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Last Updated: December 22, 2024

WELLBUTRIN XL Drug Patent Profile


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

Wellbutrin Xl is a drug marketed by Bausch and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Wellbutrin Xl

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

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Summary for WELLBUTRIN XL
Drug patent expirations by year for WELLBUTRIN XL
Drug Prices for WELLBUTRIN XL

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Recent Clinical Trials for WELLBUTRIN XL

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

SponsorPhase
PfizerPhase 1
Mclean HospitalPhase 4
Kenya Medical Research InstitutePhase 4

See all WELLBUTRIN XL clinical trials

Pharmacology for WELLBUTRIN XL
Paragraph IV (Patent) Challenges for WELLBUTRIN XL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
WELLBUTRIN XL Extended-release Tablets bupropion hydrochloride 150 mg and 300 mg 021515 1 2004-09-21

US Patents and Regulatory Information for WELLBUTRIN XL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 021515-001 Aug 28, 2003 AB3 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bausch WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 021515-002 Aug 28, 2003 AB3 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for WELLBUTRIN XL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 021515-001 Aug 28, 2003 6,096,341 ⤷  Subscribe
Bausch WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 021515-002 Aug 28, 2003 6,143,327 ⤷  Subscribe
Bausch WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 021515-002 Aug 28, 2003 6,096,341 ⤷  Subscribe
Bausch WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 021515-001 Aug 28, 2003 6,143,327 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

WELLBUTRIN XL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for WELLBUTRIN XL

Introduction

WELLBUTRIN XL, a brand name for bupropion hydrochloride extended-release tablets, has been a significant player in the treatment of major depressive disorder (MDD) and seasonal affective disorder (SAD). This article delves into the market dynamics and financial trajectory of WELLBUTRIN XL, highlighting its growth drivers, market trends, and the strategies employed by its manufacturers.

Clinical Significance and Indications

WELLBUTRIN XL is indicated for the treatment of MDD and the prevention of seasonal major depressive episodes in patients with SAD. It works by preventing the reuptake of dopamine and norepinephrine, which helps in elevating mood and energy levels. The extended-release formulation allows for once-daily dosing, enhancing patient compliance and reducing adverse effects associated with immediate-release formulations[1][4].

Market Growth and Trends

The market for bupropion hydrochloride extended-release tablets, including WELLBUTRIN XL, has experienced significant growth in recent years. This growth is largely driven by the increasing incidence of mental health illnesses and the growing focus on efficient treatment alternatives. The global market is projected to expand at a compound annual growth rate (CAGR) of approximately 8-10%, with estimates suggesting the market will exceed several billion dollars in value over the next few years[1].

Historical Sales and Pricing Strategies

Historically, WELLBUTRIN XL has seen substantial sales growth, particularly under the management of Valeant Pharmaceuticals. Despite a decline in the number of prescriptions, dollar sales of WELLBUTRIN XL increased significantly due to strategic price hikes. For instance, between 2013 and 2015, sales of WELLBUTRIN XL rose from around $150 million to over $300 million, with the retail price for a year’s supply increasing to about $17,000. This was achieved through 11 price increases over two years, with an average quarterly increase of 21%[3].

Role of Specialty Pharmacies

Valeant's strategy also involved partnerships with specialty pharmacies, such as Direct Success Inc., to enhance sales. These pharmacies helped in securing reimbursement and ensuring that prescriptions were filled without generic substitutes, which contributed to the growth spurt in WELLBUTRIN XL sales[3].

Impact of Generic Competition

Generic competition has been a significant factor in the market dynamics of WELLBUTRIN XL. Generic versions of the 300mg and 150mg tablets became available in 2006 and 2008, respectively, leading to a decline in sales. For example, US sales of WELLBUTRIN XL dropped by 70% in the first quarter of 2009 compared to the previous year[5].

Divestment and Ownership Changes

In 2009, GlaxoSmithKline (GSK) divested the US commercial rights for WELLBUTRIN XL to Biovail International Laboratories for $510 million. This move was part of GSK's strategy to reshape its US business and maximize the value of its current assets. GSK retained rights to WELLBUTRIN XL outside the US[5].

Financial Performance

The financial performance of WELLBUTRIN XL has been robust, despite challenges from generic competition. The drug's high pricing strategy and effective marketing have contributed to its revenue. For instance, the partnership with specialty pharmacies and the practice of covering co-pays for consumers while increasing prices to insurers helped maintain high sales figures[3].

Future Outlook

The future outlook for WELLBUTRIN XL and similar bupropion hydrochloride extended-release formulations remains positive. The increasing awareness of mental health issues and the need for effective antidepressants are expected to drive market growth. However, the market will likely face continued pressure from generic competition and regulatory scrutiny over pricing practices[1].

Regulatory and Market Challenges

Regulatory challenges, particularly regarding pricing practices, have been a significant issue for WELLBUTRIN XL. Insurers have begun to scrutinize price increases more closely, which could impact future sales. Additionally, the emergence of new treatments and the evolving landscape of mental health care may present both opportunities and challenges for the drug[3].

Conclusion

The market dynamics and financial trajectory of WELLBUTRIN XL are characterized by significant growth driven by clinical efficacy, strategic pricing, and effective marketing. However, the drug faces challenges from generic competition, regulatory scrutiny, and evolving market trends. As the global market for bupropion hydrochloride extended-release tablets continues to grow, manufacturers must navigate these complexities to maintain market share.

Key Takeaways

  • Clinical Efficacy: WELLBUTRIN XL is effective in treating MDD and SAD, with a once-daily dosing regimen that enhances patient compliance.
  • Market Growth: The market for bupropion hydrochloride extended-release tablets is growing at a CAGR of 8-10%, driven by increasing mental health awareness.
  • Pricing Strategies: Strategic price hikes and partnerships with specialty pharmacies have significantly impacted sales.
  • Generic Competition: Generic versions have affected sales, but the brand has maintained revenue through effective marketing.
  • Regulatory Scrutiny: Pricing practices are under increasing regulatory scrutiny, which may impact future sales.

FAQs

Q: What is WELLBUTRIN XL used for? A: WELLBUTRIN XL is used for the treatment of major depressive disorder (MDD) and the prevention of seasonal major depressive episodes in patients with seasonal affective disorder (SAD).

Q: How has the sales performance of WELLBUTRIN XL been in recent years? A: Despite a decline in prescriptions, dollar sales of WELLBUTRIN XL have increased due to strategic price hikes and effective marketing strategies.

Q: What role have specialty pharmacies played in the sales of WELLBUTRIN XL? A: Specialty pharmacies have helped in securing reimbursement and ensuring prescriptions are filled without generic substitutes, contributing to the growth in sales.

Q: How has generic competition affected WELLBUTRIN XL sales? A: Generic competition has led to a decline in sales, particularly after generic versions of the 300mg and 150mg tablets became available.

Q: Who currently holds the commercial rights for WELLBUTRIN XL in the US? A: The commercial rights for WELLBUTRIN XL in the US were divested to Biovail International Laboratories by GlaxoSmithKline in 2009.

Sources

  1. Market Research Intellect - "Unlocking Potential: Trends Driving the Bupropion Hydrochloride Extended Release Market"
  2. Bausch Health Companies Inc. - "2022 Annual Report"
  3. Financial Post - "How Valeant Pharmaceuticals Inc tripled prices, doubled sales of flatlining old drug Wellbutrin XL"
  4. FDA - "WELLBUTRIN XL Label"
  5. GlaxoSmithKline - "GlaxoSmithKline to divest US rights for Wellbutrin XL® to Biovail for $510 million"

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