NEURONTIN Drug Patent Profile

Which patents cover Neurontin, and when can generic versions of Neurontin launch?

Neurontin is a drug marketed by Viatris and is included in three NDAs.

The generic ingredient in NEURONTIN is gabapentin. There are twenty-nine drug master file entries for this compound. Eighty-two suppliers are listed for this compound. Additional details are available on the gabapentin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Neurontin

A generic version of NEURONTIN was approved as gabapentin by ACTAVIS ELIZABETH on September 12^th, 2003.

Summary for NEURONTIN

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	127
Patent Applications:	4,646
Drug Prices:	Drug price information for NEURONTIN
Drug Sales Revenues:	Drug sales revenues for NEURONTIN
What excipients (inactive ingredients) are in NEURONTIN?	NEURONTIN excipients list
DailyMed Link:	NEURONTIN at DailyMed

See drug prices for NEURONTIN

See drug sales revenues for NEURONTIN

Recent Clinical Trials for NEURONTIN

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

Sponsor	Phase
Dianne Lou	Phase 1/Phase 2
Viatris Specialty LLC	Phase 4
CAMC Health System	Phase 4

See all NEURONTIN clinical trials

Pharmacology for NEURONTIN

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

US Patents and Regulatory Information for NEURONTIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viatris	NEURONTIN	gabapentin	CAPSULE;ORAL	020235-001	Dec 30, 1993	AB	RX	Yes	No
Viatris	NEURONTIN	gabapentin	SOLUTION;ORAL	021129-001	Mar 2, 2000	AA	RX	Yes	Yes
Viatris	NEURONTIN	gabapentin	CAPSULE;ORAL	020235-002	Dec 30, 1993	AB	RX	Yes	No
Viatris	NEURONTIN	gabapentin	CAPSULE;ORAL	020235-003	Dec 30, 1993	AB	RX	Yes	Yes
Viatris	NEURONTIN	gabapentin	TABLET;ORAL	020882-002	Oct 9, 1998	AB1	RX	Yes	Yes
Viatris	NEURONTIN	gabapentin	TABLET;ORAL	020882-001	Oct 9, 1998	AB1	RX	Yes	No

Expired US Patents for NEURONTIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	NEURONTIN	gabapentin	TABLET;ORAL	020882-001	Oct 9, 1998	4,087,544*PED
Viatris	NEURONTIN	gabapentin	SOLUTION;ORAL	021129-001	Mar 2, 2000	6,054,482*PED
Viatris	NEURONTIN	gabapentin	CAPSULE;ORAL	020235-002	Dec 30, 1993	4,894,476*PED
Viatris	NEURONTIN	gabapentin	TABLET;ORAL	020882-001	Oct 9, 1998	5,084,479*PED
Viatris	NEURONTIN	gabapentin	SOLUTION;ORAL	021129-001	Mar 2, 2000	4,894,476*PED
Viatris	NEURONTIN	gabapentin	CAPSULE;ORAL	020235-003	Dec 30, 1993	4,894,476*PED
Viatris	NEURONTIN	gabapentin	CAPSULE;ORAL	020235-001	Dec 30, 1993	4,087,544*PED

International Patents for NEURONTIN

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

Country	Patent Number	Title	Estimated Expiration
France	2294697
Serbia	87203
European Patent Office	1395242	COMPOSITION PHARMACEUTIQUE LIQUIDE (LIQUID PHARMACEUTICAL COMPOSITION)
Peru	20030087	COMPOSICION FARMACEUTICA LIQUIDA DE UN ANALOGO DE GABA
Bulgaria	108376
Georgia, Republic of	P20053620	Liquid Pharmaceutical Composition
World Intellectual Property Organization (WIPO)	02094220

Market Dynamics and Financial Trajectory for Neurontin (Gabapentin)

Last updated: July 27, 2025

Introduction

Neurontin (gabapentin), developed by Parke-Davis in the early 1990s, has established itself as a significant player in the pharmaceutical landscape primarily for its indications in neuropathic pain, epilepsy, and off-label uses. As a gamma-aminobutyric acid (GABA) analog, Neurontin’s pharmacological profile and subsequent market performance reflect broader trends within neurologic therapeutics, regulatory shifts, and competitive pressures. This report assesses the evolving market dynamics and forecasts the financial trajectory of Neurontin over the next decade, underpinning these insights with current data and market analysis.

Market Background and Historical Overview

Initially approved by the U.S. Food and Drug Administration (FDA) in 1993 for adjunctive treatment of partial seizures, Neurontin quickly gained prominence owing to its perceived safety profile and tolerability. Its broader application to neuropathic pain conditions, such as postherpetic neuralgia, garnered additional market share. However, the global blockbuster status—peaking at approximately $3 billion in annual sales—began to decline sharply after the patent expiration in 2009.

Following patent expiry, generic formulations rapidly flooded the market, dramatically reducing Neurontin’s price point and sales volumes. Despite this, the drug continued to generate revenues due to ongoing off-label prescribing, a common phenomenon in neurological therapeutics. Currently, with generics dominating and off-label use shifting, the brand’s financial contribution has notably waned, but certain niche markets still provide revenue streams.

Market Dynamics

1. Patent Expiry and Generic Competition

The primary driver influencing Neurontin’s market trajectory remains patent expiration. The 2009 patent cliff facilitated a surge in generic gabapentin availability, which caused revenues to plummet by over 80% within a few years. The intense price competition from multiple generic manufacturers further suppressed margins. This phenomenon exemplifies a broader trend where patent expiries lead to commoditization, compressing profits and forcing pharmaceutical companies to innovate or diversify.

