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The Current Status of FTC'S Orange Book Listings Challenge


The Current Status of FTC's Orange Book Listings Challenge

The overwhelming majority of patents declared by the FTC as improperly listed in the FDA's Orange Book remain listed and in force. Thus far, ...

FTC Expands Patent Listing Challenges, Targeting More Than 300 ...

Improper Orange Book patent listings can delay cheaper generic alternatives from entering the market, keeping brand name drug prices ...

The FTC Challenges Companies' Allegedly Improper Orange Book ...

In April 2024, the FTC challenged over 300 patent listings in the Orange Book as improper or inaccurate. According to the FTC, these challenges were in part ...

The FTC's Challenge to the Listing of Device Patents in the Orange ...

On September 23, 2023, the FTC issued a policy statement advising it would be putting market participants on notice that it intends to ...

FTC and FDA Updates on Patent Listing Disputes Explained

It is clear, however, that the FTC's attempt to use the Patent Dispute Process to spur the FDA to review the legitimacy of Orange Book listings ...

Increased Scrutiny by Federal Trade Commission of Orange Book ...

listing dispute communications with the FDA under 21 C.F.R. 314.53(f)(1), which enables the. FTC to challenge patent listings in the Orange.

FTC Challenges More Patent Listings in the FDA's Orange Book

FTC's latest action targets more than 300 Orange Book patent listings across 10 different companies, which brings the total to more than 400 ...

An Antitrust Economist's Perspective on Recent FTC Scrutiny ...

However, the relative benefits and costs of listing additional patents may change as the FTC now scrutinizes Orange Book listings to identify ...

FTC Continues to 'Dispute' Orange Book Device Patent Listings, But ...

Targeted companies then have 30 days to elect to either delist or maintain their listings. In response to the November 2023 listing disputes, a ...

FTC Challenges More Than 100 Patents as Improperly Listed in the ...

The Commission said improper listings in the Orange Book may harm competition from cheaper generic alternatives and keep brand prices ...

The FTC's Criticism of “Junk” Orange Book Filings - Ropes & Gray LLP

The FTC's Criticism of “Junk” Orange Book Filings: The Latest Squall in a Regulatory Rainstorm ... The 300 additional patents relate to 20 ...

Tilman Kuhn on LinkedIn: The Current Status of FTC's Orange Book ...

Tilman Kuhn's Post · The Current Status of FTC'S Orange Book Listings Challenge: A Mixed Bag | White & Case LLP · More Relevant Posts · FTC ...

US FTC Continues Aggressive Scrutiny of Pharmaceutical Patents ...

FTC Continues to Ramp Up Scrutiny of Orange Book Patent Listings ... These patent listing challenges are just the latest step by the FTC, which ...

FTC continues to scrutinize Orange Book patent listings | DLA Piper

The Federal Trade Commission (FTC) sent its second set of warning letters to 10 companies disputing the accuracy or relevance of more than ...

Primer: FTC Scrutinizes Orange Book Listings - AAF

The FTC sent notice letters – the first tranche in November 2023 and the second in April 2024 – to drug manufacturers challenging more than 400 ...

Following Recent Policy Statement, FTC 'Disputes' 100+ Patent ...

The FTC's letters follow the agency's September 2023 policy statement announcing that “improper” Orange Book listings may be challenged “as ...

FTC challenges around 100 FDA Orange Book patent listings

The US Federal Trade Commission (FTC) announced that it issued warning letters to 10 drug manufacturers and challenged the Orange Book listings for around 100 ...

Increased Scrutiny by Federal Trade Commission of Orange Book ...

The FDA has stated that it will continue to work with the FTC to address potential efforts to impede competition. As a precaution, New Drug Application (NDA) ...

Red Alert on the Orange Book: The FTC Continues to Crack Down ...

In the letters, the FTC indicated it is using the FDA's regulatory dispute process to challenge the listing of these patents in the Orange Book ...

FTC Weighs In on Orange Book Listing of Drug-Device Patents

FTC's narrow view is shared by certain members of Congress, who have targeted NDA holders and demanded that drug-device patents be de-listed ...