TIGECYCLINE - Generic Drug Details

What are the generic sources for tigecycline and what is the scope of patent protection?

Tigecycline is the generic ingredient in two branded drugs marketed by Accord Hlthcare Inc, Amneal, Apotex, Eugia Pharma, Fresenius Kabi Usa, Meitheal, Sandoz, Xellia Pharms Aps, and Pf Prism Cv, and is included in nine NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Tigecycline has seventy patent family members in twenty-nine countries.

There are ten drug master file entries for tigecycline. Seven suppliers are listed for this compound.

Summary for TIGECYCLINE

International Patents:	70
US Patents:	7
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	63
Patent Applications:	8,120
Drug Prices:	Drug price trends for TIGECYCLINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TIGECYCLINE
What excipients (inactive ingredients) are in TIGECYCLINE?	TIGECYCLINE excipients list
DailyMed Link:	TIGECYCLINE at DailyMed

See drug prices for TIGECYCLINE

Recent Clinical Trials for TIGECYCLINE

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

Sponsor	Phase
Clinical Hospital Centre Zagreb	PHASE4
Beni-Suef University	PHASE4
Ain Shams University	PHASE2

See all TIGECYCLINE clinical trials

Pharmacology for TIGECYCLINE

Drug Class

Tetracycline-class Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for TIGECYCLINE

J01AA	Tetracyclines
J01A	TETRACYCLINES
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for TIGECYCLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	AP	RX	Yes	Yes			Y
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	AP	RX	Yes	Yes			Y
Xellia Pharms Aps	TIGECYCLINE	tigecycline	POWDER;INTRAVENOUS	205722-001	Oct 18, 2019		DISCN	No	No
Accord Hlthcare Inc	TIGECYCLINE	tigecycline	POWDER;INTRAVENOUS	208744-001	Jan 18, 2018		DISCN	No	No
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	AP	RX	Yes	Yes			Y
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	AP	RX	Yes	Yes			Y

Expired US Patents for TIGECYCLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005

EU/EMA Drug Approvals for TIGECYCLINE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Accord Healthcare S.L.U.	Tigecycline Accord	tigecycline	EMEA/H/C/005114Tygecycline Accord is indicated in adults and in children from the age of eight years for the treatment of the following infections (see sections 4.4 and 5.1):Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections (see section 4.4)Complicated intra-abdominal infections (cIAI)Tygecycline Accord should be used only in situations where other alternative antibiotics are not suitable (see sections 4.4, 4.8 and 5.1).Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Authorised	yes	no	no	2020-04-17
Pfizer Europe MA EEIG	Tygacil	tigecycline	EMEA/H/C/000644Tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections:, , , Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections, Complicated intra-abdominal infections (cIAI), , , Tygacil should be used only in situations where other alternative antibiotics are not suitable., , Consideration should be given to official guidance on the appropriate use of antibacterial agents. appropriate use of antibacterial agents.,	Authorised	no	no	no	2006-04-24

International Patents for TIGECYCLINE

Country	Patent Number	Title	Estimated Expiration
South Africa	200710151	Crystalline solid forms of tigecycline and methods of preparing same
World Intellectual Property Organization (WIPO)	2006128150
South Korea	101354093
Cyprus	1114504
Hong Kong	1113786	CRYSTALLINE SOLID FORMS OF TIGECYCLINE AND METHODS OF PREPARING SAME
Brazil	PI0610653	formas sólidas cristalinas de tigeciclina, composição compreendendo as mesmas, processo para preparação e uso das mesmas

