TILADE Drug Patent Profile

When do Tilade patents expire, and what generic alternatives are available?

Tilade is a drug marketed by King Pharms Llc and Sanofi Aventis Us and is included in two NDAs.

The generic ingredient in TILADE is nedocromil sodium. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nedocromil sodium profile page.

Summary for TILADE

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	1
Patent Applications:	3,621
DailyMed Link:	TILADE at DailyMed

Recent Clinical Trials for TILADE

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

Sponsor	Phase
CAMP Steering Committee	Phase 3
Johns Hopkins Bloomberg School of Public Health	Phase 3
National Heart, Lung, and Blood Institute (NHLBI)	Phase 3

See all TILADE clinical trials

US Patents and Regulatory Information for TILADE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
King Pharms Llc	TILADE	nedocromil sodium	AEROSOL, METERED;INHALATION	019660-001	Dec 30, 1992		DISCN	No	No
Sanofi Aventis Us	TILADE	nedocromil sodium	SOLUTION;INHALATION	020750-001	Oct 1, 1997		DISCN	No	No

Expired US Patents for TILADE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
King Pharms Llc	TILADE	nedocromil sodium	AEROSOL, METERED;INHALATION	019660-001	Dec 30, 1992	4,474,787
King Pharms Llc	TILADE	nedocromil sodium	AEROSOL, METERED;INHALATION	019660-001	Dec 30, 1992	4,760,072

International Patents for TILADE

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

Country	Patent Number	Title	Estimated Expiration
Finland	70899
Israel	74883	SOLID NEDOCROMIL SODIUM CONTAINING BOUND WATER AND ITS PREPARATION
Spain	542184
Germany	3584580
Luxembourg	85850
European Patent Office	0162556	NOVELS FORMS AND FORMULATIONS OF NEDOCROMIL SODIUM
Spain	8707222	PROCEDIMIENTO PARA LA OBTENCION DEL 9-ETIL-4,6-DIOXO-10-PROPIL-6,9-DIHIDRO-4H-PIRANO(3,2-G)QUINOLINA-2,8-DICARBOXILATO DE DIETILO (Process for obtaining diethyl 9-ethyl-4,6-dioxo-10-propyl- 6,9-dihydro-4H-pyrano[3,2-g]quinolene-2,8-dicarboxylate Process for obtaining diethyl 9-ethyl-4,6-dioxo-10-propyl- 6,9-dihydro-4H-pyrano[3,2-g]quinolene-2,8-dicarboxylate)

TILADE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tilade (Nedocromil Sodium)

Introduction

Tilade, known by its active ingredient nedocromil sodium, is an inhaled anti-inflammatory agent primarily used for the preventive management of asthma. To understand its market dynamics and financial trajectory, it is crucial to delve into its clinical efficacy, market positioning, and the broader inhalable drugs market.

Clinical Efficacy and Usage

Tilade has been extensively studied in clinical trials involving over 6,469 patients, including 993 pediatric patients. These studies have shown that Tilade is significantly effective in managing asthma symptoms and improving pulmonary function when compared to placebo. The drug is particularly effective when administered four times daily, although less frequent administration can be considered for patients under good control[1].

Market Positioning

Competitive Landscape

In the inhalable drugs market, Tilade competes with other anti-inflammatory agents and bronchodilators. The market is dominated by major pharmaceutical companies such as AstraZeneca, Novartis AG, GSK plc, and others. Tilade's unique selling point is its preventive management of asthma, which sets it apart from rescue medications like short-acting bronchodilators[4].

Market Segmentation

The inhalable drugs market is segmented based on drug class, with anti-inflammatory agents like Tilade being a key category. The market is also segmented geographically, with North America holding a significant share due to high rates of respiratory diseases[4].

Financial Trajectory

Revenue Potential

The financial trajectory of Tilade is influenced by the growing demand for inhalable drugs driven by the increasing incidence of respiratory conditions such as asthma, COPD, and bronchitis. The global inhalable drugs market is expected to register incremental growth at a CAGR of approximately 6% by 2030, which bodes well for Tilade's revenue potential[4].

Pricing and Reimbursement

Pricing and reimbursement strategies play a crucial role in the financial performance of pharmaceutical products. For Tilade, the ability to secure favorable reimbursement rates and competitive pricing will be essential in maintaining market share. The pharmaceutical industry's pricing dynamics are often influenced by market power, competition, and regulatory environments[2].

