BAQSIMI Drug Patent Profile

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

Baqsimi is a drug marketed by Amphastar Pharms Inc and is included in one NDA. There are three patents protecting this drug.

This drug has eighty-six patent family members in forty-one countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Baqsimi

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

Summary for BAQSIMI

International Patents:	86
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	2
Drug Prices:	Drug price information for BAQSIMI
What excipients (inactive ingredients) are in BAQSIMI?	BAQSIMI excipients list
DailyMed Link:	BAQSIMI at DailyMed

See drug prices for BAQSIMI

Recent Clinical Trials for BAQSIMI

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

Sponsor	Phase
Eli Lilly and Company	Phase 1
Azienda Ospedaliera Città della Salute e della Scienza di Torino	Phase 4

See all BAQSIMI clinical trials

Pharmacology for BAQSIMI

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 BAQSIMI

BAQSIMI is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amphastar Pharms Inc	BAQSIMI	glucagon	POWDER;NASAL	210134-001	Jul 24, 2019		RX	Yes	Yes			Y
Amphastar Pharms Inc	BAQSIMI	glucagon	POWDER;NASAL	210134-001	Jul 24, 2019		RX	Yes	Yes			Y
Amphastar Pharms Inc	BAQSIMI	glucagon	POWDER;NASAL	210134-001	Jul 24, 2019		RX	Yes	Yes			Y

Expired US Patents for BAQSIMI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amphastar Pharms Inc	BAQSIMI	glucagon	POWDER;NASAL	210134-001	Jul 24, 2019

EU/EMA Drug Approvals for BAQSIMI

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 BAQSIMI

See the table below for patents covering BAQSIMI around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2019147817	低血糖症の治療用経鼻粉末製剤 (NASAL POWDER FORMULATION FOR TREATMENT OF HYPOGLYCEMIA)
Hungary	E049413
Israel	285577	מערכות להובלת תרופות ושיטות (Medication delivery systems and methods)
Ukraine	121874	ПОРОШКОВА НАЗАЛЬНА КОМПОЗИЦІЯ ДЛЯ ЛІКУВАННЯ ГІПОГЛІКЕМІЇ (NASAL POWDER FORMULATION FOR TREATMENT OF HYPOGLYCEMIA)

Supplementary Protection Certificates for BAQSIMI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2875043	CR 2024 00043	Denmark		PRODUCT NAME: DASIGLUCAGON ELLER ET FARMACEUTISK SALT ELLER SOLVAT DERAF, SASOM DASIGLUCAGONHYDROCHLORID; REG. NO/DATE: EU/1/24/1829 20240725
2875043	122024000057	Germany		PRODUCT NAME: DASIGLUCAGON IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/24/1829 20240724
2875043	301294	Netherlands		PRODUCT NAME: DASIGLUCAGON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, ZOALS DASIGLUCAGON HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/24/1829 20240725

Market Dynamics and Financial Trajectory for BAQSIMI

Introduction

BAQSIMI, the first and only nasally administered glucagon, has been a significant player in the treatment of severe hypoglycemia since its FDA approval in 2019. Here, we delve into the market dynamics and financial trajectory of this innovative drug, highlighting key factors that have influenced its performance.

Clinical Significance and Market Need

BAQSIMI is designed to treat severe hypoglycemia in people with diabetes, offering a compact, portable, and ready-to-use alternative to traditional injectable glucagon. Clinical trials have demonstrated its noninferiority to injectable glucagon, with 100% of patients achieving treatment success in raising blood glucose levels[3].

Market Launch and Initial Performance

Launched by Eli Lilly and Company in 2019, BAQSIMI quickly gained traction as a rescue treatment for severe hypoglycemia. By 2022, it had generated $139.3 million in worldwide sales and was available in 27 international markets[4].

Transition to Amphastar Pharmaceuticals

In April 2023, Eli Lilly divested BAQSIMI to Amphastar Pharmaceuticals, marking a significant shift in the drug's commercial strategy. Amphastar committed to dedicated commercial investment to expand BAQSIMI's reach and enhance its diabetes portfolio[4].

Financial Performance Under Amphastar

Since the transition, BAQSIMI has contributed substantially to Amphastar's revenue. For the three months ended September 30, 2024, BAQSIMI generated $40.4 million in direct sales to customers, with an additional $6.4 million in sales made by Eli Lilly under a Transition Services Agreement (TSA), resulting in a net payment of $2.4 million to Amphastar[2][5].

