TIRZEPATIDE - Generic Drug Details

What are the generic drug sources for tirzepatide and what is the scope of freedom to operate?

Tirzepatide is the generic ingredient in four branded drugs marketed by Eli Lilly And Co and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tirzepatide has one hundred and eleven patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for TIRZEPATIDE

International Patents:	111
US Patents:	3
Tradenames:	4
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	61
What excipients (inactive ingredients) are in TIRZEPATIDE?	TIRZEPATIDE excipients list
DailyMed Link:	TIRZEPATIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TIRZEPATIDE

Dosage:

SOLUTION;SUBCUTANEOUS

Dosage:

SOLUTION;SUBCUTANEOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TIRZEPATIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Vanderbilt University Medical Center	Phase 2
University Health Network, Toronto	Phase 2
Royal North Shore Hospital	Phase 2

See all TIRZEPATIDE clinical trials

Pharmacology for TIRZEPATIDE

Drug Class	GLP-1 Receptor Agonist Glucose-dependent Insulinotropic Polypeptide Receptor Agonist
Mechanism of Action	G-Protein-linked Receptor Interactions Glucagon-like Peptide-1 (GLP-1) Agonists

Anatomical Therapeutic Chemical (ATC) Classes for TIRZEPATIDE

A10BX	Other blood glucose lowering drugs, excl. insulins
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

US Patents and Regulatory Information for TIRZEPATIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eli Lilly And Co	MOUNJARO (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-006	May 13, 2022		RX	Yes	Yes			Y	Y
Eli Lilly And Co	ZEPBOUND (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	217806-005	Nov 8, 2023		RX	Yes	Yes
Eli Lilly And Co	ZEPBOUND	tirzepatide	SOLUTION;SUBCUTANEOUS	217806-008	Mar 28, 2024		RX	Yes	Yes
Eli Lilly And Co	MOUNJARO	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-010	Jul 28, 2023		RX	Yes	Yes
Eli Lilly And Co	ZEPBOUND	tirzepatide	SOLUTION;SUBCUTANEOUS	217806-008	Mar 28, 2024		RX	Yes	Yes			Y
Eli Lilly And Co	MOUNJARO (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-005	May 13, 2022		RX	Yes	Yes			Y	Y
Eli Lilly And Co	MOUNJARO (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-004	May 13, 2022		RX	Yes	Yes			Y

EU/EMA Drug Approvals for TIRZEPATIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eli Lilly Nederland B.V.	Mounjaro	tirzepatide	EMEA/H/C/005620 Mounjaro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance or contraindications- in addition to other medicinal products for the treatment of diabetes.For study results with respect to combinations, effects on glycaemic control and the populations studied, see sections 4.4, 4.5 and 5.1.	Authorised	no	no	no	2022-09-15

International Patents for TIRZEPATIDE

Country	Patent Number	Title	Estimated Expiration
Japan	7413315
Mexico	2020013727	COMPOSICIONES AGONISTAS DE GIP/GLP1. (GIP/GLP1 AGONIST COMPOSITIONS.)
Japan	2018052933	ＧＩＰおよびＧＬＰ−１コアゴニスト化合物 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Philippines	12020552215	GIP/GLP1 AGONIST COMPOSITIONS
South Korea	20210145311	ＧＩＰ 및 ＧＬＰ-1 공효능제 화합물 (-1 GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Japan	2021506952	ＧＩＰ／ＧＬＰ１アゴニスト組成物
El Salvador	2017005453	COMPUESTOS CO-AGONISTAS DE GIP Y GLP-1

Supplementary Protection Certificates for TIRZEPATIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3242887	LUC00296	Luxembourg		PRODUCT NAME: TIRZEPATIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/22/1685 20220919
3242887	C03242887/01	Switzerland		PRODUCT NAME: TIRZEPATID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68726 02.11.2022
3242887	PA2023504	Lithuania		PRODUCT NAME: TIRZEPATIDAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/22/1685 20220915
3242887	2023C/506	Belgium		PRODUCT NAME: TIRZEPATIDE; AUTHORISATION NUMBER AND DATE: EU/1/22/1685 20220919
3242887	122023000012	Germany		PRODUCT NAME: TIRZEPATIDE UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/22/1685 20220915
3242887	301217	Netherlands		PRODUCT NAME: TIRZEPATIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/22/1685 20220919
3242887	CA 2023 00005	Denmark		PRODUCT NAME: TIRZEPATID OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/22/1685 20220919

TIRZEPATIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tirzepatide

Introduction

Tirzepatide, developed by Eli Lilly, has been making significant waves in the pharmaceutical industry, particularly in the markets for obesity and type 2 diabetes treatments. This article delves into the market dynamics and financial trajectory of tirzepatide, highlighting its performance, competitive edge, and future prospects.

Tirzepatide: A Dual GIP and GLP-1 Receptor Agonist

Tirzepatide stands out as the first and only FDA-approved dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist. This dual mechanism sets it apart from other treatments like semaglutide, which only targets GLP-1 receptors[1][3].

Clinical Performance

In clinical trials, tirzepatide has demonstrated superior weight loss outcomes compared to semaglutide. The SURMOUNT-5 trial showed that participants taking tirzepatide lost an average of 22.8 kg over 72 weeks, compared to 15.0 kg for those on semaglutide. Additionally, 31.6% of tirzepatide users achieved at least 25% weight loss, significantly higher than the 16.1% on semaglutide[1].

