Vigabatrin - Generic Drug Details

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

Vigabatrin is the generic ingredient in five branded drugs marketed by Lundbeck Pharms Llc, Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms, Annora Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Dexcel, Dr Reddys, Endo Operations, Granules, Invagen Pharms, MSN, Propel Pharma, Specgx Llc, Teva Pharms Usa, Zydus Lifesciences, Aucta, Pyros Pharms, Hikma, Ryan Labs, and Upsher Smith Labs, and is included in thirty NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Vigabatrin has three patent family members in two countries.

There are five drug master file entries for vigabatrin. Seventeen suppliers are listed for this compound.

Summary for vigabatrin

International Patents:	3
US Patents:	1
Tradenames:	5
Applicants:	22
NDAs:	30
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	30
Patent Applications:	5,859
Drug Prices:	Drug price trends for vigabatrin
What excipients (inactive ingredients) are in vigabatrin?	vigabatrin excipients list
DailyMed Link:	vigabatrin at DailyMed

See drug prices for vigabatrin

Recent Clinical Trials for vigabatrin

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

Sponsor	Phase
Amzell	Phase 3
Yale University	Phase 2
Thomas Jefferson University	Phase 2

See all vigabatrin clinical trials

Pharmacology for vigabatrin

Drug Class

Anti-epileptic Agent

Medical Subject Heading (MeSH) Categories for vigabatrin

Anticonvulsants

Enzyme Inhibitors

GABA Agents

Anatomical Therapeutic Chemical (ATC) Classes for vigabatrin

N03AG	Fatty acid derivatives
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

US Patents and Regulatory Information for vigabatrin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Specgx Llc	VIGABATRIN	vigabatrin	FOR SOLUTION;ORAL	212626-001	Jul 28, 2021		DISCN	No	No
Propel Pharma	VIGABATRIN	vigabatrin	FOR SOLUTION;ORAL	213390-001	Jul 29, 2021		DISCN	No	No
Amneal Pharms	VIGABATRIN	vigabatrin	FOR SOLUTION;ORAL	210155-001	Mar 13, 2018	AA	RX	No	No

EU/EMA Drug Approvals for vigabatrin

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
ORPHELIA Pharma SAS	Kigabeq	vigabatrin	EMEA/H/C/004534 Kigabeq is indicated in infants and children from 1 month to less than 7 years of age for:Treatment in monotherapy of infantile spasms (West's syndrome).Treatment in combination with other antiepileptic medicinal products for patients with resistant partial epilepsy (focal onset seizures) with or without secondary generalisation, that is where all other appropriate medicinal product combinations have proved inadequate or have not been tolerated.	Authorised	no	no	no	2018-09-20

International Patents for vigabatrin

Country	Patent Number	Title	Estimated Expiration
United Kingdom	202103724
World Intellectual Property Organization (WIPO)	2020039262
United Kingdom	2591389	Pharmaceuticals solution for oral dosage

Vigabatrin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Vigabatrin

Market Overview

Vigabatrin, a medication used primarily for the treatment of epilepsy and infantile spasms, has been experiencing significant growth in recent years. The market is driven by several key factors, including the increasing prevalence of neurological disorders and the need for effective treatment options.

Market Segmentation

The vigabatrin market is segmented based on product type and application.

Product Type

• Tablets: Available in various strengths, including 500 mg tablets, which are widely used due to their convenience and ease of administration[2][4].
• Powder for Oral Solution: This form is particularly useful for patients who have difficulty swallowing tablets, and it is available in 500 mg per packet[3][4].

Application

• Epilepsy: Vigabatrin is used as an adjunctive treatment for complex partial seizures and other types of epilepsy.
• Infantile Spasms: It is a primary treatment for infantile spasms, a severe form of epilepsy in infants[4].

Market Dynamics

Drivers

• Increasing Prevalence of Neurological Disorders: The rising incidence of epilepsy and infantile spasms globally is a significant driver for the vigabatrin market. As the population grows and ages, the demand for effective treatments increases[4].
• Generic Market Expansion: The availability of generic versions of vigabatrin, such as those launched by Dr. Reddy’s Laboratories, has expanded market access and reduced costs for patients. This has led to increased adoption and higher sales volumes[2][3].
• Regulatory Approvals: The FDA approval of generic versions and the designation of Competitive Generic Therapy (CGT) status have provided exclusivity periods, boosting sales for companies like Dr. Reddy’s Laboratories[2].

