BUPROPION HYDROCHLORIDE - Generic Drug Details

What are the generic sources for bupropion hydrochloride and what is the scope of freedom to operate?

Bupropion hydrochloride is the generic ingredient in eight branded drugs marketed by Accord Hlthcare, Actavis Labs Fl Inc, Anbison Lab, Annora Pharma, Aurobindo Pharma Usa, Chartwell Rx, Epic Pharma Llc, Granules, Graviti Pharms, Impax Labs, Invagen Pharms, Ipca Labs Ltd, Jubilant Generics, Lupin Ltd, Ph Health, Prinston Inc, Rising, Sandoz, Sciegen Pharms Inc, Sinotherapeutics Inc, Sun Pharm, Torrent, Twi Pharms, Watson Labs Inc, Wockhardt Ltd, Yichang Humanwell, Zhejiang Jutai Pharm, Zydus Pharms, Glaxosmithkline, Bausch, Alembic, Apnar Pharma Lp, Apotex, Cadila Pharms Ltd, Heritage Pharma, Invatech, Micro Labs, Axsome, and Nalpropion, and is included in sixty-eight NDAs. There are one hundred and forty-five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Bupropion hydrochloride has one patent family member in one country.

There are thirty drug master file entries for bupropion hydrochloride. Seventy-three suppliers are listed for this compound.

Summary for BUPROPION HYDROCHLORIDE

International Patents:	1
US Patents:	145
Tradenames:	8
Applicants:	39
NDAs:	68
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	73
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	411
Patent Applications:	2,324
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BUPROPION HYDROCHLORIDE
What excipients (inactive ingredients) are in BUPROPION HYDROCHLORIDE?	BUPROPION HYDROCHLORIDE excipients list
DailyMed Link:	BUPROPION HYDROCHLORIDE at DailyMed

Recent Clinical Trials for BUPROPION HYDROCHLORIDE

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

Sponsor	Phase
Yale University	PHASE1
American Society for Metabolic and Bariatric Surgery	PHASE1
The University of Texas Health Science Center at San Antonio	PHASE1

See all BUPROPION HYDROCHLORIDE clinical trials

Pharmacology for BUPROPION HYDROCHLORIDE

Drug Class	Aminoketone
Mechanism of Action	Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors
Physiological Effect	Increased Dopamine Activity Increased Norepinephrine Activity

Anatomical Therapeutic Chemical (ATC) Classes for BUPROPION HYDROCHLORIDE

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for BUPROPION HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FORFIVO XL	Extended-release Tablets	bupropion hydrochloride	450 mg	022497	1	2013-02-28
WELLBUTRIN XL	Extended-release Tablets	bupropion hydrochloride	150 mg and 300 mg	021515	1	2004-09-21

US Patents and Regulatory Information for BUPROPION HYDROCHLORIDE

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	11,207,281
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes	11,617,728
Aurobindo Pharma Usa	BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	090942-002	Jul 14, 2010		DISCN	No	No
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-003	Oct 4, 1996	AB1	RX	Yes	No

Expired US Patents for BUPROPION HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-004	Jun 14, 2002	5,763,493
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-004	Jun 14, 2002	5,427,798
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-002	Oct 4, 1996	5,427,798
Bausch	WELLBUTRIN XL	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021515-001	Aug 28, 2003	6,096,341

International Patents for BUPROPION HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2008038155

Supplementary Protection Certificates for BUPROPION HYDROCHLORIDE

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
0467488	SPC/GB00/019	United Kingdom		PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
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
2316456	SPC/GB17/078	United Kingdom		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.; REGISTERED: UK EU/1/14/988 20150330; UK PLGB 50742/0001 20150330

Market Dynamics and Financial Trajectory for Bupropion Hydrochloride

Last updated: November 2, 2025

Introduction

Bupropion hydrochloride, a norepinephrine-dopamine reuptake inhibitor (NDRI), has established a significant footprint in the pharmaceutical landscape for its dual application in depression management and smoking cessation. Originally developed by Burroughs Wellcome (later GlaxoSmithKline), it received FDA approval in 1985 for depression and 1997 for smoking cessation as Zyban. Its unique pharmacological profile, coupled with evolving clinical indications and market dynamics, shapes its financial trajectory and strategic positioning within the pharmaceutical industry.

