EQUETRO Drug Patent Profile

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

Equetro is a drug marketed by Validus Pharms and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has one patent family member in one country.

The generic ingredient in EQUETRO is carbamazepine. There are twenty-seven drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Equetro

A generic version of EQUETRO was approved as carbamazepine by TARO on October 3^rd, 1996.

Summary for EQUETRO

International Patents:	1
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	163
Clinical Trials:	4
Patent Applications:	4,299
Drug Prices:	Drug price information for EQUETRO
What excipients (inactive ingredients) are in EQUETRO?	EQUETRO excipients list
DailyMed Link:	EQUETRO at DailyMed

See drug prices for EQUETRO

Recent Clinical Trials for EQUETRO

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

Sponsor	Phase
Validus Pharmaceuticals	Phase 4
Creighton University	Phase 4
Tuscaloosa Research & Education Advancement Corporation	Phase 4

See all EQUETRO clinical trials

Pharmacology for EQUETRO

Drug Class	Mood Stabilizer
Mechanism of Action	Cytochrome P450 1A2 Inducers Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Paragraph IV (Patent) Challenges for EQUETRO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EQUETRO	Extended-release Capsules	carbamazepine	100 mg	021710	1	2014-05-23
EQUETRO	Extended-release Capsules	carbamazepine	200 mg and 300 mg	021710	1	2007-08-21

US Patents and Regulatory Information for EQUETRO

EQUETRO is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-001	Dec 10, 2004		RX	Yes	No	6,977,253
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-002	Dec 10, 2004		RX	Yes	No	6,977,253
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-003	Dec 10, 2004		RX	Yes	Yes	6,977,253

Expired US Patents for EQUETRO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-002	Dec 10, 2004	5,912,013
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-003	Dec 10, 2004	6,977,253
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-001	Dec 10, 2004	5,326,570
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-003	Dec 10, 2004	5,326,570
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-002	Dec 10, 2004	6,977,253
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-002	Dec 10, 2004	5,326,570
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-001	Dec 10, 2004	6,977,253

International Patents for EQUETRO

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9301804
Germany	69230112
Japan	H06511484
Austria	185268
European Patent Office	0660705	SYSTEME ET METHODE PERFECTIONNES D'ADMINISTRATION DE MEDICAMENTS ET DE TRAITEMENT DES AFFECTIONS PSYCHIATRIQUES, NEUROLOGIQUES ET AUTRES AVEC LA CARBAMAZEPINE (ADVANCED DRUG DELIVERY SYSTEM AND METHOD OF TREATING PSYCHIATRIC, NEUROLOGICAL AND OTHER DISORDERS WITH CARBAMAZEPINE)
Canada	2452588	METHODE DE TRAITEMENT DE TROUBLES AFFECTIFS BIPOLAIRES A L'AIDE DE CARBAMAZEPINE (METHODS FOR THE TREATMENT OF BIPOLAR DISORDER USING CARBAMAZEPINE)
Japan	3806740

EQUETRO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for EQUETRO (Carbamazepine XR)

Introduction

EQUETRO, an extended-release formulation of carbamazepine, is a versatile medication used in the treatment of various neurological and psychiatric conditions, including bipolar I disorder, trigeminal neuralgia, and several types of seizures. Understanding the market dynamics and financial trajectory of EQUETRO is crucial for pharmaceutical companies, investors, and healthcare providers.

Indications and Usage

EQUETRO is indicated for the treatment of acute manic or mixed episodes associated with bipolar I disorder, pain associated with trigeminal neuralgia, and as an anti-epileptic drug for partial seizures with complex symptomatology, generalized tonic-clonic seizures, and mixed seizures[4].

Market Size and Growth

The market for anticonvulsant and mood-stabilizing medications is substantial and growing. The demand for extended-release formulations like EQUETRO is driven by the need for more convenient and adherence-friendly treatment options. The global anticonvulsant market is expected to grow due to increasing prevalence of neurological disorders and advancements in drug formulations.

Competitive Landscape

EQUETRO operates in a competitive landscape dominated by other anticonvulsant and mood-stabilizing medications. However, its extended-release formulation provides a unique selling point, enhancing patient compliance and reducing the frequency of dosing. The competition is intense, with other pharmaceutical companies developing similar extended-release formulations, but EQUETRO's established brand and clinical efficacy maintain its market position[1][4].

