STEGLATRO Drug Patent Profile

When do Steglatro patents expire, and when can generic versions of Steglatro launch?

Steglatro is a drug marketed by Msd Sub Merck and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has sixty patent family members in forty-nine countries.

The generic ingredient in STEGLATRO is ertugliflozin. Two suppliers are listed for this compound. Additional details are available on the ertugliflozin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Steglatro

A generic version of STEGLATRO was approved as ertugliflozin by HETERO LABS LTD V on September 17^th, 2024.

Summary for STEGLATRO

International Patents:	60
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	4
Patent Applications:	75
Drug Prices:	Drug price information for STEGLATRO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STEGLATRO
What excipients (inactive ingredients) are in STEGLATRO?	STEGLATRO excipients list
DailyMed Link:	STEGLATRO at DailyMed

See drug prices for STEGLATRO

Recent Clinical Trials for STEGLATRO

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

Sponsor	Phase
Klinikum Wiener Neustadt	Phase 3
General Hospital Linz	Phase 3
Medical University of Vienna	Phase 3

See all STEGLATRO clinical trials

Paragraph IV (Patent) Challenges for STEGLATRO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
STEGLATRO	Tablets	ertugliflozin	5 mg and 15 mg	209803	3	2021-12-20

US Patents and Regulatory Information for STEGLATRO

STEGLATRO is protected by one US patents and one FDA Regulatory Exclusivity.

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	STEGLATRO	ertugliflozin	TABLET;ORAL	209803-001	Dec 19, 2017	AB	RX	Yes	No			Y	Y
Msd Sub Merck	STEGLATRO	ertugliflozin	TABLET;ORAL	209803-002	Dec 19, 2017	AB	RX	Yes	Yes
Msd Sub Merck	STEGLATRO	ertugliflozin	TABLET;ORAL	209803-001	Dec 19, 2017	AB	RX	Yes	No
Msd Sub Merck	STEGLATRO	ertugliflozin	TABLET;ORAL	209803-002	Dec 19, 2017	AB	RX	Yes	Yes			Y	Y

EU/EMA Drug Approvals for STEGLATRO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp & Dohme B.V.	Steglatro	ertugliflozin	EMEA/H/C/004315 Steglatro is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:as monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications.in addition to other medicinal products for the treatment of diabetes.	Authorised	no	no	no	2018-03-21

International Patents for STEGLATRO

When does loss-of-exclusivity occur for STEGLATRO?

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

African Regional IP Organization (ARIPO)

Argentina

Australia

Austria

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Dominican Republic

Ecuador

El Salvador

Eurasian Patent Organization

European Patent Office

France

Georgia, Republic of

Honduras

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

Netherlands

New Zealand

Nicaragua

Norway

Panama

Peru

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

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 STEGLATRO around the world.

Country	Patent Number	Title	Estimated Expiration
China	103497199	Dioxa-bicyclo[3.2.1]octane-2, 3, 4-triol derivatives
Uruguay	32073	DERIVADOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL
Slovenia	2334687
Taiwan	I387598
Australia	2009286380	Dioxa-bicyclo(3.2.1.)octane-2,3,4-triol derivatives