Market Overview and Indications

Bupropion's primary FDA-approved uses include Major Depressive Disorder (MDD), Seasonal Affective Disorder (SAD), and smoking cessation therapy. Its dual mechanism of increasing norepinephrine and dopamine neurotransmission distinguishes it from SSRIs, contributing to its clinical appeal. The drug’s profile as a non-serotonergic antidepressant reduces some side effects associated with SSRIs, expanding its patient acceptance.

Despite competition from newer antidepressants and smoking cessation aids, bupropion maintains steady demand driven by a broadening understanding of depression subtypes, patient preference for non-serotonergic agents, and its off-label use in weight management and ADHD (though off-label uses vary and may face regulatory scrutiny).

Market Drivers

1. Growing Prevalence of Depression and Comorbidities
   The global burden of depression is escalating, with WHO estimating over 264 million affected individuals worldwide [1]. As mental health awareness rises, more patients seek diverse pharmacological options like bupropion, especially those who experience SSRI-related side effects or insufficient response.

2. Smoking Cessation Initiatives
   With tobacco use declining in many regions but still prevalent globally, the role of bupropion in smoking cessation remains pertinent. Its approval as Zyban, combined with behavioral interventions, sustains market demand in both developed and emerging markets.

3. Expanding Off-label and Adjunctive Uses
   Research supports off-label applications such as weight loss and ADHD treatment, broadening the drug’s therapeutic landscape. While off-label prescribing is common, it depends heavily on clinician awareness and regulatory frameworks.

4. Patent Expirations and Generic Competition
   Patent expirations in the U.S. and EU have introduced numerous generic versions, significantly impacting market pricing and margins for branded products. As of late 2010s, bupropion’s patent expiry opened the market to generics, increasing accessibility but pressuring profits for originators.

Competitive Landscape

The key competitors include SSRIs (fluoxetine, sertraline), SNRIs (venlafaxine, duloxetine), and alternative smoking cessation agents such as varenicline. Generic bupropion's entry lowered prices, but branded formulations like Wellbutrin maintained preference among prescribers due to formulary considerations and patient-specific factors.

Innovative formulations such as extended-release (Wellbutrin SR, Wellbutrin XL) offered improved adherence and efficacy, sustaining demand in a competitive environment. Recently, biosimilars and combination therapies have emerged, though their impact on bupropion remains limited.

Regulatory and Clinical Trends

Regulatory agencies scrutinize off-label uses, but the FDA’s approval of bupropion’s use for SAD and smoking cessation ensures ongoing clinical relevance. Emerging research into its neuropsychiatric effects has prompted further studies, potentially expanding its indications and market size.

In response to safety concerns, notably seizure risk at higher doses, strict prescribing guidelines persist, affecting prescribing patterns and market access.

Financial Trajectory and Revenue Outlook

The global antidepressant market, valued at approximately $15 billion in 2021, is projected to grow at a CAGR of 2-4% through 2030 [2]. Bupropion’s share within this landscape depends on several factors:

• Market Penetration and Pricing Strategies
  Generic availability has driven down prices, increasing accessibility but reducing revenue per unit for manufacturers. Despite this, volume-driven growth sustains revenues, especially in emerging markets with expanding healthcare coverage.

• Brand vs. Generic Sales
  Branded products like Wellbutrin generate higher margins but face competition from lower-cost generics. Companies adopt strategies like extended-release formulations and combination therapies to maintain premium pricing.

• Off-label Expansion and New Formulations
  Formulations offering improved compliance or novel delivery mechanisms (e.g., depot injections) could generate incremental revenues, though regulatory approval is requisite.

• Patent Life and Market Exclusivity
  The expiry of key patents in the early 2010s catalyzed intensified generic competition. Ongoing patent litigation and supplementary protection certificates may influence the timeline for subsequent exclusivity.

