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
Manjunath Prakash Pai	Phase 4
Pfizer	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	RE40183
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	5,529,990

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
Denmark	1858488
Norway	923857
Australia	2006251954	Crystalline solid forms of tigecycline and methods of preparing same
Peru	20070024	FORMAS SOLIDAS CRISTALINAS DE TIGECICLINA Y METODOS PARA PREPARAR LAS MISMAS

Supplementary Protection Certificates for TYGACIL

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	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
0536515	C00536515/01	Switzerland		FORMER OWNER: WYETH HOLDINGS CORPORATION, US

Market Dynamics and Financial Trajectory for TYGACIL (Tigecycline)

Last updated: July 28, 2025

Introduction
TYGACIL (tigecycline), developed by Pfizer, is a broad-spectrum glycylcycline antibiotic approved primarily for complicated skin and intra-abdominal infections, as well as complicated pneumonia. Since its FDA approval in 2005, TYGACIL has encountered dynamic shifts in market acceptance influenced by regulatory, clinical, and competitive factors. Analyzing its market dynamics and financial trajectory provides insights into its evolving role within antimicrobial therapy and Pfizer’s strategic positioning.

Pharmacological Profile and Clinical Positioning
TYGACIL’s unique mechanism of action—binding reversibly to the 30S ribosomal subunit—confers activity against resistant pathogens, including MRSA, VRE, and certain Gram-negative bacteria. Its broad activity initially positioned it as a vital option amid rising antimicrobial resistance.

However, concerns arise from its safety profile, particularly the elevated mortality signal observed in clinical trials, which prompted labeling warnings and cautious prescribing practices. The drug's complex administration—intravenous, with limited oral options—further constrains its use.

Market Dynamics
The antibiotic market is characterized by high prescribing pressures, regulatory scrutiny, and antimicrobial stewardship efforts. TYGACIL’s market trajectory reflects these influences:

1. Regulatory and Safety Challenges
   FDA’s boxed warning for increased mortality risk has limited aggressive use and affected prescriber confidence. This regulatory caution translates into slower adoption rates compared to other antibiotics without such warnings.

2. Clinical Competition
   TYGACIL faces stiff competition from established antibiotics like vancomycin, carbapenems, and newer agents such as ceftazidime-avibactam. These compete on efficacy, safety, and ease of use, impacting TYGACIL’s market share.

3. Antimicrobial Stewardship Programs (ASPs)
   Hospital ASPs prioritize narrow-spectrum and cost-effective agents, reducing broad-spectrum antibiotic use like TYGACIL in favor of targeted therapies, constraining its utilization.

4. Emergence of Resistance
   Resistance to tigecycline and associated drugs poses an ongoing threat, potentially diminishing efficacy and market appeal. While tigecycline maintains activity against some multi-drug resistant strains, reliance on it is tempered by emerging resistance.

5. Market Penetration and Reimbursement
   Despite initial niche markets, TYGACIL’s adoption remains limited. Reimbursement challenges—due to safety concerns and comparative effectiveness—further slow growth trajectories.

Financial Trajectory
Pfizer’s revenues from TYGACIL have historically reflected modest performance within its broader antimicrobial portfolio:

• Revenue Trends
  Post-approval, TYGACIL experienced steady initial sales, boosted by the unmet clinical need for resistant infections. However, sales plateaued, with recent reports indicating declining trends attributable to safety concerns and market competition.

• Pricing Strategies
  TYGACIL’s pricing remains premium relative to traditional antibiotics, justified by its broad-spectrum activity. Nevertheless, payers’ scrutiny, driven by value-based care and safety profile concerns, has pressured reimbursement rates.

• Research & Development and Lifecycle Management
  Pfizer has not announced significant pipeline development explicitly aimed at TYGACIL, instead focusing on next-generation antibiotics. The limited lifecycle management initiatives suggest a strategic shift away from heavily investing in TYGACIL’s growth.

• Market Exit or Lifecycle Extension
  Industry analysts speculate that, absent repositioning or new clinical data, Pfizer may gradually phase out TYGACIL in favor of newer, more targeted agents. Alternatively, label expansions or new formulations could extend its relevance, but no firm plans are publicly known.

Emerging Trends and Opportunities
The increasing prevalence of multi-drug resistant infections underscores the ongoing need for efficacious antibiotics like tigecycline. Nonetheless, the drug’s safety profile and market competition necessitate strategic repositioning:

• Innovation in Delivery
  Development of oral formulations or combination therapies could enhance utility and prescribing flexibility.

• New Indications
  Expanding indications, such as using TYGACIL for emerging resistant pathogens, might reinvigorate sales, provided safety concerns are adequately addressed.

• Regulatory Pathways
  Securing approval for previously unmet needs or new bacterial strains via accelerated pathways could improve financial outcomes.

Conclusion
The financial trajectory of TYGACIL is characterized by initial optimism tempered by regulatory caution and competitive pressures. Market dynamics reveal a constrained but potentially stabilizing niche for the drug within the complex landscape of antimicrobial resistance. Pfizer’s strategic decisions will likely shape TYGACIL’s future—whether as a declining asset or as part of a broader antimicrobial stewardship strategy.

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Key Takeaways

• TYGACIL’s clinical utility is challenged by safety signals and regulatory warnings, limiting its market penetration.
• Competitive drugs with better safety profiles and narrower spectrums have constrained TYGACIL’s growth.
• Reimbursement and stewardship policies favor targeted therapy, eroding TYGACIL’s market share.
• The drug’s financial performance reflects modest revenues, with declining trends forecasted absent repositioning.
• Future opportunities hinge on innovative formulations, expanded indications, and addressing safety concerns to regain clinical and market relevance.

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FAQs

1. What are the primary factors affecting TYGACIL’s market share?
Regulatory safety warnings, risk of mortality, competition from other antibiotics, and antimicrobial stewardship programs limiting broad-spectrum antibiotic use are key factors.

2. Could TYGACIL’s safety profile improve its market vitality?
Potentially. Addressing safety concerns or obtaining new clinical data demonstrating improved risk-benefit ratios could enhance prescriber confidence and expand indications.

3. How does resistance impact TYGACIL’s future prospects?
Emerging resistance may limit its efficacy, demanding continual surveillance and potential combination strategies to sustain relevance.

4. Are there new clinical indications that could revive TYGACIL’s market?
Research into new bacterial strains or resistant infections might offer opportunities, especially if safety issues are mitigated.

5. What strategies could Pfizer employ to optimize TYGACIL’s financial trajectory?
Innovative formulations, expanding approved uses, and engaging in lifecycle management initiatives could enhance value and market presence.

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Sources:

1. FDA. Tygacil (tigecycline) Approval and Labeling Information.
2. Pfizer. Product Literature and Safety Communications.
3. Industry Reports. Antibiotics Market Analysis, 2022-2023.
4. Clinical Trial Data. Mortality Signal in TYGACIL Studies.
5. Market Dynamics Analyses. Antimicrobial Resistance Impact on Prescription Trends.