TOBI PODHALER Drug Patent Profile

When do Tobi Podhaler patents expire, and when can generic versions of Tobi Podhaler launch?

Tobi Podhaler is a drug marketed by Mylan Speciality Lp and is included in one NDA. There are seven patents protecting this drug.

This drug has sixty-one patent family members in twenty-seven countries.

The generic ingredient in TOBI PODHALER 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 Tobi Podhaler

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

Summary for TOBI PODHALER

International Patents:	61
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	8
Patent Applications:	2,106
Drug Prices:	Drug price information for TOBI PODHALER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TOBI PODHALER
What excipients (inactive ingredients) are in TOBI PODHALER?	TOBI PODHALER excipients list
DailyMed Link:	TOBI PODHALER at DailyMed

See drug prices for TOBI PODHALER

Recent Clinical Trials for TOBI PODHALER

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University Medical Center Groningen	Phase 1/Phase 2
Mylan Inc.	Phase 4
Cystic Fibrosis Foundation Therapeutics

See all TOBI PODHALER clinical trials

Pharmacology for TOBI PODHALER

Drug Class

Aminoglycoside Antibacterial

US Patents and Regulatory Information for TOBI PODHALER

TOBI PODHALER is protected by seven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013		RX	Yes	Yes
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013		RX	Yes	Yes			Y
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013		RX	Yes	Yes			Y
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013		RX	Yes	Yes			Y
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013		RX	Yes	Yes			Y
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013		RX	Yes	Yes			Y

Expired US Patents for TOBI PODHALER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013

EU/EMA Drug Approvals for TOBI PODHALER

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

International Patents for TOBI PODHALER

See the table below for patents covering TOBI PODHALER around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2183577	METHODES ET COMPOSITIONS POUR L'ADMINISTRATION PULMONAIRE D'INSULINE (METHODS AND COMPOSITIONS FOR PULMONARY DELIVERY OF INSULIN)
Japan	5372306
Estonia	200000194
Estonia	9800376
World Intellectual Property Organization (WIPO)	9916422
Russian Federation	2142815	METHODS OF PULSING SYSTEMIC ADMINISTRATION OF PARATHYROID HORMONE ACTIVE FRAGMENT AND PHARMACEUTICAL COMPOSITIONS CONTAINING BIOLOGICALLY ACTIVE N-TERMINAL FRAGMENT OF PARATHYROID HORMONE

Supplementary Protection Certificates for TOBI PODHALER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1280520	92678	Luxembourg		PRODUCT NAME: TOBRAMYCINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE. FIRST REGISTRATION: 20110725
1280520	C01280520/01	Switzerland		PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 60565 01.02.2012
1273292	C01273292/01	Switzerland		PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC 58751 28.05.2009
1280520	300722	Netherlands		PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
1280520	122015000021	Germany		PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
1280520	CA 2015 00017	Denmark		PRODUCT NAME: TOBRAMYCIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/10/652/001-003 20110720

TOBI PODHALER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TOBI PODHALER

Introduction

TOBI PODHALER, an inhalation powder formulation of tobramycin, is a critical treatment for managing cystic fibrosis (CF) in patients infected with Pseudomonas aeruginosa. This article delves into the market dynamics and financial trajectory of TOBI PODHALER, highlighting its clinical efficacy, market performance, and financial implications.

Clinical Efficacy and Approval

TOBI PODHALER has demonstrated significant clinical efficacy in treating CF patients with P. aeruginosa infections. Clinical trials, such as the EVOLVE and EDIT studies, have shown that TOBI PODHALER improves lung function, as measured by FEV1 (Forced Expiratory Volume in one second), and reduces the need for hospitalizations and intravenous antipseudomonal antibiotics[1][3].

The European Commission granted marketing authorization for TOBI PODHALER in 2011, recognizing its benefits over risks and its convenience for patients[1].

Market Indicators

Patient Population and Demand

The demand for TOBI PODHALER is driven by the prevalence of cystic fibrosis and the specific need for effective treatments against P. aeruginosa infections. Given the chronic nature of CF, the market for TOBI PODHALER is relatively stable and growing as new patients are diagnosed and existing patients continue treatment.

