Paragraph IV Patent Certifications*

The PDF contains a list of drug products for which an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification. This list includes the name of the drug product, dosage form, strength (subject of Paragraph IV certification), reference listed drug (RLD), and the date on which the first substantially complete generic drug application was submitted to the Agency (on a prospective basis beginning 3/2/04).

Nov 14, 2009

The Agency will not disclose the identity of the applicant. This information will be updated twice a month and will be as current as the last update. This information should be used for reference only. The Agency will make every effort to ensure the accuracy of the information disclosed in this list. However, any discrepancies or disparities should be discussed with the Regulatory Support Branch at 240-276-8400, before making any decisions based on this information.

FDA

Our List of Cobot Palletizing Solutions

Pharmaceutical Traceability & Inspection Innovations Report

List: Digitalization Companies From PACK EXPO

Medidex, an AI-powered medical chatbot platform, analyzed every pharmaceutical recall from 2012 through 2024, looking at both how often companies recalled products and how dangerous those recalls were.

Study Reveals the U.S. Pharmaceutical Firms with the Most FDA Recalls

An AI healthcare platform analyzed 13 years of FDA data to identify companies with highest recall rates and most dangerous violations.

Through the Line: Packaging and Processing

Through the Line: At-home Test Kits

Packaging Recycling Professionals Gathered in Person and Remotely for this Year's Packaging Recycling Summit

The Barcode Assessment revealed that while most manufacturers are now labeling medical devices with barcodes containing the mandated UDI, healthcare providers aren’t consistently scanning those barcodes at the point of care.

Bridging the Barcode Divide: Challenges in Medical Device UDI Implementation

Claire Lageat, BD Clinical and Human Factors Specialist shared expert insights into how needle choice can impact the self-injection experience.

Improving Self-Injection Delivery of Biologics Through Better Needle Choices

Pharmaceutical Innovations Report

Discover the latest breakthrough packaging technologies shaping the pharmaceutical sector. This report dives into cutting-edge innovations, from smart containers that enhance patient safety to eco-friendly materials poised to transform the industry’s sustainability practices. All from PACK EXPO. Learn how forward-thinking strategies are driving efficiency and redefining what’s possible in pharma packaging.

Learn More

List: Digitalization Companies From PACK EXPO

Looking for CPG-focused digital transformation solutions? Download our editor-curated list from PACK EXPO featuring top companies offering warehouse management, ERP, digital twin, and MES software with supply chain visibility and analytics capabilities—all tailored specifically for CPG operations.

Download Now

Products

Paragraph IV Patent Certifications*

FDA

Our List of Cobot Palletizing Solutions

Pharmaceutical Traceability & Inspection Innovations Report

List: Digitalization Companies From PACK EXPO

Study Reveals the U.S. Pharmaceutical Firms with the Most FDA Recalls

Through the Line: At-home Test Kits

Packaging Recycling Professionals Gathered in Person and Remotely for this Year's Packaging Recycling Summit

Bridging the Barcode Divide: Challenges in Medical Device UDI Implementation

Improving Self-Injection Delivery of Biologics Through Better Needle Choices

Leak Detection Equipment for Flexible Packaging

Digital Adherence Monitoring Application

Laser-Marked Desiccant Canisters

Spring 2025 Healthcare Packaging

Fall 2024 Healthcare Packaging

Spring 2024 Healthcare Packaging

Winter Healthcare Packaging 2023

Cartoning Innovations Report

Robotics Innovations Report

Avoid FDA warning letters with expert compliance strategies

E-commerce Innovations Report