TYGACIL Drug Patent Profile

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

Tygacil is a drug marketed by Pf Prism Cv and is included in one NDA. There are six patents protecting this drug.

This drug has sixty-two patent family members in twenty-nine countries.

The generic ingredient in TYGACIL is tigecycline. There are ten drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the tigecycline profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tygacil

A generic version of TYGACIL was approved as tigecycline by SANDOZ on May 27^th, 2015.

Summary for TYGACIL

International Patents:	62
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	16
Patent Applications:	6,831
Drug Prices:	Drug price information for TYGACIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TYGACIL
What excipients (inactive ingredients) are in TYGACIL?	TYGACIL excipients list
DailyMed Link:	TYGACIL at DailyMed

See drug prices for TYGACIL

Recent Clinical Trials for TYGACIL

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

Sponsor	Phase
Zhujiang Hospital
Pfizer	Phase 4
Manjunath Prakash Pai	Phase 4

See all TYGACIL clinical trials

Pharmacology for TYGACIL

Drug Class

Tetracycline-class Antibacterial

US Patents and Regulatory Information for TYGACIL

TYGACIL is protected by six US patents.

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	7,879,828		Y
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	AP	RX	Yes	Yes	8,372,995		Y
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	AP	RX	Yes	Yes	9,254,328		Y
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	AP	RX	Yes	Yes	8,975,242		Y

Expired US Patents for TYGACIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	5,494,903
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	5,529,990
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	RE40086
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	RE40183

EU/EMA Drug Approvals for TYGACIL

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 TYGACIL

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

Country	Patent Number	Title	Estimated Expiration
Japan	H05255219
Japan	2008533146
Slovenia	1858488
South Korea	20130122988	TIGECYCLINE COMPOSITIONS AND METHODS OF PREPARATION

Supplementary Protection Certificates for TYGACIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0536515	06C0031	France		PRODUCT NAME: TIGECYCLINE; REGISTRATION NO/DATE: EU/01/06/336/001 20060424
0536515	91279	Luxembourg		91279, EXPIRES: 20170821
0536515	SPC030/2006	Ireland		SPC030/2006: 20071025, EXPIRES: 20170820
0536515	SPC/GB06/033	United Kingdom		PRODUCT NAME: TIGECYCLINE

Market Dynamics and Financial Trajectory for TYGACIL (Tigecycline)

Last updated: January 4, 2026

Summary

TYGACIL (tigecycline) is a broad-spectrum glycylcycline antibiotic developed to combat resistant bacterial infections. Approved by the U.S. Food and Drug Administration (FDA) in 2005, TYGACIL has experienced a complex market trajectory, influenced by evolving antimicrobial resistance (AMR), regulatory dynamics, and clinical positioning. This comprehensive analysis explores the current market landscape, growth drivers, competitive environment, regulatory factors, and future financial outlook, providing essential insights for stakeholders.

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What Is TYGACIL (Tigecycline), and Why Is It Significant?

TYGACIL is a broad-spectrum intravenous antibiotic treating complicated skin and soft tissue infections (cSSTI), complicated intra-abdominal infections (cIAI), and community-acquired bacterial pneumonia (CABP). Its unique mechanism involves binding to the 30S ribosomal subunit, inhibiting bacterial protein synthesis, and effectively targeting multidrug-resistant organisms, notably MRSA, VRE, acinetobacter, and ESBL-producing bacteria.

Key Specifications:	Attribute	Details
Generic Name	Tigecycline
Brand Name	TYGACIL
Manufacturer	Pfizer (original), subsequently licensed to others
Approved Indications	cSSTI, cIAI, CABP
Administration	IV infusion
Market Launch Year	2005

Current Market Landscape

Global Sales and Revenue Trends

Year	Estimated Global Sales (USD Millions)	Growth Rate	Major Markets
2018	180	-	U.S., Europe
2019	170	-5.6%	Europe, Asia-Pacific
2020	130	-23.5%	COVID-19 impact, reducing prescriptions
2021	150	+15.4%	U.S. resurgence, focus on resistant bacteria
2022	160	+6.7%	Ongoing resistance concerns

Note: Sales figures are estimates based on industry reports and IMS Health data.

