GVOKE HYPOPEN Drug Patent Profile

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

Gvoke Hypopen is a drug marketed by Xeris and is included in one NDA. There are two patents protecting this drug.

This drug has twenty-four patent family members in fifteen countries.

The generic ingredient in GVOKE HYPOPEN is glucagon. There are twelve drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the glucagon profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Gvoke Hypopen

A generic version of GVOKE HYPOPEN was approved as glucagon by FRESENIUS KABI USA on May 8^th, 2015.

Summary for GVOKE HYPOPEN

International Patents:	24
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	28
Drug Prices:	Drug price information for GVOKE HYPOPEN
DailyMed Link:	GVOKE HYPOPEN at DailyMed

See drug prices for GVOKE HYPOPEN

Pharmacology for GVOKE HYPOPEN

Drug Class	Antihypoglycemic Agent Gastrointestinal Motility Inhibitor
Physiological Effect	Decreased GI Motility Decreased GI Smooth Muscle Tone Decreased Glycolysis Increased Gluconeogenesis Increased Glycogenolysis

US Patents and Regulatory Information for GVOKE HYPOPEN

GVOKE HYPOPEN is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Xeris	GVOKE HYPOPEN	glucagon	SOLUTION;SUBCUTANEOUS	212097-003	Sep 10, 2019		RX	Yes	Yes			Y
Xeris	GVOKE HYPOPEN	glucagon	SOLUTION;SUBCUTANEOUS	212097-004	Sep 10, 2019		RX	Yes	Yes			Y
Xeris	GVOKE HYPOPEN	glucagon	SOLUTION;SUBCUTANEOUS	212097-003	Sep 10, 2019		RX	Yes	Yes			Y
Xeris	GVOKE HYPOPEN	glucagon	SOLUTION;SUBCUTANEOUS	212097-004	Sep 10, 2019		RX	Yes	Yes			Y

EU/EMA Drug Approvals for GVOKE HYPOPEN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Tetris Pharma B.V	Ogluo	glucagon	EMEA/H/C/005391 Ogluo is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.	Authorised	no	no	no	2021-02-11
Eli Lilly Nederland B.V.	Baqsimi	glucagon	EMEA/H/C/003848 Baqsimi is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 4 years and over with diabetes mellitus.	Authorised	no	no	no	2019-12-16

International Patents for GVOKE HYPOPEN

See the table below for patents covering GVOKE HYPOPEN around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	4327804	PROCÉDÉS DE PRODUCTION DE FORMULATIONS DE GLUCAGON THÉRAPEUTIQUES STABLES DANS DES SOLVANTS POLAIRES APROTIQUES (METHODS FOR PRODUCING STABLE THERAPEUTIC GLUCAGON FORMULATIONS IN APROTIC POLAR SOLVENTS)
Canada	2999404	METHODES DE PRODUCTION DE FORMULATIONS THERAPEUTIQUES STABLES DANS DES SOLVANTS POLAIRES APROTIQUES (METHODS FOR PRODUCING STABLE THERAPEUTIC FORMULATIONS IN APROTI C POLAR SOLVENTS)
Japan	6835831
European Patent Office	3352780	PROCÉDÉS DE PRODUCTION DE FORMULATIONS DE GLUCAGON THÉRAPEUTIQUES STABLES DANS DES SOLVANTS POLAIRES APROTIQUES (METHODS FOR PRODUCING STABLE THERAPEUTIC GLUCAGON FORMULATIONS IN APROTIC POLAR SOLVENTS)
World Intellectual Property Organization (WIPO)	2016196976
Israel	258298	שיטות לייצור תכשירי גלוקגון יציבים בסולבנטים פולרים אפרוטים (Methods for producing stable therapeutic glucagon formulations in aprotic polar solvents)

GVOKE HYPOPEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Gvoke HypoPen

Introduction to Gvoke HypoPen

Gvoke HypoPen, developed by Xeris Pharmaceuticals, is a revolutionary liquid stable glucagon in an auto-injector designed to treat severe hypoglycemia in patients with diabetes. This innovative product has significantly impacted the market dynamics and financial performance of Xeris Pharmaceuticals.

Market Need and Unmet Patient Needs

The market for emergency glucagon treatment is substantial, with an estimated 3.5 million people with diabetes in Europe and 12.5 million in Japan and China who are clinically appropriate for such treatment[3]. Gvoke HypoPen addresses a critical unmet need by providing a ready-to-use, easy-to-administer glucagon formulation that is more convenient and user-friendly compared to traditional glucagon emergency kits.

Launch and Commercial Performance

Initial Launch and Uptake

The Gvoke HypoPen was launched in July 2020, following the successful launch of Gvoke PFS (Prefilled Syringe) in January 2020. Despite the challenges posed by the COVID-19 pandemic, the product saw a positive response from the diabetes community. The company quickly adapted to a virtual selling model to minimize the pandemic's impact on sales and patient access[4].