Competitive Landscape

The market for CF treatments is competitive, with various inhalation therapies available. However, TOBI PODHALER's unique formulation and proven efficacy give it a strong position. The availability of a generic version of tobramycin may impact market dynamics, but the branded TOBI PODHALER remains a preferred option due to its convenience and established clinical profile[4].

Financial Performance

Revenue and Sales

The financial performance of TOBI PODHALER is influenced by its sales across different regions. For instance, Mylan (now part of Viatris), a major pharmaceutical company, reported significant revenues from its respiratory products, including TOBI PODHALER. In the third quarter of 2018, Mylan's Europe segment saw an increase in net sales, partly due to new product sales and higher volumes of existing products like TOBI PODHALER[2].

Pricing and Cost

The cost of TOBI PODHALER is substantial, reflecting its specialized nature and the high demand for effective CF treatments. A supply of 280 capsules (28 mg each) can cost around $9,116, although prices can vary depending on the pharmacy and any available discounts or patient assistance programs[4].

Profit Margins and Adjusted Earnings

Pharmaceutical companies like Mylan typically report adjusted gross margins and earnings that account for various factors, including purchase accounting, litigation settlements, and interest expenses. For Mylan, the adjusted gross margin was around 55% in the third quarter of 2018, indicating a healthy profit margin for their products, including TOBI PODHALER[2].

Risk Management and Safety

The use of TOBI PODHALER comes with a risk management plan to ensure safe usage. This includes monitoring for decreased susceptibility of P. aeruginosa to tobramycin and managing potential side effects such as oropharyngeal pain, dysphonia, and hemoptysis[1][3].

Market Expansion and Growth Prospects

Geographical Expansion

TOBI PODHALER's marketing authorization in the European Union and its availability in other regions contribute to its global market presence. The drug's effectiveness and convenience are key factors in its expansion into new markets.

Innovations and Future Developments

Continuous innovation in inhalation technologies and the development of new formulations could impact the market dynamics of TOBI PODHALER. However, its established clinical profile and patient preference are likely to maintain its market position.

Patient Assistance and Access Programs

To make TOBI PODHALER more accessible, various patient assistance programs and copay cards are available. These programs help reduce the financial burden on patients, ensuring that they can continue their treatment without significant interruptions[4].

Key Takeaways

• Clinical Efficacy: TOBI PODHALER has proven efficacy in treating CF patients with P. aeruginosa infections, improving lung function and reducing hospitalizations.
• Market Performance: The drug has a strong market position due to its convenience and established clinical profile.
• Financial Trajectory: Significant revenues are generated from TOBI PODHALER, with healthy profit margins for pharmaceutical companies.
• Risk Management: A risk management plan is in place to ensure safe usage and monitor potential side effects.
• Market Expansion: Global market presence and patient assistance programs contribute to its growth prospects.

FAQs

What is TOBI PODHALER used for?

TOBI PODHALER is used to manage cystic fibrosis in patients infected with Pseudomonas aeruginosa, improving lung function and reducing the need for hospitalizations and intravenous antibiotics.

How effective is TOBI PODHALER in clinical trials?

Clinical trials have shown that TOBI PODHALER significantly improves FEV1 and reduces respiratory-related hospitalizations and the need for IV antipseudomonal antibiotics compared to placebo[1][3].

What are the common side effects of TOBI PODHALER?

Common side effects include oropharyngeal pain, dysphonia, hemoptysis, and headache[3].

How much does TOBI PODHALER cost?

The cost of TOBI PODHALER can be around $9,116 for a supply of 280 capsules, although prices may vary depending on the pharmacy and available discounts[4].

Are there any patient assistance programs for TOBI PODHALER?

Yes, various patient assistance programs and copay cards are available to help reduce the financial burden on patients[4].

Cited Sources

1. European Medicines Agency (EMA). Tobi Podhaler | European Medicines Agency (EMA).
2. Mylan. Mylan Reports Third Quarter 2018 Results and Reaffirms 2018.
3. TOBI PODHALER HCP. Digital PDF - TOBI® PODHALER® (tobramycin inhalation powder).
4. Drugs.com. Tobi Prices, Coupons, Copay Cards & Patient Assistance.