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. Seventy-eight 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:	2
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	126
Patent Applications:	4,301
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	020882-002	Oct 9, 1998	4,894,476*PED
Viatris	NEURONTIN	gabapentin	CAPSULE;ORAL	020235-003	Dec 30, 1993	4,024,175
Viatris	NEURONTIN	gabapentin	SOLUTION;ORAL	021129-001	Mar 2, 2000	6,054,482*PED
Viatris	NEURONTIN	gabapentin	TABLET;ORAL	020882-001	Oct 9, 1998	6,054,482*PED
Viatris	NEURONTIN	gabapentin	TABLET;ORAL	020882-002	Oct 9, 1998	5,084,479*PED
Viatris	NEURONTIN	gabapentin	CAPSULE;ORAL	020235-003	Dec 30, 1993	6,054,482*PED
Viatris	NEURONTIN	gabapentin	CAPSULE;ORAL	020235-002	Dec 30, 1993	4,024,175

International Patents for NEURONTIN

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

Country	Patent Number	Title	Estimated Expiration
China	100346779
World Intellectual Property Organization (WIPO)	02094220
Denmark	581475
European Patent Office	1395242	COMPOSITION PHARMACEUTIQUE LIQUIDE (LIQUID PHARMACEUTICAL COMPOSITION)
Japan	H04210915	NOVEL THERAPY FOR NERVE DENATURATION DISEASE
Hong Kong	1062646
Denmark	0414263

NEURONTIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Gabapentin (NEURONTIN)

Introduction

Gabapentin, marketed under the brand name NEURONTIN, is a versatile medication used primarily for the treatment of epilepsy, neuropathic pain, and other neurological conditions. The market for gabapentin is experiencing significant growth, driven by several key factors. Here, we delve into the market dynamics and financial trajectory of gabapentin.

Market Size and Growth

The global gabapentin market is projected to experience substantial growth over the coming years. As of 2022, the market size was valued at approximately USD 2.2 billion and is expected to reach USD 3.7 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 5.90% during the forecast period from 2023 to 2032[3,.

Another forecast suggests that the market could even surpass USD 4.95 billion by 2033, with a CAGR of 6.12% from 2024 to 2033[4].

Key Market Drivers

Several factors are driving the growth of the gabapentin market:

Increasing Prevalence of Neuropathic Pain and Seizures

The rising incidence of neuropathic pain conditions, such as diabetic neuropathy, shingles, and spinal cord injuries, is a significant driver. Gabapentin's effectiveness in managing these conditions has increased its demand[1][3][4].

Growing Demand for Pain Management

The use of gabapentin as a pain management drug is on the rise, particularly for conditions where conventional opioids are less effective. This shift towards gabapentin is driven by its efficacy and relatively safer side effect profile compared to opioids[1][3].

Regulatory Support

Regulatory bodies, such as the FDA, support the introduction of new generic drug formulations, which enhances product availability and affordability in regions like North America[1][3].

Market Segmentation

The gabapentin market is segmented based on several criteria:

By Application

• Epilepsy: This segment held the largest revenue share in 2022 and is expected to continue dominating the market due to the global rise in the prevalence of active epilepsy[3].
• Neuropathic Pain: This segment is anticipated to experience the fastest CAGR during the forecast period due to the increasing prevalence of chronic pain conditions[3].
• Restless Legs Syndrome and Others: These segments also contribute to the market growth, though to a lesser extent[4].

By Dosage Form

• Tablets, Capsules, Oral Solutions: These are the primary dosage forms available in the market[4].

By Type

• Generic and Branded: The branded segment is expected to grow significantly, with a CAGR of 8.7%, due to innovative formulations, increased marketing efforts, and premium pricing[4].

By Distribution Channel

• Hospital Pharmacy, Retail Pharmacy, Online Pharmacy: These channels play crucial roles in the distribution and accessibility of gabapentin[4].

