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Pharmaceutical Industry › FDA Approval › Orphan Drugs

Mayer Brown

In Neurelis v. Brenner, The FDA’s “Indication-Specific” View of Orphan Exclusivity is (Again) Struck Down

Mayer Brown on

The legal battle over the scope of orphan drug exclusivity continues, as the U.S. Food and Drug Administration (“FDA”) has recently lost a second case concerning the exclusivity provisions of the Orphan Drug Act (“ODA”)....more

Goodwin

Henlius Receives Orphan-Drug Designation for HLX22 (anti-HER2 mAb) for Gastric Cancer

Goodwin on

On March 19, 2025, Shanghai Henlius Biotech announced that the FDA has granted Orphan Drug Designation for HLX22, an anti-HER2 monoclonal antibody, for the treatment of gastric cancer. HLX22 binds to HER2 extracellular...more

Brownstein Hyatt Farber Schreck

FDA Nominee Makary on the Orphan Drug Act

Brownstein Hyatt Farber Schreck on

President-elect Trump’s nominee for commissioner of Food and Drugs, Martin A. Makary, MD, MPH, argued in 2016 that Congress should reform the Orphan Drug Act (ODA) because drug companies “are gaming the system to use the law...more

Holland & Hart LLP

Alternative Means for FDA Approval of Pet Care Drugs – Part 3: Differences Between Major and Minor Species

Holland & Hart LLP on

This update is the final in a multi-part series exploring FDA approval of pet care drugs. In part one of our series we discussed that before an animal drug product can be legally marketed for use in animals, a New Animal Drug...more

Arnall Golden Gregory LLP

The Sun Will Come Up Tomorrow for Another Company: An Interesting Orphan Drug Exclusivity Decision

Arnall Golden Gregory LLP on

Last month, the Food and Drug Administration’s Office of Orphan Products Development (“OOPD”) found that one prescription drug company was able to, essentially, breach another’s orphan drug exclusivity (and have its new drug...more

Morgan Lewis - As Prescribed

When Words of Encouragement May Indicate More: Congress Focuses on Rare Disease Approval Process

Morgan Lewis - As Prescribed on

While many provisions of the FY 2023 Consolidated Appropriations Act (Omnibus) have received much attention, one has flown under the radar. In its explanatory statement on the Omnibus, the US Congress indicated that it is...more

Arnall Golden Gregory LLP

The Sun Will Come Up Tomorrow (or Will It)? FDA Issues Notification About Orphan Drug Exclusivity in Light of Recent Court...

Arnall Golden Gregory LLP on

Recently, the Food and Drug Administration published a Notification to clarify its policy about orphan drug exclusivity. The agency issued the announcement because the U.S. Court of Appeals for the 11th Circuit found that FDA...more

Haug Partners LLP

A Tale of Two Orphans: The Potential Ramifications of an Orphan Drug “Cutting in Line”

Haug Partners LLP on

Orphan drugs are the pharmaceutical industry’s way of helping those who suffer from rare conditions. Thanks to the Orphan Drug Act, such patients can get the medications they need, and pharmaceutical companies can be duly...more

Hogan Lovells

Eleventh Circuit decision could significantly expand scope of orphan exclusivity

Hogan Lovells on

With the issuance of its mandate on January 28, 2022, in Catalyst Pharmaceuticals, Inc. v. Becerra, the U.S. Court of Appeals for the Eleventh Circuit has upheld the orphan exclusivity for Catalyst Pharmaceuticals, Inc....more

Proskauer - The Patent Playbook

In the Orphan Drug Approval Race, Winner Takes All? Ramifications of Catalyst Pharms. v. Becerra

Proskauer - The Patent Playbook on

How is orphan drug exclusivity affected when the FDA-approved use for an orphan drug is arguably narrower than the treatment of the rare disease it was designated for? By way of background, a sponsor can obtain orphan drug...more

Hogan Lovells

FDA’s Bendeka decision reverses approvals of Treanda generics

Hogan Lovells on

Wednesday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the D.C. Circuit Court in Eagle...more

Knobbe Martens

FDA Approves Zelboraf for Treatment of a Rare Cancer

Knobbe Martens on

On November 6th, 2017, the U.S. Food and Drug Administration (FDA) approved the drug Zelboraf (vemurafenib), for the treatment of Erdheim-Chester Disease (ECD). The FDA approved Zelboraf under Priority Review, Breakthrough...more

Fox Rothschild LLP

FDA Approving Orphan Drugs At A Record Pace

Fox Rothschild LLP on

It is only August, but the U.S. Food and Drug Administration (FDA) is on track to set a record for orphan drugs approved this year. At last count, 42 orphan drugs have been approved between January 1, 2017 and August 9, 2017....more

Akerman LLP - Health Law Rx

Rare but Not Forgotten: FDA Speeds Review of Orphan Drug Requests

Akerman LLP - Health Law Rx on

Ever heard of Hailey-Hailey Disease? How about factor V deficiency or Hemimegalencephaly? These are a few examples of rare diseases, e.g., those afflicting fewer than 200,000 Americans. Rare diseases have long had trouble...more

Knobbe Martens

Tesaro Receives Early FDA Approval for Ovarian Cancer Drug Zejula

Knobbe Martens on

On March 27, 2017, the U.S. Food and Drug Administration approved the use of the poly ADP-ribose polymerase (PARP) inhibitor, Zejula (niraparib), for the maintenance treatment of recurrent ovarian, fallopian tube, or primary...more

Knobbe Martens

Orphan Drug Designation

Knobbe Martens on

“Orphan drug” is a designation given to certain pharmaceutical and biological products (drugs) that would likely not be developed due to a relatively small patient population and limited potential for profitability. In the...more

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