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The Generic Injectables Market

generic injectables   Published February 2017  •  Catalog no. GJR393F17  •  Price US $3,850

The generic injectable drug segment is a rapidly evolving and highly competitive market that lacks a true data compass to assist decision makers in mapping strategies for success in this segment. Attempting to determine the optimal time to file an ANDA application is a process that can be worth significant profits for first-to-filers. But it is a process that is marked by little in the way of analytical decision support and in which litigation has become a staple defensive mechanism for both the filer and the branded drug owner. There are 235 distinct APIs for which there is at least one approved generic injectable ANDA. These 235 APIs account for 1,182 approved ANDAs. Including all approved doses, the current universe of generic injectables consists of 1,726 unique injectable products. These products are currently 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.

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The Generic Injectables Market – 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


The Generic Injectables Market – Summary of Contents

Executive Summary

The Market Opportunity

The Economics of Injectable Drugs

Growth in Injectables

Demand Drivers

Competitive Landscape

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


Formulation Factors

Generic Injectables Market Analysis

Drug Class Analysis

Adrenergic Agents

Anabolic Agents











Bone Resorption Inhibitors


Folic Acid Metabolites

Growth Hormone Inhibitors

Muscle Relaxants

Narcotic Analgesics


Opioid Antagonist



Therapeutic Class Analysis





Pain Management

Other Key Classes

Market Factors

Regulatory Issues

Litigation Issues

Evolving ANDA Filing Strategies

The Role of CMOs

Healthcare Economics

Company Analysis