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-eight 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:	138
Clinical Trials:	85
Patent Applications:	4,148
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

Expired US Patents for WELLBUTRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-001	Dec 30, 1985	4,438,138
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-002	Dec 30, 1985	4,057,323
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-002	Dec 30, 1985	4,425,363

International Patents for WELLBUTRIN

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

Country	Patent Number	Title	Estimated Expiration
Germany	2059618
Malaysia	7700107	BIOLOGICALLY ACTIVE KETONES
Canada	977778

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
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	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

WELLBUTRIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Wellbutrin (Bupropion Hydrochloride)

Introduction to Wellbutrin

Wellbutrin, known generically as Bupropion Hydrochloride, is an atypical antidepressant primarily used to treat major depressive disorder (MDD), seasonal affective disorder (SAD), and as an aid in smoking cessation. The drug's extended-release formulation, Wellbutrin XL, has been a significant player in the mental health treatment market.

Market Growth and Drivers

The global market for Bupropion Hydrochloride Extended Release tablets has experienced remarkable growth in recent years. This growth is driven by several key factors:

Increasing Prevalence of Mental Health Disorders

The rising incidence of mental health illnesses, particularly among adolescents and young adults, has significantly boosted the demand for effective antidepressants. Approximately 1 in 5 adults in the U.S. experiences mental illness each year, with depression being one of the leading causes of disability worldwide[1].

Enhanced Patient Compliance and Efficacy

The extended-release formulation of Bupropion Hydrochloride allows for a gradual release of the medication into the bloodstream, providing sustained therapeutic effects and minimizing side effects. This formulation enhances patient compliance and reduces the adverse effects associated with immediate-release drugs[1].

Regulatory Approvals and Expanding Indications

Regulatory agencies have been approving new indications for Bupropion Hydrochloride, expanding its use beyond depression to include anxiety disorders and smoking cessation. This regulatory momentum increases the potential market size and encourages pharmaceutical companies to invest in expanding the therapeutic applications of Bupropion[1].

Financial Trajectory

Market Size and Growth Rate

The global market for Bupropion Hydrochloride Extended Release tablets is projected to exceed several billion dollars in value over the next few years, with a compound annual growth rate (CAGR) of approximately 8-10%. This significant growth is fueled by the increasing awareness of mental health issues and the corresponding rise in prescriptions for effective antidepressants[1].

Investment and Research

Investors are recognizing the potential of the Bupropion Hydrochloride Extended Release market, leading to increased funding for research and development. Pharmaceutical companies are investing heavily in clinical trials to further validate the efficacy and safety of Bupropion, especially in specific populations such as those with comorbid conditions. Strategic partnerships between biotech firms and research institutions are also on the rise, focusing on enhancing the formulation and delivery of Bupropion Hydrochloride[1].

Historical Transactions and Market Impact

In 2009, GlaxoSmithKline (GSK) divested the US rights for Wellbutrin XL to Biovail for $510 million. This transaction was part of GSK's strategy to reshape its US business and manage the transition in its product portfolio. The deal highlighted the significant value of Wellbutrin XL in the market, even in the face of generic competition that began in 2006 and 2008 for different dosages[2].

Cost and Pricing Dynamics

Factors Influencing Cost

The cost of Wellbutrin without insurance varies based on factors such as dosage, the pharmacy used, and available savings programs. Generally, there is not a significant cost difference between Wellbutrin XL and Wellbutrin SR, although the extended-release formulation may require fewer doses, potentially lowering the overall cost[5].

Generic Competition

The introduction of generic versions of Wellbutrin has led to lower costs for patients. Generic drugs contain the same active ingredients as brand-name drugs but do not require the same costly testing, resulting in marketplace competition that drives down prices[5].

Long-Term Cost Management

Patients taking Wellbutrin long-term can manage costs by opting for a 90-day supply, which can reduce the number of trips to the pharmacy and help lower the overall cost. This option, if approved by insurance companies, can be a cost-effective strategy[5].

Innovations and Future Prospects

Alternative Delivery Methods

Recent innovations include alternative delivery methods such as transdermal patches and subcutaneous injections. These new delivery methods are part of ongoing research partnerships aimed at enhancing product formulation and catering to unmet needs in mental health treatment[1].

Personalized Medicine

The trend towards personalized medicine allows healthcare providers to tailor antidepressant therapy to individual patients. Bupropion Hydrochloride is an appealing option for patients who do not respond well to traditional treatments, further solidifying its position in the market[1].

Key Takeaways

• The global market for Bupropion Hydrochloride Extended Release tablets is experiencing significant growth driven by increasing mental health awareness and the need for effective antidepressants.
• The extended-release formulation enhances patient compliance and efficacy, making it a preferred option for clinicians and patients.
• Regulatory approvals for new indications and investments in research and development are key drivers of market growth.
• The cost of Wellbutrin can be managed through generic options, savings programs, and long-term supply strategies.
• Innovations in delivery methods and personalized medicine are expected to further boost the market.

FAQs

What is the primary use of Wellbutrin (Bupropion Hydrochloride)?

Wellbutrin is primarily used to treat major depressive disorder (MDD), seasonal affective disorder (SAD), and as an aid in smoking cessation.

How does the extended-release formulation of Wellbutrin benefit patients?

The extended-release formulation allows for a gradual release of the medication into the bloodstream, providing sustained therapeutic effects and minimizing side effects, which enhances patient compliance.

What are the key drivers of the growth in the Bupropion Hydrochloride market?

The growth is driven by the increasing prevalence of mental health disorders, rising awareness, and investment in effective treatment options, as well as regulatory approvals for new indications.

How can patients manage the cost of Wellbutrin?

Patients can manage costs by opting for generic versions, using savings programs, and getting a 90-day supply if approved by their insurance company.

What are some of the recent innovations in the Bupropion Hydrochloride market?

Recent innovations include alternative delivery methods such as transdermal patches and subcutaneous injections, as well as a focus on personalized medicine to tailor treatment to individual patients.

Sources

1. Market Research Intellect: "Unlocking Potential: Trends Driving the Bupropion Hydrochloride Extended Release Market"[1].
2. GlaxoSmithKline: "GlaxoSmithKline to divest US rights for Wellbutrin XL® to Biovail for $510 million"[2].
3. FDA: "Wellbutrin (bupropion hydrochloride) tablets label"[3].
4. Valuates Reports: "Bupropion Hydrochloride - Market Size"[4].
5. Medical News Today: "Wellbutrin cost 2024: Coupons and more"[5].