SEMAGLUTIDE - Generic Drug Details

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

Semaglutide is the generic ingredient in three branded drugs marketed by Novo and is included in three NDAs. There are thirty-five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Semaglutide has four hundred and seventeen patent family members in thirty-nine countries.

Two suppliers are listed for this compound.

Summary for SEMAGLUTIDE

International Patents:	417
US Patents:	35
Tradenames:	3
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	16
Clinical Trials:	285
Patent Applications:	2,359
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SEMAGLUTIDE
What excipients (inactive ingredients) are in SEMAGLUTIDE?	SEMAGLUTIDE excipients list
DailyMed Link:	SEMAGLUTIDE at DailyMed

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

Dosage:

SOLUTION;SUBCUTANEOUS

Dosage:

TABLET;ORAL

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 SEMAGLUTIDE

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

Sponsor	Phase
Pichamol Jirapinyo, MD, MPH	Phase 4
Rijnstate Hospital	Phase 4
Second Xiangya Hospital of Central South University	Phase 1

See all SEMAGLUTIDE clinical trials

Pharmacology for SEMAGLUTIDE

Drug Class	GLP-1 Receptor Agonist
Mechanism of Action	Glucagon-like Peptide-1 (GLP-1) Agonists

Anatomical Therapeutic Chemical (ATC) Classes for SEMAGLUTIDE

A10BJ	Glucagon-like peptide-1 (GLP-1) analogues
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for SEMAGLUTIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RYBELSUS	Tablets	semaglutide	3 mg, 7 mg and 14 mg	213051	1	2024-07-15
OZEMPIC	Injection	semaglutide	2 mg/3 mL	209637	1	2024-04-11
OZEMPIC	Injection	semaglutide	8 mg/3 mL	209637	1	2022-12-21
WEGOVY	Injection	semaglutide	0.25 mg/0.5 mL 0.5 mg/0.5 mL 1 mg/0.5 mL 1.7 mg/0.75 mL 2.4 mg/0.75 mL	215256	1	2022-10-20
OZEMPIC	Injection	semaglutide	2 mg/1.5 mL and 4 mg/3 mL	209637	7	2021-12-06

US Patents and Regulatory Information for SEMAGLUTIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novo	WEGOVY	semaglutide	SOLUTION;SUBCUTANEOUS	215256-002	Jun 4, 2021		RX	Yes	Yes
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-003	Mar 28, 2022		RX	Yes	Yes			Y
Novo	WEGOVY	semaglutide	SOLUTION;SUBCUTANEOUS	215256-002	Jun 4, 2021		RX	Yes	Yes
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019		RX	Yes	Yes			Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-003	Mar 28, 2022		RX	Yes	Yes			Y

Expired US Patents for SEMAGLUTIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-001	Dec 5, 2017
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-004	Oct 6, 2022
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019

EU/EMA Drug Approvals for SEMAGLUTIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novo Nordisk A/S	Wegovy	semaglutide	EMEA/H/C/005422 Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of- ≥30 kg/m² (obesity), or- ≥27 kg/m² to	Authorised	no	no	no	2022-01-06
Novo Nordisk A/S	Ozempic	semaglutide	EMEA/H/C/004174 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 cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.	Authorised	no	no	no	2018-02-08
Novo Nordisk A/S	Rybelsus	semaglutide	EMEA/H/C/004953 Rybelsus is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin combination with other medicinal products for the treatment of diabetes.For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.	Authorised	no	no	no	2020-04-03

International Patents for SEMAGLUTIDE

Country	Patent Number	Title	Estimated Expiration
Taiwan	I372629
Slovenia	2991671
Serbia	58039	ORALNO DOZIRANJE GLP-1 JEDINJENJA (ORAL DOSING OF GLP-1 COMPOUNDS)
Russian Federation	2600440	ТВЕРДЫЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ АГОНИСТ GLP-1 И СОЛЬ N-(2-ГИДРОКСИБЕНЗОИЛ)АМИНО)КАПРИЛОВОЙ КИСЛОТЫ (SOLID COMPOSITIONS CONTAINING AGONIST TO GLP AND SALT OF N-(2-HYDROXYBENZOYL)AMINO)CAPRYLIC ACID)
Australia	2021207313	Pharmaceutical formulations

