SESQUIENT Drug Patent Profile

Which patents cover Sesquient, and when can generic versions of Sesquient launch?

Sesquient is a drug marketed by Lupin and is included in one NDA. There are five patents protecting this drug.

This drug has fifty-one patent family members in fourteen countries.

The generic ingredient in SESQUIENT is fosphenytoin sodium. There are eight drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the fosphenytoin sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sesquient

A generic version of SESQUIENT was approved as fosphenytoin sodium by FRESENIUS KABI USA on August 6^th, 2007.

Summary for SESQUIENT

International Patents:	51
US Patents:	5
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	88
Patent Applications:	2,656
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SESQUIENT
What excipients (inactive ingredients) are in SESQUIENT?	SESQUIENT excipients list
DailyMed Link:	SESQUIENT at DailyMed

US Patents and Regulatory Information for SESQUIENT

SESQUIENT is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin	SESQUIENT	fosphenytoin sodium	SOLUTION;INTRAVENOUS	210864-001	Nov 5, 2020		DISCN	Yes	No			Y
Lupin	SESQUIENT	fosphenytoin sodium	SOLUTION;INTRAVENOUS	210864-002	Nov 5, 2020		DISCN	Yes	No			Y
Lupin	SESQUIENT	fosphenytoin sodium	SOLUTION;INTRAVENOUS	210864-001	Nov 5, 2020		DISCN	Yes	No			Y
Lupin	SESQUIENT	fosphenytoin sodium	SOLUTION;INTRAVENOUS	210864-002	Nov 5, 2020		DISCN	Yes	No			Y
Lupin	SESQUIENT	fosphenytoin sodium	SOLUTION;INTRAVENOUS	210864-001	Nov 5, 2020		DISCN	Yes	No			Y
Lupin	SESQUIENT	fosphenytoin sodium	SOLUTION;INTRAVENOUS	210864-001	Nov 5, 2020		DISCN	Yes	No			Y

International Patents for SESQUIENT

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20200106100	알킬화된 시클로덱스트린 조성물 및 이의 제조 및 사용 방법 (Alkylated Cyclodextrin Compositions and Processes for Preparing and using the same)
Mexico	2014010323	COMPOSICIONES DE CICLODEXTRINA ALQUILADA Y PROCESOS PARA PREPARAR Y UTILIZAR LAS MISMAS. (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME.)
European Patent Office	2268269	COMPOSITIONS DE CYCLODEXTRINE À GROUPEMENTS ÉTHER SULFOALKYLIQUE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)
Russian Federation	2747757	КОМПОЗИЦИИ АЛКИЛИРОВАННОГО ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ (COMPOSITIONS OF ALKYLATED CYCLODEXTRIN AND METHODS OF THEIR PREPARATION AND APPLICATION)
Japan	2012072160	SULFOALKYL ETHER CYCLODEXTRIN COMPOSITION
Eurasian Patent Organization	201000828	СОСТАВЫ НА ОСНОВЕ СУЛЬФОАЛКИЛЬНЫХ ЭФИРОВ ЦИКЛОДЕКСТРИНА

Supplementary Protection Certificates for SESQUIENT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0473687	C980045	Netherlands		PRODUCT NAME: FOSPHENYTOINUM-DI-NATRICUM; NATL REGISTRATION NO/DATE: RVG 22758 19980702; FIRST REGISTRATION: GB PL 00019/0157 19980204
0473687	3/1999	Austria		PRODUCT NAME: FOSPHENYTOIN-NATRIUM; NAT. REGISTRATION NO/DATE: 1-22664 19980728; FIRST REGISTRATION: GB 00019/0157 19980204
0145340	99C0005	Belgium		PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
0473687	99C0008	Belgium		PRODUCT NAME: FOSPHENYTOINUM DINATRICUM; REGISTRATION NO/DATE: 19 IS 102 F12 19980901; FIRST REGISTRATION: GB PL00019/1057 19980204
0473687	SPC/GB98/030	United Kingdom		PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204

SESQUIENT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SESQUIENT

Introduction to SESQUIENT

SESQUIENT, developed by Sedor Pharmaceuticals, LLC, is a fosphenytoin sodium for injection that has received FDA approval for the treatment of status epilepticus in adult and pediatric patients. This approval marks a significant milestone in the management of this critical condition, which is characterized by prolonged or repeated seizures that can lead to irreversible brain damage or death if not treated promptly[1][3][4].

Market Need and Impact

Status epilepticus is a medical emergency that requires immediate and effective treatment. The traditional challenges in treating this condition include the time it takes to administer the medication, as it often requires preparation and transportation from the pharmacy to the point of care. SESQUIENT addresses this issue by being ready-to-dilute and stable at room temperature, allowing for point-of-care storage and fast administration in emergency rooms, intensive care units, first responder vehicles, and long-term care facilities[1][3][4].

Competitive Advantage

SESQUIENT is the only FDA-approved fosphenytoin that offers room temperature stability, making it a unique and valuable asset in the treatment of status epilepticus. This feature significantly reduces the time between diagnosis and treatment, potentially improving patient outcomes and reducing hospital costs associated with the condition[1][3][4].

