VERSED Drug Patent Profile

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

Versed is a drug marketed by HLR and Roche and is included in two NDAs.

The generic ingredient in VERSED is midazolam hydrochloride. There are nine drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Versed

A generic version of VERSED was approved as midazolam hydrochloride by FRESENIUS KABI USA on June 20^th, 2000.

Summary for VERSED

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	47
Clinical Trials:	110
Patent Applications:	4,263
DailyMed Link:	VERSED at DailyMed

Recent Clinical Trials for VERSED

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

Sponsor	Phase
Stanford University	Phase 2
Lawson Health Research Institute	Phase 3
University of Texas Southwestern Medical Center	Phase 3

See all VERSED clinical trials

US Patents and Regulatory Information for VERSED

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hlr	VERSED	midazolam hydrochloride	INJECTABLE;INJECTION	018654-002	May 26, 1987		DISCN	Yes	No
Hlr	VERSED	midazolam hydrochloride	INJECTABLE;INJECTION	018654-001	Dec 20, 1985		DISCN	Yes	No
Roche	VERSED	midazolam hydrochloride	SYRUP;ORAL	020942-001	Oct 15, 1998		DISCN	Yes	No

Expired US Patents for VERSED

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hlr	VERSED	midazolam hydrochloride	INJECTABLE;INJECTION	018654-002	May 26, 1987
Roche	VERSED	midazolam hydrochloride	SYRUP;ORAL	020942-001	Oct 15, 1998
Hlr	VERSED	midazolam hydrochloride	INJECTABLE;INJECTION	018654-001	Dec 20, 1985

International Patents for VERSED

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

Country	Patent Number	Title	Estimated Expiration
Sweden	7902667
Ireland	41844
Norway	147109
Austria	A697775

VERSED Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Understanding the Landscape

When analyzing the market dynamics and financial trajectory of a drug or a pharmaceutical company, it is crucial to consider several key factors, including market competition, innovation, patient needs, and financial performance. Here, we will delve into these aspects using relevant examples and data, although the specific drug "VERSED" is not directly mentioned in the provided sources.

Market Competition and Innovation

First-Mover Advantage

In the pharmaceutical industry, the first-mover advantage can be significant. Companies that introduce first-in-class drugs often gain a strong market position due to physician familiarity and patient trust. For instance, Biogen's Spinraza, the first treatment for spinal muscular atrophy (SMA), has generated approximately $10 billion in revenue over its lifetime, highlighting the value of being first to market[1].

Fast Followers and Market Crowding

However, fast followers can still capture significant market share by offering better efficacy, convenience, or other advantages. The SMA market, for example, has seen new entrants like Novartis' Zolgensma and Genentech's Evrysdi, which have gained substantial market traction despite entering later. This competition has expanded the total SMA market by nearly 50% in just two years[1].

Different Modalities

The introduction of new therapeutic modalities can dramatically shift market dynamics. Different modalities, such as gene therapies, small molecules, and biologics, each have their pros and cons, and patient segments may weigh these differently. For example, Zolgensma, an AAV-based gene therapy, offers a potential one-and-done cure but comes with a high price tag and safety concerns, while Evrysdi, a small molecule, is taken orally daily and has become a preferred treatment due to its convenience[1].

Financial Performance

Funding and Valuation

For companies developing new drugs, funding and valuation are critical. While the sources do not provide specific financial details for a drug named "VERSED," we can look at similar companies in the pharmaceutical and healthcare sectors. For instance, Versed Skincare, a company in the beauty and personal care industry, has raised $11 million over three funding rounds, illustrating the importance of securing adequate funding for product development and market entry[2].

Revenue and Market Share

Revenue generation and market share are key indicators of a drug's financial success. In the case of SMA treatments, new entrants have not only captured market share but also expanded the overall market size. For example, Evrysdi generated over $650 million in worldwide sales in its first full year after launch and almost doubled its sales the following year[1].

Patient Needs and Market Expansion

Expanding Market Size

The introduction of new treatments can significantly expand the market size by increasing patient access and treatment options. The SMA market, for example, grew from $3.0 billion in 2020 to $4.4 billion in 2022, driven by new modalities and treatments[1].

Choice and Hope for Patients

New therapeutic modalities offer patients much-needed hope and choice. Each modality caters to different patient segments, providing options that were previously unavailable. This diversity in treatment options is a positive development for patient care and market growth[1].

Emerging Competition and Future Outlook

Crowded Pipelines

The pharmaceutical pipeline is often crowded, especially for popular targets. For instance, there are currently 56 PD(L)1 inhibitors in development, and multiple companies are pursuing the same disease indications with different modalities. This crowding can stifle innovation and create bottlenecks in clinical trials[1].

New Indications and Modalities

Despite the challenges, new modalities and indications offer significant opportunities. Emerging competition in areas like Factor XI anticoagulation, hypercholesterolemia, and Alpha1 antitrypsin deficiency is expected to drive market growth and innovation[1].

Key Takeaways

• First-Mover Advantage: Being first to market can provide a significant competitive edge, but fast followers can still capture substantial market share by offering better efficacy or convenience.
• Different Modalities: New therapeutic modalities can shift market dynamics and offer patients more choices, each with its own pros and cons.
• Financial Performance: Adequate funding and strong revenue generation are crucial for the success of new drugs.
• Patient Needs: Expanding treatment options can significantly increase market size and provide more hope and choice for patients.
• Emerging Competition: The pharmaceutical pipeline is often crowded, but new modalities and indications continue to offer opportunities for growth and innovation.

FAQs

What is the impact of first-mover advantage in the pharmaceutical industry?

The first-mover advantage can be significant, allowing companies to gain a strong market position due to physician familiarity and patient trust. However, fast followers can still capture market share by offering better efficacy or convenience.

How do different therapeutic modalities affect market dynamics?

Different modalities bring their own pros and cons and cater to different patient segments. This diversity in treatment options expands the market size and provides patients with more choices.

What role does funding play in the development of new drugs?

Adequate funding is critical for the development and market entry of new drugs. Companies often secure funding through various rounds to support their research, development, and marketing efforts.

How does the introduction of new treatments affect the overall market size?

The introduction of new treatments can significantly expand the market size by increasing patient access and treatment options, as seen in the SMA market.

What are the challenges and opportunities in a crowded pharmaceutical pipeline?

A crowded pipeline can stifle innovation and create bottlenecks in clinical trials. However, new modalities and indications continue to offer opportunities for growth and innovation, driving market expansion and patient care improvements.

Sources

1. Outclassed: The Battle for Therapeutic Market Share - a16z.com
2. Versed Stock Price, Funding, Valuation, Revenue & Financials - cbinsights.com
3. Midazolam Injection Market Size And Forecast - marketresearchintellect.com
4. A cost-effectiveness analysis of propofol versus midazolam for procedural sedation - pubmed.ncbi.nlm.nih.gov
5. Midazolam Hydrochloride: Detailed Review of its Transformative R&D Success - synapse.patsnap.com