LASMIDITAN SUCCINATE - Generic Drug Details

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

Lasmiditan succinate is the generic ingredient in one branded drug marketed by Eli Lilly And Co and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lasmiditan succinate has one hundred and eighteen patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for LASMIDITAN SUCCINATE

International Patents:	118
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	17
Patent Applications:	1
DailyMed Link:	LASMIDITAN SUCCINATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LASMIDITAN SUCCINATE

Constraining patent/regulatory exclusivity:

11,053,214

Dosage:

TABLET;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.

Anatomical Therapeutic Chemical (ATC) Classes for LASMIDITAN SUCCINATE

N02CC	Selective serotonin (5HT1) agonists
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for LASMIDITAN SUCCINATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
REYVOW	Tablets	lasmiditan succinate	50 mg and 100 mg	211280	1	2024-01-31

US Patents and Regulatory Information for LASMIDITAN SUCCINATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-003	Dec 18, 2020		DISCN	Yes	No	7,423,050		Y	Y
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-001	Jan 31, 2020		RX	Yes	No
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-002	Jan 31, 2020		RX	Yes	Yes
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-003	Dec 18, 2020		DISCN	Yes	No
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-001	Jan 31, 2020		RX	Yes	No	7,423,050		Y	Y
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-003	Dec 18, 2020		DISCN	Yes	No	11,053,214		Y	Y

Expired US Patents for LASMIDITAN SUCCINATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-001	Jan 31, 2020	8,748,459
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-002	Jan 31, 2020	8,748,459
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-003	Dec 18, 2020	8,748,459

International Patents for LASMIDITAN SUCCINATE

Country	Patent Number	Title	Estimated Expiration
Taiwan	202116749	Processes and intermediate for the large-scale preparation of 2,4,6-trifluoro-N-[6-(1-methyl-piperidine-4-carbonyl)-pyridin-2-yl]-benzamide hemisuccinate, and preparation of 2,4,6-trifluoro-N-[6-(1-methyl-piperidine-4-carbonyl)-pyridin-2-yl]-benzamide
Japan	2010159272	PYRIDINOYL-PIPERIDINE AS 5-HT1F AGONIST
Colombia	2019005290	Composiciones y métodos relacionados con agonistas de piridinoilpiperidina 5-ht1f
Ukraine	124433	ПІРИДИНОЇЛПІПЕРИДИН, ЙОГО ЗАСТОСУВАННЯ ДЛЯ ЛІКУВАННЯ МІГРЕНІ ТА ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ НА ЙОГО ОСНОВІ (COMPOSITIONS AND METHODS RELATED TO PYRIDINOYLPIPERIDINE 5-HT1F AGONISTS)
South Korea	20240027877	2,4,6-트리플루오로-N-[6--피리딘-2-일]-벤즈아미드헤미숙시네이트의 대규모 제조를 위한 방법 및 중간체, 및 2,4,6-트리플루오로-N-[6--피리딘-2-일]-벤즈아미드 아세테이트의 제조 (246--N-[6-1---4---2-]- 246--N-[6-1---4---2-]- Processes and intermediate FOR THE LARGE-SCALE PREPARATION OF 246-trifluoro-N-[6-1-methyl-piperidine-4-carbonyl-pyridin-2-yl]-benzamide Hemisuccinate And preparation of 246-TRIFLUORO-N-[6-1-METHYL-PIPERIDINE-4-CARBONYL-PYRIDIN-2-YL]-BENZAMIDE Acetate)
Eurasian Patent Organization	007966	ПИРИДИНОИЛПИПЕРИДИНЫ КАК АГОНИСТЫ 5-HT (PYRIDINOYLPIPERIDINES AS 5-HTAGONISTS)

LASMIDITAN SUCCINATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lasmiditan Succinate

Introduction

Lasmiditan succinate, a novel acute treatment for migraine, has been making significant waves in the pharmaceutical industry since its FDA approval in 2019. This drug, developed by Eli Lilly and Company, targets serotonin receptors to provide relief from migraine attacks without the vasoconstrictive side effects associated with traditional treatments.

Market Size and Projections

The global market for lasmiditan succinate is poised for substantial growth. As of 2023, the market size was valued at approximately USD 350 million. It is projected to reach around USD 980 million by 2032, indicating a robust growth trajectory[4].

For lasmiditan hemisuccinate, a closely related form, the market size was valued at USD 100 billion in 2023 and is expected to reach USD 214.36 billion by 2031, growing at a 10% CAGR from 2024 to 2031[3].

Growth Drivers

Several factors are driving the growth of the lasmiditan succinate market:

Increasing Prevalence of Migraines

The rising number of migraine cases globally is a significant driver. Migraines affect a substantial portion of the population, and the need for effective and safe treatments is on the rise[3].

Efficacy and Safety Profile

Lasmiditan succinate's unique mode of action, targeting serotonin receptors without vasoconstrictive effects, makes it an attractive option for patients and healthcare professionals. Continuous clinical trials have reinforced its efficacy and safety profile, further boosting market demand[3].

Global Distribution Networks

The expansion of pharmaceutical companies' distribution networks has made lasmiditan succinate more accessible worldwide, contributing to its market growth[3].

Regulatory Approvals and Strategic Partnerships

Regulatory approvals in multiple jurisdictions and strategic partnerships for research and development have accelerated market penetration. These collaborations enhance the drug's visibility and availability, driving up demand[3].

