GABAPENTIN - Generic Drug Details

What are the generic sources for gabapentin and what is the scope of patent protection?

Gabapentin is the generic ingredient in four branded drugs marketed by Actavis Elizabeth, Alkem, Amneal Pharms Ny, Ascent Pharms Inc, Aurobindo Pharma, Chartwell Rx, Cspc Ouyi, Granules, Hikma, Invagen Pharms, Ipca Labs Ltd, Laurus, Marksans Pharma, Norvium Bioscience, Rising, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Ltd, Sun Pharm Industries, Taro, Teva Pharms, Watson Labs, Zhejiang Yongtai, Viatris, Acella Pharms Llc, Amneal Pharms, Annora Pharma, Belcher, Mission Pharmacal, Pai Holdings Pharm, Rubicon, Abon Pharms Llc, Alkem Labs Ltd, Apotex, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Hikma Pharms, Humanwell, Invatech, Ivax Sub Teva Pharms, Lupin Ltd, Ranbaxy, Teva, Teva Pharms Usa, Zydus Pharms, Zydus Pharms Usa Inc, Almatica, and Azurity, and is included in seventy-one NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Gabapentin has twenty-four patent family members in nine countries.

There are twenty-nine drug master file entries for gabapentin. Seventy-eight suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for GABAPENTIN

International Patents:	24
US Patents:	6
Tradenames:	4
Applicants:	49
NDAs:	71
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	78
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	518
Patent Applications:	7,121
Drug Prices:	Drug price trends for GABAPENTIN
Drug Sales Revenues:	Drug sales revenues for GABAPENTIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GABAPENTIN
What excipients (inactive ingredients) are in GABAPENTIN?	GABAPENTIN excipients list
DailyMed Link:	GABAPENTIN at DailyMed

See drug prices for GABAPENTIN

See drug sales revenues for GABAPENTIN

Recent Clinical Trials for GABAPENTIN

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

Sponsor	Phase
University of Miami	Phase 3
Tanta University	N/A
Beni-Suef University	Phase 2

See all GABAPENTIN clinical trials

Generic filers with tentative approvals for GABAPENTIN

Applicant	Application No.	Strength	Dosage Form
		600MG	TABLET; ORAL
		300MG	TABLET; ORAL
		600MG	TABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for GABAPENTIN

Drug Class	Anti-epileptic Agent
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Anatomical Therapeutic Chemical (ATC) Classes for GABAPENTIN

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GRALISE	Tablets	gabapentin	300 mg and 600 mg	022544	1	2011-10-31

US Patents and Regulatory Information for GABAPENTIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ipca Labs Ltd	GABAPENTIN	gabapentin	TABLET;ORAL	209855-002	May 29, 2024	AB1	RX	No	No
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-002	Dec 13, 2011		RX	Yes	No			Y	Y
Aurobindo Pharma	GABAPENTIN	gabapentin	CAPSULE;ORAL	078787-003	Jan 31, 2008	AB	RX	No	No
Rising	GABAPENTIN	gabapentin	TABLET;ORAL	217995-001	Jul 19, 2023	AB1	RX	No	No

Expired US Patents for GABAPENTIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-001	Jan 28, 2011
Viatris	NEURONTIN	gabapentin	TABLET;ORAL	020882-002	Oct 9, 1998
Viatris	NEURONTIN	gabapentin	CAPSULE;ORAL	020235-003	Dec 30, 1993
Viatris	NEURONTIN	gabapentin	SOLUTION;ORAL	021129-001	Mar 2, 2000

International Patents for GABAPENTIN

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1773311
Australia	2006332690
Japan	2009522294
Taiwan	200800155

GABAPENTIN Market Analysis and Financial Projection Experimental

Gabapentin Market Dynamics and Financial Trajectory

Introduction to Gabapentin

Gabapentin, a medication initially developed as an antiepileptic drug, has expanded its utility to treat a variety of neurological and chronic pain conditions. Its efficacy in managing neuropathic pain, postherpetic neuralgia, and restless leg syndrome, among other conditions, has driven significant market growth.

Current Market Valuation and Growth Projections

As of 2023, the gabapentin market is valued at approximately USD 2.11 billion. It is projected to reach USD 3.54 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 5.3% during the forecast period[1][2].

Key Drivers of Market Growth

Increasing Prevalence of Neuropathic Pain

The global aging population is a significant factor contributing to the rise in neuropathic pain cases. As the population ages, the demand for medications like gabapentin that effectively treat this type of pain is increasing[1].

Growing Off-Label Use

Gabapentin is increasingly prescribed off-label for various conditions, including anxiety, mood disorders, and insomnia. This expanded use has significantly boosted the demand for the medication[1][2].

Increased Awareness and Availability

Greater awareness of gabapentin's effectiveness and its wider availability have contributed to its growing popularity. More people are now aware of the medication's benefits, leading to increased prescriptions and sales[1].

