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Last Updated: January 2, 2025

TOBI Drug Patent Profile


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

Tobi is a drug marketed by Mylan Speciality Lp and is included in two NDAs. There are seven patents protecting this drug and one Paragraph IV challenge.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Tobi

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

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Summary for TOBI
Drug patent expirations by year for TOBI
Drug Prices for TOBI

See drug prices for TOBI

Pharmacology for TOBI
Paragraph IV (Patent) Challenges for TOBI
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TOBI Inhalation Solution tobramycin 300 mg/5 mL 050753 1 2009-06-29

US Patents and Regulatory Information for TOBI

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Mylan Speciality Lp TOBI tobramycin SOLUTION;INHALATION 050753-001 Dec 22, 1997 AN RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 6 of 6 entries

EU/EMA Drug Approvals for TOBI

CompanyDrugnameInnProduct Number / IndicationStatusGenericBiosimilarOrphanMarketing AuthorisationMarketing 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 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
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
>Company>Drugname>Inn>Product Number / Indication>Status>Generic>Biosimilar>Orphan>Marketing Authorisation>Marketing Refusal
Showing 1 to 3 of 3 entries

International Patents for TOBI

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

CountryPatent NumberTitleEstimated Expiration
Australia 688166 ⤷  Subscribe
Austria 183080 ⤷  Subscribe
Canada 2179305 NOUVELLE FORMULATION AMELIOREE D'AMINOGLUCOSIDE POUR ADMINISTRATION SOUS FORME D'AEROSOL (NOVEL AND IMPROVED AMINOGLYCOSIDE FORMULATION FOR AEROSOLIZATION) ⤷  Subscribe
Denmark 0734249 ⤷  Subscribe
European Patent Office 0734249 NOUVELLE FORMULATION AMELIOREE D'AMINOGLUCOSIDE POUR ADMINISTRATION SOUS FORME D'AEROSOL (NOVEL AND IMPROVED AMINOGLYCOSIDE FORMULATION FOR AEROSOLIZATION) ⤷  Subscribe
Greece 3031770 ⤷  Subscribe
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 6 of 6 entries

Supplementary Protection Certificates for TOBI

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
1280520 122015000021 Germany ⤷  Subscribe PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
1280520 300722 Netherlands ⤷  Subscribe PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
1280520 92678 Luxembourg ⤷  Subscribe PRODUCT NAME: TOBRAMYCINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE. FIRST REGISTRATION: 20110725
1273292 C01273292/01 Switzerland ⤷  Subscribe PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC 58751 28.05.2009
1280520 C01280520/01 Switzerland ⤷  Subscribe PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 60565 01.02.2012
1280520 CA 2015 00017 Denmark ⤷  Subscribe PRODUCT NAME: TOBRAMYCIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/10/652/001-003 20110720
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 6 of 6 entries

TOBI Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for TOBI

Overview of TOBI

TOBI, or Tobramycin Inhalation Solution, is an aminoglycoside antibiotic used primarily to treat lung infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis (CF). It is administered through a nebulizer, turning the medication into a mist that is inhaled, which helps reduce bacterial counts in the airways and improve lung function[2][5].

Market Size and Growth

The cystic fibrosis market, within which TOBI operates, was valued at $8.2 billion in 2020 and is projected to grow at a compound annual growth rate (CAGR) of more than 4% from 2021 to 2025. This growth is driven by several factors, including the continued uptake of high-priced CFTR modulator therapies and the increasing life expectancy of CF patients[1].

Key Drivers of Growth

Continued Uptake of CFTR Modulators

While TOBI itself is not a CFTR modulator, the overall growth in the CF market benefits from the adoption of these newer therapies. However, TOBI remains a crucial component in managing lung infections, which are a significant concern for CF patients[1].