Supplementary Protection Certificates for SEMAGLUTIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1863839	661	Finland
1863839	22/2018	Austria		PRODUCT NAME: SEMAGLUTID; REGISTRATION NO/DATE: EU/1/17/1251 20180212
1863839	2018C/016	Belgium		PRODUCT NAME: OZEMPIC - SEMAGLUTIDE; AUTHORISATION NUMBER AND DATE: EU/1/17/1251 20180212
1863839	C201830026	Spain		PRODUCT NAME: OZEMPIC-SEMAGLUTIDA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1251; DATE OF AUTHORISATION: 20180208; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1251; DATE OF FIRST AUTHORISATION IN EEA: 20180208
1863839	122018000075	Germany		PRODUCT NAME: OZEMPIC-SEMAGLUTID; REGISTRATION NO/DATE: EU/1/17/1251 20180208

SEMAGLUTIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Semaglutide

Introduction to Semaglutide

Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, has revolutionized the treatment of type 2 diabetes and obesity. Developed by Novo Nordisk, it is marketed under various brand names, including Ozempic, Rybelsus, and Wegovy. Here’s a detailed look at the market dynamics and financial trajectory of semaglutide.

Market Size and Growth

The semaglutide market is experiencing rapid growth driven by increasing demand for effective treatments for diabetes and obesity. As of 2023, the global semaglutide market was valued at USD 105 million, and it is projected to reach USD 165 million by 2032, growing at a CAGR of 5.2% from 2024 to 2032[1].

However, more recent and comprehensive estimates suggest a much larger market. By 2024, the semaglutide market is expected to reach USD 27.55 billion and is forecasted to grow at a CAGR of 12.80% to reach USD 50.34 billion by 2029[4].

Geographical Market Distribution

• North America: Currently leads the market and is expected to continue as the largest market share holder due to high prevalence rates of diabetes and obesity[1][4].
• Europe: Expected to show lucrative growth following North America, driven by the rising incidence of type 2 diabetes and obesity[1].
• Asia Pacific: Anticipated to grow at the highest CAGR during the forecast period due to rapid urbanization, changing lifestyles, and increasing health issues such as diabetes and obesity[1][4].
• Latin America, Middle East, and Africa: These regions are also expected to hold a considerable share of the market during the projected period[1].

Key Drivers of Market Growth

• Increasing Prevalence of Diabetes and Obesity: With 422 million people globally suffering from diabetes and obesity rates spiraling out of control, the demand for semaglutide is on the rise[1].
• Government Initiatives and Campaigns: Programs like "Cities Changing Diabetes" by Novo Nordisk and the Steno Diabetes Centre Copenhagen contribute to market growth by raising awareness and promoting prevention and control of diabetes[1].
• Clinical Efficacy and Expanded Indications: Semaglutide’s proven efficacy in managing blood sugar levels and aiding in weight loss, along with expanded FDA labels for cardiovascular risk reduction, further boost its market appeal[2][4].

Financial Performance of Semaglutide-Based Products

Novo Nordisk has seen remarkable financial success with its semaglutide-based products. In 2022, Ozempic sales surged by 77% in DKK (61% at constant exchange rates) to DKK 59,750 million (USD 8.4 billion). Rybelsus sales increased by 134% in DKK (114% at CER) to DKK 11,299 million (USD 1.6 billion). The obesity care segment, including Wegovy, saw a 101% DKK (84% CER) sales jump to DKK 16,864 million (USD 2.4 billion)[2].