Supplementary Protection Certificates for STEGLATRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2334687	C02334687/01	Switzerland		FORMER OWNER: PFIZER INC., US
2334687	2018/028	Ireland		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
2334687	2018C/027	Belgium		PRODUCT NAME: ERTUGLIFLOZINE, DESGEWENST IN KRISTALVORM, MET NAME ALS CO-KRISTAL MET L-PYROGLUTAMINEZUUR, EN SPECIFIEK ALS ERTUGLIFLOZIN L-PYROGLUTAMINE ZUUR; AUTHORISATION NUMBER AND DATE: EU/1/18/1267 20180323
2334687	132018000000441	Italy		PRODUCT NAME: ERTUGLIFLOZIN(STEGLATRO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1267, 20180323
2334687	SPC/GB18/026	United Kingdom		PRODUCT NAME: ERTUGLIFOZIN, OPTIONALLY AS A CRYSTAL FORM, PARTICULARLY AS A CO-CRYSTAL WITH L-PYROGLUTAMIC ACID, AND SPECIFICALLY AS ERTUGLIFOZIN L-PYROGLUTAMIC ACID; REGISTERED: UK EU/1/18/1267/001(NI) 20180321; UK EU/1/18/1267/002(NI) 20180321; UK EU/1/18/1267/003(NI) 20180321; UK EU/1/18/1267/004(NI) 20180321; UK EU/1/18/1267/005(NI) 20180321; UK EU/1/18/1267/006(NI) 20180321; UK PLGB 53095/0064 20180321; UK PLGB 53095/0065 20180321; UK EU/1/18/1267/007(NI) 20180321; UK EU/1/18/1267/008(NI) 20180321; UK EU/1/18/1267/009(NI) 20180321; UK EU/1/18/1267/010(NI) 20180321; UK EU/1/18/1267/011(NI) 20180321; UK EU/1/18/1267/012(NI) 20180321

STEGLATRO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for STEGLATRO

Introduction

STEGLATRO (ertugliflozin), a sodium-glucose cotransporter 2 (SGLT-2) inhibitor, was approved by the U.S. Food and Drug Administration (FDA) in December 2017 for the treatment of type 2 diabetes. Developed through a collaboration between Merck and Pfizer, STEGLATRO has entered a highly competitive market dominated by other SGLT-2 inhibitors. Here, we delve into the market dynamics and financial trajectory of STEGLATRO.

Market Entry and Competition

STEGLATRO entered the market as a late entrant in the SGLT-2 inhibitor class, which was already crowded with established players like Invokana (canagliflozin) from Johnson & Johnson, Jardiance (empagliflozin) from Boehringer Ingelheim and Eli Lilly, and Farxiga (dapagliflozin) from AstraZeneca[1].

Clinical Efficacy and Differentiation

Despite being a late entrant, STEGLATRO has shown significant clinical efficacy. It demonstrated substantial HbA1c reductions, particularly when combined with Merck’s DPP-4 inhibitor Januvia (sitagliptin) and metformin. The VERTIS SITA and VERTIS Factorial trials highlighted its effectiveness in reducing HbA1c levels, as well as its benefits in weight loss and blood pressure reduction[1][4].

Regulatory Approvals

STEGLATRO and its fixed-dose combinations, STEGLUJAN (ertugliflozin and sitagliptin) and SEGLUROMET (ertugliflozin and metformin), received FDA approval in December 2017. Additionally, it gained EU approval in March 2018[1][4].

Market Forecast and Sales Projections

The 2018 Drugs to Watch report by Clarivate Analytics predicted that STEGLATRO would achieve significant sales by 2022. The report forecasted STEGLATRO to generate $1.087 billion in sales by 2022, placing it among the top SGLT-2 inhibitors in the market, although behind Farxiga and Jardiance[1].

Financial Performance

Merck and Pfizer share the revenues and costs of STEGLATRO on a 60/40 percent basis, respectively. The list prices set by Merck were $8.94 per day for STEGLATRO, $17.45 per day for STEGLUJAN, and $8.94 per day for SEGLUROMET. These prices do not include discounts that may be applied[4].

Sales Growth and Market Share

While STEGLATRO has not yet reached the sales levels of its competitors like Farxiga and Jardiance, it has contributed to the growth of Merck’s pharmaceutical segment. The rapid rise in sales of SGLT-2 inhibitors as a class has been driven by their strong efficacy data, convenient oral administration, and additional benefits such as weight loss and blood pressure reduction[1].

Cardiovascular Outcomes

Cardiovascular outcomes data are crucial for the long-term success of SGLT-2 inhibitors. STEGLATRO is currently undergoing a cardiovascular outcomes study (VERTIS CV), with results expected to further solidify its position in the market. Positive cardiovascular data, as seen with Jardiance and other competitors, are key to gaining market share and regulatory approvals for cardiovascular risk reduction[1].