Budget Impact and Cost Analysis

A key aspect of the market dynamics is the budget impact of incorporating lasmiditan succinate into formularies. Studies have shown that adding lasmiditan to formularies that already include other novel acute treatments like ubrogepant and rimegepant results in lower budget impact.

Cost Savings

In a US commercial plan perspective, the addition of lasmiditan resulted in total savings of -$927,657 over a 3-year time horizon for the population with a previous history of using one or more oral triptans or contraindicated to triptans. For those with a history of using two or more oral triptans or contraindicated, the savings were -$466,518 over the same period. These savings were primarily due to reductions in drug acquisition costs[2].

Average Cost Per Member Per Month (PMPM)

The average incremental cost per PMPM was -0.03 and -0.01, respectively, indicating a favorable cost profile for payers[2].

Market Segmentation

The lasmiditan succinate market is segmented based on several factors:

Type

The market includes various forms such as oral tablets, intranasal spray, intravenous injection, transdermal patch, and sublingual tablets. Each form caters to different patient needs and preferences[3].

Application

The primary applications include acute migraine treatment, preventive migraine therapy, chronic headache management, and pain relief. The versatility of lasmiditan succinate in addressing different aspects of migraine care is a significant market driver[3].

Geography

The market is analyzed across geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region presents unique market dynamics and growth opportunities[3].

Key Players

Several pharmaceutical companies are key players in the lasmiditan succinate market:

Eli Lilly and Company

As the originator of lasmiditan succinate, Eli Lilly and Company plays a pivotal role in its development, marketing, and distribution[2].

Other Major Players

Companies like Allergan, Teva Pharmaceuticals, Amgen, Lundbeck, Dr. Reddy’s Laboratories, Cipla, Sun Pharmaceutical, Mylan, Pfizer, Novartis, and Merck are also significant players, contributing to the market's competitive landscape[3].

Clinical Trials and Development

Lasmiditan succinate has undergone extensive clinical trials to establish its efficacy and safety. Here are some key points:

Phase 3 Trials

Phase 3 trials have shown positive results, with no significant cardiovascular events reported in the elderly population during the treatment-emergent period[5].

Adverse Events

Common adverse events reported include dizziness, fatigue, and paraesthesia, but these are generally mild and transient[5].

Financial Performance

The financial performance of lasmiditan succinate is closely tied to its market growth and adoption.

Revenue Projections

With a projected market size of USD 980 million by 2032, the revenue potential for lasmiditan succinate is substantial. This growth is expected to contribute significantly to the financial performance of pharmaceutical companies involved in its production and distribution[4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of lasmiditan succinate:

FDA Approval

The FDA approval in 2019 marked a significant milestone for lasmiditan succinate, paving the way for its commercialization and widespread use[5].

Global Regulatory Approvals

Regulatory approvals in multiple jurisdictions have facilitated the global distribution and accessibility of the drug, further enhancing its market position[3].

Consumer and Healthcare Professional Awareness

Increasing awareness among consumers and healthcare professionals about the benefits of non-vasoconstrictive drugs is driving market demand.

Benefits of Non-Vasoconstrictive Drugs

The lack of vasoconstrictive side effects makes lasmiditan succinate an appealing option for patients who are contraindicated to or fail to respond to traditional oral triptans. This awareness is driven by ongoing clinical trials and positive patient outcomes[3].

Key Takeaways

• Market Growth: The lasmiditan succinate market is expected to grow significantly, reaching USD 980 million by 2032.
• Efficacy and Safety: The drug's unique mode of action and favorable safety profile are key drivers of market demand.
• Budget Impact: Adding lasmiditan succinate to formularies results in lower budget impact due to reduced drug acquisition costs.
• Market Segmentation: The market is segmented by type, application, and geography, offering diverse growth opportunities.
• Regulatory Environment: FDA approval and global regulatory approvals have been crucial for the drug's commercial success.
• Consumer Awareness: Increasing awareness about the benefits of non-vasoconstrictive drugs is driving market demand.

FAQs

Q: What is the projected market size for lasmiditan succinate by 2032?

A: The global market size for lasmiditan succinate is projected to reach around USD 980 million by 2032[4].

Q: What are the primary applications of lasmiditan succinate?

A: The primary applications include acute migraine treatment, preventive migraine therapy, chronic headache management, and pain relief[3].

Q: How does lasmiditan succinate impact the budget of healthcare plans?

A: The addition of lasmiditan succinate to formularies results in lower budget impact due to reductions in drug acquisition costs[2].

Q: What are the common adverse events associated with lasmiditan succinate?

A: Common adverse events include dizziness, fatigue, and paraesthesia, which are generally mild and transient[5].

Q: Who are the key players in the lasmiditan succinate market?

A: Key players include Eli Lilly and Company, Allergan, Teva Pharmaceuticals, Amgen, Lundbeck, and others[3].

Sources

1. Market Research Intellect: Global Lasmiditan Succinate Market.
2. PubMed: Budget impact of lasmiditan for the acute treatment of migraine.
3. Market Research Intellect: Global Lasmiditan Hemisuccinate Market.
4. Dataintelo: Lasmiditan Succinate Market Research Report 2032.
5. Synapse: Lasmiditan Succinate - Drug Targets, Indications, Patents.