over the next five years, driven by increased antidepressant prescriptions, new indications, and expanding generic markets. The global market could reach USD 2 billion by 2028, contingent upon regulatory and competitive factors.

Dextromethorphan

Stable, with modest growth projections around 3-4% CAGR, attributable to consistent OTC demand. Market saturation and the impact of alternative treatments may temper growth.

Impact of Patent Expiries and Biosimilars

Patent expirations for key formulations, such as Wellbutrin SR, released in 2006, have significantly increased generic competition ([6]). Biosimilars and alternative therapies threaten market share, leading to downward pressure on prices and margins.

Emerging Opportunities and Challenges

• For Bupropion: Expansion into combination therapies, novel delivery mechanisms, and novel indications (e.g., seasonal affective disorder) could elevate revenues.

• For Dextromethorphan: Development of abuse-deterrent formulations, novel delivery, and combination products could sustain growth amid regulatory pressures.

Market Risks

• Regulatory restrictions, especially concerning abuse potential and off-label uses.
• Pricing pressures from generics and biosimilars.
• Evolving consumer preferences and healthcare reimbursement changes.

Conclusion

The market trajectories for Bupropion Hydrochloride and Dextromethorphan Hydrobromide reveal divergent yet interconnected dynamics. Bupropion's growth hinges on expanding mental health awareness, regulatory approvals for new indications, and competition within branded and generic spaces. Conversely, Dextromethorphan's stability relies on OTC sales, with growth influenced by formulation innovations and regulatory oversight.

Both compounds face competitive and regulatory pressures, but their fundamental therapeutic roles ensure continued relevance. Stakeholders should prioritize innovation, monitor regulatory developments, and capitalize on emerging markets to optimize growth.

Key Takeaways

• Bupropion Hydrochloride presents a promising growth trajectory driven by mental health demand, generic market expansion, and potential new indications, despite increasing competition and patent expiries.

• Dextromethorphan Hydrobromide maintains stable revenues from OTC sales but faces regulatory scrutiny and market saturation risks; innovation in formulations remains critical.

• Regulatory trends significantly influence market dynamics; firms must adapt to restrictions on misuse while leveraging approvals for new indications.

• Generic and biosimilar entry exerts downward pressure on prices in both markets, demanding strategic differentiation through formulation and delivery innovations.

• Emerging markets present untapped potential, with expanding healthcare access underpinning long-term growth opportunities.

FAQs

1. How might regulatory changes impact the future market for Bupropion?
Regulatory agencies may impose stricter guidelines on off-label use and biosimilar approvals, impacting market entry and pricing strategies. Conversely, approval of new indications can foster growth. Companies must stay abreast of evolving standards to adapt product portfolios accordingly.

2. What role does patent expiration play in the market dynamics of Bupropion?
Patent expiry opens the market to generic competition, leading to price erosion but also creating opportunities for lower-cost formulations. This transition often results in increased accessibility and volume but reduces margins for originator brands.

3. Are there emerging formulations of Dextromethorphan that could disrupt the market?
Yes. Extended-release formulations and abuse-deterrent combinations aim to reduce misuse and adapt to regulatory restrictions, potentially reviving growth in specific segments.

4. How significant is the impact of OTC availability on Dextromethorphan's market stability?
OTC status ensures broad accessibility and steady consumer demand. However, it also exposes the market to regulatory risks related to misuse, requiring manufacturers to innovate safer formulations and educate consumers.

5. What are the key strategic considerations for pharmaceutical companies operating in these markets?
Companies should focus on developing new formulations, expanding indications, navigating regulatory landscapes effectively, and exploring emerging markets to foster sustainable growth amid competitive pressures.

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Sources

[1] Food and Drug Administration. "Bupropion: FDA Approval History." 2022.
[2] National Center for Complementary and Integrative Health. "Dextromethorphan." 2022.
[3] Grand View Research. "Antidepressants Market Size & Growth." 2022.
[4] MarketWatch. "OTC Cold Remedy Market Overview." 2022.
[5] U.S. FDA. "Regulatory Actions on Dextromethorphan." 2021.
[6] Patent Information Database. "Bupropion Patent Expiry and Market Impact." 2022.