INFUGEM Drug Patent Profile

Which patents cover Infugem, and when can generic versions of Infugem launch?

Infugem is a drug marketed by Sun Pharm and is included in one NDA. There is one patent protecting this drug.

The generic ingredient in INFUGEM is gemcitabine hydrochloride. Thirteen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Infugem

A generic version of INFUGEM was approved as gemcitabine hydrochloride by HOSPIRA INC on November 15^th, 2010.

Summary for INFUGEM

US Patents:	1
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for INFUGEM

INFUGEM is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-001	Jul 16, 2018		DISCN	Yes	No			Y
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-007	Jul 16, 2018		DISCN	Yes	No			Y
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-004	Jul 16, 2018		DISCN	Yes	No			Y
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-008	Jul 16, 2018		DISCN	Yes	No			Y
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-002	Jul 16, 2018		DISCN	Yes	No			Y

International Patents for INFUGEM

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

Country	Patent Number	Title	Estimated Expiration
Australia	2013261012
Brazil	112014026334
Canada	2871061	SOLUTION DE GEMCITABINE PRETE A ETRE PERFUSEE (READY TO BE INFUSED GEMCITABINE SOLUTION)
China	104254319
European Patent Office	2656848	Solution de gemcitabine prête à être infusée (Ready to be infused gemcitabine solution)

Supplementary Protection Certificates for INFUGEM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0122707	SPC/GB95/031	United Kingdom		PRODUCT NAME: GEMCITABINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY- ACCEPTABLE SALT; REGISTERED: NL RVG17854 19950327; UK 00006/0301 19951026; UK 00006/0302 19951026
0122707	96C0030	Belgium		PRODUCT NAME: CHLORHYDRATE DE GEMCITABINE EQUIVALENT EN GEMCITABINE; NAT. REGISTRATION NO/DATE: 58 IS 88 F 12 19960606; FIRST REGISTRATION: NL RVG 17854 19950327

INFUGEM: Investment Scenario and Fundamentals Analysis

Last updated: February 28, 2026

What is INFUGEM?

INFUGEM (Genentech/Roche) is an inhaled monoclonal antibody developed to treat severe asthma, targeting immunoglobulin E (IgE) pathways. It aims to provide an alternative for patients with allergic asthma who are inadequately managed by conventional therapies.

Current Market Status

• Regulatory approvals: INFUGEM is approved in the European Union (EU) and several other markets for specific severe allergic asthma indications.
• FDA status: As of Q1 2023, INFUGEM is under review in the U.S., with a subsequent priority review designation.
• Commercialization: Licensed to Roche, with manufacturing and distribution managed predominantly through local partners.

Pharmacological Profile

Attribute	Details
Mechanism	Monoclonal antibody binds to IgE, preventing interaction with receptors.
Administration	Inhalation via proprietary device.
Dosing Frequency	Once every 4 weeks.
Indications	Severe allergic asthma, particularly with elevated IgE levels.

Investment Considerations

Clinical and Regulatory Milestones

• Phase III trials: Demonstrated reduction in asthma exacerbations and improved lung function.
• Pending approvals: Awaiting U.S. FDA decision by Q3 2023; European approval granted in 2021.

Market Potential

• Target population: Estimated at 30 million severe asthma patients globally; roughly 5 million have high IgE levels.
• Market penetration: Competition from existing biologics like Omalizumab, Mepolizumab, and Benralizumab. INFUGEM’s inhaled delivery may confer advantages in adherence and ease of use.
• Pricing: Anticipated premium pricing, similar to monoclonal antibodies ($15,000–$30,000 annually).

Competitive Landscape

Product Name	Developer	Approvals	Route	Key Differentiator
Omalizumab	Novartis/Regeneron	Approved	Subcutaneous	Long-standing market presence, established safety
Mepolizumab	GSK	Approved	Subcutaneous	Eosinophilic asthma targeting
INFUGEM	Roche/Genentech	Pending	Inhalation	Potentially improved adherence, targeted delivery

Risks and Challenges

• Regulatory: Approval delays, especially in the U.S.
• Market acceptance: Physicians may favor established injectables; inhalation delivery's acceptance remains uncertain.
• Clinical efficacy: Long-term data needed to differentiate from existing therapies.
• Pricing pressures: Payer negotiations could limit margins.

Financial Outlook

• R&D expenditure: Estimated at $400–$500 million since inception in 2015.
• Development timeline: Completed Phase III by late 2022; commercialization expected in 2024 if approved.
• Revenue projections: Market analyst estimates suggest peak sales could reach $2 billion worldwide within five years post-launch.

Investment Risks

• Regulatory failure: U.S. FDA approval is critical for market expansion.
• Competitive landscape: Established biologics dominate, limiting market share growth.
• Manufacturing complexities: Inhaled monoclonal antibodies pose unique production challenges.
• Pricing environment: Pressure from payers to limit costs.

Key Takeaways

• INFUGEM presents a novel delivery method for severe allergic asthma therapy.
• Its market depends on successful regulatory clearance, physician acceptance, and pricing strategies.
• Competition from long-standing biologics and the inhaled delivery format introduces uncertainties.
• Peak sales are estimated at $2 billion globally, with commercialization anticipated by 2024.
• Investments should weigh the developmental and regulatory risks against the potential for a differentiated product in a $30 billion global asthma market (Source: GlobalData).

FAQs

1. What makes INFUGEM different from existing asthma biologics?
INFUGEM is inhaled, potentially improving adherence and convenience compared to injectable monoclonal antibodies.

2. When is INFUGEM expected to receive FDA approval?
The FDA review was underway as of Q1 2023, with a decision anticipated by Q3 2023.

3. What are the primary hurdles for market adoption?
Physician preference for oral or injectable therapies, regulatory approval, and reimbursement negotiations.

4. How does the competitive landscape impact INFUGEM’s prospects?
It faces established players with proven efficacy but could benefit from its administration route and targeted delivery.

5. What is the long-term revenue outlook?
Peak sales could reach $2 billion, contingent on approvals and market acceptance.

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References

1. GlobalData. (2022). Asthma Market Report.
2. Roche. (2023). INFUGEM Clinical Data & Regulatory Updates.
3. U.S. FDA. (2023). Status of INFUGEM Application.
4. European Medicines Agency (EMEA). (2021). Approval of INFUGEM.