GLP-1 Drug Shortages: Causes, Status & Alternatives
**For nearly three years, millions of patients couldn't fill their prescriptions for Ozempic, Wegovy, Mounjaro, and Zepbound.** The shortage stretched from early 2022 through early 2025, driven by demand that overwhelmed manufacturing capacity.
For nearly three years, millions of patients couldn't fill their prescriptions for Ozempic, Wegovy, Mounjaro, and Zepbound. The shortage stretched from early 2022 through early 2025, driven by demand that overwhelmed manufacturing capacity. In that time, a parallel industry of compounding pharmacies emerged to fill the gap — only to face its own regulatory reckoning when the FDA declared the shortage over.
As of February 2026, the formal shortage is resolved. But the story is far from over. Patients are navigating higher costs, shifting insurance coverage, legal battles over compounding, and a pipeline of oral GLP-1 drugs that could reshape access by the end of the year.
Table of Contents
- What Caused the GLP-1 Shortage
- Timeline: How the Shortage Unfolded
- Current FDA Shortage List Status
- Manufacturing Scale-Up: Billions of Dollars at Work
- The Compounding Connection
- Patient Options in 2026
- The Next Wave: Oral GLP-1 Drugs
- Insurance and Affordability Challenges
- The Pipeline: What's Coming After Semaglutide and Tirzepatide
- Frequently Asked Questions
- The Bottom Line
- References
What Caused the GLP-1 Shortage
The shortage wasn't caused by a single event. It resulted from several forces converging at once, each amplifying the others.
Demand That No One Predicted
Semaglutide fills increased by 442% between January 2021 and December 2023. Ozempic was approved for type 2 diabetes in 2017. Wegovy was approved for weight loss in 2021. When clinical trial results showing 15-17% body weight reduction hit mainstream media, demand exploded in a way that pharmaceutical forecasting models didn't anticipate. Doctors who had never prescribed GLP-1 drugs began writing prescriptions. Telehealth platforms made access even easier. The result was a demand curve that outpaced every supply projection.
Manufacturing Complexity
Semaglutide and tirzepatide are biologic medications — peptides manufactured through precise fermentation and synthesis processes in tightly controlled environments. Unlike small-molecule pills, these drugs can't be scaled up by simply running additional production lines. Each manufacturing expansion requires specialized equipment, validated cleanroom facilities, trained personnel, and FDA inspection. The timeline from investment decision to production output is measured in years, not months.
Supply Chain Disruptions
The COVID-19 pandemic created lingering disruptions in raw material availability, shipping logistics, and labor supply. These hit pharmaceutical manufacturing harder than most industries because of the specialized nature of the inputs. Active pharmaceutical ingredient (API) sourcing, fill-finish capacity, and pre-filled pen device manufacturing all faced bottlenecks.
Dose-Specific Bottlenecks
Not all doses were equally affected. Lower starting doses — 0.25mg and 0.5mg semaglutide pens — ran out first. This created a cascade problem: without the starting doses needed for safe dose titration, providers couldn't initiate new patients on treatment. Meanwhile, patients already on higher maintenance doses continued refilling, further constraining supply of those doses.
Limited Competition
Until very recently, the injectable GLP-1 market was essentially a duopoly. Novo Nordisk produced all semaglutide (Ozempic and Wegovy). Eli Lilly produced all tirzepatide (Mounjaro and Zepbound). With no generic competitors and no alternative manufacturers, any production shortfall had nowhere to be absorbed.
Inventory Hoarding
Reports emerged of distributors and pharmacies holding extra inventory in anticipation of deepening shortages. While rational for individual actors, this behavior worsened the shortage for everyone else by removing supply from circulation.
Timeline: How the Shortage Unfolded
| Date | Event |
|---|---|
| March 2022 | FDA first lists semaglutide injection as in shortage |
| December 2022 | Tirzepatide (Mounjaro) added to FDA shortage list |
| Throughout 2023 | Both drugs remain in shortage; compounding pharmacies begin producing versions at scale |
| November 2023 | Wegovy approved for cardiovascular risk reduction, further increasing demand |
| June 2024 | Novo Nordisk invests $6.5 billion in U.S. manufacturing capacity |
| October 2024 | FDA announces tirzepatide shortage resolved; removes from shortage list |
| December 2024 | Tirzepatide officially off shortage list (December 19) |
| February 2025 | FDA declares semaglutide shortage resolved (February 21) |
| March-May 2025 | Compounding pharmacy deadlines pass — 503A (April 22) and 503B (May 22) for semaglutide; 503A (February 19) and 503B (March 19) for tirzepatide |
| September 2025 | FDA issues 50+ warning letters to GLP-1 compounders and manufacturers |
| November 2025 | Government pricing agreements announced with Novo Nordisk and Eli Lilly |
| January 2026 | Oral semaglutide (Wegovy pill) launches in the U.S. |
| February 2026 | All semaglutide and tirzepatide products considered fully available |
Current FDA Shortage List Status
As of February 2026, the FDA considers all dosage forms of injectable semaglutide and tirzepatide to be in adequate supply. Both Ozempic and Wegovy (semaglutide) and both Mounjaro and Zepbound (tirzepatide) are off the FDA Drug Shortage List.
