Why is there Mounjaro shortage in 2023? Mounjaro (pronounced moun-JAHR-OH) is an injectable medication used to treat type 2 diabetes in adults. The disease can be treated with diet and exercise to improve blood sugar (glucose). Type 2 diabetes is a disease characterized by high blood glucose levels. Tirzepatide is another name for Mounjaro.
Mounjaro works by imitating GLP-1 and GIP, hormones released by our stomach after eating, to support blood sugar control. These hormones instruct our body to produce more insulin, less sugar, and slow digestion. All of these actions aid in the reduction of blood sugar levels.
Eli Lilly and Company and its subsidiaries own or license the trademarks of Mounjaro and its delivery device base. Lilly’s Mounjaro (tirzepatide) injection was approved by the FDA in May 2022 as the first and only GIP and GLP-1 receptor agonist for treating adults with type 2 diabetes.
Mounjaro will come in six doses: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg. It will be delivered in Lilly’s well-known auto-injector pen, complete with a pre-attached, hidden needle that patients will not have to handle by seeing.
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Is there a shortage of Mounjaro?
With its new GIP/GLP-1 launch, Mounjaro, and its established diabetes smash hit, Trulicity, Eli Lilly is in a strong position. Already there is a temporary shortage of Novo Nordisk’s competitor products, Wegovy and Ozempic. Thus, a Lilly executive said, this has contributed to “unbelievable demand” for the drugmaker’s incretin-based drugs.
Still, the fact that so many patients want Trulicity and Mounjaro, which were approved for Type 2 diabetes, is a concern. Mounjaro could be a double-edged sword for Lilly. The executives warned of supply challenges ahead of a capacity-doubling manufacturing expansion planned for the end of 2023 on November 20, 2022.
In the third quarter of 2022, Trulicity and Mounjaro fared remarkably well, earning $1.85 billion and $187.3 million in sales, respectively. Mounjaro’s results easily exceeded forecasts for revenue of $81 million. According to Eli Lilly CFO Anat Ashkenazi, during the company’s third-quarter results call, the “low supply of competitors’ GLP-1s” contributed to the high drug demand.
Mounjaro supply shortage
In addition to Mounjaro’s recent approval for Type 2 diabetes, the medication is fighting with Novo’s Wegovy for the FDA Fast Track designation in treating obesity. However, Lilly’s capacity to meet rising demand in most worldwide markets has been tested by its rival’s supply issues.
Based on the findings, Lilly is working hard to satisfy consumer demand and will take steps to minimize any negative effects on current Trulicity users. The strategy includes stopping new patient starts outside of the United States.
Regarding Mounjaro, the business plans to take measures to guarantee access and supply for patients with Type 2 diabetes. The CFO stated that although net revenue was not anticipated to be affected, those efforts could have a negative impact on prescription volume.
The response by the people to Mounjaro has been overwhelmingly favorable. However, the corporation is in a dangerous scenario because of the unpredictability of competitor GLP’s supply. Mounjaro adherence, dose adjustment rates, and other issues are still being worked out.
Therefore, it is realistic to predict that weekly output forecasts on Mounjaro will only match demand each week due to its dynamic nature. This would also lead to delays in meeting wholesale orders.
Is Mounjaro available?
Tirzepatide (Mounjaro) is now available in US pharmacies. According to a declaration by Eli Lilly and Company, Mounjaro will be available in US pharmacies beginning on June 7, 2022. Tirzepatide, a drug approved for the treatment of type 2 diabetes, may be on track to become a new drug to treat overweight people as well.
Now that the FDA has granted it Fast Track designation. According to Maggie Pfeiffer, associate director of Lilly Diabetes Communications, Mounjaro is now commercially available for people with type 2 diabetes.
Is Mounjaro going to be a game-changer?
In a press release on October 6, 2022, Eli Lilly announced that the FDA had granted Mounjaro Fast Track designation as a potential treatment for people with weight-related health symptoms. These symptoms include obesity and being overweight. This designation allows Lilly to apply to the FDA. It is for the approval of a medicine for new indications on a rolling basis as alternative research is conducted rather than used all at once.
Suppose the results of Lilly’s trial are positive. In that case, the Fast Track designation could mean a faster FDA approval of Mounjaro for obesity and overweight and a quicker entry into the market. Lilly also stated that its research, which is part of the SURMOUNT-2 trial, could be completed by late April 2023.
The news comes after experts speculated that Mounjaro could be rebranded as an obesity drug. This will happen after study results reveal the drug’s weight-loss potential in people with type 2 diabetes and obesity, also as obesity free of type 2 diabetes symptoms.
Is a generic version of Mounjaro available?
There is currently no medicinally equivalent version of Mounjaro in the United States. Please keep in mind that fraudulent online pharmacies may try to sell an illegal generic version of Mounjaro. These medications could be fake and dangerous. If you buy medicines online, ensure you are doing so from a reputable and legitimate online pharmacy. If you have doubts about purchasing medications online, consult your doctor.
Side Effects of Mounjaro
Mounjaro may cause thyroid tumors, including thyroid cancer. Keep an eye out for symptoms such as a lump or swelling in the neck, hoarseness, difficulty swallowing, or shortness of breath. The patient should inform the doctor if they experience any of the below symptoms:
- If the patient or any member of their family has ever had medullary thyroid carcinoma,
- If the patient has type 2 multiple endocrine neoplasias,
- If the patient is allergic to Mounjaro or any of its ingredients.
In these cases, the patients should not use Mounjaro. Mounjaro may have serious side effects, such as:
- Low blood sugar levels (hypoglycemia)
- Severe allergic reactions
- Kidney issues (kidney failure)
- severe stomach issues
- Vision changes
- Gallbladder issues
Additionally, nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion, and stomach (abdominal) pain are the most common side effects of Mounjaro. These are not the only potential side effects of Mounjaro. Patients must discuss with their doctors if any side effects bother them or do not go away.
Conclusion
The company is ramping up its efforts to address supply chain issues. According to studies, Lilly will work hard to avoid or limit any short-term impact on people with Type 2 diabetes.
Also, Lilly has plans to build significant additional manufacturing capacity for its injectable incretin medications in 2023. This is to address the high demand for Trulicity and Mounjaro and to gain market share while Novo’s shortfall persists.
Lilly anticipates more actions and extensions at other sites to double the business’s incretin drug manufacturing capacity by the end of next year.
References:
- https://www.drugs.com/ mounjaro.html
- https://investor.lilly.com/news-releases/ news-release-details/fda-approves-lillys-mounjarotm-tirzepatide-injection-first-and
- https://www.drugs.com/availability/ generic-mounjaro.html#:~:text=No.,be%20 counterfeit%20and%20 potentially%20 unsafe.
- https://www.endocrinologynetwork.com/ view/tirzepatide-now-available-in-us-pharmacies-ushering-in-new-era-of-glucose-lowering
- https://www.everydayhealth.com/ type-2-diabetes/a-q-a-on-tirzepatide-mounjaro-a-novel-diabetes-drug-with-the-adas-dr-robert-gabbay/
- https://www.fiercepharma.com/ manufacturing/eli-lilly-performs-injectable-incretin-tightrope-walk-novo-nordisk-shortages-drive
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