Market Impact

The obesity drug market is experiencing rapid growth, and tirzepatide is poised to capture a significant share. Semaglutide, currently a market leader, is projected to generate $27.55 billion in revenue in 2024 and reach $50.34 billion by 2029, growing at a CAGR of 12.8%. However, analysts predict that tirzepatide could overtake semaglutide in the long run, with potential annual sales of up to $48 billion by 2030[1][2][3].

Financial Performance

Eli Lilly's revenue has seen a substantial boost due to the strong sales of tirzepatide under its two brand names: Mounjaro for type 2 diabetes and Zepbound for obesity. In Q2 2024, Lilly generated $11.3 billion in revenue, a 36% year-on-year increase, with Mounjaro and Zepbound contributing over $4 billion combined. The company has raised its full-year 2024 revenue guidance to $45.4 billion to $46.6 billion, an increase of $3 billion from previous forecasts[4].

Sales Projections

• Mounjaro: Sales reached $2.2 billion in Q4 2023 and are projected to continue growing, with forecasts suggesting it could top Novo Nordisk’s Ozempic in sales by 2027 and become the leading drug in the obesity and diabetes market by 2029, with projected sales of $27 billion that year[2].
• Zepbound: Projected sales for Zepbound are significant, with estimates ranging from $2.2 billion to $2.7 billion for 2024. Analysts predict that Zepbound could fetch $26 billion in annual sales by 2030, with roughly two-thirds of that sum related to obesity treatment[2][3].

Competitive Pricing

Lilly has positioned Zepbound competitively in the market. The starting cash price for Zepbound is $1,059.87, which is lower than Wegovy’s $1,302. With insurance and special savings programs, the cost can be as low as $25 for eligible patients, making it more accessible[3].

Supply Chain Improvements

Historical supply constraints have been a challenge for Lilly, but recent investments in manufacturing capacity have helped stabilize the supply of tirzepatide products. The company has invested $2.5 billion in a new production facility in Germany and $5.3 billion in its Indiana footprint, ensuring all doses of Mounjaro and Zepbound were removed from the FDA’s Drug Shortage database[4].

Future Milestones

Lilly is gearing up for several clinical and regulatory milestones for tirzepatide. These include FDA submissions for heart failure with preserved ejection fraction and obstructive sleep apnea. A Phase III head-to-head study of tirzepatide versus semaglutide, SURMOUNT-5, is also underway, with results expected in November 2024[4].

Analyst Optimism

Analysts are highly optimistic about tirzepatide’s future. Bank of America analyst Geoff Meacham predicts sales could hit $48 billion annually. Guggenheim analysts expect Zepbound to potentially overtake Humira as the best-selling drug of all time in the long run[2][3].

Market Growth Potential

The broader market for anti-obesity drugs, including Zepbound, is projected to hit $100 billion per year by 2030, a 16-fold increase from 2023 levels. This growth is driven by the urgent medical need for novel weight management therapies, with roughly 70% of American adults having either obesity or overweight conditions[2].

Conclusion

Tirzepatide is revolutionizing the treatment landscape for obesity and type 2 diabetes, with its dual GIP and GLP-1 receptor agonist mechanism offering superior weight loss outcomes. The financial trajectory for tirzepatide is robust, with significant sales growth projected in the coming years. As supply chain issues are addressed and new indications are pursued, tirzepatide is poised to dominate the market.

Key Takeaways

• Superior Clinical Outcomes: Tirzepatide outperforms semaglutide in weight loss.
• Strong Financial Performance: Significant revenue growth driven by Mounjaro and Zepbound.
• Competitive Pricing: Zepbound is priced competitively to enhance market accessibility.
• Supply Chain Improvements: Recent investments have stabilized the supply of tirzepatide products.
• Future Milestones: Upcoming clinical and regulatory milestones could expand tirzepatide’s indications.
• Market Growth Potential: The anti-obesity drug market is projected to reach $100 billion by 2030.

FAQs

Q: What is the mechanism of action of tirzepatide? A: Tirzepatide works by mimicking natural hormones that regulate appetite, targeting both GLP-1 and GIP receptors to reduce calorie intake[1][3].

Q: How does tirzepatide compare to semaglutide in clinical trials? A: Tirzepatide has shown superior weight loss outcomes in clinical trials, with participants losing an average of 22.8 kg compared to 15.0 kg for those on semaglutide[1].

Q: What are the projected sales for Zepbound in 2024? A: Analysts project Zepbound sales to range from $2.2 billion to $2.7 billion in 2024[2][3].

Q: How is Lilly addressing supply chain issues for tirzepatide? A: Lilly has invested heavily in manufacturing capacity, including new production facilities, to stabilize the supply of Mounjaro and Zepbound[4].

Q: What are the future indications being pursued for tirzepatide? A: Lilly is pursuing FDA submissions for heart failure with preserved ejection fraction and obstructive sleep apnea, among other indications[4].

Sources

1. Business Standard: "Lilly's tirzepatide challenges semaglutide in obesity drug market"
2. Drug Discovery Trends: "Eli Lilly's Mounjaro sales projected to triple in 2024"
3. Drug Discovery Trends: "Lilly to price tirzepatide for obesity competitively"
4. BioSpace: "Lilly Beats Q2 Expectations as Tirzepatide Supply Stabilizes, Raises Full-Year Revenue Guidance by $3B"