Novo Nordisk has confirmed that production facilities operate 24 hours a day, seven days a week, with all doses shipped regularly to wholesalers. The company invested $6.5 billion in U.S. manufacturing capacity during the shortage.
That said, "resolved" on the FDA's list doesn't always mean "available at your pharmacy." Localized supply issues can still occur due to distribution logistics, pharmacy ordering patterns, and regional demand spikes. Patients may occasionally need to check multiple pharmacies or wait a few days for restocking.
Manufacturing Scale-Up: Billions of Dollars at Work
Both manufacturers responded to the shortage with massive capital investment.
Novo Nordisk
- $6.5 billion invested in U.S. manufacturing expansion
- Facilities running 24/7 for all Ozempic and Wegovy doses
- Continues to expand fill-finish capacity for pre-filled injection pens
- Launched oral semaglutide (Wegovy pill, 25mg) in January 2026
Eli Lilly
- Increased investment at its Lebanon, Indiana manufacturing site to $9 billion for API production for Zepbound and Mounjaro
- Medicine production at Lebanon expected to begin late 2026, scaling up through 2028
- More than $50 billion in total U.S. manufacturing expansion since 2020, including projects in Texas, Indiana, and Puerto Rico
- $1.2 billion invested in Puerto Rico facility for oral medicine production (orforglipron focus)
- $3 billion expansion of injectable drug manufacturing facility
- Pre-built $1.5 billion in inventory for orforglipron to avoid repeating the tirzepatide launch shortages
These investments represent an unprecedented manufacturing build-out for a single drug class. The combined spending from Novo Nordisk and Eli Lilly exceeds the GDP of many small countries — a measure of both the market opportunity and the scale of the supply gap that needed closing.
The Compounding Connection
The shortage created a secondary market that became a story in itself.
How Compounding Filled the Gap
Under sections 503A and 503B of the FD&C Act, compounding pharmacies can produce copies of FDA-approved drugs when those drugs are listed on the FDA's shortage list. During the nearly three-year semaglutide shortage, compounding pharmacies stepped in at scale, offering compounded semaglutide at $100-$300 per month compared to $1,000+ for brand-name products. Telehealth platforms like Hims & Hers and others built entire business models around compounded GLP-1 access.
The Regulatory Reckoning
When the FDA declared the shortages resolved, the legal basis for compounding evaporated. Deadlines were set for pharmacies to stop production. But many compounders didn't stop willingly.
The Outsourcing Facilities Association (OFA) sued the FDA, arguing the agency "recklessly" trusted manufacturer claims about adequate supply without independent verification. U.S. District Judge Mark Pittman sided with the FDA, denying preliminary injunctions for both semaglutide and tirzepatide compounding.
In September 2025, the FDA issued more than 50 warning letters to companies still compounding or marketing GLP-1 drugs. The letters targeted false claims — particularly companies calling compounded products "generic versions" of brand-name drugs.
Adverse Events
The compounding debate isn't just legal — it's medical. The FDA reported receiving more than 455 adverse event reports for compounded semaglutide and more than 320 for compounded tirzepatide. While these numbers should be weighed against millions of doses dispensed, they fueled the FDA's argument that compounded versions pose safety risks that brand-name products don't.
What Compounders Are Doing Now
Some compounding companies have found workarounds. Rather than compounding copies of semaglutide or tirzepatide, some now offer different salt forms (like semaglutide sodium instead of semaglutide acetate), arguing these constitute different products not covered by the brand manufacturers' exclusivity. The FDA's position on these workarounds has been hostile, but legal challenges continue.
Patient Options in 2026
For patients who need GLP-1 therapy, here are the available pathways.
