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STEGLUJAN Drug Patent Profile

Which patents cover Steglujan, and what generic alternatives are available?

Steglujan is a drug marketed by Msd Sub Merck and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and thirty-eight patent family members in fifty-two countries.

The generic ingredient in STEGLUJAN is ertugliflozin; sitagliptin phosphate. One supplier is listed for this compound. Additional details are available on the ertugliflozin; sitagliptin phosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Steglujan

Steglujan was eligible for patent challenges on December 19, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 21, 2030. This may change due to patent challenges or generic licensing.

There have been twenty-nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for STEGLUJAN

International Patents:	138
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for STEGLUJAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STEGLUJAN
What excipients (inactive ingredients) are in STEGLUJAN?	STEGLUJAN excipients list
DailyMed Link:	STEGLUJAN at DailyMed

See drug prices for STEGLUJAN

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

Constraining patent/regulatory exclusivity:

9,308,204

NDA:

209805

Dosage:

TABLET;ORAL

^*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.

Pharmacology for STEGLUJAN

Drug Class	Dipeptidyl Peptidase 4 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

US Patents and Regulatory Information for STEGLUJAN

STEGLUJAN is protected by four US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 9,308,204.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-001	Dec 19, 2017		RX	Yes	No	8,080,580		Y	Y
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-002	Dec 19, 2017		RX	Yes	Yes	9,439,901
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-001	Dec 19, 2017		RX	Yes	No	7,326,708*PED				Y

Expired US Patents for STEGLUJAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-002	Dec 19, 2017	7,078,381
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-001	Dec 19, 2017	6,890,898
Msd Sub Merck	STEGLUJAN	ertugliflozin; sitagliptin phosphate	TABLET;ORAL	209805-002	Dec 19, 2017	7,459,428

International Patents for STEGLUJAN

When does loss-of-exclusivity occur for STEGLUJAN?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Australia

Canada

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Japan

Montenegro

New Zealand

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering STEGLUJAN around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20120093321	DIOXA-BICYCLO [3.2.1] OCTANE-2,3,4-TRIOL DERIVATIVES
Panama	8840801	DERIVAOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL
Cyprus	1115949

Supplementary Protection Certificates for STEGLUJAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	0790041-8	Sweden		PRODUCT NAME: SITAGLIPTINFOSFATMONOHYDRAT
1412357	SPC/GB08/040	United Kingdom		PRODUCT NAME: SITAGLIPTIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE MONOPHOSPHATE, PLUS METFORMIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE HYDROCHLORIDE.; REGISTERED: CH 58450 01-03 20080408; UK EU/1/08/455/001 20080716; UK EU/1/08/455/002 20080716; UK EU/1/08/455/003 20080716; UK EU/1/08/455/004 20080716; UK EU/1/08/455/005 20080716; UK EU/1/08/455/006 20080716; UK EU/1/08/455/007 20080716; UK EU/1/08/455/008 20080716; UK EU/1/08/455/009 20080716; UK EU/1/08/455/010 20080716; UK EU/1/08/455/011 20080716; UK EU/1/08/455/012 20080716; UK EU/1/08/455/013 20080716; UK EU/1/08/455/014 20080716
1412357	CA 2008 00035	Denmark		PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID

STEGLUJAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for STEGLUJAN

Introduction

STEGLUJAN, a fixed-dose combination of ertugliflozin (Steglatro) and sitagliptin (Januvia), is a significant addition to the sodium glucose co-transporter-2 (SGLT-2) inhibitor market for the treatment of type 2 diabetes. Here, we delve into the market dynamics and financial trajectory of STEGLUJAN, highlighting its competitive landscape, pricing strategies, and forecasted performance.

Competitive Landscape

STEGLUJAN enters a crowded market dominated by other SGLT-2 inhibitors such as Invokana (canagliflozin) from Johnson & Johnson, Jardiance (empagliflozin) from Eli Lilly and Boehringer Ingelheim, and Farxiga (dapagliflozin) from AstraZeneca. Each of these drugs has established a strong presence, with Jardiance being the first to demonstrate heart benefits and Invokana being the first-to-market SGLT-2 inhibitor[1][4].

FDA Approval and Market Entry

STEGLUJAN received FDA approval in December 2017, along with its single-component counterpart Steglatro and another combination product, Segluromet (ertugliflozin and metformin). The approval was based on clinical trial data, including a head-to-head combination test against Januvia, which showed promising efficacy and safety profiles[1][5].

Pricing Strategy

The list price for STEGLUJAN was set at $17.45 per day, or approximately $523.50 for a 30-day supply. However, this is the sticker price before rebate deals with payers, and the actual cost could be lower due to negotiations for formulary placement. This pricing strategy is crucial in a market where cost is a significant factor in drug adoption[1].