Supplementary Protection Certificates for TIGECYCLINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0536515	300244	Netherlands		PRODUCT: TIGECYCLINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF METAALCOMPLEX, IN HET BIJZONDER TIGECYCLINE; FIRST REGISTRATION, DATE: EU/1/06/336/001, 20060424
0536515	SPC/GB06/033	United Kingdom		PRODUCT NAME: TIGECYCLINE
0536515	2006/030	Ireland		PRODUCT NAME: TIGECYCLINE OR A PHARMACOLOGICALLY ACCEPTABLE ORGANIC OR INORGANIC SALT OR METAL COMPLEX THEREOF; REGISTRATION NO/DATE: EU/1/06/336/001 20060424
0536515	06C0031	France		PRODUCT NAME: TIGECYCLINE; REGISTRATION NO/DATE: EU/01/06/336/001 20060424
0536515	C300244	Netherlands		PRODUCT: TIGECYCLINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF METAALCOMPLEX, IN HET BIJZONDER TIGECYCLINE; FIRST REGISTRATION, DATE: EU/1/06/336/001, 20060424

Market Dynamics and Financial Trajectory for Tigecycline

Last updated: July 27, 2025

Introduction

Tigecycline, a glycylcycline antibiotic derivative of tetracycline, has carved a niche within the global antimicrobial landscape. Approved by the U.S. Food and Drug Administration (FDA) in 2005, it is positioned mainly for complicated skin and soft tissue infections, intra-abdominal infections, and community-acquired pneumonia. As antimicrobial resistance escalates, the drug’s role, market potential, and financial outlook are undergoing significant transformation driven by regulatory trends, competitive landscape, and clinical needs.

This analysis explores the key market dynamics influencing tigecycline’s trajectory and forecasts its financial prospects amidst evolving healthcare demands.

Market Overview

Indications and Clinical Positioning

Tigecycline's spectrum includes multi-drug resistant organisms such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococci (VRE), and certain Gram-negative bacteria like Acinetobacter baumannii. Its broad-spectrum activity positions it as a critical agent in combating resistant pathogens, especially in hospital settings. However, its use remains constrained by safety concerns, including increased mortality signals noted in some clinical trials, limiting widespread adoption outside specific indications.

Market Penetration and Usage Trends

Post-approval, tigecycline experienced initial growth driven by its novel mechanism and activity against resistant infections. However, usage plateaued due to safety warnings, competition from other antibiotics, and limited approvals for broader indications. As of 2022, it held a niche but significant position in hospital formularies globally, especially in regions such as North America and Europe.

Market Drivers

Rising Antimicrobial Resistance

The global spike in multidrug-resistant infections underscores the urgent need for new or repurposed antibiotics like tigecycline. According to the CDC, resistant infections cause over 2.8 million illnesses annually in the U.S., with approximately 35,000 related deaths (2022). This critical need supports continued utilization and stimulates R&D investments in glycylcycline derivatives.

Regulatory and Policy Environment

Regulatory bodies have maintained tigecycline’s authorization for specific uses, with the FDA emphasizing careful risk-benefit analyses. International agencies, including EMA and WHO, recognize its importance against resistant pathogens, fostering environments conducive to cautious expansion of its use.

Hospital Antibiotic Stewardship

Infection control policies and antimicrobial stewardship programs (ASPs) impact tigecycline's market penetration. Efforts aim to optimize antibiotic use, which may restrict overt prescriptions but also consolidate its position for resistant infections where alternatives are ineffective.

Innovation and Pipeline Development

While no new versions of tigecycline have reached the commercial stage, ongoing research into glycylcyclines and combination therapies could influence future market dynamics. The potential introduction of next-generation derivatives may either cannibalize or expand tigecycline’s niche.

Market Challenges

Safety Profile and Regulatory Restrictions

Its association with increased all-cause mortality, particularly in ventilator-associated pneumonia studies, restricts broader indications (FDA, 2010). These safety concerns necessitate restricted prescribing, influencing revenue potential.

Pricing and Reimbursement Policies

Tigecycline’s high cost and limited reimbursement in some markets impede broad adoption. Payors increasingly favor value-based pricing related to clinical outcomes, placing financial pressure on manufacturers.

Competitive Landscape

Newer antibiotics targeting resistant bacteria, such as ceftazidime-avibactam and meropenem-vaborbactam, threaten tigecycline's market share. Pharmacoeconomic evaluations favor agents with improved safety profiles and narrower spectra, challenging its prominence.

