IZBA Drug Patent Profile

Which patents cover Izba, and what generic alternatives are available?

Izba is a drug marketed by Novartis and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-nine patent family members in twenty-three countries.

The generic ingredient in IZBA is travoprost. There are fifteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the travoprost profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Izba

A generic version of IZBA was approved as travoprost by CHARTWELL RX on March 1^st, 2013.

Summary for IZBA

International Patents:	39
US Patents:	4
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	71
Patent Applications:	4,008
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for IZBA
DailyMed Link:	IZBA at DailyMed

Paragraph IV (Patent) Challenges for IZBA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
IZBA	Ophthalmic Solution	travoprost	0.003%	204822	1	2015-12-30

US Patents and Regulatory Information for IZBA

IZBA is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	IZBA	travoprost	SOLUTION/DROPS;OPHTHALMIC	204822-001	May 15, 2014		DISCN	Yes	No			Y
Novartis	IZBA	travoprost	SOLUTION/DROPS;OPHTHALMIC	204822-001	May 15, 2014		DISCN	Yes	No			Y
Novartis	IZBA	travoprost	SOLUTION/DROPS;OPHTHALMIC	204822-001	May 15, 2014		DISCN	Yes	No			Y
Novartis	IZBA	travoprost	SOLUTION/DROPS;OPHTHALMIC	204822-001	May 15, 2014		DISCN	Yes	No			Y

EU/EMA Drug Approvals for IZBA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novartis Europharm Limited	Izba	travoprost	EMEA/H/C/002738 Decrease of elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma (see section 5.1). Decrease of elevated intraocular pressure in paediatric patients aged 3 years to < 18 years with ocular hypertension or paediatric glaucoma.	Authorised	no	no	no	2014-02-20
Novartis Europharm Limited	Travatan	travoprost	EMEA/H/C/000390 Decrease of elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma (see section 5.1).Decrease of elevated intraocular pressure in paediatric patients aged 2 months to < 18 years with ocular hypertension or paediatric glaucoma (see section 5.1).	Authorised	no	no	no	2001-11-27

International Patents for IZBA

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

Country	Patent Number	Title	Estimated Expiration
Denmark	3042646
Denmark	2599475
European Patent Office	2705836	Compositions pharmaceutiques à biodisponibilité souhaitable (Pharmaceutical compositions having desirable bioavailability)
Denmark	2265251
Taiwan	I544927
Spain	2637028
European Patent Office	2599475	Composition pharmaceutique à biodisponibilité souhaitable (Pharmaceutical composition having desirable bioavailability)

Supplementary Protection Certificates for IZBA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1920764	PA2012017	Lithuania		PRODUCT NAME: TRAVOPROSTUM; NAT. REGISTRATION NO/DATE: LT 02/7821/3 20020402; FIRST REGISTRATION: EU/1/01/199/001 - EU/1/01/199/002 20011127
1920764	C01920764/01	Switzerland		PRODUCT NAME: TRAVOPROST; REGISTRATION NUMBER/DATE: SWISSMEDIC 55910 22.05.2002
1514548	C300671	Netherlands		PRODUCT NAME: TRAVOPROST; REGISTRATION NO/DATE: EG EU/1/01/199/001-002 20011128
1920764	SPC/GB12/038	United Kingdom		PRODUCT NAME: TRAVOPROST; REGISTERED: UK EU/1/01/199/001-002 20011129
1920764	12C0045	France		PRODUCT NAME: TRAVOPROST; REGISTRATION NO/DATE: EU/1/01/199/001 20011127
1514548	CA 2014 00038	Denmark		PRODUCT NAME: TRAVOPROST; REG. NO/DATE: EU/1/01/199/001-002 20011127
1920764	1290027-0	Sweden		PRODUCT NAME: TRAVOPROST

IZBA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: IZBA

Introduction

Understanding the market dynamics and financial trajectory of a specific drug, such as IZBA, involves analyzing various factors including competition, pricing, regulatory environment, and pharmacoeconomic evaluations. Here, we will delve into these aspects to provide a comprehensive overview of IZBA.

Drug Overview: IZBA

IZBA, a formulation of travoprost, is used in the treatment of conditions such as open-angle glaucoma and ophthalmic hypertension. It is a prostaglandin analogue, which works by reducing intraocular pressure.

Market Entry and Competition

Generic Entry and Competition

The entry of generic drugs into the market significantly impacts the dynamics of pharmaceutical pricing and competition. For IZBA, the presence of generic competitors would follow a pattern similar to other generic drugs. More firms tend to enter markets with greater expected rents, and the entry process is influenced by the expected market size and profitability[1].

