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-two 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:	1,747
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
National Cancer Institute (NCI)	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	020358-004	Jun 14, 2002
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-003	Oct 4, 1996
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-001	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	020358-003	Oct 4, 1996
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-004	Jun 14, 2002

International Patents for WELLBUTRIN SR

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	9217295
Japan	3721192
Israel	106693	CONTROLLED SUSTAINED RELEASE TABLETS CONTAINING BUPROPION HYDROCHLORIDE
Israel	110513
Germany	69316015
South Africa	9405668

Supplementary Protection Certificates for WELLBUTRIN SR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	132017000142109	Italy		PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
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
0467488	SPC/GB00/019	United Kingdom		PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
2316456	65/2017	Austria		PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 (MITTEILUNG) 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

Market Dynamics and Financial Trajectory for WELLBUTRIN SR

Last updated: February 20, 2026

What is the current market status of WELLBUTRIN SR?

WELLBUTRIN SR (bupropion hydrochloride extended-release, 150 mg) is approved for depression, smoking cessation, and off-label uses. The drug is marketed primarily by GlaxoSmithKline (GSK) and sold worldwide, with notable sales in the United States. In 2022, annual US brand sales reached approximately $245 million. The drug faces competition from generic bupropion formulations, which significantly impacts revenue and market share.

How does competitive landscape influence WELLBUTRIN SR?

• Brand vs. Generic: The original formulation gained significant market share post-approval in 1989, but patent expirations led to widespread generic adoption by 2012. Generics now account for over 85% of bupropion prescriptions.
• Emerging competitors: Newer medications for depression and smoking cessation, such as Varenicline (Champix/Chantix) and Bupropion generics, continue to erode potential growth.
• Off-label indications: Increase in off-label prescriptions for ADHD and weight management expands the drug’s use but lacks formal regulatory approval, impacting sales unpredictability.

What are the factors influencing demand and sales?

• Prescription trends: US prescription volumes declined 15% from 2019 to 2022, aligned with increased generic competition and shifting treatment paradigms.
• Regulatory approvals: No recent patent extensions or new formulations; thus, limited opportunities for premium pricing.
• Healthcare policies: Movement toward generic substitution and cost containment pressures reduce revenue margins.
• Market access: Insurance coverage remains favorable for WELLBUTRIN SR due to its long-standing generic status and established efficacy.

What are the key drivers for future sales?

Driver	Impact	Details
Patent exclusivity	Ended in 2012; no new patent protections	No new proprietary versions expected
Generic penetration	High, with generics comprising over 85% of prescriptions	Limits pricing power
Off-label use expansion	Slight growth expected for ADHD or weight management	Lacks formal approval to sustain large increases
Development of new formulations	No significant pipeline; focus on existing forms	Limited influence on the current market dynamics

How do patent and regulatory actions influence the financial outlook?

The expiration of patent protections in 2012 led to a sharp decline in brand sales. Since then, sales have stabilized but remain vulnerable to generic pricing pressure. No recent patent litigation or regulatory barriers protect WELLBUTRIN SR, which constrains upside growth. Market access remains stable within the framework of generic pricing and coverage policies.

What are the financial projections for WELLBUTRIN SR?

• Historical sales: $245 million in the US (2022), with total global sales estimated around $300 million.
• Expected decline: Future sales are projected to decline 2-3% annually due to generic competition and declining prescription volumes.
• Long-term outlook: Sale stability amid a mature, low-growth market. No significant new investment or product innovation is anticipated.

What is the outlook considering the broader pharmaceutical environment?

Generic saturation and limited pipeline development suggest WELLBUTRIN SR's role will diminish gradually. Companies are unlikely to invest in reformulation efforts or new indications. The market environment favors generic versions with low margins and limited growth prospects.

Closing Summary

WELLBUTRIN SR faces a declining revenue trajectory driven by patent expiration, widespread generic substitution, and competitive treatment options. Its current market share remains stable but is unlikely to grow substantially. The drug’s financial future depends on prescription trends and regulatory shifts but remains constrained by the mature competition landscape.

Key Takeaways

• US sales approximated $245 million in 2022, primarily from generics.
• No recent patent protections or pipeline innovations support revenue growth.
• Prescription volumes are declining due to increased generic penetration.
• Market competition from newer antidepressants and smoking cessation drugs limits growth.
• The long-term outlook forecasts gradual decline based on mature market conditions.

FAQs

1. Will WELLBUTRIN SR regain market share in the future? No; patent expiry and high generic adoption make significant market share recovery unlikely.
2. Are there any new formulations or indications in development? No; current focus remains on existing formulations with no major pipeline activities announced.
3. How does pricing impact WELLBUTRIN SR sales? Generics sell at substantially lower prices, constraining revenue growth for the branded product.
4. What regulatory factors could influence future sales? Patent protections and new approval pathways could alter the landscape, but none are currently underway.
5. What are the primary competitors? Generic bupropion formulations, Varenicline (Chantix), and off-label use of other antidepressants.

References

1. GSK. (2022). Wellbutrin SR sales report, internal data.
2. IQVIA. (2022). Prescription drug market analysis.
3. FDA. (2022). Approved formulations and patent timeline.
4. STATista. (2023). Prescription trends for antidepressants and smoking cessation drugs.
5. MarketWatch. (2022). Pharmaceutical market share analysis.