GABAPENTIN ENACARBIL - Generic Drug Details

What are the generic sources for gabapentin enacarbil and what is the scope of freedom to operate?

Gabapentin enacarbil is the generic ingredient in one branded drug marketed by Azurity and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Gabapentin enacarbil has one hundred and forty-six patent family members in twenty-six countries.

There is one drug master file entry for gabapentin enacarbil. One supplier is listed for this compound.

Summary for GABAPENTIN ENACARBIL

International Patents:	146
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	29
Patent Applications:	407
What excipients (inactive ingredients) are in GABAPENTIN ENACARBIL?	GABAPENTIN ENACARBIL excipients list
DailyMed Link:	GABAPENTIN ENACARBIL at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for GABAPENTIN ENACARBIL

Constraining patent/regulatory exclusivity:

8,795,725

Dosage:

TABLET, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for GABAPENTIN ENACARBIL

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

Sponsor	Phase
Azurity Pharmaceuticals	Phase 4
National Institute on Aging (NIA)	Phase 4
University of Texas at Austin	Phase 4

See all GABAPENTIN ENACARBIL clinical trials

Pharmacology for GABAPENTIN ENACARBIL

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

Anatomical Therapeutic Chemical (ATC) Classes for GABAPENTIN ENACARBIL

N02BF	Gabapentinoids
N02B	OTHER ANALGESICS AND ANTIPYRETICS
N02	ANALGESICS
N	Nervous system

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for GABAPENTIN ENACARBIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HORIZANT	Extended-release Tablets	gabapentin enacarbil	300 mg and 600 mg	022399	1	2019-04-29

US Patents and Regulatory Information for GABAPENTIN ENACARBIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-001	Apr 6, 2011		RX	Yes	Yes	8,114,909
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-002	Dec 13, 2011		RX	Yes	No	8,795,725		Y
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-001	Apr 6, 2011		RX	Yes	Yes	8,686,034
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-001	Apr 6, 2011		RX	Yes	Yes	8,795,725		Y
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-002	Dec 13, 2011		RX	Yes	No	8,114,909

Expired US Patents for GABAPENTIN ENACARBIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-001	Apr 6, 2011	8,048,917
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-002	Dec 13, 2011	8,048,917

International Patents for GABAPENTIN ENACARBIL

Country	Patent Number	Title	Estimated Expiration
Singapore	146643	TREATING OR PREVENTING RESTLESS LEGS SYNDROME USING PRODRUGS OF GABA ANALOGS
Japan	4310271
China	1675165	Methods for synthesis of acyloxyalkyl derivatives of GABA analogs
New Zealand	579515	Treating or preventing restless legs syndrome using prodrugs of gaba analogs
Austria	516801

GABAPENTIN ENACARBIL Market Analysis and Financial Projection

Gabapentin Enacarbil Market Dynamics and Financial Trajectory

Market Introduction

Gabapentin enacarbil, a prodrug of gabapentin, is an analgesic and anticonvulsant medication primarily used to treat moderate to severe restless legs syndrome (RLS) and to relieve nerve pain following shingles (post-herpetic neuralgia)[1][2][4].

Market Growth Drivers

The gabapentin enacarbil market is driven by several key factors:

High Prevalence of Neurological Disorders

The increasing prevalence of neurological disorders such as RLS and post-herpetic neuralgia among the population is a significant driver. As more people are diagnosed with these conditions, the demand for effective treatments like gabapentin enacarbil rises[1][2].

Increasing R&D in Analgesic Drugs

Continuous research and development in the field of analgesic drugs are leading to improved formulations and delivery methods, such as the extended-release tablets of gabapentin enacarbil. This innovation enhances patient compliance and efficacy, contributing to market growth[1][4].

Effectiveness in Treatment

Gabapentin enacarbil's proven effectiveness in treating RLS and post-herpetic neuralgia is a major driver. Positive clinical trial results, such as those from XenoPort's Phase 4 trial, reinforce its therapeutic value and boost market confidence[5].

Market Restraints

Despite the growth drivers, there are several restraints affecting the market:

Side Effects

Common side effects of gabapentin enacarbil, including dizziness, drowsiness, ataxia, somnolence, and nausea, can deter some patients from using the drug. These adverse reactions can impact patient adherence and overall market growth[1][5].

Emergence of Alternative Drugs

The pharmaceutical market is highly competitive, and the emergence of new drugs can pose a challenge to gabapentin enacarbil's market share. Alternative treatments may offer better efficacy or fewer side effects, attracting patients away from gabapentin enacarbil[3].

Regulatory Challenges

Strict regulatory requirements for drug approval and post-marketing surveillance can slow down the market growth. Compliance with FDA regulations, such as those imposed on XenoPort for Horizant, adds to the complexity and cost of maintaining market presence[5].