2. Off-Label Use and Physician Prescribing Behavior

Despite incoming generics, off-label prescribing sustains some demand for Neurontin. Physicians often prescribe gabapentin for conditions beyond approved indications, including bipolar disorder, anxiety, and sleep disorders, despite regulatory warnings about off-label efficacy and safety concerns. This off-label use, in the absence of patent protection, enables certain stakeholders to maintain revenues, albeit at diminished levels. The ongoing debate over the clinical evidence supporting these off-label applications influences prescribing practices and regulatory oversight.

3. Regulatory and Legal Environment

Legal actions, including numerous lawsuits alleging off-label marketing misconduct, have impacted both public perception and market access strategies. In 2014, Pfizer (which acquired Warner-Lambert, the original patent holder before divestitures) settled federal investigations for unlawful drug marketing practices related to Neurontin, leading to reputational and financial repercussions. Such regulatory developments influence corporate strategies surrounding branding and marketing, further accelerating the shift toward generic reliance.

4. Competitive Landscape and Emerging Therapies

Several newer anticonvulsants and neuropathic pain medications have entered the market, offering alternative mechanisms and improved efficacy profiles. Drugs like pregabalin (Lyrica), which was developed by Pfizer as a successor to Neurontin, captured market share due to patent protections and marginally improved pharmacokinetic profiles. The competition from such agents pressures Neurontin’s remaining market segments, especially for specific indications.

5. Market Segmentation and Niche Opportunities

While the general market for Neurontin has contracted considerably, niche segments—pediatric, refractory cases, or specific neurological disorders—still maintain marginal demand. Additionally, emerging regional markets, particularly in developing economies, continue to present opportunities due to less stringent regulatory environments and lower generic penetration.

Financial Trajectory: Forecasting Through 2030

1. Revenue Decline Post-Patent Expiry

Following patent expiration in 2009, revenues collapsed sharply. Although off-label prescribing and niche litigation-related sales mitigated some decline temporarily, the overall trend has been negative. Current estimates suggest Neurontin generates less than $200 million annually globally, predominantly from legacy markets in the U.S., Europe, and select Asian countries (IQVIA, 2022).

2. Impact of Market Saturation and Generic Competition

By 2025, continued generic saturation and controlled prescriber influence are expected to reduce revenues further. The proliferation of low-cost generics diminishes profit margins, with forecasted annual revenue decreases of approximately 5-7% over the next five years unless novel indications or formulations are introduced.

3. Potential for Lifecycle Extension or Repositioning

Given the declining trajectory, pharmaceutical companies may explore lifecycle extension strategies, including:

• Developing New Formulations: Extended-release or combination products.
• Reprofiling for New Indications: Clinical trials targeting specific refractory conditions.
• Regional Market Expansion: Focusing on emerging markets with less extensive generic penetration.

However, such strategies face hurdles regarding clinical validation, regulatory approval, and competitive entry by newer agents.

4. Long-term Outlook to 2030

Considering the market trends, the forecast indicates a continued decline in Neurontin revenue, stabilizing at a residual niche level. The population relying on off-label use may persist, but its impact diminishes as newer therapies with better safety profiles replace gabapentin in clinical practice.

Projected annual revenues by 2030 anticipate a further decrease, stabilizing around $50–$100 million globally. The majority of remaining sales are expected from regional markets and legacy therapeutic indications, with little likelihood of significant growth absent novel formulations or indications.

Market Outlook Summary

• The original blockbuster status of Neurontin faded post-patent expiry.
• Generic competition and regulatory scrutiny significantly curtailed revenues.
• Off-label use sustains limited demand but faces increasing clinical and regulatory challenges.
• Emerging therapies and newer anticonvulsants overshadow Neurontin in most indications.
• Long-term revenues are projected to decline gradually into a niche market with minimal growth prospects.

Key Takeaways

• Patent expiration in 2009 marked a pivotal shift, transforming Neurontin from a branded blockbuster to a commoditized product.
• Generic proliferation, coupled with legal and regulatory constraints, depresses revenues and margins.
• Off-label prescribing remains a secondary revenue source but diminishes due to clinical and legal challenges.
• The rise of alternative therapies, notably pregabalin, erodes Neurontin’s market share.
• Future growth hinges on lifecycle extension strategies, but these face significant hurdles, with revenues likely stabilizing at a fraction of peak levels.

FAQs

1. How has patent expiration affected Neurontin’s market share?
Patent expiry in 2009 led to rapid generic entry, drastically reducing Neurontin’s market share and revenues. The shift resulted in price competition and minimized brand dominance.

2. What role does off-label use play in Neurontin’s current market?
Off-label prescribing sustains residual demand, particularly for certain neuropathic and psychiatric conditions; however, regulatory scrutiny and clinical evidence limitations restrict growth.

3. Are there therapeutic developments that could revive Neurontin’s revenues?
Potential exists if new formulations, combinations, or indications gain regulatory approval, but significant clinical and commercial hurdles exist, making revival unlikely.

4. How does the competitive landscape impact Neurontin’s future?
The emergence of improved newer agents like pregabalin and gabapentinoids continues to erode Neurontin’s market. Competition from generics further limits pricing power.

5. What strategic moves can pharmaceutical companies consider for Neurontin?
Strategies include exploring niche or refractory indications, regional market expansion, or lifecycle extensions through reformulation or novel delivery methods.

References

[1] IQVIA. (2022). Global Medicine Spending and Usage Trends.
[2] U.S. Food and Drug Administration (FDA). (1993). Neurontin (Gabapentin) New Drug Application.
[3] U.S. Department of Justice. (2014). Settlement re: Unlawful Marketing of Neurontin.
[4] MarketResearch.com. (2023). Neurological Disorder Therapeutics Market Analysis.
[5] EvaluatePharma. (2022). 10-Year Forecast for Central Nervous System Drugs.