BETHKIS Drug Patent Profile

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

Bethkis is a drug marketed by Chiesi and is included in one NDA.

The generic ingredient in BETHKIS 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 Bethkis

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

Summary for BETHKIS

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	2
Drug Prices:	Drug price information for BETHKIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BETHKIS
What excipients (inactive ingredients) are in BETHKIS?	BETHKIS excipients list
DailyMed Link:	BETHKIS at DailyMed

See drug prices for BETHKIS

Recent Clinical Trials for BETHKIS

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

Sponsor	Phase
Mylan Inc.
Cystic Fibrosis Foundation Therapeutics
Novartis Pharmaceuticals

See all BETHKIS clinical trials

Pharmacology for BETHKIS

Drug Class

Aminoglycoside Antibacterial

Paragraph IV (Patent) Challenges for BETHKIS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BETHKIS	Inhalation Solution	tobramycin	300 mg/4 mL	201820	1	2017-08-31

US Patents and Regulatory Information for BETHKIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chiesi	BETHKIS	tobramycin	SOLUTION;INHALATION	201820-001	Oct 12, 2012	AN	RX	Yes	Yes

Expired US Patents for BETHKIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	BETHKIS	tobramycin	SOLUTION;INHALATION	201820-001	Oct 12, 2012
Chiesi	BETHKIS	tobramycin	SOLUTION;INHALATION	201820-001	Oct 12, 2012
Chiesi	BETHKIS	tobramycin	SOLUTION;INHALATION	201820-001	Oct 12, 2012

EU/EMA Drug Approvals for BETHKIS

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 BETHKIS

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

Country	Patent Number	Title	Estimated Expiration
Denmark	1273292
Bulgaria	66328
European Patent Office	1273292	Formulation optimisée de tobramycine pour administration sous forme d'aérosol (Optimised formulation of tobramycin for aerosolization)
Germany	60103527

Supplementary Protection Certificates for BETHKIS

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	300722	Netherlands		PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
1273292	C01273292/01	Switzerland		PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC 58751 28.05.2009
1280520	122015000021	Germany		PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720

BETHKIS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for BETHKIS

Overview of BETHKIS

BETHKIS (tobramycin inhalation solution) is a nebulized therapy specifically designed for the management of cystic fibrosis (CF) patients who are colonized with Pseudomonas aeruginosa. It is part of the aminoglycosides drug class and has been approved for patients six years of age and older[4].

Market Size and Growth

The cystic fibrosis market, within which BETHKIS operates, was valued at $8.2 billion in 2020 and is projected to grow at a CAGR of more than 4% from 2021 to 2025. This growth is driven by several factors, including the increasing prevalence of CF, advancements in CFTR modulator therapies, and the launch of new treatments[1].

Key Drivers of Growth

Continued Uptake of High-Priced Therapies

The market growth is significantly influenced by the continued uptake of high-priced therapies such as Trikafta/Kaftrio and the upcoming launch of next-generation triple combinations like VX-121 + tezacaftor + VX-561 (deutivacaftor). These advanced therapies improve lung health and extend the life expectancy of CF patients, thereby increasing the demand for complementary treatments like BETHKIS[1].

Increasing CF Patient Population

The growth in the CF patient population due to overall population growth and increasing life expectancy of CF patients also contributes to the demand for BETHKIS. As more patients live longer with the disease, the need for effective management options like BETHKIS increases[1].

Launch of New Treatments

The launch of new treatments, including BETHKIS itself, expands the therapeutic options available to CF patients. BETHKIS, in particular, offers a targeted solution for managing Pseudomonas aeruginosa, a common and challenging infection in CF patients[4].

Market Barriers

Reimbursement Challenges

One of the significant barriers to the growth of BETHKIS and other CF treatments is the slow reimbursement for novel therapies in some European countries and Canada. This can limit access to these treatments for patients in these regions[1].

Shift in Treatment Paradigms

The improved lung health resulting from the use of advanced CFTR modulators like Trikafta/Kaftrio has led to a decrease in the usage of symptomatic drug classes such as antibiotics, mucolytics, and anti-inflammatory drugs. However, BETHKIS, being an antibiotic, still maintains its relevance in managing specific infections like Pseudomonas aeruginosa[1].

