Eli Lilly suing GLP1 compounders & related companies

Compounding GLP1s is now almost effectively a thing of the past. Companies like HIMS which heavily depended on compounding for cheap supply of GLP1s no longer offer it as an option:

HIMS ends compounded Semaglutide offering

Hims announces it will stop providing compounded Semaglutide, after removal from the FDA shortage list.

GLP1 GuideGLP1.Guide Staff

Eli Lilly is taking this one step further and suing many corporations involved GLP1 compounding, including some TeleHealth providers:

• Aios Inc
• Capitol Contours
• Houston Weight Loss Centers of Texas
• Cleveland Health Group
• Lucy’s Laser & MedSpa
• Aequita Corporation
• Willow Health Services
• Adonis Health

What products are linked to the companies being sued?

It's a bit difficult to tell at a glance which providers correspond to which companies so we'll lay them out below:

• Fella Health (Aios Inc)
• Delilah (Aios Inc)
• Mochi Health (Aequita Corporation)
• Willow Health
• HenryMeds (Adonis Health)

Other corporations being sued

Metabolic MD is also facing a lawsuit for trademark infringement and false advertising amongst other claims:

Eli Lilly and Company v Wellness & Health Care Cost Consultants, LLC dba Metabolic Md, Complaint

United States District Court Southern District of Ohio Eli Lilly and Company v Wellness & Health Care Cost Consultants, LLC dba Metabolic Md Complaint June 20, 2024 Read the document.

Partnership for Safe Medicines

Another plaintiff is one person in particular – Stuart Lerner of Hawai'i:

Eli Lilly and Company v Stuart Lerner M.D., LLC , Complaint

Return to the list of compounded GLP-1 lawsuits United States District Court Southern District of Hawai’i Eli Lilly and Company v Stuart Lerner, MD, LLC Complaint June 20, 2024 Read the document.

Partnership for Safe Medicines

Stuart created a website called "Mounjaro Hawaii" which happens to sell compounded (rather than official) Tirzepatide.

The facts seem stacked in Eli Lilly's favor on this case, but it has yet to play out (and things like a settlement may well happen).

Clearly Eli Lilly is doing what it can to protect it's brand names (as any company might be expected to), but also cracking down on those who might still try to profit from compounded GLP1s.

Have any cases been concluded?

Some cases have concluded already, in particular a case last year when Eli Lilly settled with a Spa in South Carolina:

Eli Lilly settles with spa selling knockoff Mounjaro, Zepbound amid crackdown on fake GLP-1 meds

After Eli Lilly sued several companies that were allegedly selling unauthorized versions of its tirzepatide products, the drugmaker has successfully cracked down on one of them. | Under legal pressure from Eli Lilly, a medical spa has agreed to pay an undisclosed settlement and undertake several “corrective actions,” such as noting publicly that compounded versions of Lilly’s tirzepatide products are not approved by the FDA.

Fierce PharmaZoey Becker

While the agreed-upon terms of the settlement do not seem too onerous (there were no significant monetary sums), there is definitely a chilling effect (which is likely warranted at this point, since shortage is over) on firms that might do something similar.

Do compounders have any hope to win these cases?

The case against the compounders looks to be cut and dry – violations of trade mark usage or misrepresentations about what is included in the drugs seem to be fairly fact-based and clearly delineated.

That said, the resulting remedies are unlikely to be large – many of these companies are tiny in contrast to a juggernaut like Eli Lilly, and with most companies already reeling from impact to their business models, there just isn't much that can be extracted without causing summary bankruptcy (if monetary awards are even sought).

The state of play seems to be unchanging in this area – compounded GLP1s are no longer an option, and until more patents expire getting access to affordable GLP1s will be difficult.