Pricing and Revenue

The pricing of EQUETRO is a critical factor in its market dynamics. While the drug is generally priced higher than some immediate-release formulations, its extended-release benefits can justify the cost for many patients and healthcare providers. The revenue generated from EQUETRO is significant, contributing to the overall financial health of the pharmaceutical companies that manufacture and distribute it.

Financial Performance

The financial performance of EQUETRO is tied to the broader financial health of its manufacturing and distributing companies. For instance, the revenue from prescription medications like EQUETRO contributes to the operating income and net investment income of these companies. However, detailed financial data specific to EQUETRO is not publicly disclosed, but it is part of the larger pharmaceutical market that sees significant investment and revenue[2].

Supply and Demand

Ensuring a stable supply of EQUETRO is crucial for maintaining market share. Similar to other high-demand medications, EQUETRO can face supply chain challenges, particularly if demand outstrips production capacity. Manufacturers must balance production with demand to avoid shortages, which can impact patient care and market reputation[3].

Regulatory Environment

The regulatory environment plays a vital role in the market dynamics of EQUETRO. Regulatory approvals and updates, such as changes in warnings and precautions, can influence prescribing patterns and patient safety. For example, recent updates to the warnings and precautions section of EQUETRO's labeling highlight the importance of monitoring for significant bone marrow depression[4].

Patient Compliance and Adherence

Extended-release formulations like EQUETRO are designed to improve patient compliance by reducing the frequency of dosing. This can lead to better therapeutic outcomes and increased patient satisfaction. Improved compliance also translates into higher market demand and revenue for the drug.

Side Effects and Safety Profile

EQUETRO has a well-documented side effect profile, which includes dizziness, somnolence, nausea, vomiting, and ataxia among others. The safety profile, while generally favorable, requires careful monitoring, especially for rare but serious side effects like aplastic anemia and agranulocytosis[1][4].

Switching from Immediate-Release to Extended-Release

Switching patients from immediate-release carbamazepine to EQUETRO requires careful management to ensure therapeutic equivalence. The same total daily dose of carbamazepine should be administered, and patients should be closely monitored for seizure control and other therapeutic responses[1][4].

Discontinuation

Discontinuing EQUETRO should be done gradually to avoid abrupt discontinuation, which can increase the risk of seizures. This careful discontinuation process is crucial for maintaining patient safety and preventing adverse outcomes[1][4].

Market Projections

The market for anticonvulsant and mood-stabilizing medications is projected to grow, driven by increasing prevalence of neurological and psychiatric disorders. EQUETRO, with its extended-release formulation, is well-positioned to capture a significant share of this growing market.

Key Takeaways

• Indications: EQUETRO is used for bipolar I disorder, trigeminal neuralgia, and various types of seizures.
• Market Growth: The market is driven by increasing prevalence of neurological disorders and the need for convenient treatment options.
• Pricing and Revenue: EQUETRO's pricing is justified by its extended-release benefits, contributing significantly to pharmaceutical company revenues.
• Supply and Demand: Ensuring stable supply is crucial to maintain market share and patient care.
• Regulatory Environment: Regulatory updates can influence prescribing patterns and patient safety.
• Patient Compliance: Extended-release formulation improves patient compliance and therapeutic outcomes.

FAQs

What are the primary indications for EQUETRO?

EQUETRO is indicated for the treatment of acute manic or mixed episodes associated with bipolar I disorder, pain associated with trigeminal neuralgia, and as an anti-epileptic drug for partial seizures with complex symptomatology, generalized tonic-clonic seizures, and mixed seizures[4].

How does EQUETRO differ from immediate-release carbamazepine?

EQUETRO is an extended-release formulation, allowing for twice-daily administration compared to the more frequent dosing required for immediate-release carbamazepine[1][4].

What are the common side effects of EQUETRO?

Common side effects include dizziness, somnolence, nausea, vomiting, ataxia, and others. Rare but serious side effects include aplastic anemia and agranulocytosis[1][4].

How should patients be switched from immediate-release to EQUETRO?

Patients should be switched to the same total daily dose of carbamazepine, and closely monitored for therapeutic responses and seizure control[1][4].

Why is gradual discontinuation of EQUETRO important?

Gradual discontinuation is important to avoid abrupt discontinuation, which can increase the risk of seizures[1][4].

Sources

1. RxList: Equetro (Carbamazepine XR): Side Effects, Uses, Dosage...
2. BlackRock TCP Capital Corp.: FORM 10-Q
3. Goldman Sachs: Weighing the GLP-1 market
4. DailyMed: EQUETRO- carbamazepine capsule, extended release