• Emerging Market Opportunities
  Rapid population growth and increased mental health awareness in Asia-Pacific and Latin America are expanding the user base. Local manufacturers and international pharma companies are investing in these regions to capitalize on unmet needs.

Market Risks and Challenges

• Safety Concerns and Regulatory Scrutiny
  Seizure risk necessitates cautious dosing, which may limit high-dose prescriptions. Regulatory bans on off-label uses could constrain revenue streams.

• Competitive Pressure
  The proliferation of alternative antidepressants and cessation therapies creates stiff competition, especially as many competitors leverage aggressive pricing strategies.

• Market Saturation and Patent Cliff
  The patent expiry journey for bupropion remains a major factor influencing market profitability. While generics dominate, innovative formulations or combination therapies can offset these pressures selectively.

• Pricing and Reimbursement Policies
  Cost containment pressures and strict reimbursement regulations in developed markets may compress margins, especially for branded versions.

Future Market Trend Predictions

1. Accelerated Adoption of Biosimilars and Generics
   In the wake of patent expirations, biosimilars, although less relevant for small molecules like bupropion, are unlikely to impact significantly. Instead, more focus will be on generics, which could erode revenue shares for branded versions further.

2. Expansion into Adjunctive and Off-label Uses
   Ongoing research could legitimize new indications, especially if supported by clinical trials demonstrating efficacy in weight management or ADHD, providing new revenue streams.

3. Digital and Personalized Medicine Integration
   The rise of digital health solutions may introduce tools to optimize treatment adherence, indirectly boosting the drug’s market trajectory.

4. Regulatory Shifts Favoring Cost-effective Therapies
   Policy shifts favoring cheaper generic options could suppress branded sales but expand overall market volume, benefiting volume-driven sales.

Conclusion

Bupropion hydrochloride’s market landscape is shaped by its established therapeutic roles, patent expiries, and emerging off-label indications. While generic competition compresses profit margins, a broadening global mental health crisis and interest in neuropsychiatric adjuncts sustain robust demand. Future growth hinges on regulatory acceptance for new indications, formulation innovations, and navigating the competitive pressures of cost containment. Strategic players must adapt to a dynamic environment where patent cliffs coexist with expanding markets, especially in emerging economies.

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Key Takeaways

• Market growth is driven by rising depression prevalence and smoking cessation needs worldwide.
• Generic formulations have reduced per-unit revenue but increased market penetration and access.
• Off-label uses and formulation innovations present avenues for revenue expansion.
• Patent expirations markedly influence market competitiveness, necessitating product lifecycle management.
• Emerging markets offer significant growth potential due to demographic and healthcare infrastructure developments.

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FAQs

1. What are the primary therapeutic indications for Bupropion Hydrochloride?
Bupropion is primarily prescribed for Major Depressive Disorder (MDD), Seasonal Affective Disorder (SAD), and smoking cessation. Off-label uses include weight management and ADHD, though these are less common and subject to regulatory review.

2. How have patent expirations affected the market for Bupropion Hydrochloride?
Patent expirations in the early 2010s opened the market to generic competitors, leading to significant price reductions and increased accessibility but decreased revenues for brand-name manufacturers.

3. What are the main challenges facing Bupropion’s future market growth?
Challenges include safety concerns like seizure risk, fierce generic competition, regulatory restrictions on off-label uses, and policy-driven reimbursement pressures in developed markets.

4. Are there ongoing efforts to expand Bupropion’s indications?
Yes, ongoing clinical research explores off-label and investigational uses, such as weight loss and ADHD, which could expand its market if supported by regulatory approvals.

5. What is the outlook for Bupropion Hydrochloride in emerging markets?
Emerging markets offer substantial growth opportunities due to increasing mental health awareness, expanding healthcare infrastructure, and unmet treatment needs, making them strategic targets for future expansion.

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References

[1] World Health Organization. Depression Fact Sheet. 2022.
[2] Grand View Research. Antidepressant Market Size & Trends. 2021.