KITABIS PAK Drug Patent Profile

Which patents cover Kitabis Pak, and when can generic versions of Kitabis Pak launch?

Kitabis Pak is a drug marketed by Pulmoflow Inc and is included in one NDA.

The generic ingredient in KITABIS PAK is tobramycin. There are eighteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the tobramycin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Kitabis Pak

A generic version of KITABIS PAK was approved as tobramycin by BAUSCH AND LOMB on November 29^th, 1993.

Summary for KITABIS PAK

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	78
Patent Applications:	2,106
Drug Prices:	Drug price information for KITABIS PAK
What excipients (inactive ingredients) are in KITABIS PAK?	KITABIS PAK excipients list
DailyMed Link:	KITABIS PAK at DailyMed

See drug prices for KITABIS PAK

Pharmacology for KITABIS PAK

Drug Class

Aminoglycoside Antibacterial

US Patents and Regulatory Information for KITABIS PAK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pulmoflow Inc	KITABIS PAK	tobramycin	SOLUTION;INHALATION	205433-001	Dec 2, 2014	AN	RX	No	No

EU/EMA Drug Approvals for KITABIS PAK

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Viatris Healthcare Limited	Tobi Podhaler	tobramycin	EMEA/H/C/002155 Tobi Podhaler is indicated for the suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis. See sections 4.4 and 5.1 regarding data in different age groups.Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Authorised	no	no	no	2011-07-20
Pari Pharma GmbH	Vantobra (previously Tobramycin PARI)	tobramycin	EMEA/H/C/005086 Vantobra is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF).Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Authorised	no	no	no	2019-02-18
Pari Pharma GmbH	Vantobra	tobramycin	EMEA/H/C/002633 Vantobra is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF).Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Withdrawn	no	no	no	2015-03-18

KITABIS PAK Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Kitabis Pak

Introduction

Kitabis Pak, a combination product consisting of tobramycin inhalation solution and a Pari LC Plus Reusable Nebulizer, is used primarily for the treatment of cystic fibrosis. Understanding the market dynamics and financial trajectory of this drug is crucial for stakeholders, including pharmaceutical companies, healthcare providers, and patients.

Regulatory Background

Kitabis Pak is approved under the 505(b)(2) New Drug Application (NDA) pathway, which allows for the approval of drugs that are similar to already approved drugs but with some differences[4].

• The approval process involved extensive labeling revisions to align with current regulatory standards.
• The product's final approval was contingent upon the expiration of the patent for TOBI, the reference listed drug.

Market Outlook

Patent Expiry and Generic Competition

The patent for TOBI, the reference drug for Kitabis Pak, expired in 2014. This expiry has opened the market to generic competition, which can significantly impact the financial trajectory of Kitabis Pak.

• Generic versions of tobramycin are expected to reduce the market share and revenue of branded products like Kitabis Pak[3].

Market Size and Growth

The market for tobramycin, including both branded and generic versions, is projected to grow.

• By 2028, the tobramycin eye drops market alone is expected to reach $1.37 billion, with a Compound Annual Growth Rate (CAGR) of 12.4% from 2023[3].

Specialty Drug Spending

Kitabis Pak falls under the category of specialty drugs, which have seen significant growth in recent years.

• Specialty drug spending increased by 44% of the total increase in spending in the Vermont Medicaid program in SFY2021, indicating a broader trend of increased spending on specialty drugs[1].

Financial Trajectory

Revenue and Sales

The financial performance of Kitabis Pak is influenced by several factors, including the number of prescriptions, pricing, and competition from generics.

• The revenue from Kitabis Pak would have been substantial before the patent expiry of TOBI, but it is expected to decline as generic versions enter the market.
• The overall tobramycin market, however, continues to grow, driven by increasing demand for cystic fibrosis treatments.

Cost and Pricing

The cost per prescription of specialty drugs like Kitabis Pak has been increasing.

• In the Vermont Medicaid program, the average gross cost per claim for all drugs increased by 10%, and the average net cost per claim increased by 14.5% in SFY2021, reflecting higher costs and lower rebates for newer specialty drugs[1].

Patient Access and Co-Pay Assistance

To maintain market share and patient access, manufacturers often offer co-pay assistance programs.

• Kitabis Pak offers a co-pay assistance program that covers up to $1440 per prescription, making the drug more accessible to patients despite its high cost[5].

Competitive Landscape

Generic Competition

The entry of generic tobramycin products into the market poses a significant challenge to Kitabis Pak.

• Generic drugs typically offer a cheaper alternative, which can lead to a shift in market share away from branded products.

Therapeutic Alternatives

The cystic fibrosis treatment market is evolving with new therapeutic alternatives.

• Spending on drugs used to treat cystic fibrosis, such as those included in the Vermont Medicaid program, has increased significantly, indicating a growing market but also increased competition[1].

Impact of Healthcare Policies

Medicaid and Medicare

Changes in Medicaid and Medicare policies can significantly impact the financial trajectory of Kitabis Pak.

• For instance, the extension of Medicaid eligibility during the COVID-19 public health emergency has increased the number of eligible members, which can affect the demand for specialty drugs like Kitabis Pak[2].

Prior Authorization and Formulary Management

Healthcare organizations often implement prior authorization and formulary management to control costs.

• The Pharmacy and Therapeutics Committee in Oregon, for example, developed new or revised prior authorization criteria for various drugs, including those in the same therapeutic class as Kitabis Pak[2].

Key Takeaways

• Regulatory Environment: The approval and ongoing regulation of Kitabis Pak are critical to its market presence.
• Generic Competition: The expiry of the TOBI patent and the entry of generic tobramycin products will significantly impact Kitabis Pak's revenue.
• Specialty Drug Spending: The increasing trend in specialty drug spending benefits Kitabis Pak but also introduces higher costs and competition.
• Patient Access Programs: Co-pay assistance programs help maintain patient access despite high costs.
• Healthcare Policies: Changes in Medicaid and Medicare policies, as well as prior authorization and formulary management, can influence demand and revenue.

FAQs

What is Kitabis Pak used for?

Kitabis Pak is used for the treatment of cystic fibrosis, combining tobramycin inhalation solution with a Pari LC Plus Reusable Nebulizer.

How has the patent expiry of TOBI affected Kitabis Pak?

The patent expiry of TOBI has opened the market to generic competition, which is expected to reduce the market share and revenue of Kitabis Pak.

What is the projected growth of the tobramycin market?

The tobramycin eye drops market is expected to reach $1.37 billion by 2028, with a CAGR of 12.4% from 2023.

How do co-pay assistance programs impact Kitabis Pak?

Co-pay assistance programs make Kitabis Pak more accessible to patients by covering a significant portion of the prescription cost, up to $1440 per prescription.

What are the key factors influencing the financial trajectory of Kitabis Pak?

Key factors include generic competition, specialty drug spending trends, patient access programs, and healthcare policy changes.

Sources

1. Pharmacy Best Practices and Cost Control Program Report - Vermont Department of Health Access.
2. Section 1115 Annual Report - Oregon Health Authority.
3. Generic TOBRAMYCIN INN entry - Drug Patent Watch.
4. NDA-205433 Kitabis Pak - FDA.
5. Kitabis Pak Co-Pay Assistance - Kitabis.com.