WELLBUTRIN Drug Patent Profile

When do Wellbutrin patents expire, and when can generic versions of Wellbutrin launch?

Wellbutrin is a drug marketed by Glaxosmithkline and Bausch and is included in three NDAs.

The generic ingredient in WELLBUTRIN is bupropion hydrochloride. There are thirty-eight drug master file entries for this compound. Seventy-three suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Wellbutrin

A generic version of WELLBUTRIN was approved as bupropion hydrochloride by APNAR PHARMA LP on February 7^th, 2000.

Summary for WELLBUTRIN

US Patents:	0
Applicants:	2
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	145
Clinical Trials:	85
Patent Applications:	4,787
Drug Prices:	Drug price information for WELLBUTRIN
Drug Sales Revenues:	Drug sales revenues for WELLBUTRIN
What excipients (inactive ingredients) are in WELLBUTRIN?	WELLBUTRIN excipients list
DailyMed Link:	WELLBUTRIN at DailyMed

See drug prices for WELLBUTRIN

See drug sales revenues for WELLBUTRIN

Recent Clinical Trials for WELLBUTRIN

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

Sponsor	Phase
Pfizer	Phase 1
Mclean Hospital	Phase 4
National Cancer Institute (NCI)	Phase 4

See all WELLBUTRIN clinical trials

US Patents and Regulatory Information for WELLBUTRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-001	Dec 30, 1985		DISCN	Yes	No
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-004	Jun 14, 2002	AB1	RX	Yes	Yes
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-001	Oct 4, 1996		DISCN	No	No
Bausch	WELLBUTRIN XL	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021515-001	Aug 28, 2003	AB3	RX	Yes	No
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-002	Dec 30, 1985		DISCN	Yes	No
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-003	Dec 30, 1985		DISCN	Yes	No
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-003	Oct 4, 1996	AB1	RX	Yes	No

Expired US Patents for WELLBUTRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-003	Dec 30, 1985
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-002	Dec 30, 1985
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-001	Dec 30, 1985
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-003	Dec 30, 1985
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-002	Dec 30, 1985
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-002	Dec 30, 1985
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-001	Dec 30, 1985

International Patents for WELLBUTRIN

See the table below for patents covering WELLBUTRIN around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	386127
Australia	8365882
Australia	583833
Japan	H0343248
Netherlands	172148
Zambia	14070	BIOLOGICALLY ACTIVE KETONES
Australia	557056

Supplementary Protection Certificates for WELLBUTRIN

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
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	LUC00054	Luxembourg		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; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330

Market Dynamics and Financial Trajectory for Wellbutrin

Last updated: July 29, 2025

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Introduction

Wellbutrin, the brand name for bupropion, is a widely prescribed antidepressant developed and marketed by GlaxoSmithKline (GSK), now available as a generic. Its unique pharmacological profile—primarily as a norepinephrine-dopamine reuptake inhibitor—has positioned it as an alternative to SSRIs (selective serotonin reuptake inhibitors) for treating depression, seasonal affective disorder, and aiding smoking cessation. Analyzing Wellbutrin’s market dynamics and financial trajectory illuminates key factors influencing its commercial performance amid evolving healthcare landscapes.

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Market Position and Therapeutic Use

Therapeutic Profile

Wellbutrin’s clinical advantages include lower sexual dysfunction risk, stimulant-like energizing effects, and off-label uses such as weight management and ADHD treatment. Its dual utility in depression and smoking cessation bolsters its market appeal. The FDA approved bupropion for smoking cessation in 1997 (marketed as Zyban), expanding its application beyond depression.

Market Penetration and Competition

The drug captured significant market share within the antidepressant class, competing predominantly with SSRIs like sertraline, fluoxetine, and newer agents such as vortioxetine. Its favorable side effect profile and dual indications have sustained its popularity, although recent entrants—such as vilazodone—offer competitive alternatives.

Patent Expiry and Generics

GSK's original patent for Wellbutrin XL expired in the early 2010s, leading to widespread generic manufacturing by multiple pharmaceutical firms. Generics significantly eroded brand-specific revenues, with generics now accounting for approximately 80% of prescriptions (per IQVIA data). The availability of lower-cost generics intensified price competition, impacting overall revenue.

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Market Dynamics and Drivers

Rising Prevalence of Depression and Substance Use Disorders

The global burden of depression continues to grow, with WHO estimating over 264 million affected worldwide. Increased awareness, destigmatization, and healthcare access have driven prescriptions. Additionally, the recognition of bupropion’s efficacy in smoking cessation and weight management broadens its patient base.

Regulatory and Reimbursement Trends

Healthcare payers increasingly favor cost-effective generics, limiting revenue potential for brand-name drugs. However, newer formulations like Wellbutrin XL, with extended-release profiles, command higher prices and better adherence, partially offsetting generic competition.