Financial Aspects

Pricing

The cost for BETHKIS (75 mg/mL) inhalation solution is around $3,266 for a supply of 112 milliliters, depending on the pharmacy. This makes it a significant expense for patients, although generic versions and patient assistance programs can help mitigate the cost[5].

Patient Assistance Programs

To make BETHKIS more accessible, companies like Cornerstone Therapeutics have implemented patient assistance programs such as Cornerstone CareDirect. These programs provide reimbursement support and additional resources to help patients afford the treatment[4].

Competitive Landscape

BETHKIS operates in a competitive market with several other pharmaceutical companies offering treatments for CF. Key players include Vertex, Chiesi, Viatris, Nestlé HealthScience, Gilead, Teva, Roche/Genentech, AbbVie/Allergan, and others. Chiesi, for instance, offers other inhaled antibiotic products like Bramitob/Bethkis and Quinsair, which compete with BETHKIS in the market[1].

Clinical Efficacy

BETHKIS has demonstrated significant clinical efficacy in improving lung function in CF patients. In clinical trials, BETHKIS showed an absolute increase in FEV1 % predicted compared to placebo, indicating its effectiveness in managing lung infections associated with CF[2][4].

Geographic Market

The US dominates the cystic fibrosis market, accounting for more than 75% of the market by 2030. The UK is expected to have the second-highest sales, followed by other European countries. BETHKIS, being approved for use in these regions, benefits from this market dynamics[1].

Future Outlook

Given the ongoing advancements in CF treatments and the increasing demand for effective management options, BETHKIS is likely to maintain its position as a valuable treatment for CF patients. The launch of new therapies and the expansion of patient assistance programs will continue to influence the financial trajectory of BETHKIS.

"The continued uptake of high-priced Trikafta/Kaftrio and label expansion to a growing population of CF patients" are significant drivers of growth in the CF market, which indirectly benefits treatments like BETHKIS[1].

Key Takeaways

• Market Growth: The CF market is projected to grow at a CAGR of more than 4% from 2021 to 2025.
• Key Drivers: Continued uptake of high-priced therapies, increasing CF patient population, and launch of new treatments.
• Market Barriers: Slow reimbursement in some regions and shift in treatment paradigms.
• Financial Aspects: High pricing, but mitigated by patient assistance programs.
• Competitive Landscape: Operates in a competitive market with several other pharmaceutical companies.
• Clinical Efficacy: Demonstrated significant improvement in lung function in CF patients.

FAQs

1. What is BETHKIS used for? BETHKIS is used for the management of cystic fibrosis patients who are colonized with Pseudomonas aeruginosa[4].

2. How much does BETHKIS cost? The cost for BETHKIS (75 mg/mL) inhalation solution is around $3,266 for a supply of 112 milliliters[5].

3. What are the key drivers of growth for BETHKIS in the CF market? The key drivers include the continued uptake of high-priced therapies, increasing CF patient population, and the launch of new treatments[1].

4. What are the main barriers to the growth of BETHKIS? The main barriers include slow reimbursement in some regions and the decreased usage of symptomatic drug classes due to improved lung health from advanced CFTR modulators[1].

5. Are there any patient assistance programs available for BETHKIS? Yes, programs like Cornerstone CareDirect provide reimbursement support and additional resources to help patients afford BETHKIS[4].

Sources

1. GlobalData: Cystic Fibrosis - Global Drug Forecast and Market Analysis to 2030.
2. FDA: BETHKIS® (Tobramycin Inhalation Solution) - accessdata.fda.gov.
3. PubMed: The economics of follow-on drug research and development.
4. Biospace: Cornerstone Therapeutics Inc. Launches BETHKIS(R) (Tobramycin Inhalation Solution) for Management of Cystic Fibrosis Patients with Pseudomonas aeruginosa.
5. Drugs.com: Bethkis Prices, Coupons, Copay Cards & Patient Assistance.