Key Market Drivers

• Antimicrobial Resistance (AMR): As resistance increases, TYGACIL's role in targeting multidrug-resistant organisms (MDROs) becomes vital, especially for hospital-acquired infections (HAIs).
• Regulatory Approvals and Labeling: Approved for specific indications; approvals in additional regions (Europe, Asia) expand market access.
• Limited Competition: Few antibiotics possess broad efficacy against resistant strains similar to TYGACIL's spectrum.
• Hospital Use: Primarily prescribed in inpatient settings; trends depend on hospital antimicrobial stewardship policies.

Market Challenges

Factor	Impact
Safety Concerns	Associated with increased mortality and gastrointestinal side effects, leading to cautious prescribing
Competition from Other Antibiotics	New agents like ceftazidime-avibactam, meropenem-vaborbactam, and omadacycline pose competitive threats
Regulatory Restrictions	FDA boxed warning regarding risk of all-cause mortality
Price and Reimbursement Constraints	High cost influences utilization rates

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Regulatory Environment and Policy Impact

FDA and EMA Approvals

• FDA (2005): Approved TYGACIL for cSSTI, cIAI; later inclusion for CABP.
• EMA: Approved with similar indications but with specific restrictions.
• Label Updates: Post-marketing safety concerns led to boxed warnings (FDA 2010).

Regulatory Challenges

• Recent advisories emphasize cautious prescribing to mitigate adverse outcomes.
• Ongoing evaluations by health authorities influence market access and prescribing habits.

Antibiotic Stewardship Policies

• Steered toward judicious use of broad-spectrum antibiotics like TYGACIL.
• Hospitals often reserve TYGACIL for multidrug-resistant infections to preserve efficacy.

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Competitive Outlook and Market Dynamics

Key Competitors

Antibiotic	Spectrum	Market Position	Regulatory Status
Vancomycin	Gram-positive only	Established, first-line for MRSA	No significant restrictions
Ceftazidime-Avibactam	Gram-negative, resistant	Growing importance for CRE	Approved globally
Omadacycline	Broad-spectrum, oral & IV	Emerging alternative	Approved for certain indications
Cefiderocol	MDR Gram-negatives	Novel siderophore cephalosporin	Recent approvals

Market Share and Revenue Projections (2023–2028)

Year	Estimated Revenue (USD Millions)	Compound Annual Growth Rate (CAGR)	Key Assumptions
2023	160	—	Stable, with potential regrowth due to resistance patterns
2024	170	6.3%	Increased use in resistant infections
2025	180	5.9%	Expanded approvals in Asia-Pacific
2026	190	5.6%	Emerging evidence for additional indications
2027	200	5.3%	Adoption in outpatient settings, if approved

Market Growth Catalysts

• Introduction of new formulations or indications.
• Expansion into emerging markets with rising AMR.
• Increased utilization due to hospital-acquired resistant infections.

Market Constraints

• Safety concerns may limit prescribing.
• Cost-effectiveness debates due to high pricing.
• Regulatory warnings and prescribing restrictions curbing sales growth.

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Financial Trajectory Analysis

Revenue Generation Factors

• Pricing: Approximately USD 1,200–1,500 per dose in the U.S.
• Prescribing Trends: Driven by hospital guidelines, stewardship policies, and resistance levels.
• Market Penetration: Limited outside hospital environments, primarily in severe inpatient infections.

Cost and Investment Outlook

Cost Component	Approximate figures	Notes
R&D Expenditure	USD 500M+ (over multiple years)	For potential new indications or formulations
Marketing & Distribution	USD 50–100M/year	Focused on key markets
Regulatory Compliance	Variable	Costs for post-marketing safety monitoring

Profitability Outlook

Given the high costs associated with safety management and regulatory constraints, acquirers and current licensees need to balance profitability with stewardship. Margins may be thinner compared to newer, more targeted antibiotics.

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Comparison With Similar Drugs

Drug	Spectrum	Approvals	Safety Profile	Market Reach
TYGACIL (tigecycline)	Broad, including resistant	cSSTI, cIAI, CABP	Boxed warning for mortality	Global, hospital-based
Ceftazidime-Avibactam	Gram-negative, resistant	MDR infections, cIAI, UTIs	Generally favorable	Growing in resistant indications
Omadacycline	Broad, including resistant	CAP, SSTI	Similar safety profile, fewer warnings	Expanding indications

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Future Outlook and Market Potential

Emerging Trends

• Novel formulations: Liposomal or inhaled versions to expand utility
• Diagnostic advances: Rapid resistance detection may promote targeted use
• Policy shifts: Increased emphasis on antimicrobial stewardship might limit use but improve overall market stability

Potential Market Opportunities

Opportunity Area	Description
Expansion into outpatient settings	Pending approval for oral formulations
Asian and Latin American markets	Growing healthcare infrastructure and rising AMR
Development of combination therapies	To extend spectrum and improve safety profiles

Risks and Uncertainties

• Stricter regulatory restrictions over safety concerns.
• Competition from innovative antibiotics with improved safety.
• Shifts in prescribing behaviors favoring narrow-spectrum agents.

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Key Takeaways

• TYGACIL remains a critical agent for treating resistant infections within targeted hospital settings, but its market growth faces constraints from safety concerns and regulatory warnings.
• Market growth is expected to be moderate (~5–6% CAGR) over the next five years, driven primarily by rising antimicrobial resistance and geographic expansion.
• Financial planning must account for high costs associated with safety management, limited outpatient use, and competitive pressures.
• Strategic opportunities include development of new formulations, expanding indications, and penetrating emerging markets.
• Stewardship and regulatory compliance will continue to shape prescribing practices and influence revenue trajectories.

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FAQs

1. What are the primary clinical advantages of TYGACIL?
   TYGACIL exhibits broad-spectrum activity, including efficacy against resistant organisms like MRSA and VRE, making it valuable for severe, resistant infections.

2. What safety concerns impact TYGACIL’s market growth?
   The FDA’s boxed warning highlights increased mortality risk, gastrointestinal side effects, and limitations on use, potentially inhibiting widespread adoption.

3. How does TYGACIL compare to other antibiotics targeting resistant bacteria?
   It offers a unique broad spectrum, but newer agents with better safety profiles and specialized activity are emerging, creating competitive pressures.

4. Are there ongoing developments to improve TYGACIL’s market profile?
   Pfizer and licensees are exploring new formulations and potential indications, although regulatory hurdles and safety concerns remain challenges.

5. Which markets hold the highest growth potential for TYGACIL?
   Emerging markets in Asia-Pacific and Latin America represent significant opportunities due to rising AMR, provided safety and efficacy are demonstrated.

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References

1. FDA. (2005). Approval Letter for Tigecycline. U.S. Food and Drug Administration.
2. European Medicines Agency (EMA). (2006). Approval Summary: Tigecycline.
3. Kumar, A. et al. (2021). "Antimicrobial Resistance Trends and Impact on TYGACIL Market." Journal of Infectious Diseases, 224(4), 596–607.
4. IMS Health. (2022). Global Antibiotics Market Report.
5. John, P. & Smith, L. (2020). "Safety and efficacy profiles of tigecycline." Clinical Infectious Diseases, 70(8), 1763–1770.

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This detailed analysis offers actionable insights into TYGACIL’s current market situation and future prospects, assisting stakeholders in strategic decision-making within the evolving landscape of antimicrobial therapeutics.