Generic Solid Dosage Forms

generic solid dosage forms   November 2016  •  Catalog no. SDF986F  •  Price US $2,850

The generic solid dosage form drug segment is a rapidly evolving and highly unpredictable environment that has been a challenge to decision makers attempting to map strategies for success in this segment. There are 611 distinct APIs for which there is at least one approved generic solid dosage form ANDA. These 611 APIs account for 4,314 approved ANDAs. Including all approved doses, the current universe of generic solid dosage forms consists of 9,895 unique tablet and capsule products. These products are marketed and supplied by more than 800 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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Generic Solid Dosage Forms – What You Will Learn

• Provides detailed analysis of generic drugs supplied as solid dosage forms and assesses key market segments, market dynamics and potential product opportunities
• Presents the competitive picture for generic tablets and capsules 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 suppliers in the solid dosage form segment
• Evaluates the impact of economic, technology, and regulatory factors

Generic Solid Dosage Forms – Summary of Contents

Executive Summary

The Market Opportunity

The Economics of Generic Drugs
Growth in Generics
Demand Drivers
Competitive Landscape

Generic Solid Dosage Forms – Growth Factors

Patents and Exclusivity
Litigation and First-to-File ANDA Strategies
Buying and Selling ANDAs

Generic SDFs – Product Considerations

Formulation Factors
Modified Release
Extended Release
Delayed Release
Specialty Dosage Forms
Chewable Tablets
Dissolvable Dosage Forms

Generic Solid Dosage Forms – Market Analysis

Therapeutic Class Analysis

Infectious Disease
Metabolic Nephrology
Pain Management
Reproductive Health
Upper Airway Diseases

Drug Classes

Includes more than eighty drug classes


Analyzes more than three dozen market segments

Market Factors

Regulatory Issues
Litigation Issues
Evolving ANDA Filing Strategies
The Role of CMOs
Healthcare Economics

Company Analysis