Effective Treatment of Pseudomonas Aeruginosa

TOBI is specifically effective against Pseudomonas aeruginosa, a common and damaging bacterium in CF patients. Studies have shown that TOBI use is associated with a 21% reduction in mortality among CF patients with this infection, highlighting its critical role in patient care[4].

Patient Assistance Programs

Financial assistance programs, such as those offered by Simplefill, help make TOBI more accessible to patients who might otherwise struggle with the cost. These programs alleviate financial stress and ensure continuous treatment, contributing to the drug's market stability[5].

Market Barriers

Reimbursement Challenges

One of the main barriers to the growth of the CF market, including TOBI, is the slow reimbursement for novel therapies in some countries. This can affect the adoption rate of TOBI and other CF treatments, particularly in regions where reimbursement processes are slower[1].

Shift in Treatment Paradigms

The increasing effectiveness of CFTR modulators has led to a decrease in the usage of symptomatic drug classes, including antibiotics like TOBI. However, TOBI remains essential for managing specific infections and is likely to continue being prescribed alongside newer therapies[1].

Financial Impact

Cost and Accessibility

TOBI is a costly medication, which can be a significant burden for patients and their families. Patient assistance programs play a crucial role in making this medication more affordable. For instance, Simplefill helps patients enroll in programs that can reduce or eliminate the cost of TOBI prescriptions[5].

Revenue Contribution

While specific revenue figures for TOBI are not provided, it is part of the broader cystic fibrosis market. The market's growth and the continued need for effective infection management ensure that TOBI contributes significantly to the overall revenue of pharmaceutical companies involved in CF treatments.

Competitive Landscape

Key Players

The CF market includes several key players, such as Novartis, which manufactures TOBI. Other major players in the CF market include Vertex, Chiesi, Viatris, and Gilead, among others. These companies are involved in various aspects of CF treatment, from CFTR modulators to symptomatic therapies[1].

Future Outlook

Continued Innovation

The CF market is expected to see continued innovation, with new therapies and combinations being developed. For example, the launch of next-generation triple combination therapies like VX-121 + tezacaftor + VX-561 (deutivacaftor) will further shape the market landscape. However, TOBI's niche in treating specific lung infections ensures its continued relevance[1].

Growing Patient Population

The increasing life expectancy of CF patients and the overall population growth across the 7 major markets (US, France, Germany, Italy, Spain, UK, and Canada) will continue to drive demand for effective treatments like TOBI[1].

Key Takeaways

  • Market Growth: The CF market, including TOBI, is expected to grow at a CAGR of more than 4% from 2021 to 2025.
  • Effective Treatment: TOBI is crucial for managing Pseudomonas aeruginosa infections, reducing mortality by 21% in CF patients.
  • Financial Accessibility: Patient assistance programs are vital for making TOBI affordable for patients.
  • Competitive Landscape: Novartis, the manufacturer of TOBI, operates within a competitive market that includes other major pharmaceutical companies.
  • Future Outlook: Continued innovation in CF treatments and a growing patient population will influence TOBI's market dynamics.

FAQs

What is TOBI used for?

TOBI is used to treat lung infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis. It is an inhaled antibiotic that reduces bacterial counts in the airways and improves lung function[2][5].

How does TOBI work?

TOBI works by killing or stopping the growth of bacteria that cause infections in the lungs of CF patients. When inhaled as a mist, it decreases the bacterial count, reducing infections and improving lung function[2][5].

What are the benefits of using TOBI?

Using TOBI has been associated with a 21% reduction in mortality among CF patients with Pseudomonas aeruginosa infections. It also improves lung function and reduces the severity of lung infections[4].

Are there any financial assistance programs for TOBI?

Yes, there are financial assistance programs available for TOBI, such as those offered by Simplefill. These programs help patients who struggle with the cost of the medication by finding and enrolling them in assistance programs[5].

How is TOBI administered?

TOBI is administered through a nebulizer machine that turns the medication into a mist, which is then inhaled by the patient[2][5].

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