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:	103
Clinical Trials:	59
Patent Applications:	6,904
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
Tata Memorial Centre	Phase 2
Zhengzhou Sixth People's Hospital, China	Phase 4
No.85 Hospital, Changning, Shanghai, China	Phase 4

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
Eugia Pharma	TIGECYCLINE	tigecycline	POWDER;INTRAVENOUS	206335-001	Jun 11, 2019	AP	RX	No	No
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	AP	RX	Yes	Yes			Y
Fresenius Kabi Usa	TIGECYCLINE	tigecycline	POWDER;INTRAVENOUS	205645-001	Dec 1, 2016	AP	RX	Yes	Yes
Accord Hlthcare Inc	TIGECYCLINE	tigecycline	POWDER;INTRAVENOUS	208744-001	Jan 18, 2018		DISCN	No	No
Sandoz	TIGECYCLINE	tigecycline	POWDER;INTRAVENOUS	091620-001	May 27, 2015	AP	RX	No	No

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/005114 Tygecycline 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/000644 Tygacil 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
Mexico	2007014735	FORMAS CRISTALINAS DE TIGECICLINA Y METODOS PARA PREPARAR LAS MISMAS. (CRYSTALLINE SOLID FORMS OF TIGECYCLINE AND METHODS OF PREPARING SAME.)
Denmark	1890996
Japan	2013100354	CRYSTALLINE SOLID FORMS OF TIGECYCLINE AND METHOD OF PREPARING THE SAME
Taiwan	200720232	Crystalline solid forms of tigecycline and methods of preparing same
European Patent Office	1858488	COMPOSITIONS DE TIGECYCLINE ET LEURS METHODES DE PREPARATION (TIGECYCLINE COMPOSITIONS AND METHODS OF PREPARATION)
Israel	185924	תכשירים טיגיציקלנים ושיטות להכנה (Tigecycline compositions and methods of preparation)

Supplementary Protection Certificates for TIGECYCLINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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	06C0031	France		PRODUCT NAME: TIGECYCLINE; REGISTRATION NO/DATE: EU/01/06/336/001 20060424

TIGECYCLINE Market Analysis and Financial Projection Experimental

Tigecycline Market Dynamics and Financial Trajectory

Market Overview

The Tigecycline market is a significant segment of the global pharmaceutical industry, driven primarily by its efficacy in treating complex bacterial infections. Tigecycline, a glycylcycline antibiotic, has gained prominence for its broad-spectrum activity against pathogens, including those resistant to conventional antibiotics[1].

Current Market Size and Growth Projections

As of recent estimates, the Tigecycline market was valued at approximately USD 1487.1 million in 2023. It is forecasted to reach a readjusted size of USD 4498.2 million by 2030, with a Compound Annual Growth Rate (CAGR) of around 24.04% during the forecast period[1][3].

COVID-19 Impact

The COVID-19 pandemic had a substantial impact on the Tigecycline market. Initially, the focus on COVID-19 led to delayed diagnosis and treatment of other infectious diseases, resulting in a temporary decline in Tigecycline demand. However, as healthcare systems adjusted to the post-pandemic scenario, the importance of antimicrobial stewardship and the judicious use of antibiotics like Tigecycline became more evident, leading to a gradual recovery in the market[1].

Driving Factors

Several key factors are driving the growth of the Tigecycline market:

Rising Antibiotic Resistance

The increasing prevalence of antibiotic-resistant infections has created a critical need for effective antibiotics like Tigecycline, capable of combating resistant pathogens[1].

Hospital-Acquired Infections

Tigecycline plays a crucial role in managing hospital-acquired infections, a growing concern within healthcare facilities[1].

Infectious Disease Outbreaks

The occurrence of infectious disease outbreaks underscores the importance of having effective antibiotics like Tigecycline available in the medical armamentarium[1].

Surgical Prophylaxis

Tigecycline is used for surgical prophylaxis in high-risk surgical procedures, further boosting its demand[1].

Off-Label Use

The off-label use of Tigecycline in treating various infections beyond its approved indications is a significant driving factor, especially in regions with limited antibiotic options[1].

Market Opportunities

The Tigecycline market presents several opportunities for growth:

Escalating Antibiotic Resistance

The rising threat of antibiotic resistance is expected to increase the demand for effective antibiotics like Tigecycline[1].

Expanding Clinical Indications

Ongoing research into Tigecycline's efficacy in treating a broader range of infections, such as ventilator-associated pneumonia and complicated intra-abdominal infections, can unlock new market segments[1].

