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:	103
Clinical Trials:	16
Patent Applications:	4,763
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
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	AP	RX	Yes	Yes	10,588,975		Y
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	AP	RX	Yes	Yes	9,694,078		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/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 TYGACIL

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

Country	Patent Number	Title	Estimated Expiration
Cyprus	1114253
Poland	175957
Hungary	T63145
Hong Kong	1011348
Russian Federation	2007143160	КРИСТАЛЛИЧЕСКИЕ ФОРМЫ ТАЙГЕЦИКЛИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ
Taiwan	275616

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	SPC/GB06/033	United Kingdom		PRODUCT NAME: TIGECYCLINE
0536515	CA 2006 00027	Denmark
0536515	C00536515/01	Switzerland		FORMER OWNER: WYETH HOLDINGS CORPORATION, US
0536515	0690028-6	Sweden		PRODUCT NAME: TIGECYKLIN
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

TYGACIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TYGACIL (Tigecycline)

Introduction to TYGACIL (Tigecycline)

TYGACIL, known generically as tigecycline, is a broad-spectrum antibiotic developed by Pfizer. It is used to treat serious bacterial infections, including urinary tract infections, acne, gonorrhea, and chlamydia. Tigecycline is particularly valuable for treating infections caused by resistant gram-positive and gram-negative bacteria, especially in patients with a history of penicillin allergy or antimicrobial-related toxicities[1][3][5].

Market Drivers

Increasing Prevalence of Bacterial Infections

The global tigecycline products market is driven by the increasing prevalence of bacterial infections such as gonorrhea and chlamydia. For instance, in the U.S., there were 555,608 reported cases of gonorrhea in 2017, and 1,598,354 cases of chlamydia trachomatis were reported in 2016. This rising incidence of bacterial infections has led pharmaceutical companies to focus on launching products for their treatment, thereby increasing demand for tigecycline[1].

Generic Versions and Affordability

The launch of generic versions of TYGACIL has also boosted the market. Companies like Sandoz Inc. and Fresenius Kabi have introduced generic versions of tigecycline at lower prices, making the drug more affordable and accessible to a wider patient population. This has contributed significantly to the growth of the global tigecycline products market[1].

Market Restraints

Side Effects and Mortality Risks

Despite its efficacy, tigecycline is associated with several side effects, including lower back or side pain, painful or difficult urination, vision or hearing problems, and fever or chills. More critically, there is an increased risk of all-cause mortality in patients receiving tigecycline, particularly for hospital-acquired or ventilator-associated pneumonia. This has led to restrictions on its use and warnings in its labeling[1][5].

Cost and Patient Preference

The cost of tigecycline is another significant restraint. The drug is administered via intravenous infusion, which is more expensive compared to oral antibiotics like amoxicillin. For example, the cost of a 500 mg amoxicillin oral tablet is approximately $23.99, while the cost of a tigecycline injection is around $79.22. Patients often prefer oral tablets due to their cost-effectiveness, which can reduce the demand for tigecycline[1].

COVID-19 Impact

The COVID-19 pandemic has had a negative impact on the global tigecycline products market. Pharmaceutical companies faced challenges such as regulatory revisions, changes in demand, delays in generic medicine approvals, disruptions in supply chains, and restrictions on product exportation due to lockdown policies. These factors have hindered the growth of the market during the pandemic period[1].

Regional Analysis

North America

In North America, the demand for tigecycline is increasing due to the high prevalence of chlamydia and gonorrhea. For instance, in the U.S., there were 1,598,354 reported cases of chlamydia trachomatis in 2016. Pharmaceutical companies are focusing on product launches in this region to address these bacterial infections[1].

Europe

Europe also faces a significant burden of chlamydia and gonorrhea, driving the demand for tigecycline. In England, over 44,500 people were diagnosed with gonorrhea in 2017 among those under 25 years old. Companies like Accord Healthcare have received marketing authorization for tigecycline injection in Europe, further boosting the market[1].

