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

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

One supplier is listed for this compound.

Summary for bupropion hydrochloride; dextromethorphan hydrobromide

International Patents:	249
US Patents:	130
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

Constraining patent/regulatory exclusivity:

11,191,739

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	11,291,638
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes	9,474,731
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes	11,752,144
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes	11,185,515
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes	10,463,634
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes	12,042,473

International Patents for bupropion hydrochloride; dextromethorphan hydrobromide

Country	Patent Number	Title	Estimated Expiration
Brazil	112020017179
New Zealand	764077
European Patent Office	4631571
European Patent Office	3908270
Australia	2020349419	Dosage forms and methods for enantiomerically enriched or pure bupropion
Israel	252417

Supplementary Protection Certificates for bupropion hydrochloride; dextromethorphan hydrobromide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	349 22-2017	Slovakia		PRODUCT NAME: KOMBINACIA NALTREXONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM A BUPROPIONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/988 20150330
2316456	2017C/064	Belgium		PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
0467488	SPC/GB00/019	United Kingdom		PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
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	CR 2017 00062	Denmark		PRODUCT NAME: NALTREXON ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NALTREXONHYDROCHLORID, OG BUPROPION ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER BUPROPIONHYDROCHLORID; REG. NO/DATE: EU/1/14/988 20150330
2316456	1790064-8	Sweden		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; REG. NO/DATE: EU/1/14/988 20150330

Market Dynamics and Financial Trajectory for Bupropion Hydrochloride and Dextromethorphan Hydrobromide

Last updated: February 16, 2026

Overview of the Drugs

• Bupropion hydrochloride: An atypical antidepressant marketed under brands like Wellbutrin and Zyban. It is approved for depression, smoking cessation, and off-label for ADHD.
• Dextromethorphan hydrobromide: An antitussive agent found in over-the-counter cough medicines, marketed under brands like Delsym and Robitussin. Recently attracting interest for its potential in neurological and psychiatric indications.

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What Are the Market Sizes and Growth Rates?

Drug	Global Market Size (2022)	Projected CAGR (2023-2028)	Key Drivers
Bupropion Hydrochloride	$1.5 billion	4.8%	Rising depression prevalence, expanded indications
Dextromethorphan	$560 million	3.2%	Increased OTC consumption, interest in neurological uses

Source: IQVIA, 2022; MarketResearch.com, 2023 estimates

Market Segmentation and Distribution

• Bupropion hydrochloride: Major segment sales from antidepressant prescriptions in North America, with expansion into ADHD treatments.
• Dextromethorphan: Primarily OTC sales in North America and Europe, with a niche market for abuse deterrent formulations and neurological research.

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Regulatory Status and Approvals

• Bupropion: Approved for depression, smoking cessation, and off-label use for ADHD. FDA has approved extended-release formulations with patents until 2030, with generic versions from 2011 following patent expiry.
• Dextromethorphan: OTC status largely stable but subject to regulatory scrutiny due to abuse potential. Recent approvals for combination therapies targeting neurological conditions in specific markets.

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Patent Landscape and Generic Competition

• Bupropion:
  • Patents expired in the US in 2011.
  • Generic versions dominate the market, reducing prices and margins.
• Dextromethorphan:
  • No recent patents, but formulations blending dextromethorphan with other agents often filed with narrow patent protections, affecting economic prospects.

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Commercial Strategies and R&D Trends

• Bupropion:
  • Focus on new delivery systems (e.g., transdermal patches).
  • Development of adjunct therapies for major depressive disorder.
• Dextromethorphan:
  • Repurposing for neurological conditions such as pseudobulbar affect.
  • Innovation in abuse-deterrent formulations.

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Revenue Drivers and Challenges

Bupropion:

• Drivers: Large prescription base, off-label use, multiple formulations.
• Challenges: Patent expiration, price erosion, competition from SSRIs and SNRIs.

Dextromethorphan:

• Drivers: OTC availability, expanding research into new indications.
• Challenges: Regulatory scrutiny, potential abuse, stricter classification in some regions.

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Financial Trajectory Outlook

• Bupropion:
  • Revenue decline predicted from 2024 onward due to patent loss but stabilized through new formulations and off-label uses.
  • Estimated revenues in 2023: approximately $1.3 billion globally.
• Dextromethorphan:
  • Growth expected at a compound rate of 3-4% over five years, with increased interest from research pipelines.
  • Estimated revenues in 2023: around $560 million, with marginal growth driven by product innovations.

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Key Market Risks

• Patent expiration and generic competition are long-term risks for both drugs.
• Regulatory changes could impact OTC status or restrict indications.
• Market saturation in developed regions limits growth potential.

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Conclusion

The outlook for bupropion hydrochloride and dextromethorphan hydrobromide hinges on patent management, regulatory environment, and emerging therapeutic uses. While bupropion faces patent erosion, diversification into new formulations and indications can sustain revenues. Dextromethorphan’s growth relies on expanding research and over-the-counter markets amid regulatory oversight.

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Key Takeaways

• Bupropion's market size is approximately $1.5 billion, with a CAGR of 4.8%, but faces patent expiry and generic competition.
• Dextromethorphan produces around $560 million annually, with steady but moderate growth.
• Both drugs are influenced by regulatory trends, with potential for expansion through novel formulations or new indications.
• Intellectual property protection remains crucial for maintaining competitive advantage, especially for branded drugs.
• Market growth will be constrained by regulatory, patent, and competitive dynamics, with niche opportunities in research and off-label therapy.

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FAQs

1. What factors most influence the market for bupropion?
Prescription volume, patent status, developing new formulations, and off-label uses significantly impact its market.

2. How does recent regulatory scrutiny impact dextromethorphan?
Potential for tighter controls due to abuse concerns and regulatory attention on OTC status could limit sales growth.

3. Are there opportunities for new indications for these drugs?
Yes. Bupropion is being researched for weight management and cognitive disorders. Dextromethorphan shows promise for neurological disorders.

4. How do patent expirations affect revenue streams?
Patent expirations open markets for generics, reducing prices and profit margins for branded formulations.

5. What are the main competitors for these drugs?
For bupropion, SSRIs and SNRIs like sertraline and venlafaxine. For dextromethorphan, other OTC cough suppressants and emerging neurological drugs.

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Citations

[1] IQVIA, 2022. Market analysis report.
[2] MarketResearch.com, 2023. Drug market forecasts.