WELLBUTRIN SR Drug Patent Profile

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

Wellbutrin Sr is a drug marketed by Glaxosmithkline and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Wellbutrin Sr

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

Summary for WELLBUTRIN SR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	85
Patent Applications:	1,623
Drug Prices:	Drug price information for WELLBUTRIN SR
DailyMed Link:	WELLBUTRIN SR at DailyMed

See drug prices for WELLBUTRIN SR

Recent Clinical Trials for WELLBUTRIN SR

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

Sponsor	Phase
Pfizer	Phase 1
Mclean Hospital	Phase 4
Kenya Medical Research Institute	Phase 4

See all WELLBUTRIN SR clinical trials

Pharmacology for WELLBUTRIN SR

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

US Patents and Regulatory Information for WELLBUTRIN SR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-001	Oct 4, 1996		DISCN	No	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	020358-002	Oct 4, 1996	AB1	RX	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 SR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-002	Oct 4, 1996
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-003	Oct 4, 1996
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-003	Oct 4, 1996
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-002	Oct 4, 1996
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-004	Jun 14, 2002
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-004	Jun 14, 2002
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-001	Oct 4, 1996

International Patents for WELLBUTRIN SR

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

Country	Patent Number	Title	Estimated Expiration
Japan	3721192
Spain	2111168
Israel	127919	STABILIZED PHARMACEUTICAL COMPOSITIONS CONTAINING BUPROPION
Cyprus	2143	Sustained release tablets containing bupropion
Slovenia	711154
Greece	3025794
European Patent Office	0711154	COMPOSITION PHARMACEUTIQUE STABILISEE CONTENANT DU BUPROPION (STABILIZED PHARMACEUTICAL COMPOSITION CONTAINING BUPROPION)

Supplementary Protection Certificates for WELLBUTRIN SR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
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
0656775	CR 2000 00018	Denmark		PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
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
0467488	SPC/GB00/019	United Kingdom		PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607

Market Dynamics and Financial Trajectory for Wellbutrin SR

Last updated: July 28, 2025

Introduction

Wellbutrin SR, the sustained-release formulation of bupropion, is a prominent antidepressant with unique pharmacological properties. Approved initially in 1985, with sustained-release formulations introduced later, Wellbutrin SR has established a distinctive position within the psychiatric medication landscape. Its market dynamics and financial trajectory are influenced by factors such as regulatory developments, patent landscape, competitive environment, and shifts in prescribing trends.

This analysis examines the evolving market forces shaping Wellbutrin SR’s commercial trajectory, providing business professionals insights into strategic opportunities and challenges.

Pharmacological Profile and Clinical Appeal

Wellbutrin SR (bupropion hydrochloride sustained-release) operates primarily as a norepinephrine-dopamine reuptake inhibitor (NDRI). Its unique mechanism offers advantages over traditional antidepressants, including:

• Lower risk of sexual dysfunction
• Smaller impact on weight gain
• Minimal drug-drug interactions
• Potential benefits in smoking cessation (marketed as Zyban, developed by GlaxoSmithKline)

These attributes underpin its widespread adoption for major depressive disorder (MDD), seasonal affective disorder, and its off-label use for ADHD.

Market Dynamics

1. Patent and Regulatory Landscape

Patent protections critically influence Wellbutrin SR’s market exclusivity. Bupropion was initially developed by Burroughs Wellcome, acquired by GlaxoSmithKline. The active molecule’s patent expired in the early 2000s, resulting in multiple generic versions' entry, significantly reducing wholesale and retail prices. Despite this, branded formulations like Wellbutrin SR have maintained competitive positioning through formulation-specific patents and regulatory exclusivities (designations of the sustained-release formulation often protect formulation patents, not the active ingredient).

However, the expiration of key patents has precipitated a shift towards generic formulations, which now dominate sales. Nevertheless, the branded product retains clinical brand loyalty, especially among prescribers perceiving slight differences in bioavailability or dosing convenience.

2. Market Penetration and Prescriber Preference

Genricization has triggered commoditization, but branded Wellbutrin SR maintains a niche through physician preference, especially in cases where formulary restrictions favor branded drugs, and patients with insurance coverage that favors branded drugs.

3. Competitive Landscape

The antidepressant market is intensely competitive, characterized by:

• Generic SSRIs (e.g., sertraline, fluoxetine)
• SNRIs (e.g., duloxetine, venlafaxine)
• Other atypical antidepressants (e.g., trazodone, mirtazapine)
• Novel mechanisms including new MOA agents and multimodal antidepressants

While Wellbutrin SR’s unique dopaminergic activity provides a differentiator, its market share faces challenges from newer agents with improved efficacy or side-effect profiles. Notably, the rise of generic bupropion formulations has driven prices downward, exerting pressure on revenue from branded formulations.

