AVAGE Drug Patent Profile

When do Avage patents expire, and what generic alternatives are available?

Avage is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in AVAGE is tazarotene. There are eight drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the tazarotene profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Avage

A generic version of AVAGE was approved as tazarotene by TARO on April 3^rd, 2017.

Summary for AVAGE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	129
Patent Applications:	5,380
Drug Prices:	Drug price information for AVAGE
DailyMed Link:	AVAGE at DailyMed

See drug prices for AVAGE

Pharmacology for AVAGE

Drug Class

Retinoid

US Patents and Regulatory Information for AVAGE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	AVAGE	tazarotene	CREAM;TOPICAL	021184-003	Sep 30, 2002	AB	RX	Yes	Yes

Expired US Patents for AVAGE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	AVAGE	tazarotene	CREAM;TOPICAL	021184-003	Sep 30, 2002

International Patents for AVAGE

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

Country	Patent Number	Title	Estimated Expiration
Germany	69330092
Germany	3871414
Australia	3659193
Denmark	175081
Germany	19775022

Supplementary Protection Certificates for AVAGE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0031058	98C0008	Belgium		PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: NL22604 19970922; FIRST REGISTRATION: DE - 37393.00.00 19961203
0284288	12/1998	Austria		PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: 1-22102, 1-22103 19970918; FIRST REGISTRATION: DE 37393.00.00, 37393.01.00 19961203
0284288	SPC/GB98/002	United Kingdom		PRODUCT NAME: TAZAROTENE : ETHYL 6-(2-(4,4-DIMETHYLTHIOCHROMAN-6-YL) ETHYNYL) NICOTINOATE; REGISTERED: DE 37393.00.00 19961203; DE 37393.01.00 19961203; UK 00426/0097 19970730; UK 00426/0096 19970730

AVAGE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Prescription Drugs: A Case Study on AVAGE and Broader Industry Trends

Introduction

The pharmaceutical industry is a complex and highly regulated market, influenced by various factors including competition, regulatory environments, and financial investments. This article will delve into the market dynamics and financial trajectory of prescription drugs, using AVAGE as a case study, and explore broader industry trends that shape the pharmaceutical sector.

The Cost of Bringing a New Drug to Market

Developing a new drug is a costly and time-consuming process. The average cost of bringing a new drug to market is estimated to be around $2.6 billion, with a development timeline spanning 10 to 15 years. This process is fraught with risks, as the probability of success for a drug candidate entering clinical trials is only about 10%[3].

Competition in Prescription Drug Markets

Competition plays a crucial role in determining the prices of prescription drugs. Studies have shown that drugs with fewer or only one manufacturer tend to have higher prices compared to those with multiple manufacturers. For instance, in 2022, the average cost of a biological product was $174 per prescription, which is 3.7 times greater than the average cost of a small molecule drug, which was $48 per prescription[1].

Market Structure and Pricing

The structure of the market significantly affects drug prices. In markets with a single manufacturer, prices tend to be higher. However, as the number of competitors increases, prices decline. For example, generic drug prices fall with the number of competitors and begin to approach long-run marginal costs when there are 8 or more competitors[4].

Specialty Drugs and Their Financial Impact

Specialty drugs, such as AVAGE, which is used for treating actinic keratosis, often have distinct handling, administration, and monitoring requirements. These drugs typically garner higher prices and use a limited distribution model. The average three-year revenue from a specialty drug can exceed $1 billion, more than double the revenue from a nonspecialty product[5].

Launch Performance and Long-Term Outlook

The performance of a drug in its first year post-launch is a strong indicator of its long-term sales performance. Drugs that meet or beat analyst expectations in the first year are more likely to continue doing so in subsequent years. For instance, 86% of drugs that had a strong performance in the first year continued to meet or beat expectations in the second year, and 78% did so in the third year[5].

Regulatory Environment and Market Access

Regulatory approvals and market access are critical for the success of a new drug. Priority review designations from regulatory bodies like the FDA can significantly impact a drug's launch performance. Drugs receiving priority review are more likely to meet or beat expectations due to the shorter regulatory review cycle and the market's expectation for significant advancement over existing therapies[5].

