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. Six 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:	6,152
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	9,254,328
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	10,588,975
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	RE40183
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	9,694,078
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	5,494,903

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
Argentina	053827	COMPOSICIONES DE TIGECICLINA Y METODOS DE PREPARACION
Argentina	109500	COMPOSICIONES DE TIGECICLINA Y MÉTODOS DE PREPARACIÓN
Australia	2006223226	Tigecycline compositions and methods of preparation
Brazil	PI0608464	composições de tigeciclina e processos de preparação
Canada	2602089	COMPOSITIONS DE TIGECYCLINE ET LEURS METHODES DE PREPARATION (TIGECYCLINE COMPOSITIONS AND METHODS OF PREPARATION)
China	101132775	Tigecycline compositons and methods of preparation
China	102512429	Tigecycline compositions and methods of preparation

Supplementary Protection Certificates for TYGACIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0536515	CA 2006 00027	Denmark
0536515	91279	Luxembourg		91279, EXPIRES: 20170821
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	SPC/GB06/033	United Kingdom		PRODUCT NAME: TIGECYCLINE
0536515	SPC030/2006	Ireland		SPC030/2006: 20071025, EXPIRES: 20170820
0536515	C00536515/01	Switzerland		FORMER OWNER: WYETH HOLDINGS CORPORATION, US

Last updated: June 10, 2026

TYGACIL (tigecycline) Market Dynamics and Financial Trajectory (Sales, Share, and Patent-Driven Risk)

Executive summary: TYGACIL (tigecycline) entered a hospital-centric segment with constrained substitution and intense formulary resistance from rapid-loading parenteral competitors. After peak adoption, annual global sales shifted from growth to erosion as broader formularies, antibiotic stewardship, and competition from newer cephalosporin, carbapenem, and beta-lactam/beta-lactamase inhibitor classes reduced discretionary use outside the narrow approved indications. Near-term economics are shaped less by life-cycle renewals and more by (1) exclusivity and patent estate timing for U.S. and major ex-U.S. markets, (2) generic or authorized-competitor penetration risk at brand-to-generic switching points, and (3) hospital procurement dynamics tied to unit pricing, inventory contracting, and outcomes evidence for “resistant infection” programs.

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How has TYGACIL’s sales trajectory changed since launch?

Quick read (directional): TYGACIL’s commercial pattern is typical of late-stage antibiotics: strong early uptake tied to broad “resistant infection” demand, followed by declining share as stewardship tightened and competing agents took formulary positions.

Global and U.S. sales: what usually drives up or down

Key financial swing factors for tigecycline include:

• Formulary placement vs. restriction: Tigecycline is frequently restricted to specific infection types or resistance contexts. Restriction increases volatility because switching a hospital’s restricted policy requires committee action.
• DOSING and administration logistics: Tigecycline dosing is weight-based and regimen-consistent, but procurement decisions often hinge on total cost of therapy and administration time.
• Stewardship and outcomes performance: Antibiotic stewardship programs target broader-spectrum agents and reduce empiric use where alternative pathways exist. Tigecycline’s use patterns are heavily influenced by local guidance.
• Competitive class substitution: Competition typically comes from agents positioned for similar categories (complicated intra-abdominal infections, complicated skin and skin structure infections, hospital-acquired/ventilator-associated bacterial pneumonia) with procurement leverage.

Where the brand faces unit-price pressure

Even when a hospital stays “brand-loyal” on paper, financial pressure shows up through:

• Contracted rebates and tiering: Large group purchasing organizations (GPOs) can push price down as long as multiple suppliers are in the bid set.
• Switching to lower-cost generics/authorized alternatives: Once generic tigecycline or therapeutically equivalent competitors are available in a given channel, brand economics usually shift quickly.

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What market dynamics affect tigecycline profitability in hospitals?

Featured snippet answer: Profitability tracks hospital contracting cycles, stewardship restrictions, and replacement by competing parenteral antibiotics in the same infection syndromes.

1) Antibiotic stewardship and restriction policies

Hospitals often limit tigecycline to patients with resistant organisms or when first-line regimens fail. That caps volume growth and makes quarters dependent on restriction exceptions.

2) Procurement mechanics

Hospital pharmacy departments and group purchasing organizations price tigecycline with:

• tender-based unit pricing,
• performance-based contracting where available, and
• substitutability rules in the formulary.

3) Clinical place in therapy

TYGACIL is used in complicated infections, but decision-making can shift to antibiotics where comparative efficacy and safety profiles align better with local protocols.

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What patents protect TYGACIL and how strong is the patent estate?

Executive answer: TYGACIL’s U.S. patent-driven brand protection historically relied on composition and method-related claims tied to tigecycline and its specific therapeutic uses and formulations. The practical strength for financial trajectory depends on whether exclusivity “blocks” are still enforceable at the time a generic is ready to launch.

Patent estate components that matter commercially

For a mature antibiotic brand, the most commercially material estate elements are:

• Composition of matter claims that prevent any direct generic entry.
• Formulation or manufacturing patents that block “same drug, different physical form” workarounds.
• Method-of-use patents that can deter carve-outs unless FDA labeling is negotiated away.
• Regulatory exclusivities (where applicable) that extend barriers beyond patents.

Exclusivity erosion risk

Financial impact usually accelerates when:

• composition-of-matter coverage ends,
• label carve-outs reduce method-of-use leverage, and
• generic entrants file and proceed with Paragraph IV strategies.

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When does TYGACIL lose U.S. exclusivity and what generic entry risks exist?

Featured snippet answer: The generic risk is highest around patent expiration windows and any Paragraph IV-related entry timing that follows FDA approval and label resolution.

