ERTUGLIFLOZIN - Generic Drug Details

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

Ertugliflozin is the generic ingredient in four branded drugs marketed by Aurobindo Pharma Ltd, Hetero Labs Ltd V, and Msd Sub Merck, and is included in five NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ertugliflozin has sixty patent family members in forty-nine countries.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for ERTUGLIFLOZIN

International Patents:	60
US Patents:	5
Tradenames:	4
Applicants:	3
NDAs:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	39
Patent Applications:	105
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ERTUGLIFLOZIN
What excipients (inactive ingredients) are in ERTUGLIFLOZIN?	ERTUGLIFLOZIN excipients list
DailyMed Link:	ERTUGLIFLOZIN at DailyMed

Recent Clinical Trials for ERTUGLIFLOZIN

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

Sponsor	Phase
Ain Shams University	Phase 2/Phase 3
Getz Pharma	Phase 4
Yale University	Phase 4

See all ERTUGLIFLOZIN clinical trials

Generic filers with tentative approvals for ERTUGLIFLOZIN

Applicant	Application No.	Strength	Dosage Form
		15MG	TABLET;ORAL
		5MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for ERTUGLIFLOZIN

A10BK	Sodium-glucose co-transporter 2 (SGLT2) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for ERTUGLIFLOZIN

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 ERTUGLIFLOZIN

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	209805-002	Dec 19, 2017		RX	Yes	Yes	9,308,204		Y
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	209805-001	Dec 19, 2017		RX	Yes	No
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-003	Dec 19, 2017		RX	Yes	No

EU/EMA Drug Approvals for ERTUGLIFLOZIN

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 ERTUGLIFLOZIN

Country	Patent Number	Title	Estimated Expiration
Japan	2012500842
Lithuania	C2334687
Japan	4825322
Georgia, Republic of	P20135803	DIOXA-BICYCLO[3.2.1.]OCTANE-2,3,4-TRIOL DERIVATIVES

Supplementary Protection Certificates for ERTUGLIFLOZIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2334687	LUC00079	Luxembourg		PRODUCT NAME: ERTUGLIFLOZINE, EVENTUELLEMENT SOUS FORME CRISTALLINE, EN PARTICULIER EN TANT QUE CO-CRISTAL AVEC L'ACIDE L-PYROGLUTAMIQUE, ET PLUS SPECIFIQUEMENT EN TANT QU'ACIDE ERTUGLIFLOZINE L-PYROGLUTAMIQUE; AUTHORISATION NUMBER AND DATE: EU/1/18/1267 20180323
2334687	C20180023 00266	Estonia		PRODUCT NAME: ERTUGLIFLOSIIN;REG NO/DATE: EU/1/18/1267 23.03.2018
2334687	1890026-6	Sweden		PRODUCT NAME: ERTUGLIFLOZIN,OPTIONALLY IN THE FORM OF ERTUGLIFOZIN L- PYROGLUTAMIC ACID; REG. NO/DATE: EU/1/18/1267 20180323
2334687	132018000000441	Italy		PRODUCT NAME: ERTUGLIFLOZIN(STEGLATRO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1267, 20180323

ERTUGLIFLOZIN Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Ertugliflozin (Steglatro)

Introduction to Ertugliflozin

Ertugliflozin, marketed as Steglatro, is a sodium-glucose co-transporter-2 (SGLT-2) inhibitor developed by Pfizer and Merck for the treatment of type 2 diabetes. It was approved by the U.S. FDA in December 2017 and received EU approval in March 2018[1][4].

Market Entry and Competition

Steglatro entered a crowded SGLT-2 inhibitor market, competing with established drugs like Invokana (canagliflozin), Jardiance (empagliflozin), and Farxiga (dapagliflozin). Despite being a late entrant, Steglatro has several strengths that help it gain market share. It is available in various formulations, including fixed-dose combinations with Januvia (sitagliptin) as Steglujan and with metformin as Segluromet[1][4].

Clinical Efficacy and Differentiators

Steglatro has demonstrated significant clinical efficacy, particularly in combination therapies. The VERTIS SITA and VERTIS Factorial trials showed substantial HbA1C reductions when Steglatro was combined with Januvia and metformin, respectively. Additionally, Steglatro has shown monotherapy efficacy and significant weight loss and blood pressure-lowering effects[1].

Cardiovascular Benefits

A key differentiator for SGLT-2 inhibitors is their cardiovascular benefits. While Steglatro's cardiovascular outcomes study (VERTIS CV) was ongoing at the time of its approval, other SGLT-2 inhibitors like Jardiance and Farxiga have already demonstrated cardiovascular benefits in landmark trials such as the EMPA-REG OUTCOME and DECLARE studies. Positive cardiovascular data are crucial for consolidating Steglatro's market position[1][2].