Market Segmentation

The gabapentin enacarbil market is segmented based on type and application:

Type

• Capsule
• Tablet

Extended-release tablets, such as Horizant, have shown significant growth due to their convenience and efficacy[1][2][4].

Application

• Post-Herpetic Neuralgia (PHN)
• Restless Legs Syndrome (RLS)
• Others

These segments help in understanding the specific needs and trends within different therapeutic areas[1][2][4].

Regional Framework

The market is analyzed across five major regions:

North America

• The U.S. is a significant market due to high awareness and diagnosis rates of neurological disorders.
• Companies like XenoPort and GSK have seen substantial growth in this region[1][2][5].

Europe

• Europe also presents a large market due to the prevalence of RLS and PHN.
• Regulatory environments and healthcare systems play a crucial role in market dynamics here[1][2].

Asia-Pacific (APAC)

• APAC is expected to show rapid growth due to increasing healthcare spending and awareness of neurological treatments.
• Countries like China and India are key markets due to their large populations and growing healthcare needs[1][2].

Middle East and Africa (MEA)

• This region is growing but faces challenges related to healthcare infrastructure and regulatory frameworks.
• There is potential for growth as awareness and healthcare access improve[1][2].

South and Central America

• Similar to MEA, this region has growth potential but is constrained by healthcare infrastructure and economic factors[1][2].

Financial Trajectory

The financial outlook for the gabapentin enacarbil market is positive:

Market Size and Growth Rate

• The market size is expected to grow significantly from 2023 to 2031, with a projected CAGR of around XX%[1][2][4].
• The global market size is anticipated to reach USD XX million by 2031[1][2].

Revenue and Sales

• Net sales of gabapentin enacarbil, such as those of Horizant, have shown substantial growth. For example, Horizant sales increased by 34% in the fourth quarter of 2013 compared to the third quarter[5].
• The revenue growth is driven by increasing prescriptions and expanding therapeutic applications[1][2].

Key Players and Market Strategies

Several key players are active in the gabapentin enacarbil market:

Company Profiles

• Arbor Pharma
• Astellas
• GlaxoSmithKline
• Glenmark Pharma
• Pfizer
• Depomed
• Teva
• Mylan
• Novartis
• Apotex
• Sun Pharmaceutical
• Aurobindo Pharma
• Intas
• Amneal
• Marksans Pharma
• Alkem
• Jiangsu Enhua
• Jiangsu Hengrui
• Sailike Pharma[2]

Growth Strategies

• Organic growth strategies include product launches, product approvals, and patent filings.
• Inorganic growth strategies involve acquisitions, partnerships, and collaborations to expand business and customer base[1][2].

Market Opportunities and Challenges

Opportunities

• Increasing patient awareness and diagnosis rates of neurological disorders.
• Expanding therapeutic applications through ongoing research.
• Growing demand in emerging markets[1][2][3].

Challenges

• Potential side effects and patient adherence issues.
• Regulatory challenges and strict approval processes.
• Competition from new drugs and alternative treatments[1][3][5].

Key Takeaways

• The gabapentin enacarbil market is driven by the high prevalence of neurological disorders and continuous R&D in analgesic drugs.
• The market is segmented by type (capsule, tablet) and application (PHN, RLS, others), with extended-release tablets showing significant growth.
• Regional analysis highlights North America, Europe, and APAC as key markets.
• Financial projections indicate a positive growth trajectory with a significant CAGR from 2023 to 2031.
• Key players employ both organic and inorganic growth strategies to maintain market presence.

FAQs

Q: What is gabapentin enacarbil used for? A: Gabapentin enacarbil is used to treat moderate to severe restless legs syndrome (RLS) and to relieve nerve pain following shingles (post-herpetic neuralgia)[1][2][4].

Q: What are the common side effects of gabapentin enacarbil? A: Common side effects include dizziness, drowsiness, ataxia, somnolence, and nausea[1][5].

Q: Which regions are expected to show significant growth in the gabapentin enacarbil market? A: North America, Europe, and Asia-Pacific (APAC) are expected to show significant growth due to high prevalence rates and increasing healthcare spending[1][2].

Q: Who are the key players in the gabapentin enacarbil market? A: Key players include Arbor Pharma, Astellas, GlaxoSmithKline, Glenmark Pharma, Pfizer, and others[2].

Q: What is the projected market size of gabapentin enacarbil by 2031? A: The market size is expected to reach USD XX million by 2031, growing at a CAGR of around XX% from 2023 to 2031[1][2][4].

Cited Sources:

1. The Insight Partners: Gabapentin Enacarbil Market Insights and Growth by 2031
2. Market Research Intellect: Gabapentin Enacarbil Market Size, Scope And Forecast Report
3. GlobeNewswire: Gabapentin Market revenue is expected to increase by USD 4.1 Billion by 2032
4. Cognitive Market Research: Global Gabapentin Enacarbil Market Report 2024 Edition
5. Sleep Review: Q4 Horizant Sales Up 34% Compared to Q3