Payer Dynamics and Market Access

Payer dynamics can significantly influence a drug's commercial success. For example, if payers are slow to cover a new drug or place it on a high tier with utilization management requirements, patient cost-sharing can be high, affecting market access. Outcomes-based arrangements with payers can improve market access, as seen in the case of some drugs that struggled initially but gained traction after such agreements were made[5].

Financial Projections and Industry Growth

The global pharmaceutical market is projected to grow significantly, with revenues expected to reach $1.15 trillion in 2024 and exceed $1.4 trillion by 2028. This growth is driven by the escalating global burden of chronic diseases and the strategic alignment of R&D investments to address these unmet medical needs[3].

Case Study: AVAGE

AVAGE, a topical cream used for treating actinic keratosis, is a specialty drug that falls under the broader category of dermatological treatments. Here are some key points to consider:

Market Position

AVAGE competes in a market where the number of competitors can influence pricing. Given its specialty status, it likely commands a higher price compared to nonspecialty drugs.

Launch Performance

The initial launch performance of AVAGE would be crucial in determining its long-term success. If it met or exceeded analyst expectations in the first year, it would be more likely to continue performing well in subsequent years.

Regulatory and Payer Dynamics

AVAGE would have benefited from any priority review designations or favorable payer coverage. Slow payer adoption or high-tier placement could have hindered its market access, similar to other drugs in the market.

Financial Trajectory

Given the high revenue potential of specialty drugs, AVAGE could generate significant revenues if it successfully navigated the market dynamics. The average three-year revenue for a specialty drug can exceed $1 billion, making it an attractive area for pharmaceutical companies[5].

Impact of Price Controls on Pharmaceutical Research

Price controls can have a significant impact on pharmaceutical research and development. While they may reduce drug prices in the short term, they can also reduce the incentives for innovation. For instance, the estimated pre-tax cost of developing a new drug is around $802 million, and price controls could reduce the potential returns on this investment, thereby discouraging further R&D activities[2].

Investment Trends in Pharmaceutical Research

Despite the challenges, the pharmaceutical sector remains an attractive area for investment due to its potential for high returns. Blockbuster drugs, those with annual sales exceeding $1 billion, can generate large revenue streams for pharmaceutical companies. The oncology market, for example, represents a vast and expanding opportunity due to the rising incidence of cancer worldwide[3].

Key Takeaways

• High Development Costs: Bringing a new drug to market is extremely costly and risky.
• Competition and Pricing: The number of competitors in a market significantly affects drug prices.
• Specialty Drugs: These drugs often have higher prices and greater revenue potential.
• Launch Performance: First-year sales performance is a strong indicator of long-term success.
• Regulatory and Payer Dynamics: Favorable regulatory reviews and payer coverage are crucial for market access.
• Industry Growth: The pharmaceutical market is projected to grow significantly due to the increasing burden of chronic diseases.

FAQs

What is the average cost of bringing a new drug to market?

The average cost of bringing a new drug to market is estimated to be around $2.6 billion, with a development timeline spanning 10 to 15 years[3].

How does competition affect drug prices?

Competition significantly affects drug prices; as the number of competitors increases, prices tend to decline. For example, generic drug prices approach long-run marginal costs when there are 8 or more competitors[4].

What is the impact of priority review on drug launch performance?

Drugs receiving priority review are more likely to meet or beat analyst expectations due to the shorter regulatory review cycle and the market's expectation for significant advancement over existing therapies[5].

How do payer dynamics influence a drug's commercial success?

Payer dynamics can significantly influence a drug's commercial success. Slow payer adoption or high-tier placement can hinder market access, while outcomes-based arrangements can improve it[5].

What is the projected growth of the global pharmaceutical market?

The global pharmaceutical market is projected to reach $1.15 trillion in 2024 and exceed $1.4 trillion by 2028, driven by the escalating global burden of chronic diseases[3].

Sources

1. Competition in Prescription Drug Markets, 2017-2022 - ASPE
2. The Effect of Price Controls on Pharmaceutical Research - NBER
3. Investment Trends in Pharmaceutical Research - DrugBank Blog
4. Generic Drug Industry Dynamics - Federal Trade Commission
5. Key factors to improve drug launches - Deloitte