4. Off-Label Use and Expansion Opportunities

Beyond depression, Wellbutrin SR is prescribed off-label for smoking cessation, weight management, and ADHD. These off-label uses have expanded the drug's market scope, although directly marketing feasible through regulatory restrictions.

5. Pricing Trends and Insurance Dynamics

Price erosion due to generics, coupled with insurance formulary preferences, impacts revenue. Large pharmacy benefit managers (PBMs) favor low-cost generics, limiting brand-market share growth. Nevertheless, continued demand persists from prescribers who prefer branded formulations for perceived consistency or due to formulary restrictions.

Financial Trajectory

1. Revenue Trends and Market Share

Prior to patent expirations, Wellbutrin SR generated substantial revenue for GSK. Post-patent loss, revenue from branded Wellbutrin SR declined markedly, with sales increasingly driven by generics. According to IQVIA data, the global antidepressant market was valued at approximately $13.8 billion in 2022, with bupropion contributing a significant share.

The sales trajectory for Wellbutrin SR has now stabilized at a lower level, with estimates indicating a decline of approximately 30–40% since the patent cliff, primarily due to generic competition.

2. Impact of Market Penetration in Developing Countries

Emerging markets present growth opportunities due to increasing mental health awareness and expanding healthcare coverage. However, price sensitivity limits revenue potential unless branded formulations are positioned as premium options.

3. Future Revenue Drivers

Potential growth factors include:

• Enhanced formulations: Extended-release or combination formulations with improved adherence
• New indications: Regulatory approval for additional therapeutic uses, such as obesity or smoking cessation, could stimulate sales
• Market expansion: Increasing antidepressant utilization in underpenetrated regions

4. Challenges in Sustaining Revenue

Declining branded sales, intense competition, and rising generic prevalence pose ongoing challenges. Companies seeking to capitalize on Wellbutrin SR often focus on lifecycle management strategies, such as reformulations, obtaining new patents via formulations, or leveraging brand loyalty.

Strategic Outlook

Given current market conditions, Wellbutrin SR's financial future hinges on its ability to navigate:

• Patent expiry impacts leading to revenue erosion
• Development of new formulations to extend patent life and improve patient compliance
• Diversification through new indications and off-label use promotion within regulatory boundaries
• Pipeline integration with complementary therapies or formulations (e.g., combination products targeting comorbidities)

Key Factors Influencing Market Trajectory

Factor	Impact	Strategic Response
Patent expiration	Revenue decline	Formulation innovation, lifecycle management
Generic competition	Price erosion	Focus on brand loyalty, niche indications
Off-label expansion	Revenue opportunities	Medical education, clinical research support
Emerging markets	Growth potential	Local partnerships, tailored marketing
Regulatory landscape	Market access	Proactive adaptation to regulations

Conclusion

The market dynamics for Wellbutrin SR are characterized by a transition from patent-protected sales to a predominantly generic landscape. While revenue has declined from peak levels, strategic initiatives focusing on formulation innovation, expansion into new indications, and emerging markets could foster a stable long-term trajectory. Business professionals should monitor patent statuses, competitive moves, and regulatory developments to optimize portfolio positioning.

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Key Takeaways

• Patent expirations dramatically reduced Wellbutrin SR’s premium pricing and sales, leaving generics dominant in the market.
• Despite declining revenues, branded Wellbutrin SR maintains a niche through prescriber loyalty and formulary considerations.
• The competitive environment is intensifying, with generic equivalents and alternative antidepressants pressuring market share.
• Growth opportunities exist in developing formulations, expanding indications, and entering emerging markets.
• Long-term profitability depends on innovation, lifecycle management, and adaptation to market and regulatory shifts.

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FAQs

1. How has patent expiration affected Wellbutrin SR sales?
   Patent expiration led to widespread generic availability, significantly reducing branded sales and forcing a shift toward generic formulations with lower price points.

2. What are the main competitors to Wellbutrin SR in the antidepressant market?
   Main competitors include SSRIs (e.g., sertraline, fluoxetine), SNRIs (e.g., duloxetine), and newer agents with different mechanisms of action.

3. Are there emerging indications that could impact Wellbutrin SR's market?
   Potential future indications, such as weight management or ADHD, could expand its application, provided regulatory approvals are obtained.

4. What strategies can companies employ to sustain revenue from Wellbutrin SR?
   Strategies include reformulation, patent extension via formulation patents, marketing to niche markets, and expanding into emerging regions.

5. Is Wellbutrin SR profitable given the current market landscape?
   While revenues have declined, optimized lifecycle management and expanded indications can sustain profitability, though margins are under pressure from generics.

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References

[1] IQVIA. (2023). Global antidepressant market report.
[2] U.S. Food & Drug Administration. (2012). Patent and exclusivity data for bupropion.
[3] GSK Annual Reports. (2022). Financial overview of Wellbutrin product lines.
[4] IMS Health. (2022). Prescription trends for antidepressants worldwide.