In 2023, these trends continued with Ozempic sales soaring by 60% in DKK (66% CER) to DKK 95,718 million (USD 13.9 billion), and the obesity care segment seeing a 147% DKK (154% CER) sales increase to DKK 41,632 million (USD 6.0 billion)[2].

Market Projections and Potential

Goldman Sachs projects the global GLP-1 market, including semaglutide, to reach a total addressable market of $100 billion by 2030. This estimate is supported by promising results from additional outcomes studies, such as the SELECT cardiovascular outcomes study, which demonstrated a 20% reduction in major cardiovascular events in patients taking semaglutide[3].

The potential introduction of oral GLP-1s, which are currently in clinical trials, could further expand the market. These oral therapies are expected to be more convenient and potentially less expensive, making them more accessible to a broader patient population[3].

Impact on Healthcare and Economy

The success of semaglutide and other GLP-1 drugs is not only transforming healthcare but also having broader economic implications. For instance, analysts predict that these drugs could bolster the U.S. GDP by up to 1% by curbing obesity-related health complications and improving workplace productivity. Additionally, the potential for a "slimmer society" could lead to significant savings in sectors such as aviation, with estimates suggesting airlines could save up to $80 million per year in jet fuel costs if passengers lost an average of 10 pounds[2].

Challenges and Future Directions

Despite the promising outlook, the market faces several challenges. These include payer resistance, safety concerns, and the need for more convenient administration options, particularly oral formulations, to improve patient adherence and acceptance[2].

Novo Nordisk is addressing these challenges through ongoing innovation, including the development of higher-dose and more convenient semaglutide formulations. The recent expansion of the FDA label for Wegovy, which includes cardiovascular risk reduction, has also stoked investor interest and further solidified the drug's market position[2].

Competitive Landscape

Novo Nordisk currently dominates the GLP-1 market, but competition is increasing. Other companies, such as Eli Lilly with its drug tirzapatide, are entering the market, and new weight loss drugs are slated for FDA approval. This competition is expected to drive innovation and potentially lower prices, making GLP-1 therapies more accessible to a wider population[2][5].

Key Takeaways

• The semaglutide market is growing rapidly, driven by increasing demand for diabetes and obesity treatments.
• North America leads the market, with Asia Pacific expected to grow at the highest CAGR.
• Semaglutide’s clinical efficacy and expanded indications are key drivers of market growth.
• Novo Nordisk has seen significant financial success with its semaglutide-based products.
• The market is projected to reach $100 billion by 2030, with potential for further growth through oral GLP-1s.
• Despite challenges, innovation and competition are expected to continue driving the market forward.

Frequently Asked Questions (FAQs)

Q: What is the current market size of the semaglutide market? A: As of 2024, the semaglutide market is expected to reach USD 27.55 billion[4].

Q: Which region is expected to grow at the highest CAGR in the semaglutide market? A: The Asia Pacific region is anticipated to grow at the highest CAGR during the forecast period[1][4].

Q: What are the key drivers of the semaglutide market growth? A: Key drivers include the increasing prevalence of diabetes and obesity, government initiatives, and the clinical efficacy of semaglutide[1][2].

Q: How has Novo Nordisk's financial performance been with semaglutide-based products? A: Novo Nordisk has seen significant financial success, with sales of Ozempic, Rybelsus, and Wegovy surging in recent years[2].

Q: What are the potential broader economic impacts of semaglutide and other GLP-1 drugs? A: These drugs could bolster the U.S. GDP by up to 1% and have significant savings in various sectors such as aviation[2].

Cited Sources:

1. Marketdataforecast.com: Semaglutide Market Size, Share, Growth & Trends Report, 2032
2. Drugdiscoverytrends.com: Novo Nordisk achieves 74% growth surge, clinching fastest-growing...
3. Goldmansachs.com: Weighing the GLP-1 market - Goldman Sachs
4. Mordorintelligence.com: Semaglutide Market Size & Share Analysis - Industry Research Report
5. Alpha-sense.com: Weight Loss Drugs: What to Know in 2024 - AlphaSense