KARBINAL ER Drug Patent Profile

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

Karbinal Er is a drug marketed by Aytu and is included in one NDA. There are two patents protecting this drug.

This drug has twenty-one patent family members in fourteen countries.

The generic ingredient in KARBINAL ER is carbinoxamine maleate. There are seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the carbinoxamine maleate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Karbinal Er

A generic version of KARBINAL ER was approved as carbinoxamine maleate by GENUS on March 19^th, 2003.

Summary for KARBINAL ER

International Patents:	21
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Patent Applications:	1,287
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for KARBINAL ER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KARBINAL ER
DailyMed Link:	KARBINAL ER at DailyMed

See drug prices for KARBINAL ER

See drug sales revenues for KARBINAL ER

Pharmacology for KARBINAL ER

Drug Class	Histamine-1 Receptor Antagonist
Mechanism of Action	Histamine H1 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for KARBINAL ER

R06AA	Aminoalkyl ethers
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

US Patents and Regulatory Information for KARBINAL ER

KARBINAL ER is protected by two US patents.

Patents protecting KARBINAL ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aytu	KARBINAL ER	carbinoxamine maleate	SUSPENSION, EXTENDED RELEASE;ORAL	022556-001	Mar 28, 2013		RX	Yes	Yes			Y
Aytu	KARBINAL ER	carbinoxamine maleate	SUSPENSION, EXTENDED RELEASE;ORAL	022556-001	Mar 28, 2013		RX	Yes	Yes			Y

International Patents for KARBINAL ER

See the table below for patents covering KARBINAL ER around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2435569	КОМПОЗИЦИИ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ ЛЕКАРСТВЕННОЕ ВЕЩЕСТВО - ИОНООБМЕННАЯ СМОЛА (COMPOSITIONS WITH MODIFIED RELEASE, CONTAINING COMPLEXES MEDICATION-ION-EXCHANGING RESIN)
China	102488652	Modified release formulations containing drug-ion exchange resin complexes
Russian Federation	2008140944	КОМПОЗИЦИИ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ ЛЕКАРСТВЕННОЕ ВЕЩЕСТВО-ИОНООБМЕННАЯ СМОЛА
Japan	2009530298
Spain	2378573
European Patent Office	2018160	FORMULATIONS A LIBERATION MODIFIEE CONTENANT DES COMPLEXES MEDICAMENT - RESINE ECHANGEUSE D'IONS (MODIFIED RELEASE FORMULATIONS CONTAINING DRUG-ION EXCHANGE RESIN COMPLEXES)