Generic entry risk pathways

For tigecycline, generic entry risk typically comes through:

• Hatch-Waxman ANDA for a labeled generic tigecycline product,
• authorized generics if the brand/holder licenses a distributor, and
• therapeutic substitution rather than legal replacement if clinical formularies shift to alternatives.

Commercial consequences of a generic switch

A generic launch generally triggers:

• rapid decline in brand net price due to contracted discounts,
• redistribution of pharmacy demand to the lower-cost unit,
• residual brand demand only where contracts or clinical protocols mandate it.

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What is the Orange Book status of TYGACIL?

Featured snippet answer: Orange Book status determines whether brand exclusivity is tied to unexpired patents, listed exclusivities, or both, and informs Paragraph IV timing for would-be ANDA filers.

How to read Orange Book listings for financial impact

For a brand with declining volume, the Orange Book still matters because:

• it can delay generic replacement,
• it can create settlement-based “switch date” outcomes, and
• it can preserve price in remaining contracted accounts.

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Which companies compete with TYGACIL in complicated infections?

Executive answer: Competition comes from broad parenteral antibiotic classes used for the same syndromes, and the competitive set changes by hospital and guideline.

Competitive substitution map (class-level)

Common substitution pressures include:

• carbapenems for hospital-acquired and resistant Gram-negative coverage,
• beta-lactam/beta-lactamase inhibitor combinations for broad Gram-negative activity,
• newer cephalosporins for resistant pneumonia and skin/soft tissue indications (where locally preferred),
• older agents where stewardship protocols prioritize narrower-spectrum options.

Why class competition reduces net sales even without generic tigecycline

Even if tigecycline remains protected legally, formulary committee preferences can rotate patient allocation to alternative agents, which reduces brand volume and bargaining power.

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What patent litigation affects TYGACIL and how do settlements change launch timing?

Featured snippet answer: Patent litigation affects the time window for generic launches; settlements usually convert litigation uncertainty into a defined “off-ramp” date for exclusivity or eligibility.

Where litigation most directly hits the financial trajectory

• If Paragraph IV cases produce “early entry” settlements, brand revenue declines faster than if generic launch is delayed.
• If courts narrow claim scope, generics may proceed with fewer label restrictions.
• If settlements require authorized supply, the brand’s holder may monetize some portion of the economics.

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How do formulation and method-of-use patents influence generic workarounds?

Executive answer: Formulation patents can block non-infringing physical changes, while method-of-use patents can force generics into label carve-outs. Together they can delay practical market switching even when composition claims are weak.

Method-of-use label carve-out risk

If method-of-use patents are asserted, generics may seek labeling that omits protected uses. The financial effect depends on whether omitting the method removes the high-volume prescribing population.

Formulation and manufacturing barriers

If manufacturing patents specify key process controls or formulation properties, generic entrants may need additional process validation, increasing time-to-market and tightening legal risk for investors.

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How does TYGACIL compare with competing antibiotics on access, dosing, and contracting leverage?

Featured snippet answer: Compared with many newer agents, tigecycline’s contracting leverage often depends on restricted formulary access and antibiotic stewardship policies, which reduces volume optionality.

Pricing power drivers

TYGACIL pricing power typically improves with:

• limited therapeutic alternatives that remain acceptable under hospital protocols,
• contracted exclusivity through supply agreements, and
• strong outcomes evidence within a defined indication.

Pricing power drains

Pricing power usually weakens with:

• broader guideline inclusion of alternative agents,
• increasing prevalence of approved regimens that cover similar pathogens,
• unit cost improvements from generic competition or competitive tender wins.

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What FDA regulatory status issues matter for TYGACIL’s commercial future?

Featured snippet answer: FDA label wording determines both prescribing behavior and the legal route for generic ANDA labeling approvals.

Labeling and prescribing linkage

Even with unchanged patents, FDA labeling can:

• change physicians’ comfort level,
• shift stewardship committees’ approved workflows, and
• influence the probability that generics can offer “same use” labeling.

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Revenue exposure: what portion of antibiotic budgets does TYGACIL represent?

Executive answer: Antibiotic budgets are concentrated in a small number of guideline-preferred agents. Mature brands like TYGACIL often represent a diminishing share as hospital formularies diversify and steering protocols reduce empiric use.

How exposure shows up in financial statements

For a brand-phase portfolio holder or IP monetization vehicle, exposure concentrates in:

• gross-to-net compression (rebates, chargebacks),
• contract renegotiations during generic or authorized competitor entry windows, and
• post-expiration price reversion.

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Key takeaways

• TYGACIL’s financial trajectory is governed by hospital formulary restriction, antibiotic stewardship restrictions, and replacement by competing parenteral antibiotic classes, not by broad consumer-type demand.
• Patent estate strength affects the timing of generic replacement, but even protected periods can lose sales if guidelines shift.
• The Orange Book and any Paragraph IV litigation outcomes are the highest-leverage determinants for near-term brand economics because they can accelerate or delay switch dates.
• Formulation and method-of-use coverage can slow practical substitution via label carve-outs and manufacturing constraints, but the financial outcome depends on whether the carved-out uses represent high-volume prescribing.

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FAQs

1. Does tigecycline face substitution even before patent expiration, and what hospital factors drive it?
2. How do Paragraph IV certifications for tigecycline typically influence settlement timing and generic launch dates?
3. What labeling changes can reduce the commercial impact of a generic tigecycline entry?
4. How do group purchasing organization (GPO) contracts affect gross-to-net and brand unit sales for TYGACIL?
5. What non-patent exclusivities or FDA regulatory constraints can extend brand survival for tigecycline?

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References (APA)

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. Hatch-Waxman Act framework and Paragraph IV ANDA provisions. U.S. Food and Drug Administration and relevant statutes.