Innovation and Line Extensions

While attempts have been made to develop novel formulations—such as sustained-release or combination therapies—few have achieved significant market penetration. Nonetheless, investment in combination products and alternative delivery systems continues as an industry trend.

Off-Label and Adjunct Indications

Off-label uses, including weight management and ADHD, support sustained demand. Off-label prescribing, often covered by insurance, maintains revenue streams despite regulatory limitations.

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Financial Trajectory Analysis

Historical Revenue Trends

Pre-patent expiry, Wellbutrin generated annual revenues exceeding $1 billion worldwide, reflecting its widespread adoption. Post-patent expiry, sales declined sharply due to generic competition, with revenue dropping to hundreds of millions annually.

Current Revenue Landscape

Despite sales erosion, Wellbutrin continues to generate consistent revenue, estimated at approximately $250-$300 million globally (per IQVIA). The revenues are now predominantly from generic formulations, with the brand-name variant accounting for a marginal percentage.

Impact of Patent Landscape and Market Entry

The expiration of key patents—particularly the controlled-release formulations—has significantly influenced revenue trajectories. The entry of numerous generic manufacturers has led to price erosion and prescribers’ preference for cost-efficient options.

Emerging Market and Future Growth Potential

Growth in emerging markets, where patented drugs are less dominant and mental health awareness is rising, presents potential growth avenues. However, market access, regulatory hurdles, and local pricing policies influence actual revenue potential.

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Future Outlook and Strategic Considerations

Market Stability of Generic Bupropion

The extensive generic competition implies limited upside for brand-name revenues unless GSK innovates with new formulations or delivery mechanisms.

Potential for Reformulation and New Indications

Investment in extended-release or combination formulations may provide incremental revenue, especially if approved for new indications. However, the high costs and regulatory hurdles present challenges.

Reimbursement and Pricing Pressures

Global push for drug affordability is likely to sustain generic pricing pressures, constraining margins for branded variants.

Impact of Digital and Telehealth Platforms

Increased adoption of telemedicine may facilitate continued prescribing, especially for off-label uses. Digital health integrations could also enhance adherence, supporting sustained revenue.

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Regulatory and Legal Landscape

Legal challenges associated with patent disputes or regulatory non-compliance can impact market stability. GSK’s recent strategic shifts include focusing on novel compounds and biosimilars, which may divert attention away from established drugs like Wellbutrin.

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Conclusion

Wellbutrin’s market dynamics are characterized by significant initial success, followed by substantial erosion post-patent expiry due to generic competition. Its therapeutic versatility sustains demand, particularly for off-label uses, but revenue growth prospects hinge on innovation and expanding into emerging markets. A business strategy centered on reformulation and novel indications could provide incremental gains, although the overall financial trajectory remains constrained by generic market saturation.

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Key Takeaways

• Patent expiration has led to widespread generic adoption, toning down revenues from the original brand.

• Market demand driven by depression prevalence and expanding off-label indications sustains steady, albeit reduced, sales.

• Price competition among generics has suppressed profit margins, emphasizing the importance of innovation or niche therapeutic positioning.

• Emerging markets present growth avenues, contingent on regulatory and reimbursement frameworks.

• Strategic focus should include developing new formulations, exploring novel indications, and leveraging digital healthcare to extend market viability.

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FAQs

1. How has patent expiration affected Wellbutrin’s market share?
Patent expiration led to the proliferation of generic versions, which now comprise the majority of prescriptions. This shift drastically reduced brand-name sales, transforming Wellbutrin into a largely commoditized product with limited revenue growth potential.

2. Are there new formulations of Wellbutrin in development?
Current efforts focus on extended-release and combination formulations to improve adherence and expand indications. However, no significant new formulations have recently been approved, and development remains cautious due to market saturation.

3. What are the competitive advantages of Wellbutrin over other antidepressants?
Its lower risk of sexual dysfunction, energizing side effects, and efficacy in smoking cessation make it attractive. These qualities serve as differentiators, especially for patients intolerant to SSRIs.

4. Can Wellbutrin’s off-label uses significantly impact its revenue?
While off-label uses such as weight management and ADHD contribute to steady prescribing, they are not officially sanctioned, limiting formal marketing and reimbursements, thus having limited impact on revenue.

5. What market opportunities exist for Wellbutrin in emerging economies?
Growing mental health awareness, increasing healthcare access, and lower generic entry barriers create potential markets. Success depends on local regulatory approval, pricing strategies, and healthcare infrastructure support.

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References

1. IQVIA. "Pharmaceutical Market Data," 2022.
2. World Health Organization (WHO). "Depression Fact Sheet," 2022.
3. U.S. Food and Drug Administration (FDA). "FDA Approvals," 1997.
4. GlaxoSmithKline Annual Reports, 2010-2022.
5. Industry Reports on Generic Market Trends, 2022.