Clinical Efficacy and Safety

The clinical trials for STEGLUJAN demonstrated its efficacy in lowering A1C levels. In a frontline study, patients taking the lowest dose of Steglatro (5 mg) alongside Januvia saw their A1C levels decrease by 1.6%, compared to a 0.4% decline in the placebo arm. This data is pivotal in convincing payers and physicians of the drug's value[1].

Market Forecast

According to the 2018 Drugs to Watch report by Clarivate Analytics, STEGLUJAN is predicted to be a significant contributor to the rapidly rising SGLT-2 inhibitor market. By 2022, STEGLUJAN was forecasted to achieve sales of approximately $1.275 billion, placing it among the top SGLT-2 inhibitors in terms of revenue[4].

Market Trends and Challenges

The SGLT-2 inhibitor market is dynamic, with trends influenced by clinical outcomes and regulatory actions. For instance, Jardiance gained market share following its cardiovascular benefits approval and the FDA's warning on Invokana's amputation risk. Real-world evidence also suggests that SGLT-2 inhibitors could be used earlier in treatment, potentially expanding the patient pool[1].

Real-World Evidence and Expansion

Real-world analyses have shown that SGLT-2 inhibitors, including STEGLUJAN, can significantly reduce heart failure hospitalizations and deaths. This evidence supports the case for using these drugs earlier in treatment, which could further boost their market presence[1].

Financial Performance and Projections

The financial performance of STEGLUJAN is closely tied to its ability to compete with established brands. Given its strong clinical data and the combination with Januvia, STEGLUJAN is well-positioned to capture a significant share of the market. The predicted sales of $1.275 billion by 2022 indicate a robust financial trajectory, although this is subject to market dynamics and competitive pressures[4].

Global Market Potential

While the primary focus is on the U.S. market, the global potential for SGLT-2 inhibitors is substantial. As more countries adopt these drugs, the market size is expected to grow, although pricing strategies may need to be adjusted for different healthcare systems and economic conditions[4].

Conclusion

STEGLUJAN's entry into the SGLT-2 inhibitor market marks a significant addition to the treatment options for type 2 diabetes. With its strong clinical efficacy, strategic pricing, and favorable market forecasts, STEGLUJAN is poised to be a valuable player in this rapidly growing market segment.

Key Takeaways

• Competitive Landscape: STEGLUJAN competes with established SGLT-2 inhibitors like Invokana, Jardiance, and Farxiga.
• Pricing Strategy: List price set at $17.45 per day, with potential for lower costs through rebate deals.
• Clinical Efficacy: Demonstrated significant reduction in A1C levels in clinical trials.
• Market Forecast: Predicted to achieve $1.275 billion in sales by 2022.
• Market Trends: Influenced by clinical outcomes and regulatory actions.
• Global Potential: Significant global market potential, subject to pricing adjustments.

FAQs

Q: What is STEGLUJAN, and how does it differ from other SGLT-2 inhibitors? A: STEGLUJAN is a fixed-dose combination of ertugliflozin (Steglatro) and sitagliptin (Januvia), distinguishing it from other SGLT-2 inhibitors through its combination with a DPP-4 inhibitor.

Q: How was STEGLUJAN priced upon its market entry? A: The list price for STEGLUJAN was set at $17.45 per day, or approximately $523.50 for a 30-day supply, before any rebate deals.

Q: What clinical data supports the efficacy of STEGLUJAN? A: Clinical trials showed that patients taking the lowest dose of Steglatro alongside Januvia experienced a 1.6% reduction in A1C levels, compared to a 0.4% decline in the placebo arm.

Q: How does STEGLUJAN fit into the broader SGLT-2 inhibitor market? A: STEGLUJAN is forecasted to be a significant contributor to the SGLT-2 inhibitor market, with predicted sales of $1.275 billion by 2022, placing it among the top drugs in its class.

Q: What are the potential global market implications for STEGLUJAN? A: The global market potential for STEGLUJAN is substantial, but pricing strategies may need to be adjusted for different healthcare systems and economic conditions.

Sources

1. FiercePharma: Merck, Pfizer won their FDA nod for fourth-to-market SGLT2 drug ...
2. Oregon Drug Use Review / Pharmacy & Therapeutics Committee: Patterns of changes in bipolar depressive symptoms revealed by trajectory analysis among patients with bipolar disorder.
3. Goldman Sachs: Weighing the GLP-1 market.
4. Clarivate: Pfizer and Merck's Steglatro for type 2 diabetes: a valuable addition to the rapidly rising SGLT-2 inhibitor market.
5. Biospace: FDA Approves SGLT2 Inhibitor STEGLATRO (ertugliflozin) and Fixed-Dose Combination STEGLUJAN (ertugliflozin and sitagliptin) for Adults with Type 2 Diabetes.