Brand-Name Injectable Products
| Product | Active Ingredient | Indication | Approximate Monthly Cost (List) |
|---|---|---|---|
| Ozempic | Semaglutide | Type 2 diabetes | ~$935 |
| Wegovy | Semaglutide | Weight management, CV risk | ~$1,350 |
| Mounjaro | Tirzepatide | Type 2 diabetes | ~$1,023 |
| Zepbound | Tirzepatide | Weight management | ~$1,060 |
Lower-Cost Options
Zepbound single-dose vials: Eli Lilly introduced self-pay vials at approximately $399/month in late 2024 as a direct response to the compounding market. These are lower-cost alternatives to the standard pre-filled pens.
Zepbound multi-dose pen: Available at the lowest dose starting at $299, with additional doses up to $449 — representing a $50 discount from current direct-to-patient prices.
Mounjaro on LillyDirect: Eli Lilly added Mounjaro to its direct-to-patient platform with pricing 50-60% off current list prices for self-pay patients.
Oral semaglutide (Wegovy pill): Launched January 2026 with starting cash prices as low as $149 per month for self-pay patients, making it the most affordable GLP-1 option currently available.
Manufacturer Savings Programs
Both Novo Nordisk and Eli Lilly offer co-pay cards, patient assistance programs, and direct pharmacy options. These can reduce out-of-pocket costs significantly for eligible patients.
Medicare Coverage (New in 2026)
Starting as early as April 2026, Medicare Part D will cover anti-obesity medicines for qualifying beneficiaries. The negotiated price is $245 per month, with Medicare beneficiaries paying a $50 copay per month for Wegovy, Zepbound, Ozempic, and Mounjaro. States will also be able to expand access through Medicaid.
This represents a sea change. Previously, Medicare did not cover medications prescribed solely for obesity — a policy that excluded millions of elderly and disabled Americans from GLP-1 treatment.
TrumpRx.gov
The Trump administration launched a self-pay platform that connects patients to manufacturer discount programs. Average monthly costs for weight loss injections through TrumpRx start around $350, with projections of dropping to roughly $250 within two years.
The Next Wave: Oral GLP-1 Drugs
The biggest shift in GLP-1 access isn't about manufacturing — it's about drug form. Oral GLP-1 drugs could make the entire shortage era a footnote.
Oral Semaglutide (Wegovy Pill)
Novo Nordisk's oral semaglutide 25mg launched in the U.S. in January 2026. The OASIS 4 trial showed 13.6% mean weight loss at 64 weeks — less than injectable Wegovy's ~15-17% but still meaningful. Patients take one pill daily on an empty stomach, waiting 30 minutes before eating or drinking.
The oral format eliminates injection barriers and could dramatically expand the patient population willing to start treatment. Cash prices starting at $149/month also address the affordability gap.
Orforglipron (Eli Lilly)
Orforglipron is Eli Lilly's oral GLP-1 receptor agonist, currently under FDA review with a decision expected in the second quarter of 2026. It received a Commissioner's National Priority Voucher, which expedites review.
What makes orforglipron different from oral semaglutide:
- It's a small molecule, not a peptide. This matters enormously for manufacturing. Small molecules are cheaper and easier to produce at scale than peptides, which could prevent future shortages.
- No food or water restrictions. Patients can take orforglipron at any time of day without fasting beforehand — a significant practical advantage over oral semaglutide.
- No refrigeration required. Injectable GLP-1 drugs need cold chain logistics. Orforglipron stores at room temperature.
- Head-to-head advantage. In the ACHIEVE-3 trial, orforglipron outperformed oral semaglutide across all primary and secondary endpoints. High-dose orforglipron lowered A1C by 2.2% versus 1.4% for high-dose oral semaglutide. Weight loss was 73.6% greater at the highest dose comparison.
Eli Lilly has pre-built $1.5 billion in orforglipron inventory — a direct lesson from the tirzepatide launch shortages.
What Medicare Pricing Could Look Like
If approved, orforglipron would be covered under the same Medicare agreements, with beneficiaries paying no more than $50 per month.
Insurance and Affordability Challenges
The GLP-1 market creates a paradox: drugs that work better than almost anything before them, at prices that most patients can't afford without insurance.
The Coverage Retreat
While Medicare is expanding coverage, some commercial insurers are moving in the opposite direction. Blue Cross Blue Shield of Massachusetts plans to eliminate coverage of GLP-1s for weight loss in 2026, citing the impact of drug costs on premiums. California's Medi-Cal program ended coverage for GLP-1s prescribed solely for weight loss effective January 1, 2026, regardless of manufacturer price reductions.