Regional Analysis

The market is geographically segmented into several regions:

North America

• This region held the largest market revenue share in 2022 and is expected to maintain its dominance. The U.S. market holds the largest share within North America, while Canada is the fastest-growing market in the region[1][3][4].

Europe

• The European market is the second largest globally. Factors such as rising demand for anticonvulsants, government initiatives, and product approvals contribute to its growth[1].

Asia-Pacific and Rest of the World

• These regions also show potential for growth, though they are currently smaller compared to North America and Europe. The increasing prevalence of neurological diseases and advancements in healthcare infrastructure are expected to drive growth in these regions[1][3].

Competitive Landscape

The gabapentin market is competitive, with several key players:

• Zydus Pharmaceuticals, Inc.
• Glenmark Pharmaceuticals
• Viatris (formerly Pfizer): Known for its branded version, NEURONTIN[1][3].

Regulatory Environment

As a prescription drug, gabapentin is subject to strict regulations and approval procedures. Pharmaceutical companies must adhere to these regulations to ensure the safety, effectiveness, and proper use of gabapentin. Regulatory scrutiny also focuses on combating misuse and abuse of the drug[3].

Financial Projections

The financial trajectory of gabapentin is promising:

• Market Size in 2023: Approximately USD 2.75 billion[4].
• Projected Market Size by 2032: USD 3.7 billion[3].
• Projected Market Size by 2033: USD 4.95 billion[4].
• CAGR: 5.90% from 2023 to 2032 and 6.12% from 2024 to 2033[3][4].

Challenges and Opportunities

Challenges

• Regulatory Scrutiny: Strict regulations and the need for careful medication management can pose challenges for market growth[4].
• Misuse and Abuse: Efforts to combat the misuse and abuse of gabapentin can impact prescription practices and market dynamics[4].

Opportunities

• Increasing Awareness: Growing awareness and understanding of neuropathic pain and neurological disorders offer opportunities for market expansion[3].
• Innovative Formulations: The introduction of new and innovative formulations, such as extended-release versions, can enhance patient adherence and market growth[4].

"The rising cases of neuropathic pain conditions and certain neurological disorders that gabapentin is commonly used to treat act as drivers in this market."[3]

Key Takeaways

• The gabapentin market is expected to grow significantly, driven by the increasing prevalence of neuropathic pain and seizures.
• North America dominates the market, with the U.S. holding the largest share.
• The branded segment is anticipated to grow faster due to innovative formulations and premium pricing.
• Regulatory support and increasing awareness of neuropathic pain are key drivers.
• The market faces challenges such as regulatory scrutiny and the need to combat misuse and abuse.

FAQs

What is the projected market size of gabapentin by 2032?

The gabapentin market is expected to reach USD 3.7 billion by 2032, growing at a CAGR of 5.90% from 2023 to 2032[3].

Which region holds the largest market share for gabapentin?

North America holds the largest market revenue share for gabapentin, with the U.S. being the largest market within this region[1][3][4].

What are the primary applications of gabapentin?

The primary applications of gabapentin include epilepsy, neuropathic pain, and restless legs syndrome[3][4].

Which segment is expected to grow the fastest in the gabapentin market?

The neuropathic pain segment is anticipated to experience the fastest CAGR during the forecast period due to the increasing prevalence of chronic pain conditions[3].

What are the key drivers of the gabapentin market?

The key drivers include the rising prevalence of neuropathic pain and seizures, increasing usage as a pain management drug, and regulatory support for new generic drug introductions[1][3][4].

Sources

1. Globenewswire: Gabapentin Market Size to Hit USD 3.7 Billion by 2032 at 5.90 CAGR - Report by Market Research Future (MRFR)[1].
2. BMJ: Secular trends in gabapentinoid dispensing by compensated workers in Louisiana[2].
3. Market Research Future: Gabapentin Market Size - Market Research Future[3].
4. Precedence Research: Gabapentin Market Size To Surpass USD 4.95 Billion By 2033[4].
5. Drug Patent Watch: Generic GABAPENTIN INN equivalents, pharmaceutical patent and regulatory information[5].