CETYLEV Drug Patent Profile

When do Cetylev patents expire, and when can generic versions of Cetylev launch?

Cetylev is a drug marketed by Arbor Pharms Llc and is included in one NDA. There are three patents protecting this drug.

This drug has one patent family member in one country.

The generic ingredient in CETYLEV is acetylcysteine. There are three drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cetylev

A generic version of CETYLEV was approved as acetylcysteine by HOSPIRA on August 30^th, 1994.

Summary for CETYLEV

International Patents:	1
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	158
Clinical Trials:	1
Patent Applications:	3,690
Drug Prices:	Drug price information for CETYLEV
DailyMed Link:	CETYLEV at DailyMed

See drug prices for CETYLEV

Recent Clinical Trials for CETYLEV

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

Sponsor	Phase
University of Maryland	Phase 1/Phase 2
University of Maryland, Baltimore	Phase 1/Phase 2

See all CETYLEV clinical trials

US Patents and Regulatory Information for CETYLEV

CETYLEV is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Arbor Pharms Llc	CETYLEV	acetylcysteine	TABLET, EFFERVESCENT;ORAL	207916-002	Jan 29, 2016		DISCN	Yes	No
Arbor Pharms Llc	CETYLEV	acetylcysteine	TABLET, EFFERVESCENT;ORAL	207916-001	Jan 29, 2016		DISCN	Yes	No			Y
Arbor Pharms Llc	CETYLEV	acetylcysteine	TABLET, EFFERVESCENT;ORAL	207916-002	Jan 29, 2016		DISCN	Yes	No			Y
Arbor Pharms Llc	CETYLEV	acetylcysteine	TABLET, EFFERVESCENT;ORAL	207916-002	Jan 29, 2016		DISCN	Yes	No			Y
Arbor Pharms Llc	CETYLEV	acetylcysteine	TABLET, EFFERVESCENT;ORAL	207916-001	Jan 29, 2016		DISCN	Yes	No			Y
Arbor Pharms Llc	CETYLEV	acetylcysteine	TABLET, EFFERVESCENT;ORAL	207916-001	Jan 29, 2016		DISCN	Yes	No

International Patents for CETYLEV

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2662077	COMPOSITION EFFERVESCENTE CONTENANT DE LA N-ACÉTYL-CYSTÉINE (EFFERVESCENT COMPOSITIONS CONTAINING N-ACETYLCYSTEINE)

CETYLEV Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CETYLEV

Introduction

CETYLEV, an effervescent tablet formulation of acetylcysteine, was approved by the FDA in January 2016 for the treatment of acetaminophen overdose. Here, we delve into the market dynamics and financial trajectory of this drug.

Therapeutic Class and Indication

CETYLEV belongs to the class of antidotes and is specifically indicated to prevent or reduce hepatic injury due to acetaminophen overdose. This is a critical therapeutic area, given the high incidence of acetaminophen overdoses and the potential for severe liver damage if left untreated[1][5].

Market Need and Demand

The demand for antidotes to acetaminophen overdose is significant due to the common use of acetaminophen as an over-the-counter pain reliever and the risk of accidental or intentional overdoses. The mortality rate from acetaminophen overdose can be as high as 5-6% if not treated promptly, but this rate drops to 0.7% when acetylcysteine is administered within 0 to 24 hours of the overdose[1].

Competitive Landscape

CETYLEV entered a market where other formulations of acetylcysteine, such as Mucomyst, were already established. The approval of CETYLEV was based on a comparative bioavailability study with Mucomyst, rather than new efficacy and safety trials, which helped in expediting the approval process[1].

Generic Availability

Although CETYLEV itself has been discontinued in the U.S., generic versions of acetylcysteine effervescent tablets may still be available. This transition to generic formulations can impact the financial trajectory of the original brand[4][5].

Financial Performance

The financial performance of CETYLEV would have been influenced by several factors, including the initial market reception, competition from existing products, and the transition to generic versions.

• Initial Market Reception: Upon its approval, CETYLEV would have generated revenue based on its unique formulation and the need for an effective antidote to acetaminophen overdose. However, the lack of new efficacy and safety trials might have limited its market differentiation.
• Competition: The presence of established brands like Mucomyst would have competed with CETYLEV for market share. This competition could have affected the pricing and revenue generation for CETYLEV.
• Transition to Generics: The discontinuation of the CETYLEV brand and the potential availability of generic versions would have significantly impacted its financial trajectory. Generic versions typically reduce the revenue for the original brand as they offer a cheaper alternative[4].

Global Pharmaceutical Market Trends

The broader pharmaceutical market trends also play a crucial role in the financial trajectory of specific drugs. Global spending on medicines is expected to increase by 38% through 2028, driven by innovative therapeutics and despite losses of exclusivity and the lower costs of generics and biosimilars[3].

Revenue Impact

Given that CETYLEV has been discontinued, its direct revenue contribution would have ceased. However, the overall market for acetylcysteine formulations remains, with generic versions potentially capturing the market share that CETYLEV once held.

Example of Pharmaceutical Market Dynamics

To illustrate the impact of market dynamics, consider Vertex Pharmaceuticals, which reported a significant increase in product revenue in 2023, driven by innovative therapeutics. This example highlights how new and innovative products can drive revenue growth, but also how the loss of exclusivity and the introduction of generics can affect revenue[2].

Regulatory and Compliance Costs

The development and approval of CETYLEV involved significant regulatory and compliance costs. The drug was approved under a 505(b)(2) application, which relies on the FDA's previous findings of efficacy and safety for similar drugs. Compliance with Good Clinical Practices (GCP) and other regulatory requirements added to these costs[1].

Key Takeaways

• Market Need: CETYLEV addressed a critical need for an antidote to acetaminophen overdose.
• Competitive Landscape: The drug faced competition from established brands and eventually generic versions.
• Financial Impact: The discontinuation of CETYLEV and the availability of generic versions significantly impacted its revenue.
• Global Trends: The pharmaceutical market is driven by innovative therapeutics and affected by the transition to generics.

FAQs

1. What is CETYLEV used for? CETYLEV is used to treat acetaminophen overdose and prevent or reduce hepatic injury[5].

2. Why was CETYLEV approved without new efficacy and safety trials? CETYLEV was approved based on a comparative bioavailability study with the established drug Mucomyst, leveraging the FDA's previous findings of efficacy and safety for Mucomyst[1].

3. What happened to the CETYLEV brand? The CETYLEV brand has been discontinued in the U.S., but generic versions of acetylcysteine effervescent tablets may still be available[4].

4. How does the transition to generic versions affect the financial trajectory of a drug? The transition to generic versions typically reduces the revenue for the original brand as generics offer a cheaper alternative[4].

5. What are the broader market trends affecting pharmaceutical revenue? Global spending on medicines is expected to increase, driven by innovative therapeutics, despite losses of exclusivity and the lower costs of generics and biosimilars[3].

Cited Sources

1. Pharmadesk Solutions - Clinical Review for NDA 207-916: Cetylev – N-acetylcysteine effervescent tablets.
2. Vertex Pharmaceuticals - Fourth Quarter and Full Year 2023 Financial Results.
3. IQVIA - The Global Use of Medicines 2024: Outlook to 2028.
4. Drugs.com - Generic Cetylev Availability.
5. Drugs.com - Cetylev: Indications, Side Effects, Warnings.