This creates a coverage patchwork where access depends on your insurer, your state, and your diagnosis. A patient with type 2 diabetes is more likely to get coverage than a patient with obesity alone — even though both conditions benefit from the same drug.
The Cost Burden
Without insurance, brand-name injectable GLP-1 drugs cost $1,000+ per month. Even with the new lower-cost options (Zepbound vials at $399, oral semaglutide at $149), GLP-1 therapy remains a significant expense for most Americans. A 2026 survey found that 70% of Americans believe GLP-1 drugs are only accessible to the wealthy.
Generic Timeline
Generic competition is the long-term solution to affordability, but it's not imminent. Novo Nordisk's primary U.S. patent on semaglutide doesn't expire until 2031, with secondary patents potentially extending protection through 2033 or beyond. Tirzepatide's patent protection runs through at least 2027 under statutory exclusivity.
The Canadian market may see generic semaglutide sooner — Novo's primary patent expires there in 2026. But generic entry in the U.S. remains years away.
The Pipeline: What's Coming After Semaglutide and Tirzepatide
The GLP-1 market is about to get crowded. Several next-generation drugs could reshape the treatment options available by 2027-2028.
Survodutide (Boehringer Ingelheim/Zealand Pharma)
A dual GLP-1/glucagon receptor agonist that showed 14.9% mean weight loss over 49 weeks in Phase 2. The SYNCHRONIZE Phase 3 program is fully enrolled (1,481 patients), with results expected in the first half of 2026 and FDA filing to follow. Potential approval in 2027. Survodutide has received FDA Breakthrough Therapy Designation.
Retatrutide (Eli Lilly)
A triple agonist targeting GLP-1, GIP, and glucagon receptors. Phase 3 trials showed patients on the highest dose lost nearly 29% of body weight after about 16 months — the most weight loss ever demonstrated in an obesity drug trial. Eli Lilly is completing seven additional Phase 3 trials expected to read out in 2026.
CT-388 (Roche)
A dual GLP-1/GIP agonist that achieved 22.5% placebo-adjusted weight loss at 48 weeks in Phase 2, with no signs of a plateau. Roche is fast-tracking this into a Phase 3 program in early 2026.
CagriSema (Novo Nordisk)
Combines semaglutide with cagrilintide (an amylin analog). Phase 3 results are expected in 2026. The combination targets multiple satiety pathways simultaneously.
Additional Programs
Viking Therapeutics, Structure Therapeutics, AstraZeneca, and Pfizer all have oral obesity drugs in development. The pipeline suggests that within 3-5 years, patients may have 10 or more GLP-1 and multi-agonist options — a dramatic shift from the duopoly that contributed to the original shortage.
Frequently Asked Questions
Is there still a shortage of Ozempic or Wegovy?
No. As of February 2026, the FDA considers both semaglutide products to be in adequate supply nationally. Localized availability issues may occasionally occur at individual pharmacies, but the systemic shortage that began in 2022 has been resolved.
Can I still get compounded semaglutide?
The legal window for compounded semaglutide has closed. The FDA issued deadlines in spring 2025 for compounders to cease production, and has since issued more than 50 warning letters to companies still operating. Some vendors continue to sell semaglutide or alternative formulations, but purchasing these products carries legal risk and safety concerns.
What is the cheapest way to get a GLP-1 drug in 2026?
Oral semaglutide (the Wegovy pill) is currently the most affordable option at approximately $149/month for self-pay patients. Zepbound single-dose vials start at $399/month. If orforglipron receives FDA approval, it may offer competitive pricing with the added convenience of no fasting requirements. For Medicare beneficiaries, the new government agreements cap copays at $50/month starting in April 2026.
When will generic semaglutide be available?
Generic semaglutide is not expected in the U.S. until at least 2031, when Novo Nordisk's primary patent expires. Secondary patents could extend protection through 2033. In Canada and China, the primary patent expires in 2026, which may lead to earlier generic availability in those markets.
What caused the shortage in the first place?
The shortage resulted from a perfect storm: a 442% surge in demand driven by weight-loss prescriptions, manufacturing complexity of biologic peptide drugs, COVID-era supply chain disruptions, limited competition (only two manufacturers), and dose-specific bottlenecks that prevented new patient starts.
Will the new oral GLP-1 drugs prevent future shortages?
