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Last Updated: December 24, 2024

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STEGLUJAN Drug Patent Profile


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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

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Summary for STEGLUJAN
Drug patent expirations by year for STEGLUJAN
Drug Prices for STEGLUJAN

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for STEGLUJAN
Generic Entry Date for STEGLUJAN*:
Constraining patent/regulatory exclusivity:
NDA:
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

US Patents and Regulatory Information for STEGLUJAN

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of STEGLUJAN is ⤷  Subscribe.

This potential generic entry date is based on patent ⤷  Subscribe.

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 ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
Msd Sub Merck STEGLUJAN ertugliflozin; sitagliptin phosphate TABLET;ORAL 209805-002 Dec 19, 2017 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Msd Sub Merck STEGLUJAN ertugliflozin; sitagliptin phosphate TABLET;ORAL 209805-001 Dec 19, 2017 RX Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Msd Sub Merck STEGLUJAN ertugliflozin; sitagliptin phosphate TABLET;ORAL 209805-002 Dec 19, 2017 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Msd Sub Merck STEGLUJAN ertugliflozin; sitagliptin phosphate TABLET;ORAL 209805-001 Dec 19, 2017 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Msd Sub Merck STEGLUJAN ertugliflozin; sitagliptin phosphate TABLET;ORAL 209805-001 Dec 19, 2017 RX Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for STEGLUJAN

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)

Patent: 99
Patent: Dioxa-bicyclo[3.2.1]octane-2,3,4-triol de derivatives
Estimated Expiration: ⤷  Subscribe

Australia

Patent: 10310956
Patent: Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 77857
Patent: DERIVES DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL (DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES)
Estimated Expiration: ⤷  Subscribe

Costa Rica

Patent: 120289
Patent: DERIVADOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL
Estimated Expiration: ⤷  Subscribe

Croatia

Patent: 0150107
Estimated Expiration: ⤷  Subscribe

Cyprus

Patent: 15949
Estimated Expiration: ⤷  Subscribe

Denmark

Patent: 96583
Estimated Expiration: ⤷  Subscribe

Ecuador

Patent: 12011946
Patent: DERIVADOS DE DIOXA- BICICLO [3.2.1] OCTANO- 2 ,3,4- TRIOL
Estimated Expiration: ⤷  Subscribe

Eurasian Patent Organization

Patent: 1983
Patent: ПРОИЗВОДНЫЕ ДИОКСАБИЦИКЛО[3.2.1]ОКТАН-2,3,4-ТРИОЛА (DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES)
Estimated Expiration: ⤷  Subscribe

Patent: 1290267
Patent: ПРОИЗВОДНЫЕ ДИОКСАБИЦИКЛО[3.2.1]ОКТАН-2,3,4-ТРИОЛА
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 96583
Patent: DERIVES DE DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL (DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES)
Estimated Expiration: ⤷  Subscribe

Georgia, Republic of

Patent: 0146104
Patent: DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 96156
Estimated Expiration: ⤷  Subscribe

Patent: 13509393
Estimated Expiration: ⤷  Subscribe

Montenegro

Patent: 016
Patent: DERIVATI DIOKSABICIKLO[3.2.1]OKTAN-2,3,4-TRIOLA (DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES)
Estimated Expiration: ⤷  Subscribe

New Zealand

Patent: 9945
Patent: Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Estimated Expiration: ⤷  Subscribe

Poland

Patent: 96583
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 96583
Estimated Expiration: ⤷  Subscribe

Serbia

Patent: 827
Patent: DERIVATI DIOKSA-BICIKLO[3.2.1]OKTAN-2,3,4-TRIOLA (DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES)
Estimated Expiration: ⤷  Subscribe

Slovenia

Patent: 96583
Estimated Expiration: ⤷  Subscribe

South Africa

Patent: 1203486
Patent: DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 1426180
Estimated Expiration: ⤷  Subscribe

Patent: 120093321
Patent: DIOXA-BICYCLO [3.2.1] OCTANE-2,3,4-TRIOL DERIVATIVES
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 27179
Estimated Expiration: ⤷  Subscribe

Ukraine

Patent: 3416
Patent: ПОХІДНІ ДІОКСАБІЦИКЛО[3.2.1]ОКТАН-2,3,4-ТРІОЛУ[ПРОИЗВОДНЫЕ ДИОКСАБИЦИКЛО[3.2.1]ОКТАН-2,3,4-ТРИОЛА (Normal;heading 1;heading 2;heading 3;DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES)
Estimated Expiration: ⤷  Subscribe

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
New Zealand 529833 Beta-amino tetrahydroimidazo (1, 2-A) pyrazines and tetrahydrotrioazolo (4, 3-A) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes ⤷  Subscribe
Panama 8840801 DERIVAOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL ⤷  Subscribe
Luxembourg C91360 ⤷  Subscribe
Norway 2007010 ⤷  Subscribe
Iceland 2218 ⤷  Subscribe
Denmark 2334687 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for STEGLUJAN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2334687 C02334687/01 Switzerland ⤷  Subscribe FORMER OWNER: PFIZER INC., US
2334687 18C1036 France ⤷  Subscribe PRODUCT NAME: ERTUGLIFLOZINE,OPTIONNELLEMENT SOUS FORME CRISTALLINE,EN PARTICULIER EN TANT QUE CO-CRISTAL AVEC L'ACIDE L-PYROGLUTANIQUE,ET PARTICULIEREMENT ERTUGLIFOZINE ACIDE L-PYROGLUTANIQUE.; REGISTRATION NO/DATE: EU/1/18/1267 20180323
1412357 CA 2007 00040 Denmark ⤷  Subscribe
2334687 PA2018510 Lithuania ⤷  Subscribe PRODUCT NAME: ERTUGLIFLOZINAS, PASIRINKTINAI KAIP KRISTALINE FORMA, YPAC KAIP KO-KRISTALAS SU L-PIROGLUTAMO RUGSTIMI, IR YPAC KAIP ERTUGLIFLOZINO L-PIROGLUTAMO RUGSTIS; REGISTRATION NO/DATE: EU/1/18/1267 20180321
2334687 2018/028 Ireland ⤷  Subscribe PRODUCT NAME: ERTUGLIFLOZIN, OPTIONALLY AS A CRYSTAL FORM, PARTICULARLY AS A CO-CRYSTAL WITH L-PYROGLUTAMIC ACID, AND SPECIFICALLY AS ERTUGLIFLOZIN L-PYROGLUTAMIC ACID; REGISTRATION NO/DATE: EU/1/18/1267/001 EU/1/18/1267/012 20180321
1412357 SPC/GB08/040 United Kingdom ⤷  Subscribe 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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.

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