The generic injectable drug segment is a rapidly evolving and highly unpredictable environment that lacks a true data compass to assist decision makers in mapping strategies for success in this segment. There are 248 distinct APIs for which there is at least one approved generic injectable ANDA. These 248 APIs account for 1,223 approved ANDAs. Including all approved doses, the current universe of generic injectables consists of 1,746 unique injectable products. These products are marketed and supplied by slightly less than one hundred companies. Competition among the various drug and therapeutic classes is uneven, with the top ten segments accounting for a disproportionate level of activity and revenue. Understanding the underlying factors affecting business performance is key to attaining financial targets.
What You Will Learn
~ Provides detailed analysis of generic drugs supplied as injectables and assesses key market segments, market dynamics and potential product opportunities
~ Presents the competitive picture for generic injectables in two dozen drug classes
~ Evaluates the importance of ANDA filing strategies and indirect ANDA acquisition on participant growth prospects
~ Analyzes the impact of patents, exclusivity and litigation on participant market sector prospects
~ Assesses the market presence and product position of the top twenty-four generic injectables suppliers
Evaluates the impact of economic, technology, and regulatory factors
Summary of Contents
Executive Summary
The Market Opportunity
The Economics of Injectable Drugs
Growth in Injectables
Generic Injectables – Growth Factors
Patents and Exclusivity
Litigation and First-to-File ANDA Strategies
Buying and Selling ANDAs
Generic Injectables – Product Considerations
As-supplied Container
Lyophilization/Reconstitution
Formulation Factors
Generic Injectables Market Analysis
Drug Class Analysis
Adrenergic Agents
Anabolic Agents
Antibiotics
Anesthetics
Antiarrhythmics
Anticoagulants
Anticonvulsants
Antiemetics
Anti-inflammatory
Antihypertensives
Antineoplastics
Antivirals
Bone Resorption Inhibitors
Diuretics
Folic Acid Metabolites
Growth Hormone
Inhibitors
Muscle Relaxants
Narcotic Analgesics
Neurotransmitter
Opioid Antagonist
Sedatives
Vasodilators
Therapeutic Class Analysis
Cardiology
Hematology
Neurology
Pain Management
Other Key Classes
Market Factors
Regulatory Issues
Litigation Issues
Evolving ANDA Filing Strategies
The Role of CMOs
Healthcare Economics