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-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

A generic version of WELLBUTRIN was approved as bupropion hydrochloride by SENORES PHARMS 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:	5,241
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
Kenya Medical Research Institute	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	018644-002	Dec 30, 1985	4,393,078
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-002	Dec 30, 1985	4,425,363
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-003	Dec 30, 1985	4,425,363
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-001	Dec 30, 1985	4,347,257
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-002	Dec 30, 1985	3,885,046
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-001	Dec 30, 1985	4,425,363
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-003	Dec 30, 1985	3,885,046

International Patents for WELLBUTRIN

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

Country	Patent Number	Title	Estimated Expiration
Argentina	192302	UN METODO PARA PREPARAR ALFA ALQUILAMINOPROPIOFENONAS
Argentina	198945	METODO PARA PREPARAR ALFA-ALQUILAMINO PROPIOFENONAS
Austria	302276
Austria	307389
Belgium	759838
Canada	977777	BIOLOGICALLY ACTIVE KETONES
Canada	977778

Supplementary Protection Certificates for WELLBUTRIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0467488	SPC/GB00/019	United Kingdom		PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
2316456	CA 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
0656775	28/2000	Austria		PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
2316456	300918	Netherlands		PRODUCT NAME: NALTREXON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER NALTREXONHYDROCHLORIDE, EN BUPROPION OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BUPROPIONHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150330
2316456	122017000109	Germany		PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 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

Last updated: February 14, 2026

What Are the Market Dynamics for Wellbutrin?

Market position and demand drivers

Wellbutrin, the brand name for bupropion, is a widely prescribed antidepressant approved for major depressive disorder (MDD), seasonal affective disorder (SAD), and smoking cessation. Its mechanism involves dopamine and norepinephrine reuptake inhibition, differentiating it from selective serotonin reuptake inhibitors (SSRIs).

Key demand factors include:

• Increasing prevalence of depression globally, with the World Health Organization reporting over 264 million affected individuals.
• Growing awareness of non-SSRIs options, fostering prescriber diversification.
• Its off-label use for attention deficit hyperactivity disorder (ADHD) and weight management, expanding potential demand.

Market competition

Wellbutrin faces competition primarily from SSRIs (e.g., sertraline, fluoxetine), serotonin-norepinephrine reuptake inhibitors (SNRIs), and newer agents like vortioxetine. Generic versions, introduced post-patent expiry, significantly impact brand sales.

Patent and regulatory landscape

• Bupropion’s original patents expired in the U.S. in 2006, enabling generic competition.
• Despite generic entry, the Brand Wellbutrin XL retains some market share due to brand loyalty and formulation differences.
• Regulatory pressures favor generics, affecting pricing strategies and revenue.

What Is the Financial Trajectory of Wellbutrin?

Historical revenue patterns

• Pre-generic era (before 2006): Peak annual U.S. sales exceeded $2 billion.
• Post-patent expiry: Generic versions eroded approximately 70-85% of original brand revenue within two years.
• Current sales: Brand Wellbutrin (including formulations) generates approximately $300 million annually in the U.S., predominantly from refills of remaining formulations and specialized prescribing.

Market share shifts

Period	Brand Wellbutrin Sales (USD million)	Generic Bupropion Sales (USD million)	Total Market Size (USD million)
2005	>2000	0	>2000
2010	300	1700	2000
2020	250	800	1050
2022	300	700	1000

This reflects sustained but declining brand revenue, with generics dominating the market.

Pricing trends

• Brand Wellbutrin XL (300 mg): Price per tablet can reach $4 in the US.
• Generic bupropion formulations: Prices range from $0.10 to $0.50 per tablet depending on dosage and pharmacy.
• Formulation differences: Extended-release formulations command higher pricing, yet overall, generics reduce the brand’s revenue share.

Reimbursement and insurance policies

• Pharmacy benefit managers (PBMs) favor generics, influencing prescribing patterns.
• High co-payments for brand formulations limit revenue.
• Insurance guidelines favor generic substitution, further constraining brand sales.

Future revenue potential

• Patent cliff limitations: No new patent exclusivity for Wellbutrin.
• Niche uses: Off-label and expanded indications offer limited revenue potential.
• Brand renewal efforts: Marketers focus on formulations with extended-release, but innovation is limited by existing patents and generic competition.

What Are the Key External Factors Impacting Its Market and Financial Performance?

1. Regulatory environment: Increased approval of biosimilars and generics pressures brand longevity.
2. Consumer preferences: Shift towards newer, seemingly better-tolerated antidepressants reduces Wellbutrin’s appeal.
3. Pricing pressure: Healthcare reforms prioritize cost containment, affecting drug pricing strategies.
4. Competitive landscape: Emergence of novel agents, such as vortioxetine, impacts market share.
5. Generic supply and manufacturing costs: Fluctuations influence generic market prices and profitability.

Key Takeaways

• Wellbutrin’s original patent expired in 2006, leading to a sharp decline in brand revenue.
• The drug maintains a modest market share through formulations with specialized release mechanisms.
• Generic versions now account for the majority of sales, priced substantially lower than branded formulations.
• Revenues from Wellbutrin have stabilized at around $300 million annually in the U.S., driven primarily by formulary and institutional prescribing.
• Market dynamics favor generics, limiting potential for significant revenue growth without new formulations or indications.

FAQs

Q1: Is there any ongoing patent protection for Wellbutrin?

A: No; the original patents expired in 2006, allowing generic competition. Some formulation-specific patents have expired, limiting brand exclusivity.

Q2: Can Wellbutrin see a resurgence in sales?

A: Unlikely, given extensive generic penetration, unless a new formulation or indication emerges.

Q3: How does the competition impact market share?

A: Generics dominate, reducing the brand’s market share to less than 15% of total bupropion sales.

Q4: What are the prospects for new formulations?

A: Limited; existing patents restrict innovation, and market saturation by generics reduces incentives for new formulations.

Q5: What are the main revenue sources for Wellbutrin currently?

A: Prescriptions of brand formulations with extended-release mechanisms, mainly for patients who prefer brand over generic.

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References

1. WHO. Depression. 2023. https://www.who.int/news-room/fact-sheets/detail/depression

2. IBM Watson Health. Micromedex. Bupropion (Wellbutrin) patent and market data. 2023.

3. IQVIA. The Impact of Generic Entry on Antidepressant Market. 2022.

4. FDA. Approved Drug Products: Bupropion. 2022.

5. GoodRx. Bupropion pricing and formulary data. 2023.

DrugChatter Q&A for WELLBUTRIN

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