EQUETRO Drug Patent Profile

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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-six 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.

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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:	2,843
Drug Prices:	Drug price information for EQUETRO
What excipients (inactive ingredients) are in EQUETRO?	EQUETRO excipients list
DailyMed Link:	EQUETRO at DailyMed

Drug patent expirations by year 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.

Patents protecting EQUETRO

Methods for the treatment of bipolar disorder using carbamazepine
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: THE RECOMMENDED INITIAL DOSE OF EQUETRO IS 400MG/DAY GIVEN IN DIVIDED DOSES, TWICE DAILY. THE DOSE SHOULD BE ADJUSTED IN 200MG DAILY INCREMENTS TO ACHIEVE OPTIMAL CLINICAL RESPONSE.

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Glossary

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

Expired US Patents for EQUETRO

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-003	Dec 10, 2004	⤷ Sign Up	⤷ Sign Up
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-001	Dec 10, 2004	⤷ Sign Up	⤷ Sign Up
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-002	Dec 10, 2004	⤷ Sign Up	⤷ Sign Up
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-002	Dec 10, 2004	⤷ Sign Up	⤷ Sign Up
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-001	Dec 10, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for EQUETRO

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

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Country	Patent Number	Title	Estimated Expiration
Canada	2114014	SYSTEME D'ADMINISTRATION DE MEDICAMENT ET METHODE POUR TRAITER A L'AIDE DE LA CARBAMAZEPINE LES TROUBLES PSYCHIATRIQUES, NEUROLOGIQUES ET AUTRES (ADVANCED DRUG DELIVERY SYSTEM AND METHOD OF TREATING PSYCHIATRIC, NEUROLOGICAL AND OTHER DISORDERS WITH CARBAMAZEPINE)	⤷ Sign Up
Denmark	0660705		⤷ Sign Up
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)	⤷ Sign Up
Japan	3806740		⤷ Sign Up
Germany	69230112		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration