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The Paragraph Four Report®

Paragraph IV Activity includes all products that have pending and active Paragraph IV Certifications filed against them. It also includes patent challenges (or defenses) against antibiotics, 505(b)(2), and DESI products. Once a product reaches the market in generic form after final termination of litigation (typically after an appeal) in favor of the Paragraph IV applicant, the product is placed into the "Old Cases" Section.

Non-Paragraph IV Cases provides information regarding patent cases that are not generated under Paragraph IV. This information is not exhaustive, is not updated, and is provided as a courtesy; however, information is provided when The Paragraph Four Report identifies them.

Annual Sales Sales figures of the branded product as reported in the company's most recent Annual Report. The figure is for US/North America sales if reported as such and often includes the collective sales for different product forms and strengths. The currency used is the same as reported.

Case Name The name of the case (lead parties).

Case Number The number of the case.

Company The branded pharmaceutical company whose product is challenged. Typically provided as the Reference Company but also cross-referenced with other related companies such as licensees, subsidiaries, etc.

Court The Federal District Court or Court of Appeals where the case is pending.

Date Filed The date the court case (or appellate case) was filed.

Date of First Filing The date the first ANDA was filed with a Paragraph IV certification as listed in the FDA Certification List.

Dosage The form of the product.

Generic Name The generic name of the challenged product.

Judge The District Court Judge assigned to the case.

Lead Attorney/Law Firm Name of lawyer and law firm listed as lead attorney in the docket.

Litigated Patent(s) The patents challenged in litigation as initially plead.

Non-Litigated Patent(s) The patents listed with the Reference List Drug in the Orange Book that are not identified in the pleadings as being litigated.

Paragraph IV Applicant The name of the company which filed the Abbreviated New Drug Application with Paragraph IV certification.

Patent Expires The date of expiration of a patent (including Pediatric exclusivity period, if any) as listed in the Orange Book. In situations where there is no patent listed (antibiotics, for example), no independent determination is made as to the patent's expiration date.

Product The brand name of the challenged product.

Related Cases are those cases that are related to the primary case by procedural and legal standards such as identical parties, consolidation, etc and as identified by the court or parties.

Special Note Some of the Product Topics will include Special Notes. These include summaries of multiple case filings on a product and references to citizen petitions filed, SEC filings, and other information that may be helpful. Special Notes are by no means exhaustive, and we always recommend subscribers to check all available resources.

Status A brief summary on the progress of the case with critical dates as scheduled.

Strength The strength of the product as identified in the pleadings. If the pleadings do not specify strength, all strengths are included.

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©2019 Parry Ashford Inc.


The Paragraph Four Report®,® and the PFOUR logo are registered trademarks of Parry Ashford Inc. • © Parry Ashford Inc. 2019