TWINJECT 0.3 Drug Patent Profile

Which patents cover Twinject 0.3, and when can generic versions of Twinject 0.3 launch?

Twinject 0.3 is a drug marketed by Impax and is included in one NDA.

The generic ingredient in TWINJECT 0.3 is epinephrine. There are twenty-one drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the epinephrine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Twinject 0.3

A generic version of TWINJECT 0.3 was approved as epinephrine by BPI LABS on July 29^th, 2014.

Summary for TWINJECT 0.3

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	1
Patent Applications:	4,529
Formulation / Manufacturing:	see details
DailyMed Link:	TWINJECT 0.3 at DailyMed

Recent Clinical Trials for TWINJECT 0.3

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

Sponsor	Phase
University of Louisville	Phase 4
Arthroplasty Foundation, Inc.	Phase 4

See all TWINJECT 0.3 clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for TWINJECT 0.3

A01AD	Other agents for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

B02BC	Local hemostatics
B02B	VITAMIN K AND OTHER HEMOSTATICS
B02	ANTIHEMORRHAGICS
B	Blood and blood forming organs

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03AA	Alpha- and beta-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

S01EA	Sympathomimetics in glaucoma therapy
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for TWINJECT 0.3

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax	TWINJECT 0.3	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-001	May 30, 2003		DISCN	No	No

International Patents for TWINJECT 0.3

See the table below for patents covering TWINJECT 0.3 around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2012103130
Canada	2163005	SYSTEME D'INJECTION D'URGENCE, RECHARGEABLE, AUTOMATIQUE OU MANUEL (RELOADABLE AUTOMATIC OR MANUAL EMERGENCY INJECTION SYSTEM)
Norway	20080672