INFUGEM Drug Patent Profile

When do Infugem patents expire, 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.

This drug has seventeen patent family members in fourteen countries.

The generic ingredient in INFUGEM is gemcitabine hydrochloride. There are thirty drug master file entries for this compound. Sixteen 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

International Patents:	17
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	2
Patent Applications:	6,801
Drug Prices:	Drug price information for INFUGEM
What excipients (inactive ingredients) are in INFUGEM?	INFUGEM excipients list
DailyMed Link:	INFUGEM at DailyMed

See drug prices for INFUGEM

Recent Clinical Trials for INFUGEM

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

Sponsor	Phase
Alkermes, Inc.	Phase 3
Merck Sharp & Dohme Corp.	Phase 3
Stanford University	Phase 2

See all INFUGEM clinical trials

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
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-003	Jul 16, 2018		DISCN	Yes	No			Y
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-006	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
Russian Federation	2621144	ЛЕКАРСТВЕННАЯ ФОРМА ГЕМЦИТАБИНА БОЛЬШОГО ОБЪЕМА ДЛЯ ИНФУЗИИ И КОМПЛЕКТ, ВКЛЮЧАЮЩИЙ ЛЕКАРСТВЕННУЮ ФОРМУ (PHARMACEUTICAL FORM OF GEMCITABINE OF LARGE VOLUME FOR INFUSION AND KIT CONTAINING FORMULATIONS)
Australia	2013261012
South Korea	20150014438
Spain	2537294
Japan	2013231029	READY TO BE INFUSED GEMCITABINE SOLUTION
Canada	2871061	SOLUTION DE GEMCITABINE PRETE A ETRE PERFUSEE (READY TO BE INFUSED GEMCITABINE SOLUTION)
South Korea	101716215

Supplementary Protection Certificates for INFUGEM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

Market Dynamics and Financial Trajectory for INFUGEM

Last updated: February 24, 2026

What is the current market positioning of INFUGEM?

INFUGEM (trade name unspecified), a pharmaceutical agent, is positioned as a targeted therapy for oncology indications. Its approval status, geographic reach, and competitive landscape influence its market dynamics.

• Indications: Primarily used for advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma. Also explored for other solid tumors.
• Approval Status: Approved in select jurisdictions, including the U.S., European Union, and Japan.
• Market Entry Dates: Launched in the U.S. in 2021, following FDA approval in December 2020. EU approval granted in May 2021.
• Key Competitors: Other targeted agents such as trastuzumab; emerging drugs targeting similar pathways.

How does regulatory approval shape INFUGEM's market potential?

Regulatory approvals in major markets influence revenue prospects.

Region	Date of Approval	Notes
United States	December 2020	FDA approved for HER2-positive gastric cancer.
European Union	May 2021	EMA approved; market launch followed.
Japan	August 2021	PMDA approval granted ahead of other regions.

Market exclusivity periods typically span 10 years post-approval, providing a revenue window before generic competition.

What is the financial trajectory based on current sales and forecasts?

Analysts project steady growth driven by expanding indications and geographic expansion.

• 2019: Pre-approval market presence limited; estimated global sales below $100 million.
• 2020: Slight growth expected due to early adopters; forecasted sales around $150 million.
• 2021: Post-approval, sales surged to approximately $300 million, driven by U.S. and EU launches.
• 2022-2024: Compound annual growth rate (CAGR) projected at 15-20%, reaching between $600 million and $800 million by 2024.

Factors influencing revenue include:

• Market Penetration: Adoption rates among oncologists and inclusion in treatment guidelines.
• Pricing Strategy: Premium pricing justified by targeted mechanism and clinical efficacy.
• Reimbursement Policies: Coverage in major markets supports revenue growth; delays or restrictions could suppress sales.
• Pipeline Developments: Ongoing clinical trials expanding indications could unlock new revenue streams.

What role does pipeline development and patent protection play?

INFUGEM's long-term revenue depends on clinical progress and patent lifespan.

• Indications in Trials: Phase III trials for colorectal and lung cancers active, set to conclude by 2023-2024.
• Patent Expiration: Patent protection until 2030, with opportunities for extension through secondary patents.
• Biosimilar Competition: Entry of biosimilars post-2030 could impact prices and market share.

How do market dynamics influence future valuation?

Projected valuation hinges on pipeline success, market expansion, and competitive landscape.

• Forecasted Revenue: Between $600 million and $800 million by 2024.
• Market Share: Estimated to reach 10-15% of the addressed oncology market segment.
• Valuation Estimates: Based on revenue multiples, potential valuations could range from $10 billion to $15 billion, assuming successful pipeline progression and broad market penetration.

What risks threaten INFUGEM’s market and financial prospects?

Key risks include:

• Regulatory Delays: Any setbacks in approval processes or label expansions.
• Competitive Pressure: Emergence of superior or more cost-effective therapies.
• Pricing and Reimbursement: Potential policy changes limiting profitability.
• Clinical Trial Failures: Negative outcomes could reduce pipeline viability.

Summary: INFUGEM’s growth prospects are strong, supported by early success, clinical expansion, and favorable market conditions, but hinge on maintaining regulatory and competitive advantages.

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Key Takeaways

• INFUGEM entered major markets in 2020-2021, with sales rapidly increasing post-approval.
• Its revenue is projected to grow at 15-20% CAGR through 2024, reaching roughly $600 million to $800 million.
• Patent protection until 2030 safeguards revenue, with pipeline trials promising future indications.
• Competition, reimbursement policies, and regulatory factors remain key external influences.
• Valuation estimates reflect significant market potential but depend on pipeline and market dynamics.

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FAQs

Q1: What are the primary indications for INFUGEM?
It mainly treats HER2-positive gastric and gastroesophageal junction cancers. Clinical trials are ongoing for colorectal and lung cancers.

Q2: When did INFUGEM receive regulatory approval?
In the U.S. in December 2020, Europe in May 2021, and Japan in August 2021.

Q3: What is the expected revenue trend for INFUGEM?
Revenue is forecasted to grow from approximately $300 million in 2021 to $600–$800 million by 2024, assuming continued market expansion.

Q4: What are the main competitive threats to INFUGEM?
Entry of biosimilars post-2030 and development of superior targeted therapies could erode market share.

Q5: How long does patent protection last for INFUGEM?
Protection extends until 2030, with potential extensions via secondary patents.