Market Expansion Strategies

Product Differentiation

Key marketers have focused on developing gabapentin products with unique features, such as extended-release formulations. This differentiation helps in capturing a larger market share by offering patients more convenient and effective treatment options[2].

Market Expansion Through Partnerships

Companies have expanded their reach by partnering with distributors to increase the availability of gabapentin products in new markets. This strategic expansion has helped in increasing revenue generated from gabapentin sales[2].

Promotions and Marketing Campaigns

Investments in marketing and promotional campaigns have been crucial in creating awareness about gabapentin products among patients. Activities such as participating in medical conferences, sponsoring medical research, and conducting educational programs have contributed to the market's growth[2].

Competitive Pricing Strategies

Key marketers have adopted competitive pricing strategies, including offering discounts and promotions, especially on bulk purchases. This approach encourages more customers to buy gabapentin products, thereby driving sales and revenue[2].

Challenges and Safety Considerations

Regulatory Scrutiny and Misuse Concerns

The gabapentin market faces challenges related to potential misuse and dependence, leading to increased regulatory scrutiny and efforts to control its distribution. There are concerns that some gabapentin may be diverted for recreational purposes, although more research is needed to confirm this[2][5].

Side Effects and Adverse Interactions

Gabapentin's side effects, including dizziness, drowsiness, and potential interactions with other medications, have raised safety considerations. These factors necessitate careful prescribing and monitoring by healthcare professionals[2].

Generic Versions and Combination Products

The entry of generic versions of gabapentin into the market has intensified competition and driven down prices, impacting the revenue streams of key pharmaceutical companies. To counter this, manufacturers are developing combination products that contain gabapentin and other medications to improve efficacy or reduce adverse effects. For example, some combination products include gabapentin and opioids to manage chronic pain[2].

Regional Market Dynamics

Dominance of the United States

The United States is expected to dominate the global gabapentin market by capturing the maximum share by 2033. This dominance is attributed to the high prevalence of neurological and chronic pain conditions in the region, as well as the strong presence of pharmaceutical companies[2].

Financial Trajectory and Market Size Projections

• 2023 Valuation: The gabapentin market is valued at USD 2.11 billion.
• 2033 Projection: The market is expected to reach USD 3.54 billion, growing at a CAGR of 5.3% during the forecast period[1][2].

Other market research reports suggest varying projections, such as a market size of approximately USD 5.7 billion by 2032, growing at a CAGR of 7.2% from 2023 to 2032[3].

Impact of Pharmaceutical Industry Payments

Research has shown that payments from gabapentin manufacturers to physicians, particularly pain doctors and general practitioners, can influence prescribing patterns. These payments, totaling $11.5 million between 2014 and 2016, have been linked to a higher likelihood of prescribing brand-name versions of gabapentin, which are more expensive than generic versions[5].

Opportunities and Challenges

Opportunities

• Emerging Markets: The rise of emerging markets in developing countries presents opportunities for market growth.
• Untapped Opportunities: Upcoming healthcare clinics and enhanced bioavailability offer potential for expansion.
• Strategic Initiatives: Manufacturers' strategic initiatives, such as developing combination products, can bolster market growth[4].

Challenges

• Health Remuneration Policies: Lack of health remuneration policies and rising costs are expected to hinder market growth.
• Side Effects and Regulatory Issues: Side effects associated with gabapentin and strict regulatory policies pose challenges.
• Supply Chain Issues: Issues in supply chain management and product recalls can also impact market growth[4].

Key Takeaways

• The gabapentin market is anticipated to reach USD 3.54 billion by 2033, growing at a CAGR of 5.3%.
• The market is driven by increasing prevalence of neuropathic pain, growing off-label use, and increased awareness and availability.
• Key marketers are adopting strategies such as product differentiation, market expansion, and competitive pricing to uplift market revenue.
• The market faces challenges related to regulatory scrutiny, side effects, and potential misuse.
• The United States is expected to dominate the global market by 2033.

FAQs

Q: What is the current market valuation of gabapentin, and what is its projected growth? A: The gabapentin market is currently valued at USD 2.11 billion and is projected to reach USD 3.54 billion by 2033, growing at a CAGR of 5.3%[1][2].

Q: What are the key drivers of the gabapentin market growth? A: The key drivers include the increasing prevalence of neuropathic pain, growing off-label use, and increased awareness and availability of the medication[1][2].

Q: How do pharmaceutical industry payments influence gabapentin prescriptions? A: Payments from gabapentin manufacturers to physicians have been linked to a higher likelihood of prescribing brand-name versions of gabapentin, which are more expensive than generic versions[5].

Q: What challenges does the gabapentin market face? A: The market faces challenges related to regulatory scrutiny, side effects, potential misuse, and strict regulatory policies[2][4].

Q: What strategies are key marketers adopting to uplift market revenue? A: Key marketers are adopting strategies such as product differentiation, market expansion through partnerships, promotions and marketing campaigns, and competitive pricing[2].