Oral GLP-1 drugs — particularly non-peptide small molecules like orforglipron — are fundamentally easier and cheaper to manufacture than injectable biologics. Eli Lilly has also pre-built $1.5 billion in orforglipron inventory specifically to prevent launch shortages. The combination of manufacturing simplicity, multiple competing products, and preemptive stockpiling makes a repeat of the 2022-2025 shortage unlikely for the oral drug class.
Is tirzepatide (Mounjaro/Zepbound) still in shortage?
No. Tirzepatide was removed from the FDA shortage list in October-December 2024. All doses of both Mounjaro and Zepbound are currently available.
The Bottom Line
The GLP-1 shortage was a collision between unprecedented demand and the physical limits of peptide manufacturing. It lasted nearly three years, affected millions of patients, spawned a compounding industry that is now being dismantled by regulation, and prompted tens of billions of dollars in manufacturing investment.
As of early 2026, the acute crisis is over. Supply is adequate. But the deeper problems — affordability, insurance coverage gaps, and the tension between access and regulation — remain. The compounding market provided affordable access to patients who couldn't afford brand-name drugs; its closure left many of those same patients without options.
The real resolution may come not from manufacturing scale-up but from the drug pipeline. Oral GLP-1 drugs are cheaper to make, easier to distribute, and growing more effective with each clinical trial. Within two to three years, oral options from multiple manufacturers could bring genuine price competition to a market that has been defined by scarcity and high cost.
For patients navigating this market, the priorities are straightforward: explore all available savings programs, consider the new oral options as they become available, talk to your provider about the most cost-effective treatment pathway, and check back frequently — this market is changing faster than almost any other in medicine.
For more on how semaglutide and tirzepatide work, see our pharmacology guides on semaglutide and tirzepatide. For the regulatory angle on compounded versus brand-name products, see our comparison guide.
References
- U.S. Food and Drug Administration. "Drug Shortages: Semaglutide Injection." FDA. https://www.ashp.org/drug-shortages/current-shortages/drug-shortage-detail.aspx?id=813
- Pharmacy Times. "FDA Ends Semaglutide Shortage Listing, Contributing to Ongoing Legal Challenges." https://www.pharmacytimes.com/view/fda-ends-semaglutide-shortage-listing-contributing-to-ongoing-legal-challenges
- Drug Topics. "GLP-1 No Longer on FDA's Drug Shortage List." https://www.drugtopics.com/view/glp-1-no-longer-on-fda-s-drug-shortage-list
- GoodRx. "The Tirzepatide Shortage Is Over: Here's What You Need to Know." https://www.goodrx.com/classes/gip-receptor-glp-1-receptor-agonists/tirzepatide-shortage
- Wilson Sonsini. "FDA Sends Warning Letters to More Than 50 GLP-1 Compounders and Manufacturers." https://www.wsgr.com/en/insights/fda-sends-warning-letters-to-more-than-50-glp-1-compounders-and-manufacturers.html
- GoodRx. "5 Projected GLP-1 Trends in 2026." https://www.goodrx.com/classes/glp-1-agonists/glp-1-trends
- Advisory Board. "Companies Find Ways Around End of GLP-1 Shortage." https://www.advisory.com/daily-briefing/2025/05/27/glp-1-compounders
- Eli Lilly. "Lilly Increases Manufacturing Investment to $9 Billion at Newest Indiana Site." https://investor.lilly.com/news-releases/news-release-details/lilly-increases-manufacturing-investment-9-billion-newest
- Eli Lilly. "Lilly's Oral GLP-1, Orforglipron, Superior to Oral Semaglutide in Head-to-Head Trial." https://investor.lilly.com/news-releases/news-release-details/lillys-oral-glp-1-orforglipron-superior-oral-semaglutide-head
- NBC News. "What to Watch for in Weight Loss Drugs in 2026." https://www.nbcnews.com/health/health-news/weight-loss-drug-prices-2026-glp-1-pills-trumprx-what-expect-rcna249520
- CNBC. "Healthy Returns: 2026 Will Be the Year of Obesity Pills from Novo Nordisk, Eli Lilly." https://www.cnbc.com/2025/12/16/healthy-returns-obesity-pills-from-novo-nordisk-eli-lilly-are-coming.html
- AJMC. "An Ongoing Crisis: Semaglutide Shortage Raises Dual Concerns for Obesity and Diabetes Treatment." https://www.ajmc.com/view/an-ongoing-crisis-semaglutide-shortage-raises-dual-concerns-for-obesity-and-diabetes-treatment