NOURESS Drug Patent Profile

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

Nouress is a drug marketed by Baxter Hlthcare Corp and is included in one NDA. There are nineteen patents protecting this drug.

This drug has one patent family member in one country.

The generic ingredient in NOURESS is cysteine hydrochloride. There are fourteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cysteine hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Nouress

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (cysteine hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for NOURESS

International Patents:	1
US Patents:	19
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	115
Patent Applications:	3,058
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NOURESS
What excipients (inactive ingredients) are in NOURESS?	NOURESS excipients list
DailyMed Link:	NOURESS at DailyMed

US Patents and Regulatory Information for NOURESS

NOURESS is protected by nineteen US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare Corp	NOURESS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	212535-001	Dec 13, 2019		DISCN	Yes	No	10,543,186
Baxter Hlthcare Corp	NOURESS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	212535-001	Dec 13, 2019		DISCN	Yes	No	10,905,713		Y
Baxter Hlthcare Corp	NOURESS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	212535-001	Dec 13, 2019		DISCN	Yes	No	11,045,438		Y
Baxter Hlthcare Corp	NOURESS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	212535-001	Dec 13, 2019		DISCN	Yes	No	11,510,942		Y
Baxter Hlthcare Corp	NOURESS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	212535-001	Dec 13, 2019		DISCN	Yes	No	11,648,262		Y
Baxter Hlthcare Corp	NOURESS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	212535-001	Dec 13, 2019		DISCN	Yes	No	11,642,370		Y

International Patents for NOURESS

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

Country	Patent Number	Title	Estimated Expiration
Canada	3070798	COMPOSITION DE CYSTEINE ET INJECTION (CYSTEINE COMPOSITION AND INJECTION)

Supplementary Protection Certificates for NOURESS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0107734	93C0042	Belgium		PROD. NAME TETRAKIS (2-METHOXY-ISOBUTYL-ISONITRILE). CUIVRE (I) TETRAFLUOROBORATE, DIHYDRATE DE CHLORURE STANNEUX, CHLORHYDRATE DE L-CYSTEINE (MONOHYDRATE); REG NO/DATE 923 IS 3 F 12/ 19900924 ; FIRST REG CC NO DATE IE PA 200/9/1 19900817

NOURESS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nouress

Introduction

Nouress, a cysteine hydrochloride injection, is a sterile injectable product developed by Avadel Pharmaceuticals PLC for use in the hospital setting. Here, we delve into the market dynamics and financial trajectory of Nouress, highlighting key aspects that influence its position in the pharmaceutical market.

Regulatory Approval and Market Entry

Nouress received FDA approval in December 2019, marking a significant milestone for Avadel Pharmaceuticals. However, the commercial launch of Nouress has been complicated by a patent suit filed by Exela Pharma Sciences, LLC, which has delayed the product's entry into the market[4][5].

Patent and Intellectual Property

The patent landscape plays a crucial role in the pharmaceutical industry. Nouress is covered by two existing patents, with several additional patent applications pending with the USPTO. The ongoing patent dispute with Exela Pharma Sciences has significant implications for the commercialization and revenue generation of Nouress[4].

Market Competition

The hospital injectable market is highly competitive, with several established players. Avadel Pharmaceuticals faces challenges in gaining market share due to the presence of well-established competitors and the potential for further consolidation in the industry. The company's reliance on a limited number of products to generate revenue exacerbates this competitive pressure[4].

Financial Implications

Avadel Pharmaceuticals has incurred significant costs associated with the development and regulatory approval of Nouress. The delay in commercial launch due to the patent dispute has further strained the company's financial resources. As of the latest reports, Avadel Pharmaceuticals has been operating at a net loss, and the company may require additional financing to support its operations and product commercialization efforts[5].

Revenue Generation and Projections

The revenue from Avadel's existing products, such as Akovaz and Vazculep, is used to fund the research and development of new products, including Nouress. However, the lack of immediate revenue from Nouress due to the delayed commercial launch has impacted the company's overall financial performance. The potential market size and participation for Nouress are significant, but these projections are contingent on resolving the patent issues and successfully launching the product[4][5].

Regulatory and Distribution Challenges

Beyond the patent issues, Nouress is subject to significant regulatory restrictions, including safety reporting requirements and potential Risk Evaluation and Mitigation Strategy (REMS) requirements. These regulatory hurdles can delay distribution and require substantial corrective actions, adding to the financial and operational complexities[5].

Strategic Partnerships and Financing

Avadel Pharmaceuticals is exploring strategic partnerships for the commercialization, manufacturing, and distribution of Nouress. The company's ability to secure favorable financing terms or strategic partnerships will be crucial in overcoming the current challenges and ensuring the successful launch of Nouress. The recent financing activities, such as those seen in other pharmaceutical companies, highlight the importance of robust financial strategies in bringing new products to market[5].

Key Takeaways

• Regulatory Approval: Nouress received FDA approval in December 2019 but faces delays in commercial launch due to patent disputes.
• Market Competition: The product operates in a highly competitive hospital injectable market.
• Financial Strains: Avadel Pharmaceuticals has incurred significant costs and operates at a net loss, necessitating additional financing.
• Regulatory Hurdles: The product is subject to stringent regulatory requirements.
• Strategic Partnerships: Securing favorable partnerships is crucial for successful commercialization.

FAQs

Q: What is Nouress, and what is it used for? Nouress is a cysteine hydrochloride injection, a sterile injectable product approved for use in the hospital setting.

Q: Why is the commercial launch of Nouress delayed? The commercial launch of Nouress is delayed due to a patent dispute with Exela Pharma Sciences, LLC.

Q: How does the patent landscape affect Nouress? Nouress is covered by two existing patents with additional pending applications. The ongoing patent dispute significantly impacts its commercialization.

Q: What are the financial implications for Avadel Pharmaceuticals due to the delayed launch of Nouress? Avadel Pharmaceuticals has incurred significant costs and operates at a net loss, necessitating additional financing to support its operations.

Q: What regulatory challenges does Nouress face? Nouress is subject to significant regulatory restrictions, including safety reporting requirements and potential REMS requirements.