Key Drivers and Barriers

Drivers

• Increasing Incidence of Respiratory Diseases: The rising prevalence of asthma, COPD, and other respiratory conditions drives the demand for inhalable anti-inflammatory agents like Tilade[4].
• Innovations in Inhalation Devices: Advances in metered-dose inhalers (MDIs) and dry powder inhalers (DPIs) enhance the delivery and efficacy of Tilade, making it more appealing to patients and healthcare providers[4].
• Air Pollution: Increased air pollution exacerbates respiratory conditions, creating a higher demand for immediate and preventive treatments like Tilade[4].

Barriers

• Competition: The inhalable drugs market is highly competitive, with numerous established brands and new entrants. Tilade must differentiate itself through clinical efficacy and patient preference[4].
• Regulatory Approvals: Securing and maintaining regulatory approvals is crucial. Any changes in regulatory requirements or safety concerns can impact Tilade's market position[1].
• Pricing Pressure: The pharmaceutical industry faces significant pricing pressure, especially in markets with stringent reimbursement policies. Tilade must balance its pricing strategy to remain competitive while ensuring profitability[2].

Clinical Studies and Outcomes

Clinical studies have shown that Tilade significantly improves symptom control and pulmonary function. For example, in a study comparing Tilade to placebo, Tilade demonstrated superior efficacy in reducing daytime asthma, nighttime asthma, and cough symptoms. The Forced Expiratory Volume in one second (FEV1) measurements also favored Tilade over placebo throughout the study[1].

Adverse Events and Safety Profile

Tilade's safety profile is generally favorable, although it is associated with some adverse events such as unpleasant taste, coughing, pharyngitis, and rhinitis. These side effects are relatively common but typically mild and transient[1].

Market Insights and Projections

Geographic Market Share

North America is anticipated to dominate the global inhalable drugs market, including Tilade, due to the high prevalence of respiratory diseases in this region. Other key markets include Europe and Asia-Pacific, where the demand for inhalable medications is also on the rise[4].

Leading Market Players

Tilade competes with products from major pharmaceutical companies. The market share of Tilade will depend on its clinical performance, marketing strategies, and the ability of its manufacturer to innovate and adapt to changing market conditions[4].

Key Takeaways

• Clinical Efficacy: Tilade is clinically proven to be effective in managing asthma symptoms and improving pulmonary function.
• Market Growth: The global inhalable drugs market is expected to grow at a CAGR of approximately 6% by 2030.
• Competitive Landscape: Tilade competes in a highly competitive market with established brands and new entrants.
• Pricing and Reimbursement: Favorable pricing and reimbursement strategies are crucial for maintaining market share.
• Innovations in Devices: Advances in inhalation devices enhance the delivery and efficacy of Tilade.

FAQs

Q: What is Tilade used for?

Tilade is used for the preventive management of asthma. It is an inhaled anti-inflammatory agent that helps control asthma symptoms.

Q: How effective is Tilade compared to placebo?

Clinical studies have shown that Tilade is significantly more effective than placebo in reducing daytime asthma, nighttime asthma, and cough symptoms, and in improving pulmonary function[1].

Q: What are the common adverse events associated with Tilade?

Common adverse events include unpleasant taste, coughing, pharyngitis, and rhinitis. These side effects are generally mild and transient[1].

Q: Which regions are expected to dominate the inhalable drugs market?

North America is anticipated to dominate the global inhalable drugs market, followed by Europe and Asia-Pacific[4].

Q: How does Tilade fit into the broader inhalable drugs market?

Tilade is part of the anti-inflammatory segment of the inhalable drugs market, competing with other products from major pharmaceutical companies. Its unique selling point is its preventive management of asthma[4].

Sources

1. Drugs.com: Tilade: Package Insert / Prescribing Information.
2. European Commission: Case M.7919 - SANOFI / BOEHRINGER INGELHEIM CONSUMER.
3. AstraZeneca: BioPharmaceuticals | AstraZeneca.
4. GlobeNewswire: Global Inhalable Drugs Market to Register Incremental Growth at a CAGR of ~6% by 2030 | DelveInsight.