Market Forecast and Sales Projections

The 2018 Drugs to Watch report by Clarivate Analytics predicted that Steglatro would achieve significant sales by 2022. According to the report, Steglatro was forecasted to generate $1.087 billion in sales by 2022, placing it among the top SGLT-2 inhibitors in the market. This forecast was later revised upward to $1.275 billion, reflecting the growing demand for SGLT-2 inhibitors[1].

Real-World Evidence and Market Impact

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

Pricing and Cost Considerations

The wholesale acquisition costs for Steglatro and its fixed-dose combinations were set at $8.94 per day for Steglatro, $17.45 per day for Steglujan, and $8.94 per day for Segluromet. These costs do not include discounts that may be applied, which can affect the final retail price and patient affordability[4].

Collaboration and Revenue Sharing

Pfizer and Merck entered into a worldwide collaboration (excluding Japan) for the co-development and co-promotion of ertugliflozin. The agreement involves a 60/40 revenue and cost-sharing model between Merck and Pfizer, respectively, with Pfizer eligible for additional milestone payments[4].

Market Performance and Growth

By 2017, Farxiga and Jardiance had already achieved blockbuster status, with sales of $1.074 billion and $1.141 billion, respectively. The rapid rise in sales of SGLT-2 inhibitors is expected to continue, with Steglatro contributing significantly to this growth. The market is driven by the drugs' convenient oral administration, strong HbA1c efficacy, weight loss, and antihypertensive effects[1].

Challenges and Risks

Despite its potential, Steglatro faces challenges such as competition from established brands and the need for positive cardiovascular outcomes data to fully establish its market position. Additionally, general industry conditions, economic factors, and potential side effects can impact its financial trajectory[1][4].

Financial Projections and Industry Impact

The financial projections for Steglatro are optimistic, with the drug expected to be a significant contributor to the growing SGLT-2 inhibitor market. The market for these drugs is predicted to expand rapidly, driven by their clinical benefits and the increasing prevalence of type 2 diabetes.

Key Statistics

• Sales Forecast: $1.275 billion by 2022[1].
• Market Share: Expected to be among the top SGLT-2 inhibitors[1].
• Clinical Efficacy: Significant HbA1C reductions and weight loss[1].
• Cardiovascular Benefits: Ongoing study (VERTIS CV) expected to provide positive outcomes[1].

Conclusion

Ertugliflozin (Steglatro) has entered the SGLT-2 inhibitor market with strong clinical data and a robust market forecast. Its ability to reduce HbA1C levels, promote weight loss, and lower blood pressure, combined with its potential cardiovascular benefits, positions it well in a rapidly growing market.

Key Takeaways

• Strong Clinical Efficacy: Steglatro has shown significant HbA1C reductions and other clinical benefits.
• Market Competition: Enters a crowded market but has differentiators such as fixed-dose combinations.
• Cardiovascular Benefits: Ongoing studies expected to provide positive outcomes.
• Financial Projections: Forecasted to achieve $1.275 billion in sales by 2022.
• Collaboration: Pfizer and Merck collaborate on development and promotion.

FAQs

Q: What is ertugliflozin (Steglatro) used for? A: Ertugliflozin (Steglatro) is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus[3].

Q: How does Steglatro compare to other SGLT-2 inhibitors? A: Steglatro has shown similar efficacy to other SGLT-2 inhibitors but has the advantage of fixed-dose combinations with Januvia and metformin, and it is expected to contribute significantly to the growing market[1].

Q: What are the key clinical benefits of Steglatro? A: Steglatro reduces HbA1C levels, promotes weight loss, and lowers blood pressure. It also has potential cardiovascular benefits, although these are still under study[1][2].

Q: How is Steglatro priced? A: The wholesale acquisition cost for Steglatro is $8.94 per day, with similar pricing for its fixed-dose combinations. Actual retail costs may vary based on discounts and other factors[4].

Q: What is the collaboration between Pfizer and Merck for Steglatro? A: Pfizer and Merck have a worldwide collaboration (excluding Japan) for the co-development and co-promotion of ertugliflozin, with a 60/40 revenue and cost-sharing model[4].

Sources

1. Clarivate Analytics: Pfizer and Merck’s Steglatro for type 2 diabetes: a valuable addition to the rapidly rising SGLT-2 inhibitor market.
2. Frontiers in Medicine: Sodium-Glucose Co-transporter-2 Inhibitors and Nephroprotection.
3. FDA: 209803Orig1s000 209805Orig1s000 209806Orig1s000.
4. Pfizer: FDA Approves SGLT2 Inhibitor STEGLATRO™ (ertugliflozin) and Fixed-Dose Combination STEGLUJAN™ (ertugliflozin and sitagliptin) for Adults with Type 2 Diabetes.