Pharmacies making Generic Versions are being sued by Manufacturers

“Generic drugs are approved only after a rigorous review by FDA and after a set period of time that the brand product has been on the market exclusively. A generic drug is a medication with the exact same active ingredient as the brand-name drug.” It is not unusual to buy generic versions of a particular product. It will not be labeled as the same product name.

I can not take certain drugs and am confined to drugs which are more costly. I started looking at the ingredients on one patent drug which contained an 2mg of an antihistamine and 325mg of acetaminophen. To buy twenty tablets of the name brand drug (take 4-tabs a day) is $7-8. I can buy a 100 4 mg tabs of the antihistamine for $6 and 100 tabs of the acetaminophen for $4. There is no magic to this, it works, and both are common generic versions.

I am curious to see how this works out as there can be a host of other or resulting actions blocking generic versions of name brand drugs. This could have economic consequences depending on how the court rules. I used to plan the manufacture of certain drugs for a major company.

Novo Nordisk Sues to Block Pharmacy-Made Wegovy Knock-Offs, Bloomberg, Emma Court.

The issues as cited by Novo Nordisk: Compounding pharmacies make and sell Wegovy’s active ingredient. Novo Nordisk alleges pharmacies are selling unapproved drugs.

Novo Nordisk A/S sued US pharmacies making and selling versions of semaglutide, the active ingredient in Wegovy, the company’s blockbuster weight-loss drug. 

In lawsuits filed Thursday in Florida and Tennessee federal courts, Novo said that the compounding pharmacies violate state law by selling drugs that lack Food and Drug Administration approval and haven’t been sufficiently studied. 

Novo’s US unit is seeking to protect Wegovy and Ozempic, the top-selling treatments that help patients shed pounds and have more than doubled the Danish drugmaker’s share price since the beginning of 2021. Early this year, the company sued med spas and weight-loss clinics marketing compounded semaglutide, claiming trademark infringement.

Novo said in the pharmacy law suits;

“Ignoring drug-approval requirements provides defendant an unfair competitive advantage over pharmaceutical manufacturers like Novo Nordisk. Worse, it puts patients at risk by exposing them to drugs that have not been shown to be safe or effective.”

In its lawsuits, Novo cites a 2012 fungal infection outbreak, related to a compounding center, that resulted in hundreds of diagnoses and dozens of deaths. 

Thousands of compounding pharmacies in the US make custom versions of drugs for specific patients: for example, child-friendly liquid forms of solid drugs. The pharmacies are sometimes permitted to make and sell alternatives to FDA-approved drugs, often at far lower cost, and if the agency says they’re in shortage. As it has with Wegovy and Ozempic, which also contains semaglutide. 

However, the FDA doesn’t approve compounded products or have the same oversight it has with traditional prescription drugs. It has warned consumers about complaints of safety issues with compounded semaglutide. The FDA saying “patients should not use a compounded drug if an approved drug is available to treat a patient.”

Novo sued DCA Pharmacy in federal court in Nashville, Tennessee. Suits against WellHealth Rx and TruLife Pharmacy were filed in a Jacksonville, Florida, federal court and Brooksville Rx was sued in Tampa. All the suits claim the pharmacies violated state consumer protection laws by selling drugs that weren’t approved by regulators.

The pharmacies did not immediately respond to a request for comment. 

Analysts foresee Wegovy generating $4.2 billion in sales this year, and about $12.5 billion for Ozempic, a diabetes drug that’s often used for weight loss. 

Article assistance from Bob Van Voris.