Real-World Evidence

Real-world evidence suggests that SGLT-2 inhibitors, including STEGLATRO, can significantly decrease heart failure hospitalizations and deaths. This evidence supports the use of these drugs earlier in the treatment regimen, potentially expanding the patient base[1].

Pricing and Cost-Effectiveness

The cost-effectiveness of STEGLATRO is an important factor in its market dynamics. The drug's pricing strategy, including list prices and potential discounts, influences its adoption and market share. Studies on the dynamic pricing of drugs highlight the impact of price changes on the incremental cost-effectiveness ratio (ICER), which is crucial for healthcare payers and policymakers[3].

Merck’s Financial Reports

Merck’s financial reports reflect the overall performance of their pharmaceutical portfolio, including STEGLATRO. While the specific sales figures for STEGLATRO are not always detailed, the growth in Merck’s diabetes segment is partly attributed to STEGLATRO. For instance, in 2023, Merck reported an 8% growth in pharmaceutical sales, driven by various products including those in the diabetes category[2].

Conclusion

STEGLATRO has established itself as a valuable addition to the SGLT-2 inhibitor market, despite entering a crowded field. Its clinical efficacy, particularly in combination with other diabetes medications, and its potential cardiovascular benefits position it well for future growth. The financial trajectory of STEGLATRO is closely tied to the overall performance of Merck and Pfizer, as well as the broader market dynamics of the SGLT-2 inhibitor class.

Key Takeaways

• Clinical Efficacy: STEGLATRO has shown significant HbA1c reductions and additional benefits like weight loss and blood pressure reduction.
• Market Competition: It competes with established SGLT-2 inhibitors like Farxiga, Jardiance, and Invokana.
• Regulatory Approvals: FDA and EU approvals were received in 2017 and 2018, respectively.
• Sales Projections: Forecasted to generate $1.087 billion in sales by 2022.
• Financial Performance: Shared revenues and costs between Merck and Pfizer on a 60/40 basis.
• Cardiovascular Outcomes: Ongoing cardiovascular outcomes study (VERTIS CV) is crucial for long-term market success.
• Real-World Evidence: Supports earlier use in treatment regimens due to reduced heart failure hospitalizations and deaths.

FAQs

Q: What is STEGLATRO used for? A: STEGLATRO (ertugliflozin) is used for the treatment of type 2 diabetes.

Q: Who developed STEGLATRO? A: STEGLATRO was developed through a collaboration between Merck and Pfizer.

Q: What are the fixed-dose combinations of STEGLATRO? A: The fixed-dose combinations are STEGLUJAN (ertugliflozin and sitagliptin) and SEGLUROMET (ertugliflozin and metformin).

Q: What are the key clinical benefits of STEGLATRO? A: STEGLATRO offers significant HbA1c reductions, weight loss, and blood pressure-lowering effects.

Q: What is the current market forecast for STEGLATRO? A: STEGLATRO is forecasted to generate $1.087 billion in sales by 2022, according to the 2018 Drugs to Watch report.

Sources

1. Clarivate Analytics, "Pfizer and Merck's Steglatro for type 2 diabetes: a valuable addition to the rapidly rising SGLT-2 inhibitor market," June 7, 2018.
2. Merck, "Merck Announces Fourth-Quarter and Full-Year 2023 Financial Results," February 1, 2024.
3. Value in Health, "The Effect of the Drug Life Cycle Price on Cost-Effectiveness," August 3, 2022.
4. Pfizer, "FDA Approves SGLT2 Inhibitor STEGLATRO™ (ertugliflozin) and Fixed-Dose Combination STEGLUJAN™ (ertugliflozin and sitagliptin) for Adults with Type 2 Diabetes," December 22, 2017.
5. Merck, "Merck Announces Fourth-Quarter and Full-Year 2021 Financial Results," February 3, 2022.