Revenue Growth

The acquisition of BAQSIMI has been a key driver of Amphastar's revenue growth. The drug's sales have contributed to a 6% year-over-year increase in Amphastar's net revenues, reaching $191.2 million for the three months ended September 30, 2024[2][5].

Impact on Product Portfolio

BAQSIMI's integration into Amphastar's product portfolio has strengthened the company's proprietary products profile and enhanced its offerings in the diabetes segment. This strategic move aligns with Amphastar's vision of expanding its core product lines[4].

Market Dynamics and Competitive Landscape

Competitive Advantage

BAQSIMI's unique nasal administration and compact design provide a significant competitive advantage over traditional injectable glucagon products. This innovation has helped it capture a substantial market share in the treatment of severe hypoglycemia[3].

Supplier Shortages and Market Opportunities

Supplier shortages in other pharmaceutical products have indirectly benefited BAQSIMI. For instance, shortages in epinephrine and lidocaine have led to increased demand for other Amphastar products, potentially increasing the visibility and trust in the company's portfolio, including BAQSIMI[1].

Pricing and Affordability

The U.S. list price for BAQSIMI is $280.80 for a one-pack and $561.60 for a two-pack. Despite its premium pricing, Lilly and now Amphastar have committed to making the drug affordable and accessible through various affordability offerings and securing access with payers[3].

Financial Trajectory and Future Outlook

Revenue Projections

The financial trajectory for BAQSIMI looks promising, with Amphastar expecting continued growth driven by dedicated commercial investment. The terms of the agreement with Lilly include potential sales-based milestone payments of up to $450 million, indicating a strong belief in the drug's growth potential[4].

Operating Cash Flow and Share Buyback

Amphastar's strong operating cash flow of $184.4 million for the nine months ending September 30, 2024, and the $50 million increase in the share buyback program authorization, suggest a robust financial position to support further investment in BAQSIMI[2].

Challenges and Mitigants

Impairment Charges and Inventory Adjustments

Despite the positive trajectory, Amphastar has faced some challenges, including an impairment charge of $2.7 million related to the impairment of international product rights and inventory adjustments. However, these are seen as one-time adjustments rather than ongoing issues[1].

Competition and Market Fluctuations

The pharmaceutical market is highly competitive, and BAQSIMI faces competition from other glucagon products. However, its unique administration method and strong clinical efficacy data position it well to maintain market share[3].

Key Takeaways

• Innovative Product: BAQSIMI is the first and only nasally administered glucagon, offering a significant advantage in treating severe hypoglycemia.
• Strong Financial Performance: The drug has contributed substantially to Amphastar's revenue growth, with $40.4 million in direct sales for the three months ended September 30, 2024.
• Market Expansion: Dedicated commercial investment by Amphastar is expected to further expand BAQSIMI's reach.
• Competitive Advantage: Unique nasal administration and compact design provide a competitive edge.
• Financial Projections: Potential sales-based milestone payments and strong operating cash flow indicate a promising financial trajectory.

FAQs

What is BAQSIMI and how does it work?

BAQSIMI is a nasally administered glucagon used to treat severe hypoglycemia in people with diabetes. It works by raising blood glucose levels quickly and is designed for rescue situations.

Who developed and currently markets BAQSIMI?

BAQSIMI was developed by Eli Lilly and Company but was divested to Amphastar Pharmaceuticals in April 2023.

How much does BAQSIMI cost?

The U.S. list price for BAQSIMI is $280.80 for a one-pack and $561.60 for a two-pack.

What are the key factors driving BAQSIMI's revenue growth?

Key factors include dedicated commercial investment by Amphastar, unique product features, and the absence of competitors in the nasal glucagon market.

What challenges has Amphastar faced with BAQSIMI?

Amphastar has faced impairment charges and inventory adjustments, but these are seen as one-time issues rather than ongoing challenges.

Sources

1. Amphastar Pharmaceuticals, Inc. - News Detail - Amphastar Pharmaceuticals, Inc.
2. Stock Titan - Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended September 30, 2024.
3. PR Newswire - BAQSIMI™ (glucagon) Nasal Powder 3 mg, the First and Only Nasally Administered Glucagon to Treat Severe Hypoglycemia in Adults and Children with Diabetes Ages Four Years and Older Approved by FDA.
4. PR Newswire - Lilly to Divest BAQSIMI to Amphastar.
5. BioSpace - Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended September 30, 2024.