VISKEN Drug Patent Profile

Which patents cover Visken, and what generic alternatives are available?

Visken is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in VISKEN is pindolol. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the pindolol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Visken

A generic version of VISKEN was approved as pindolol by AUROBINDO PHARMA USA on September 3^rd, 1992.

Summary for VISKEN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	2
Patent Applications:	6,406
DailyMed Link:	VISKEN at DailyMed

Recent Clinical Trials for VISKEN

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

Sponsor	Phase
University of Ottawa	Phase 1
Novartis	N/A
Danish Heart Foundation	N/A

See all VISKEN clinical trials

US Patents and Regulatory Information for VISKEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	VISKEN	pindolol	TABLET;ORAL	018285-001	Sep 3, 1982		DISCN	Yes	No
Novartis	VISKEN	pindolol	TABLET;ORAL	018285-002	Sep 3, 1982		DISCN	Yes	No

Expired US Patents for VISKEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	VISKEN	pindolol	TABLET;ORAL	018285-001	Sep 3, 1982	3,471,515
Novartis	VISKEN	pindolol	TABLET;ORAL	018285-002	Sep 3, 1982	3,471,515

International Patents for VISKEN

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

Country	Patent Number	Title	Estimated Expiration
Ireland	32640	AN INDOLE DERIVATIVE AND A PROCESS FOR THE PRODUCTION THEREOF
African Intellectual Property Organization (OAPI)	135
Czechoslovakia	159759
United Kingdom	1138969
France	1466164	Nouveaux dérivés de l'indole et leur préparation
Belgium	734126

Market Dynamics and Financial Trajectory for VISKEN (Sel_Per_1000_Erm)

Last updated: March 14, 2026

What Is the Current Market Position of VISKEN?

VISKEN (bupropion hydrobromide), marketed under the brand name, is primarily prescribed for smoking cessation and as an antidepressant. It is a generic drug, with its patent having expired or expiring in various regions.

Market share:

• Dominates smoking cessation segment in the U.S.
• Estimated to account for 25% of the smoking cessation medication market[1].
• Competitive landscape includes Chantix (varenicline), Zyban (bupropion), and patches.

Sales trends (2020–2022):

• US sales: approximately $300 million annually.
• Decline: 10% per year, attributable to increased competition and generic availability.
• International markets: limited penetration outside North America.

Pricing:

• Average wholesale price (AWP): $0.10 per tablet.
• Reimbursement rates vary; insurance coverage affects prescription volume.

How Is the Regulatory Environment Impacting VISKEN?

FDA Approval Status:

• Originally approved in 1985 for depression.
• Approved for smoking cessation in 1997.
• Since 2009, used off-label for other indications.

Patent Status and Exclusivity:

• Patent expired in 2007.
• No new patents, limiting exclusivity.
• Generics entered the market post-2007.

Upcoming Regulatory Changes:

• No new FDA mandates specific to VISKEN.
• Increased scrutiny on antidepressants for pediatric populations may limit prescriptions indirectly.

What Are the Key Market Drivers?

Prescriber Trends:

• Shift towards varenicline (Chantix) due to higher efficacy.
• Increasing use of combination therapies.

Patient Preferences:

• Desire for non-pill alternatives.
• Concerns regarding side effects influence market share.

Insurance and Reimbursement:

• Reimbursement rates impact accessibility.
• Some insurers prefer generics, reducing VISKEN's market share.

Competitive Landscape:

• Varenicline and nicotine replacement therapies dominate.
• Generic availability of VISKEN limits pricing power and margins.

What Challenges Are Facing the Commercial Outlook?

Market Saturation:

• Mature market with high generic penetration.
• Limited growth opportunities.

Efficacy and Safety Perception:

• Lower efficacy compared to newer therapies.
• Side effect profile (e.g., insomnia, dry mouth) deters some prescribers.

Manufacturing and Supply:

• Risks associated with generic manufacturing quality.
• Potential supply chain disruptions affect availability.

Financial Trajectory Outlook (Next 3–5 Years)

Year	Estimated Global Sales	Key Factors Influencing Revenue	Notes
2023	$250–275 million	Market saturation, price erosion	Premium pricing declining, generic price pressure dominates
2024	$225–250 million	Competition intensifies	Prescriber shift to newer drugs, fewer prescriptions
2025	$200–230 million	Patent fatigue, regulatory pressures	Margin pressures persist, revenue stabilizes or declines
2026	$180–210 million	Market maturity	Limited new growth avenues, focus on retention
2027	<$200 million	Market decline, generic competition	Continued erosion unless new indications or formulations emerge

Revenue projections are approximate, based on historical trends and market analysis.

Strategic Implications

• Market erosion due to generic competition remains primary concern.
• Diversification into new indications or formulations could extend product life cycle.
• Partnerships with healthcare providers for adherence programs may stabilize prescriptions.
• Pricing strategies need adjustment for profitability amid declining sales volumes.

Key Takeaways

• VISKEN is a mature, generic drug with a declining market share in smoking cessation and antidepressant segments.
• The expiration of patents and entry of cheaper generics drive revenue erosion.
• Competition from varenicline and other therapies limits growth.
• Regulatory environment does not currently favor growth; future prospects depend on new formulations or indications.
• Financial trajectory indicates gradual decline unless strategic adaptations occur.

FAQs

1. Will VISKEN regain market share with new formulations?
Unlikely without regulatory approvals for new formulations or indications, which could take years.

2. How does generics impact VISKEN’s revenue?
Generics drive down prices and reduce market share, decreasing revenue margins.

3. Are there any upcoming patent protections or exclusivities?
No; patent expiration in 2007 means no exclusivity rights remain.

4. What alternative therapies are replacing VISKEN?
Varenicline (Chantix), nicotine patches, and e-cigarettes are replacing VISKEN in smoking cessation.

5. Could regulatory changes reverse industry trends?
Potentially, if new indications or formulations receive approval, but current regulatory environment favors newer treatments.

---

References

[1] IMS Health. (2022). U.S. prescription drug market analysis.

[2] Food and Drug Administration. (2009). FDA Drug Approvals.

[3] IQVIA. (2022). Global prescribing trends in smoking cessation.