Impact on Pricing

As more generic firms enter the market, prices tend to decline. Studies have shown that generic drug prices fall with the number of competitors but remain above long-run marginal costs until there are 8 or more competitors. This suggests that the initial generic monopolist for IZBA would likely charge prices 35% to 50% above long-run marginal costs, with prices decreasing as more competitors enter the market[1].

Pharmacoeconomic Evaluations

Pharmacoeconomic reviews are crucial for understanding the cost-effectiveness of a drug like IZBA.

Cost-Minimization Analysis

A cost-minimization analysis conducted by the Canadian Agency for Drugs and Technologies in Health (CADTH) compared the costs of IZBA (travoprost 0.003% PQ) with other prostaglandin analogues. The analysis showed that IZBA was cost-neutral compared to travoprost 0.004% but resulted in significant cost savings when compared to bimatoprost 0.01% and 0.03%, and latanoprost 0.005%. For instance, IZBA resulted in cost savings of $204.93 and $139.53 per patient per year compared to bimatoprost 0.01% and 0.03%, respectively[2].

Base Case and Sensitivity Analyses

The base-case analysis assumed equivalent compliance and adherence among treatments and found that IZBA was either cost-neutral or resulted in significant savings. Sensitivity analyses further supported these findings, indicating that IZBA remained a cost-effective option under various scenarios[2].

Regulatory Environment

The regulatory environment plays a significant role in the market dynamics of pharmaceuticals.

FDA Policies

Changes in FDA policies can affect the entry and pricing of generic drugs. For example, increased scrutiny of generic drug applications can raise the cost of obtaining approval, potentially reducing the number of entrants and affecting prices. Simultaneous approval of multiple generic entrants can lead to earlier competition, reducing prices but also potentially reducing expected rents and discouraging future entrants[1].

Financial Trajectory

Revenue and Profitability

The financial trajectory of IZBA would be influenced by its market position and competition. Generic revenues and profits typically grow as more firms enter the market, but these profits begin to fall after five to eight months as competition increases and price-cost margins are competed away[1].

Cost Savings and Market Impact

The cost savings associated with IZBA can have a significant impact on its market position. By offering a cost-effective alternative, IZBA can attract a larger market share, especially in healthcare systems where cost is a critical factor. This can lead to increased sales and revenue, despite the competitive pressures from other generic and branded products[2].

Market Attractiveness

Expected Profitability

The attractiveness of the market for IZBA is determined by its expected profitability. For drugs targeting small patient populations, the fixed costs of entry and the likelihood of intense post-entry price competition can make it less attractive for new entrants. However, for a drug like IZBA, which targets a relatively larger patient population with open-angle glaucoma and ophthalmic hypertension, the market remains attractive due to the potential for significant revenue and cost savings[3].

Conclusion

The market dynamics and financial trajectory of IZBA are shaped by several key factors:

• Competition: The entry of multiple generic competitors leads to lower prices and increased competition.
• Pharmacoeconomic Evaluations: IZBA is shown to be cost-effective compared to other prostaglandin analogues.
• Regulatory Environment: FDA policies can influence the number of entrants and pricing.
• Financial Trajectory: Revenue and profitability are influenced by market competition and cost savings.

Key Takeaways

• IZBA's pricing is expected to decline as more generic competitors enter the market.
• Pharmacoeconomic analyses indicate that IZBA is a cost-effective option.
• Regulatory policies can impact the number of entrants and pricing dynamics.
• The financial trajectory of IZBA is influenced by its market position and competition.

FAQs

Q: How does the entry of generic competitors affect the pricing of IZBA?

A: The entry of generic competitors leads to a decline in prices, with prices approaching long-run marginal costs when there are 8 or more competitors.

Q: What are the cost savings associated with IZBA compared to other prostaglandin analogues?

A: IZBA results in significant cost savings compared to bimatoprost 0.01% and 0.03%, and latanoprost 0.005%, with savings ranging from $38.94 to $204.93 per patient per year.

Q: How do FDA policies impact the market dynamics of generic drugs like IZBA?

A: FDA policies, such as increased scrutiny of applications or simultaneous approval of multiple generics, can affect the number of entrants and pricing dynamics.

Q: What is the expected financial trajectory for IZBA in a competitive market?

A: The financial trajectory involves initial revenue and profit growth followed by a decline in profits as competition increases and price-cost margins are competed away.

Q: Why is the market for IZBA attractive despite competitive pressures?

A: The market remains attractive due to the potential for significant revenue and cost savings, especially in healthcare systems where cost is a critical factor.

Sources

1. Generic Drug Industry Dynamics - Federal Trade Commission[1]
2. SR0516 Izba PE Report - Canada's Drug Agency[2]
3. The Economics of Drug Development: Pricing and Innovation in a Changing Market - National Bureau of Economic Research[3]
4. Competition in Prescription Drug Markets, 2017-2022 - ASPE[4]