GLP-1 Market Timeline 2025-2027

FDA found the tirzepatide (Mounjaro, Zepbound) shortage resolved on December 19, 2024, repeating the decision it first made on October 2, 2024.

503A pharmacies had until February 18, 2025. That window closed for good when a federal court denied the compounders' injunction request on March 5, 2025.

503B outsourcing facilities had until March 19, 2025.

FDA took semaglutide (Ozempic, Wegovy) off the drug shortage list, ending the shortage route for compounded copies.

503A pharmacies had until April 22, 2025, and a court ruling on April 24, 2025 ended that window.

503B outsourcing facilities had until May 22, 2025.

FDA objected to claims such as "the same active ingredient as Ozempic and Wegovy" on compounded semaglutide pages, because they imply a compounded drug equals an FDA-approved one.

In 3,127 adults with obesity and without diabetes, the 36 mg dose lowered body weight by an average of 11.2% at 72 weeks, against 2.1% on placebo.

Orforglipron is a small-molecule GLP-1 pill. Lilly later sold it as Foundayo.

Oral semaglutide became the first GLP-1 pill approved for weight loss in the US.

Novo said the 1.5 mg starting dose would cost $149 a month with its savings offers.

CMS said eligible Medicare enrollees would pay $50 for a month of GLP-1 medication under a short-term demonstration starting July 2026.

The BALANCE model itself was set to start in Medicaid as early as May 2026 and in Medicare Part D in January 2027.

Novo counted more than 3 million Wegovy pill prescriptions from January 5 through June 2, 2026, based on paid claims its partners reported.

Hims launched a compounded semaglutide pill and pulled it two days later.

Novo then sued Hims for infringing US Patent 8,129,343 and said Hims was still compounding injectable semaglutide.

The letters cited claims that compounded products were the same as FDA-approved drugs, and branding that hid who actually made the drug.

FDA called it the second group of letters to telehealth firms since its September 2025 crackdown.

Hims announced cash-pay access to Wegovy pills and injections and Ozempic injections, from $149 a month for eligible customers.

Ozempic is approved for type 2 diabetes, so weight-loss use is off-label.

Hims's first-quarter filing says it now offers compounded GLP-1s only on a limited scale.

Foundayo is the only GLP-1 pill for weight loss you can take at any time of day without food or water restrictions.

LillyDirect began shipping on April 6. Self-pay starts at $149 a month for the lowest dose.

With commercial insurance, the savings card can bring your copay down to $25 a month.

CMS delayed the Medicare Part D part of the BALANCE model for 2027 and kept the $50 Bridge running through December 31, 2027 instead.

Adults without diabetes on the 12 mg dose of Lilly's triple agonist (GIP, GLP-1 and glucagon) lost an average of 28.3% of body weight at 80 weeks.

The 4 mg dose averaged 19.0%. These are Lilly's topline results, and retatrutide is not FDA-approved.

Eligible Part D enrollees pay $50 a month for Foundayo tablets, Wegovy injection or tablets, or the Zepbound KwikPen.

Single-dose Zepbound pens and vials are not covered.

The $50 does not count toward your Part D deductible or the $2,100 out-of-pocket cap.

Your prescriber sends prior authorization to a CMS central processor, not to your Part D plan.

Adults with type 2 diabetes lost up to 20.8% of body weight at 80 weeks in TRIUMPH-2. Adults with severe obesity and heart disease lost up to 22.6% in TRIUMPH-3.

The Fifth Circuit affirmed FDA's decisions to take tirzepatide (No. 25-10600) and semaglutide (No. 25-10758) off the shortage list. Both opinions are unpublished.

Nothing changes for patients. Both drugs left the shortage list in 2024 and 2025.

Lilly says it will submit a Biologics License Application for retatrutide in the first quarter of 2027. FDA review starts after the filing.

CMS has not yet said what replaces the Bridge for Part D enrollees in 2028.