Limited Indication Expansion

Restrictions to specific infections limit market scalability. Only a handful of conditions are officially approved, which constrains revenue streams as newer agents receive approvals for more extensive uses.

Financial Trajectory and Market Forecast

Historical Revenue Trends

Initially generating hundreds of millions annually, tigecycline’s revenues plateaued post-2010 due to safety advisories and market saturation. For instance, Pfizer (the original manufacturer) reported peak sales exceeding $400 million in 2009, which declined substantially in subsequent years.

Current Market Size

Estimates place the global tigecycline market at approximately $200–250 million in 2022, with North America constituting over 50% share due to high resistant infection prevalence and hospital infrastructure. Europe accounts for approximately 25%, with Asia-Pacific rapidly expanding owing to rising antimicrobial resistance and improving healthcare access.

Projected Growth and Future Trends

Analysts project a conservative compounded annual growth rate (CAGR) of 1–3% over the next five years. This modest growth reflects the stabilized niche status, safety constraints, and competitive pressures. However, enhanced global initiatives combating resistance and potential new formulations could invigorate revenue streams.

Impact of Emerging Developments

• Next-Generation Derivatives: Pipeline candidates with improved safety could reinvigorate interest, though none are currently in advanced clinical stages.
• Combination Therapies: Synergistic regimens pairing tigecycline with other agents could extend indications.
• Generic Entrances: Patent expirations in certain jurisdictions threaten price stability but may also increase accessibility.

Strategic Implications for Stakeholders

Pharmaceutical companies must weigh investments in tigecycline’s optimization versus other pipeline agents. For healthcare providers, balancing efficacy, safety, and stewardship is crucial in prescribing practices. Policymakers should foster environments that incentivize antibiotic innovation while ensuring responsible stewardship.

Conclusion

Tigecycline’s market is characterized by a stable, albeit limited, niche within the antimicrobial segment. Its trajectory is shaped by the growing threat of resistant pathogens and the ongoing need for effective agents. While safety concerns and market competition temper growth prospects, strategic positioning and pipeline innovations could alter its future financial landscape.

Key Takeaways

• Stable Niche Position: Tigecycline remains vital against resistant infections but faces market limitations due to safety profiles.
• Growing Resistance Concerns: Increased antimicrobial resistance sustains demand but also prompts competitive innovations.
• Regulatory and Stewardship Effects: Restrictions due to safety warnings and stewardship initiatives influence prescription patterns.
• Market Size and Growth: The global market is modest, with a slow CAGR of 1–3%, influenced by safety, competition, and indications.
• Future Outlook: Pipeline development and combination therapies may extend its relevance; however, safety and reimbursement remain pivotal factors.

FAQs

1. What are the main clinical indications for tigecycline?
Tigecycline is approved primarily for complicated skin and soft tissue infections, intra-abdominal infections, and community-acquired pneumonia, especially caused by multi-drug resistant bacteria.

2. How do safety concerns impact tigecycline’s market growth?
The association with increased mortality rates in certain studies led to boxed warnings, restricting use and reducing market expansion opportunities, especially outside approved indications.

3. What is the global market size for tigecycline, and what are its growth prospects?
The global market is estimated at around $200–250 million (2022). Growth is projected modestly at 1–3% CAGR over the coming five years due to safety, competition, and indication constraints.

4. Are there any developments in tigecycline’s pipeline that could influence its market?
Currently, no advanced-stage pipeline products directly derive from tigecycline. Future innovations, such as next-generation derivatives and combinations, could influence its market if safety and efficacy hurdles are addressed.

5. How does antimicrobial resistance influence tigecycline’s financial outlook?
The rise of resistant pathogens sustains demand for agents like tigecycline, supporting its niche role; however, it also accelerates competition from newer antibiotics and necessitates responsible stewardship.

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Sources:

[1] FDA. (2010). FDA Drug Safety Communication: Tigecycline (Tygacil) and increased mortality risk.
[2] CDC. (2022). Antimicrobial Resistance Data.
[3] MarketResearch.com. (2023). Global Antibiotics Market Analysis.
[4] Pfizer Inc. Annual Reports. (2010–2022).