Asia-Pacific and Other Regions

The Asia-Pacific region and other parts of the world are also seeing growth in the tigecycline market due to increasing bacterial infection rates and the availability of generic versions. Companies like Zhejiang Hisun Pharmaceutical and Nanjing Hicin Pharmaceutical are key players in these regions[3][4].

Financial Trajectory

Market Size and Forecast

The global tigecycline drug market is expected to grow at a CAGR of 3 to 5% from its estimated valuation by 2031. The market size is categorized based on application (hospital, drug store), product type (TYGACIL, generic), and geographical regions. The forecast period from 2024 to 2031 indicates a steady growth trajectory driven by increasing demand and the launch of generic versions[3][4].

Key Players and Revenue

Key players in the global tigecycline products market include Pfizer, Sandoz, Apotex, Fresenius Kabi, Accord Healthcare, and others. These companies have been instrumental in driving the market through product launches and strategic expansions. For example, Pfizer's overall revenue has seen significant growth, though the specific revenue from TYGACIL is not isolated in their reports. However, the launch of generic versions by other companies has contributed to the market's financial health[1][2][3].

Competitive Landscape

The competitive landscape of the tigecycline market is dynamic, with multiple players vying for market share. Pfizer, as the original developer of TYGACIL, holds a significant position, but the entry of generic versions from companies like Sandoz, Apotex, and Fresenius Kabi has increased competition. Other players such as Accord Healthcare and Amneal Pharmaceuticals also play crucial roles in the market[1][3][4].

Regulatory Environment

The regulatory environment for tigecycline is stringent due to its associated risks. The FDA has updated the labeling of tigecycline to include warnings about the increased risk of all-cause mortality. Regulatory bodies in different regions also monitor the use of tigecycline closely, ensuring it is used only for FDA-approved indications and with appropriate caution[1][5].

Future Outlook

The future outlook for the tigecycline market is mixed. While the increasing prevalence of bacterial infections and the availability of generic versions are positive drivers, the side effects and mortality risks associated with tigecycline pose significant challenges. The market is expected to grow steadily, but it will be crucial for pharmaceutical companies to address the safety concerns and improve the drug's efficacy to maintain market traction.

Key Takeaways

• Increasing Demand: The market is driven by the increasing prevalence of bacterial infections such as gonorrhea and chlamydia.
• Generic Versions: The launch of generic versions has made tigecycline more affordable and accessible.
• Side Effects and Mortality Risks: The drug is associated with significant side effects and an increased risk of all-cause mortality.
• Regional Growth: North America and Europe are key regions driving the market due to high infection rates.
• Financial Growth: The market is expected to grow at a CAGR of 3 to 5% from 2024 to 2031.

FAQs

What is TYGACIL (tigecycline) used for?

TYGACIL (tigecycline) is used to treat serious bacterial infections such as urinary tract infections, acne, gonorrhea, and chlamydia, particularly in patients with resistant gram-positive and gram-negative infections.

What are the side effects of tigecycline?

Tigecycline is associated with side effects including lower back or side pain, painful or difficult urination, vision or hearing problems, fever or chills, and an increased risk of all-cause mortality.

How is tigecycline administered?

Tigecycline is administered through intravenous infusion over 30 to 60 minutes, with an initial dose of 100 mg followed by 50 mg every 12 hours.

What is the impact of COVID-19 on the tigecycline market?

The COVID-19 pandemic has negatively impacted the tigecycline market due to regulatory revisions, changes in demand, delays in generic medicine approvals, and disruptions in supply chains.

Who are the key players in the tigecycline market?

Key players include Pfizer, Sandoz, Apotex, Fresenius Kabi, Accord Healthcare, Amneal Pharmaceuticals, and others.

Sources

1. Coherent Market Insights: Tigecycline Products Market Size, Trends And Forecast To 2028.
2. Pfizer: PFIZER REPORTS FOURTH-QUARTER AND FULL-YEAR 2021.
3. Market Research Intellect: Global Tigecycline Drug Market Size And Forcast.
4. Market Research Intellect: Tigecycline drug market size and forecast Size, Trends and Forecast.
5. University of Nebraska Medical Center: Tigecycline (Tygacil).