GASTROCROM Drug Patent Profile

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

Gastrocrom is a drug marketed by Ucb Inc and Mylan Speciality Lp and is included in two NDAs.

The generic ingredient in GASTROCROM is cromolyn sodium. There are ten drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the cromolyn sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Gastrocrom

A generic version of GASTROCROM was approved as cromolyn sodium by SANDOZ on June 16^th, 1999.

Summary for GASTROCROM

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	3
Patent Applications:	4,783
Drug Prices:	Drug price information for GASTROCROM
What excipients (inactive ingredients) are in GASTROCROM?	GASTROCROM excipients list
DailyMed Link:	GASTROCROM at DailyMed

See drug prices for GASTROCROM

Recent Clinical Trials for GASTROCROM

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

Sponsor	Phase
Northwestern University	Early Phase 1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Early Phase 1
Aradign Corportation	Phase 1

See all GASTROCROM clinical trials

Pharmacology for GASTROCROM

Drug Class	Mast Cell Stabilizer
Physiological Effect	Decreased Histamine Release

US Patents and Regulatory Information for GASTROCROM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ucb Inc	GASTROCROM	cromolyn sodium	CAPSULE;ORAL	019188-001	Dec 22, 1989		DISCN	No	No
Mylan Speciality Lp	GASTROCROM	cromolyn sodium	CONCENTRATE;ORAL	020479-001	Feb 29, 1996	AA	RX	Yes	Yes

Expired US Patents for GASTROCROM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	GASTROCROM	cromolyn sodium	CAPSULE;ORAL	019188-001	Dec 22, 1989
Mylan Speciality Lp	GASTROCROM	cromolyn sodium	CONCENTRATE;ORAL	020479-001	Feb 29, 1996
Mylan Speciality Lp	GASTROCROM	cromolyn sodium	CONCENTRATE;ORAL	020479-001	Feb 29, 1996

International Patents for GASTROCROM

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

Country	Patent Number	Title	Estimated Expiration
New Zealand	185240	DOSAGE FORM, METHOD OF PREPARING, AND UNIT DOSAGE FORM OF DISODIUM CROMOGLYCATE
United Kingdom	2086227	SODIUM CROMOGLYCATE RECONSTITUTABLE POWDERS
Japan	H0137369
Australia	508134
Belgium	858858
Malaysia	7700009	PHARMACEUTICAL COMPOSITIONS CONTAINING BISCHROMONYLOXY COMPOUNDS

GASTROCROM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Gastrocrom

Introduction

Gastrocrom, a brand-name prescription drug containing the active ingredient cromolyn sodium, is primarily used to manage mastocytosis, a condition characterized by an excessive number of mast cells in the body. Here, we delve into the market dynamics and financial trajectory of Gastrocrom.

Market Indications and Usage

Gastrocrom is FDA-approved for the management of patients with mastocytosis, including both cutaneous and systemic forms of the disease. It is effective in alleviating symptoms such as diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching[1][3].

Market Demand

The demand for Gastrocrom is driven by the need for effective treatments for mastocytosis, a rare but debilitating condition. Given the specificity of the condition, the market is relatively niche. However, the drug's effectiveness in clinical trials and its approval for use in both adults and children aged 2 years and older contribute to its steady demand[1][3].

Pricing and Cost

The cost of Gastrocrom can be significant, with a supply of 480 milliliters of the oral solution costing around $1,181 for cash-paying customers. However, generic versions of cromolyn sodium are available at a lower cost, approximately $107.42 for the same quantity[2].

Patient Assistance Programs

To mitigate the high cost, various patient assistance programs (PAPs) are available. For example, the Viatris Patient Assistance Program offers cost-free or discounted medicines to individuals who are uninsured or underinsured and meet specific criteria[2].

Insurance and Mail-Order Pharmacies

Gastrocrom may be covered by some insurance plans, and using mail-order pharmacies can help reduce costs and ensure a steady supply of the medication. Some Medicare plans also cover mail-order medications, further aiding in cost management[1][2].

Financial Assistance and Copay Programs

Financial assistance is crucial for many patients. The Medicine Assistance Tool website and other resources list programs that can help lower the cost of Gastrocrom. Additionally, copay cards and discount programs, such as the Drugs.com Discount Card, can save patients up to 80% on prescription costs[1][2].