Restraints

• Side Effects and Safety Concerns: Vigabatrin is associated with a risk of permanent vision loss, which necessitates its distribution through a restricted program under the Risk Evaluation and Mitigation Strategy (REMS)[2][5].
• Competition: The market faces competition from other antiepileptic drugs, which can impact market share and growth.

Opportunities

• Emerging Markets: There is significant potential for growth in emerging markets, particularly in regions with limited access to advanced healthcare services. Companies are focusing on expanding their presence in these areas[4].
• Research and Development: Ongoing research into new applications and formulations of vigabatrin could open up additional market opportunities.

Challenges

• COVID-19 Impact: The COVID-19 pandemic has disrupted global supply chains and affected the manufacturing and delivery of pharmaceutical products, including vigabatrin. This has had a temporary negative impact on the market[4].

Financial Trajectory

Market Size and Growth

• The vigabatrin market is projected to experience robust growth from 2023 to 2031, driven by the factors mentioned above. The market size is expected to increase significantly, with forecasts indicating substantial revenue growth[1][4].

Revenue and Sales

• In the U.S. market, the Sabril® brand and generic versions of vigabatrin had sales of approximately $141 million for the twelve months ending in December 2020 and $274 million for the twelve months ending in June 2019[2][3].
• The global market is expected to see continued growth, with the CAGR projected to be significant over the forecast period[4].

Key Players and Market Share

• Companies such as Dr. Reddy’s Laboratories, Amneal Pharmaceuticals, Lundbeck, and others are key players in the vigabatrin market. These companies have been expanding their market share through product launches, generic versions, and strategic partnerships[2][4][5].

Regional Framework

The vigabatrin market is analyzed across several regions, including:

North America

• This region is a significant market due to high healthcare spending and the presence of major pharmaceutical companies[1][4].

Europe

• Europe also represents a substantial market, with a strong focus on research and development in the pharmaceutical sector[1][4].

Asia-Pacific

• The Asia-Pacific region is expected to see rapid growth due to increasing healthcare expenditure and a large patient population[1][4].

Middle East and Africa, South America

• These regions offer growth opportunities due to expanding healthcare infrastructure and increasing demand for antiepileptic medications[1][4].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the vigabatrin market. While it disrupted supply chains and manufacturing, the demand for essential medications like vigabatrin remained relatively stable. However, the pandemic highlighted the importance of robust supply chain management and the need for contingency planning in the pharmaceutical industry[4].

Key Takeaways

• The vigabatrin market is experiencing significant growth driven by increasing demand for effective treatments for epilepsy and infantile spasms.
• Generic versions and regulatory approvals are key drivers of market expansion.
• The market faces challenges such as side effects and competition but offers opportunities in emerging markets and through ongoing research.
• The financial trajectory indicates substantial revenue growth over the forecast period.

FAQs

1. What are the primary applications of vigabatrin?

Vigabatrin is primarily used as an adjunctive treatment for epilepsy and as a treatment for infantile spasms.

2. What are the different forms of vigabatrin available?

Vigabatrin is available in tablet form (e.g., 500 mg tablets) and as a powder for oral solution (e.g., 500 mg per packet).

3. What are the major side effects associated with vigabatrin?

One of the significant side effects of vigabatrin is the risk of permanent vision loss, which requires its distribution through a restricted program under the REMS.

4. Which companies are key players in the vigabatrin market?

Key players include Dr. Reddy’s Laboratories, Amneal Pharmaceuticals, Lundbeck, and others.

5. How has the COVID-19 pandemic affected the vigabatrin market?

The pandemic has disrupted supply chains but has not significantly reduced demand for vigabatrin, highlighting the need for robust supply chain management.

Cited Sources:

1. Market Research Intellect, "Vigabatrin Market Size, Scope And Forecast Report," September 2024.
2. Biospace, "Dr. Reddy's Laboratories Announces the Launch of Vigabatrin Tablets USP in the U.S. Market," February 2, 2021.
3. Biospace, "Dr. Reddy's Laboratories Announces the Launch of Vigabatrin Powder for Oral Solution USP in the U.S. Market," August 20, 2019.
4. The Insight Partners, "Vigabatrin Market Scope and Size by 2031," 2024.
5. Amneal Pharmaceuticals, "Vigabatrin," 2023.