Pre-ANDA litigation : strategies and tactics for developing a drug product and patent portfolio / Kenneth L. Dorsney, editor-in-chief.

Coordinating new drug application (NDA) and patent portfolio strategy
Preclinical R&D
Preclinical patent considerations
Clinical trials and regulatory considerations
Clinical trial-patent considerations
Trademark (TM) and nonproprietary name considerations
Investigational new drug (IND) and new drug applications (NDA)
Regulatory exclusivity
Overview of the NDA review process
Orange book listable patents
Postmarketing regulatory requirements and life cycle management
Patent prosecution
Acquiring and in-licensing pharmaceutical products : due diligence issues
Pre-litigation investigations and due diligence
Market entry business considerations for generic companies
Intellectual property considerations for generic product opportunities
Preparation of noninfringement/invalidity legal opinions
ANDA preparation (with an eye toward approval and litigation) and the FDA review
Obtaining ANDA approval and right to market
Providing notice to the NDA holder
Evaluating scenarios for launch, including marketing, and manufacturing developments
Citizen petitions
Expedited regulatory pathways
Biologic drugs and the Biologics Price Competition and Innovation Act
Pharmaceutical regulation and approval in foreign countries.