Clinical Effectiveness and Market Impact

Clinical studies have shown that Gastrocrom is effective in reducing symptoms of mastocytosis, with improvements seen within 2-6 weeks of treatment initiation. This efficacy contributes to its market presence and patient preference, despite the availability of other treatments like chlorpheniramine plus cimetidine[1][3].

Side Effects and Safety Profile

While Gastrocrom is generally well-tolerated, it can cause mild side effects such as irritability, malaise, headache, gastrointestinal problems, rash, itchiness, and muscle pain. Serious side effects, including mental health conditions and allergic reactions, are rare but require immediate medical attention[1][3].

Market Competition

Gastrocrom faces competition from other mast cell stabilizers and treatments for mastocytosis. However, its specific FDA approval and clinical efficacy make it a preferred choice for many patients and healthcare providers.

Regulatory Considerations

Gastrocrom is contraindicated in patients with hypersensitivity to cromolyn sodium. The recommended dosage must be adjusted in patients with impaired renal or hepatic function, and severe anaphylactic reactions are a rare but potential risk[3].

Geriatric Use

Clinical studies did not include sufficient numbers of subjects aged 65 and older to determine if there are differences in responses between the elderly and younger patients. However, dose selection for elderly patients should be cautious, reflecting potential decreased hepatic, renal, or cardiac function[3].

Future Outlook

The market for Gastrocrom is likely to remain stable due to its established efficacy and the ongoing need for effective treatments for mastocytosis. However, factors such as changes in insurance coverage, the development of new treatments, and fluctuations in generic drug pricing could influence its financial trajectory.

Price Growth and Economic Factors

Prescription drug prices, including those for Gastrocrom, can change due to various economic and market factors such as market dynamics, patient access, competition, manufacturing costs, and research and development expenses. These factors can lead to price increases or decreases over time[4].

"Viatris considers various factors when determining WAC pricing to include various considerations reflecting economic and market factors such as market dynamics, patient access, competition, manufacturing, supply, demand, distribution, research and development, and manufacturing and supply costs."[4]

Key Takeaways

• Market Indications: Gastrocrom is FDA-approved for managing mastocytosis in adults and children aged 2 years and older.
• Pricing: The drug is costly, but generic versions and patient assistance programs can reduce the financial burden.
• Clinical Effectiveness: Gastrocrom is effective in alleviating symptoms of mastocytosis, with improvements seen within 2-6 weeks.
• Safety Profile: The drug is generally well-tolerated but can cause mild and rare serious side effects.
• Market Competition: Gastrocrom competes with other treatments but remains a preferred choice due to its efficacy and FDA approval.
• Future Outlook: The market for Gastrocrom is expected to remain stable, influenced by factors such as insurance coverage and the development of new treatments.

FAQs

What is Gastrocrom used for?

Gastrocrom is used to manage mastocytosis, a condition characterized by an excessive number of mast cells in the body, in adults and children aged 2 years and older.

How much does Gastrocrom cost?

The cost of Gastrocrom can be around $1,181 for a 480 milliliter supply, but generic versions are available at a lower cost, approximately $107.42 for the same quantity.

Are there any patient assistance programs for Gastrocrom?

Yes, patient assistance programs such as the Viatris Patient Assistance Program offer cost-free or discounted medicines to eligible individuals.

What are the common side effects of Gastrocrom?

Common side effects include irritability, malaise, headache, gastrointestinal problems, rash, itchiness, and muscle pain. Serious side effects, though rare, can include mental health conditions and allergic reactions.

Can Gastrocrom be used in elderly patients?

Gastrocrom can be used in elderly patients, but dose selection should be cautious due to potential decreased hepatic, renal, or cardiac function.

How effective is Gastrocrom in treating mastocytosis?

Gastrocrom has been shown to be effective in reducing symptoms of mastocytosis, with improvements seen within 2-6 weeks of treatment initiation.

Sources

1. Medical News Today: Gastrocrom: Side effects, uses, cost, dosage, and more.
2. Drugs.com: Gastrocrom Prices, Coupons, Copay Cards & Patient Assistance.
3. Drugs.com: Gastrocrom: Package Insert / Prescribing Information.
4. Minnesota Department of Health: Prescription Drug Price Growth Report Data.