Licensing and Commercialization

Sedor Pharmaceuticals is actively engaged in discussions to license the rights to SESQUIENT for North America, Europe, and other territories, excluding the People’s Republic of China, where the rights have already been licensed. The company is also seeking capital to retain North American rights and commercialize the product. This strategic approach aims to maximize the global market potential of SESQUIENT[1][3][4].

Financial Trajectory of Sedor Pharmaceuticals

The FDA approval of SESQUIENT is a critical step in validating Sedor Pharmaceuticals' business model of efficient development of critical care hospital injectable products. This approval opens a significant global market for the company and is expected to contribute substantially to its revenue.

• Revenue Potential: With SESQUIENT being the first FDA-approved drug for Sedor Pharmaceuticals, it is anticipated to generate significant revenue through licensing agreements and direct sales. The company's ability to offer a unique solution for status epilepticus positions it well in the market.
• Cost Savings: By reducing the time and logistical challenges associated with traditional treatments, SESQUIENT could help healthcare providers lower costs related to the treatment of status epilepticus. This cost-effectiveness can be a strong selling point and may influence adoption rates[1][3][4].

Role of Ligand Pharmaceuticals

SESQUIENT is a Captisol-enabled product, which means it utilizes Ligand Pharmaceuticals' Captisol technology. Captisol is a solubilizing agent that enhances the solubility and stability of drugs, allowing for more efficient IV administration. Ligand Pharmaceuticals has seen significant success with its Captisol business, and the approval of SESQUIENT further validates the value of this technology.

• Royalty Revenue: Ligand Pharmaceuticals stands to benefit from royalty payments associated with the commercial success of SESQUIENT. Given the unique advantages of SESQUIENT, these royalties could contribute substantially to Ligand's revenue stream[2][4].

Future Product Development

In addition to SESQUIENT, Sedor Pharmaceuticals is preparing to enter Phase I development of its second product, Meloxicam for injection solubilized with betadex sulfobutyl ether sodium, for the potential treatment of acute post-surgical pain. If approved, this product could potentially replace or delay the use of IM/IV opioids, further expanding Sedor's portfolio and market reach[1][3][4].

Financial Performance and Growth Expectations

The financial performance of Sedor Pharmaceuticals is expected to be positively impacted by the approval and commercialization of SESQUIENT. Here are some key financial aspects:

• Revenue Growth: The company anticipates significant revenue growth driven by the sales and licensing of SESQUIENT.
• Cost Structure: The efficient development and commercialization model of Sedor Pharmaceuticals is designed to keep costs in check while maximizing revenue potential.
• Investor Confidence: The FDA approval of SESQUIENT has boosted investor confidence in Sedor Pharmaceuticals, which could lead to increased investment and further growth opportunities[1][3][4].

Market Outlook and Projections

The market outlook for SESQUIENT is promising due to its unique features and the critical need it addresses in the treatment of status epilepticus.

• Global Market Potential: With licensing discussions underway for various territories, SESQUIENT is poised to enter a significant global market.
• Competitive Landscape: The room temperature stability and point-of-care administration capabilities of SESQUIENT position it favorably against existing treatments, potentially capturing a substantial market share[1][3][4].

Key Takeaways

• Unique Product: SESQUIENT is the only FDA-approved fosphenytoin that is room temperature stable and ready-to-dilute.
• Market Need: It addresses a critical need in the treatment of status epilepticus by enabling fast and efficient administration.
• Financial Impact: The approval is expected to drive significant revenue growth for Sedor Pharmaceuticals and generate royalties for Ligand Pharmaceuticals.
• Future Development: Sedor is advancing other critical care products, including Meloxicam for injection, to further expand its market presence.

FAQs

Q: What is SESQUIENT and what is it used for?

A: SESQUIENT is a fosphenytoin sodium for injection approved by the FDA for the treatment of status epilepticus in adult and pediatric patients.

Q: What makes SESQUIENT unique?

A: SESQUIENT is the only FDA-approved fosphenytoin that is stable at room temperature and ready-to-dilute, allowing for point-of-care storage and fast administration.

Q: Who developed SESQUIENT?

A: SESQUIENT was developed by Sedor Pharmaceuticals, LLC, and utilizes Ligand Pharmaceuticals' Captisol technology.

Q: What are the potential financial benefits of SESQUIENT?

A: SESQUIENT is expected to generate significant revenue through sales and licensing agreements, and will also produce royalties for Ligand Pharmaceuticals.

Q: What other products is Sedor Pharmaceuticals developing?

A: Sedor Pharmaceuticals is preparing to enter Phase I development of Meloxicam for injection solubilized with betadex sulfobutyl ether sodium for the potential treatment of acute post-surgical pain.

Cited Sources

1. Biospace: Sedor Pharmaceuticals Receives FDA Approval for SESQUIENT (fosphenytoin sodium for injection) for the Treatment of Status Epilepticus in Adult and Pediatric Patients.
2. Ligand Pharmaceuticals: Ligand Reports Fourth Quarter and Full Year 2020 Financial Results.
3. Business Wire: Sedor Pharmaceuticals Receives FDA Approval for SESQUIENT (fosphenytoin sodium for injection) for the Treatment of Status Epilepticus in Adult and Pediatric Patients.
4. Ligand Pharmaceuticals: Ligand's Partner Sedor Pharmaceuticals Receives FDA Approval for SESQUIENT for the Treatment of Status Epilepticus in Adult and Pediatric Patients.