Prescription Volume and Sales Growth

In the second quarter of 2021, Gvoke prescriptions topped 21,000 for the first time, representing a 32% increase from the prior quarter and a 272% increase from the same period in 2020. This growth was driven by strong demand for Gvoke HypoPen, with unit sales to wholesalers and other direct customers increasing by 36% compared to the prior quarter[1].

Market Share

Gvoke’s NRx (new prescription) share of the retail glucagon market grew to approximately 16% during the second quarter of 2021, outpacing the overall glucagon market growth[1].

Financial Highlights

Revenue Growth

The launch of Gvoke HypoPen significantly boosted revenue. In the third quarter of 2020, Gvoke net sales grew by 370% quarter over quarter to $9.4 million, driven largely by the HypoPen launch[5].

Quarterly Net Sales

In the second quarter of 2021, Gvoke quarterly net sales increased by 10% to $8.8 million compared to the prior quarter, despite some negative impact from ongoing market dynamics[1].

Cost of Goods Sold and Operating Expenses

The cost of goods sold and operating expenses, including research and development (R&D) and selling, general, and administrative (SG&A) expenses, have been significant. However, these costs are aligned with the company's aggressive commercialization and development strategies. For example, in the fourth quarter of 2019, R&D expenses were $12.4 million, and SG&A expenses were $20.6 million[2].

Cash Position and Financial Stability

Xeris Pharmaceuticals maintained a strong cash position, with $116 million in cash as of the second quarter of 2021. This financial stability is crucial for continuing to invest in marketing, R&D, and potential acquisitions, such as the proposed acquisition of Strongbridge Biopharma plc[1].

Regulatory Approvals and Shelf-Life Extension

FDA Approvals

The FDA approved a Prior Approval Supplement to extend the shelf life of Gvoke 1mg from 24 months to 30 months from the date of manufacture, enhancing the product's marketability and convenience[1].

European Market Authorization

In February 2021, the European Commission granted a marketing authorization for Ogluo (the European brand name for Gvoke) for the treatment of severe hypoglycemia in adults, adolescents, and children aged two years and over with diabetes mellitus. This approval paves the way for commercial launch in select European countries starting in the fourth quarter of 2021[3].

Expansion and Distribution

Xeris Pharmaceuticals plans to expand Gvoke's availability beyond the U.S. market. The company expects Gvoke to be available in Israel and the Palestinian Authority in 2022 through a distribution agreement. Additionally, they are pursuing development and commercialization collaborations for most of their product candidates[3].

Impact of COVID-19

The COVID-19 pandemic presented significant challenges, including slowing the momentum of Gvoke PFS prescriptions and units sold. However, Xeris quickly adapted by implementing a virtual selling model and various programs to support the diabetes patient community and mitigate the pandemic's impact on their business[4].

Future Outlook and Pipeline Progress

Xeris Pharmaceuticals is intensely focused on commercial execution and pipeline progress. The company is moving forward with several clinical programs, including a Phase 2 study in broader patient populations for its Emergency Insulin Hypoglycemia (EIH) program, which is expected to start in early 2022[1].

Key Takeaways

• Strong Market Demand: Gvoke HypoPen has seen significant prescription volume and sales growth, outpacing the overall glucagon market.
• Financial Growth: Revenue has increased substantially, driven by the successful launch of Gvoke HypoPen.
• Regulatory Success: FDA and European Commission approvals have enhanced the product's shelf life and market reach.
• Global Expansion: Plans are underway to launch Gvoke in additional markets, including Europe, Israel, and the Palestinian Authority.
• Adaptation to Challenges: The company has effectively navigated the challenges posed by the COVID-19 pandemic.

FAQs

What is Gvoke HypoPen?

Gvoke HypoPen is a liquid stable glucagon in an auto-injector designed to treat severe hypoglycemia in patients with diabetes.

When was Gvoke HypoPen launched?

Gvoke HypoPen was launched in July 2020.

How has Gvoke HypoPen performed in the market?

Gvoke HypoPen has seen significant growth in prescription volume and sales, with a 32% increase in prescriptions from the prior quarter and a 272% increase from the same period in 2020.

What regulatory approvals has Gvoke HypoPen received?

Gvoke HypoPen received FDA approval for a shelf-life extension to 30 months and a marketing authorization from the European Commission for Ogluo.

How has the COVID-19 pandemic affected Gvoke HypoPen sales?

The COVID-19 pandemic initially slowed the momentum of Gvoke PFS prescriptions, but the company adapted by implementing a virtual selling model and support programs, minimizing the impact on their business.

Cited Sources

1. Xeris Pharmaceuticals Reports Second Quarter 2021 Financial Results and Recent Highlights
2. XERIS PHARMACEUTICALS, INC. - 2020 Financial Results and Highlights
3. XERIS PHARMACEUTICALS, INC. - Annual Reports
4. Xeris Pharmaceuticals Reports First Quarter 2020 Financial Results and Provides Corporate Updates
5. Xeris Pharmaceuticals Reports Third Quarter 2020 Financial Results