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SEZABY Drug Patent Profile

Which patents cover Sezaby, and what generic alternatives are available?

Sezaby is a drug marketed by Sun Pharm Inds Inc and is included in one NDA. There is one patent protecting this drug.

This drug has two patent family members in one country.

The generic ingredient in SEZABY is phenobarbital sodium. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phenobarbital sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Sezaby

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 17, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for SEZABY

International Patents:	2
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for SEZABY
What excipients (inactive ingredients) are in SEZABY?	SEZABY excipients list
DailyMed Link:	SEZABY at DailyMed

See drug prices for SEZABY

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

Constraining patent/regulatory exclusivity:

TREATMENT OF NEONATAL SEIZURES IN TERM AND PRETERM INFANTS

NDA:

215910

Dosage:

POWDER;INTRAVENOUS

^*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.

US Patents and Regulatory Information for SEZABY

SEZABY is protected by one US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on TREATMENT OF NEONATAL SEIZURES IN TERM AND PRETERM INFANTS.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds Inc	SEZABY	phenobarbital sodium	POWDER;INTRAVENOUS	215910-001	Nov 17, 2022		RX	Yes	Yes	11,857,683		Y
Sun Pharm Inds Inc	SEZABY	phenobarbital sodium	POWDER;INTRAVENOUS	215910-001	Nov 17, 2022		RX	Yes	Yes

International Patents for SEZABY

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2023175542
World Intellectual Property Organization (WIPO)	2023281441

SEZABY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sezaby

Introduction to Sezaby

Sezaby, a formulation of phenobarbital sodium, has been approved by the US FDA for the treatment of neonatal seizures in term and preterm infants. This approval marks a significant milestone, as Sezaby is the first and only product specifically approved for this indication[1].

Market Need and Incidence of Neonatal Seizures

Neonatal seizures are a critical medical condition with a significant incidence rate. In the US, the overall incidence is approximately 3 per 1000 live births, with a much higher rate in pre-term infants, ranging from 57 to 132 per 1000 live births. Most neonatal seizures occur within the first week of life, highlighting the urgent need for effective and safe treatments[1].

Efficacy and Safety of Sezaby

Sezaby has demonstrated superior efficacy compared to other treatments. It has an 80% efficacy rate in treating neonatal seizures, significantly higher than levetiracetam, which has an efficacy rate of 28%. Additionally, Sezaby is formulated without benzyl alcohol and propylene glycol, making it safer than existing marketed phenobarbital products that contain these preservatives, which can cause Gasping Syndrome in neonates and low-birth weight infants[1].

Regulatory Advantages

Sezaby has been granted an orphan drug designation by the US FDA, which provides seven years of market exclusivity. This exclusivity, combined with the FDA's commitment to remove unapproved products from the market, positions Sezaby to capture a significant market share. If the FDA enforces DESI (Drug Efficacy Study Implementation) exclusivity, Sezaby is expected to capture at least 60-90% of the neonatal seizure market[1].

Financial Projections

The financial trajectory for Sezaby looks promising. With its superior efficacy and safety profile, Sezaby is projected to achieve peak sales of USD 60-100 million. This estimate is based on the assumption that unapproved products will be removed from the market and Sezaby will dominate the neonatal seizure treatment space. The price hike for DESI-approved drugs, which can range from 500% to 1700%, further supports the potential for significant revenue growth[1].

Licensing and Royalty Agreements

Sun Pharma has outlicensed Sezaby from Sun Pharma Advanced Research (SPARC) and will pay an upfront payment of USD 10 million along with milestone payments. This agreement underscores the confidence in Sezaby's market potential and the strategic partnership between the two companies[1].

Market Context: US Pharmaceutical Market

The US pharmaceutical market is growing steadily, valued at USD 602.19 billion in 2023 and projected to reach USD 1,093.79 billion by 2033, with a CAGR of 6.15%. The branded segment, which includes innovative drugs like Sezaby, dominates the market with a revenue share of 68.19% in 2023. This growth is driven by increasing R&D investments, rising chronic disease prevalence, and government efforts to improve healthcare accessibility[3].

Global Phenobarbital Market

The global phenobarbital market, of which Sezaby is a part, is expected to grow from USD 1.58 billion in 2023 to USD 2.23 billion by 2030, with a CAGR of 5%. This growth is driven by the increasing prevalence of epilepsy and other seizure disorders, as well as the demand for effective anticonvulsant medications. North America, particularly the US, is a significant market for phenobarbital due to its high incidence of traumatic brain injuries and other seizure-causing conditions[4].

Competitive Landscape

Sezaby enters a market where unapproved phenobarbital products have been prevalent. However, with its FDA approval and orphan drug designation, Sezaby is well-positioned to outcompete these unapproved drugs. The removal of unapproved products from the market, as mandated by the FDA, will further solidify Sezaby's market position[1].

Challenges and Considerations

While Sezaby offers significant advantages, there are challenges to consider. The continued use of phenobarbital can lead to physical dependence, and abrupt discontinuation can precipitate life-threatening withdrawal reactions. Therefore, careful management and gradual tapering of the dose are necessary to mitigate these risks[5].

Key Takeaways

• Efficacy and Safety: Sezaby has an 80% efficacy rate and is safer than existing phenobarbital products due to its preservative-free formulation.
• Regulatory Exclusivity: Seven years of market exclusivity and potential removal of unapproved products position Sezaby for significant market share.
• Financial Projections: Peak sales estimated at USD 60-100 million.
• Market Context: Growing US pharmaceutical market with a strong branded segment.
• Global Market: Part of a growing global phenobarbital market driven by increasing epilepsy prevalence.
• Challenges: Potential for physical dependence and withdrawal reactions requires careful management.

FAQs

Q: What is Sezaby approved for?

Sezaby is approved by the US FDA for the treatment of neonatal seizures in term and preterm infants[1].

Q: How does Sezaby compare to other treatments for neonatal seizures?

Sezaby has an 80% efficacy rate, significantly higher than levetiracetam, which has a 28% efficacy rate[1].

Q: What are the safety advantages of Sezaby?

Sezaby is formulated without benzyl alcohol and propylene glycol, making it safer than existing marketed phenobarbital products that can cause Gasping Syndrome in neonates and low-birth weight infants[1].

Q: What is the projected market share and revenue for Sezaby?

Sezaby is expected to capture at least 60-90% of the neonatal seizure market, with projected peak sales of USD 60-100 million[1].

Q: What are the potential challenges associated with Sezaby?

The continued use of phenobarbital can lead to physical dependence, and abrupt discontinuation can precipitate life-threatening withdrawal reactions, requiring careful management and gradual tapering of the dose[5].

Sources

1. Systematix: Sun Pharma Sezaby to strengthen Sun Pharma’s US specialty portfolio.
2. FDA: Prescription Drug User Fee Act - FDA.
3. Nova One Advisor: U.S. Pharmaceutical Market Size | key Companies.
4. Coherent Market Insights: Phenobarbital Market Size, Trends and Forecast to 2030.
5. DailyMed: Sezaby- phenobarbital sodium injection.