Global Healthcare Infrastructure Development

Developing regions are investing in healthcare infrastructure, creating opportunities for Tigecycline adoption in areas with previously limited access[1].

Awareness and Education

Increased awareness and education among healthcare professionals about antibiotic resistance and the appropriate use of antibiotics can drive the demand for Tigecycline[1].

Regional Market Dynamics

The global Tigecycline market is dominated by the Asia-Pacific region, primarily due to significant adoption in the pharmaceutical industry. This region is expected to continue its dominance during the forecast period. The European and North American regions are also anticipated to witness healthy growth rates[4].

Challenges and Limitations

Despite its growth potential, the Tigecycline market faces several challenges:

Mortality Risk

Clinical trials have shown a higher all-cause mortality rate in patients treated with Tigecycline compared to those treated with comparator drugs. This has led to recommendations that Tigecycline should be reserved for use when alternative treatments are not suitable[2].

Adverse Reactions

Tigecycline is associated with several adverse reactions, including permanent discoloration of deciduous teeth, reversible inhibition of bone growth, anaphylactic reactions, and significant hepatic dysfunction. These side effects necessitate careful patient monitoring and risk assessment[2].

Regulatory Considerations

Tigecycline is not indicated for certain infections such as diabetic foot infection or hospital-acquired pneumonia, including ventilator-associated pneumonia, which limits its use in these areas[2].

Financial Trajectory

The financial trajectory of the Tigecycline market is promising, with significant growth projected over the next several years. Here are some key financial highlights:

• Current Market Size: Approximately USD 1487.1 million in 2023[3].
• Projected Market Size: Forecasted to reach USD 4498.2 million by 2030[3].
• CAGR: Around 24.04% during the forecast period[1][3].

Key Players and Market Competition

The Tigecycline market is characterized by the presence of several key players, although the market is not highly fragmented. Companies such as Pfizer, which markets Tigecycline under the brand name TYGACIL, play a significant role in the market[4].

Innovations and Formulations

Research into new formulations of Tigecycline aims to enhance its stability and efficacy. For instance, a novel formulation has shown improved stability after reconstitution and maintained its antimicrobial properties[5].

Key Takeaways

• The Tigecycline market is driven by the rising need for effective antibiotics against resistant infections.
• The market is expected to grow significantly, with a CAGR of around 24.04% until 2030.
• Regional growth is led by the Asia-Pacific region, with Europe and North America also showing promising growth.
• Despite growth potential, the market faces challenges such as higher mortality rates and adverse reactions associated with Tigecycline.
• Ongoing research into new formulations and expanding clinical indications are key opportunities for market growth.

Frequently Asked Questions (FAQs)

What is Tigecycline and how is it used?

Tigecycline is a glycylcycline antibiotic used to treat complex bacterial infections, including those resistant to conventional antibiotics. It is indicated for patients 18 years of age and older for various infections such as complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia[2].

What are the main driving factors for the Tigecycline market?

The main driving factors include the rising prevalence of antibiotic-resistant infections, the need for effective treatments for hospital-acquired infections, infectious disease outbreaks, surgical prophylaxis, and off-label use in regions with limited antibiotic options[1].

What are the potential challenges associated with Tigecycline?

Tigecycline is associated with higher all-cause mortality rates compared to comparator drugs, adverse reactions such as anaphylactic reactions and hepatic dysfunction, and limitations in its use for certain infections like diabetic foot infection and hospital-acquired pneumonia[2].

Which regions are expected to dominate the Tigecycline market?

The Asia-Pacific region currently dominates the Tigecycline market and is expected to continue its dominance during the forecast period. Europe and North America are also anticipated to witness healthy growth rates[4].

What are the future growth prospects for the Tigecycline market?

The Tigecycline market is projected to grow significantly, reaching a market size of approximately USD 4498.2 million by 2030, with a CAGR of around 24.04% during the forecast period. Expanding clinical indications, global healthcare infrastructure development, and increasing awareness about antibiotic resistance are key factors driving this growth[1][3].

Cited Sources:

1. Global Growth Insights - Tigecycline Market Size & Share | 2031 - Global Growth Insights
2. Pfizer Medical Information - TYGACIL® (tigecycline) Patient information - US
3. News Channel Nebraska - Tigecycline Market Analysis 2024: Industry Revenue, Future Demand and Regional Growth Prospects to 2032
4. IndustryARC - Tigecycline Market - Forecast(2024 - 2030) - IndustryARC
5. PLOS ONE - A Novel Formulation of Tigecycline Has Enhanced Stability ... - PLOS ONE