Remimazolam besylate - Generic Drug Details

What are the generic drug sources for remimazolam besylate and what is the scope of freedom to operate?

Remimazolam besylate is the generic ingredient in one branded drug marketed by Acacia and is included in one NDA. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Remimazolam besylate has fifty-three patent family members in twenty-four countries.

One supplier is listed for this compound.

Summary for remimazolam besylate

International Patents:	53
US Patents:	11
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	29
Patent Applications:	52
What excipients (inactive ingredients) are in remimazolam besylate?	remimazolam besylate excipients list
DailyMed Link:	remimazolam besylate at DailyMed

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

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.

Recent Clinical Trials for remimazolam besylate

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

Sponsor	Phase
Tongji Hospital	Phase 4
Zhihong LU	N/A
Seoul National University Hospital	Phase 2

See all remimazolam besylate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for remimazolam besylate

N05CD	Benzodiazepine derivatives
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for REMIMAZOLAM BESYLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BYFAVO	Powder for Injection	remimazolam besylate	20 mg/vial	212295	1	2024-10-07

US Patents and Regulatory Information for remimazolam besylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acacia	BYFAVO	remimazolam besylate	POWDER;INTRAVENOUS	212295-001	Oct 6, 2020		RX	Yes	Yes
Acacia	BYFAVO	remimazolam besylate	POWDER;INTRAVENOUS	212295-001	Oct 6, 2020		RX	Yes	Yes
Acacia	BYFAVO	remimazolam besylate	POWDER;INTRAVENOUS	212295-001	Oct 6, 2020		RX	Yes	Yes			Y
Acacia	BYFAVO	remimazolam besylate	POWDER;INTRAVENOUS	212295-001	Oct 6, 2020		RX	Yes	Yes

International Patents for remimazolam besylate

Country	Patent Number	Title	Estimated Expiration
Croatia	P20190447
Hong Kong	1137739	短效苯並二氮雜噁鹽及其多晶型 (SHORT-ACTING BENZODIAZEPINE SALTS AND THEIR POLYMORPHIC FORMS)
China	104059071	Short-acting Benzodiazepine Salts And Their Polymorphic Forms
United Kingdom	0613692

Remimazolam besylate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Remimazolam Besylate

Introduction

Remimazolam besylate, marketed as Byfavo, is a novel ultra-short-acting benzodiazepine designed for the induction and maintenance of procedural sedation. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its potential, current market performance, and future projections.

Market Potential

Procedural Sedation Market

The procedural sedation market, particularly in the U.S. and Europe, presents a significant opportunity for remimazolam. In the U.S., over 40 million procedural sedations are performed annually, with a substantial portion involving colonoscopies and endoscopies. This market is driven by the increasing demand for medical procedures and screening, with more than 80% of these procedures requiring personnel trained in anesthesia[3].

Revenue Projections

PAION, the company behind remimazolam, estimates the maximum annual revenue potential from royalties and sales to be substantial. In the U.S. and Europe, the procedural sedation market alone is projected to generate revenues of up to USD 1.5 billion annually, with remimazolam expected to capture a significant share. PAION projects peak sales potential in procedural sedation to be around EUR 40-50 million in Europe and similarly significant figures in the U.S.[3].

Current Market Performance

Commercialization

Remimazolam has been commercially launched in several regions, including South Korea, where it has received market approval for general anesthesia and procedural sedation. In China, PAION has entered into a patent assignment agreement with Humanwell, selling Chinese patents and future royalties for EUR 20.5 million, which will help fund further expansion in Europe[3].

Sales and Partnerships

PAION has established partnerships that are driving the commercialization of remimazolam. For instance, in the U.S., the local licensee Acacia is instrumental in marketing the drug. The commercialization efforts are expected to increase revenues and royalties as the product gains traction in hospital settings[3].

Financial Trajectory

Revenue Growth

Despite initial investments leading to a negative net result in 2021, PAION anticipates a positive financial trajectory. The company expects to become sustainably profitable and break even from 2024 onwards, driven by the increasing sales of remimazolam and other hospital products. The total annual revenue potential for remimazolam is estimated to be around EUR 125 million, including both procedural sedation and general anesthesia indications[3].

Investment and Expansion

PAION continues to invest in sales and marketing activities, which, although leading to short-term losses, are expected to yield long-term benefits. The company is expanding its European sales teams and developing a distribution infrastructure, which will further support the growth of remimazolam sales[3].

Competitive Advantage

Unique Pharmacological Profile

Remimazolam's rapid onset and offset of sedation, predictable duration of action, and low liability for cardiorespiratory depression make it a preferred choice over other sedative agents. Its ability to be reversed with flumazenil adds a layer of safety, distinguishing it from non-benzodiazepine medications like propofol and ketamine[1][2][4].

Clinical Applications

The drug's favorable pharmacokinetic and pharmacodynamic properties make it suitable for a wide range of clinical applications, from endoscopy and general anesthesia to sedation in critical care patients. This versatility is expected to drive its adoption in various medical settings[1][2][4].

Future Outlook

Regulatory Approvals

The European Medicines Agency (EMA) is expected to make a decision on the extension of the marketing authorization for remimazolam for general anesthesia by the end of 2022 or early 2023. This approval will further expand the drug's market reach and potential[3].

Research and Development

Future studies on remimazolam are likely to focus on adverse reactions, effects on different organ systems, and the identification of monitoring indicators. This ongoing research will help optimize its use in specific patient populations, such as those with hepatic or renal impairment, the elderly, and children[4].

Key Takeaways

• Market Potential: Remimazolam has a significant market potential in procedural sedation and general anesthesia, with estimated annual revenues of up to EUR 125 million.
• Current Performance: The drug has been commercially launched in several regions and is expected to drive revenue growth for PAION.
• Financial Trajectory: Despite initial losses, PAION anticipates becoming sustainably profitable from 2024 onwards.
• Competitive Advantage: Remimazolam's unique pharmacological profile and safety features make it a preferred choice in clinical settings.
• Future Outlook: Regulatory approvals and ongoing research are expected to further expand its market reach and optimize its use.

FAQs

What is remimazolam besylate used for?

Remimazolam besylate, marketed as Byfavo, is used for the induction and maintenance of procedural sedation. It is also being evaluated for use in general anesthesia.

How does remimazolam compare to other sedative agents?

Remimazolam has a rapid onset and offset of sedation, a predictable duration of action, and low liability for cardiorespiratory depression, making it safer and more controllable than many other sedative agents.

What are the key market regions for remimazolam?

The key market regions include the U.S. and Europe, where the procedural sedation market is particularly large and growing.

What is the financial outlook for PAION with remimazolam?

PAION expects to become sustainably profitable from 2024 onwards, driven by the increasing sales of remimazolam and other hospital products.

Are there any ongoing research or future studies planned for remimazolam?

Yes, future studies are planned to focus on adverse reactions, effects on different organ systems, and the identification of monitoring indicators to optimize its use in various patient populations.

Sources

1. Remimazolam: pharmacological characteristics and clinical applications - Anesth Pain Med, 2021.
2. Clinical Review of Remimazolam for Injection - FDA, 2020.
3. PAION Annual Report 2021 - PAION AG.
4. Bibliometric Analysis of Global Trends in Remimazolam-Related Research - PMC, 2023.
5. Non-Clinical Review of Remimazolam Besylate - FDA, 2019.