STRATTERA Drug Patent Profile

When do Strattera patents expire, and when can generic versions of Strattera launch?

Strattera is a drug marketed by Lilly and is included in one NDA.

The generic ingredient in STRATTERA is atomoxetine hydrochloride. There are sixteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the atomoxetine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Strattera

A generic version of STRATTERA was approved as atomoxetine hydrochloride by ZYDUS PHARMS USA INC on September 16^th, 2010.

Summary for STRATTERA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	156
Clinical Trials:	93
Patent Applications:	4,295
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for STRATTERA
Drug Sales Revenues:	Drug sales revenues for STRATTERA
What excipients (inactive ingredients) are in STRATTERA?	STRATTERA excipients list
DailyMed Link:	STRATTERA at DailyMed

See drug prices for STRATTERA

See drug sales revenues for STRATTERA

Recent Clinical Trials for STRATTERA

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

Sponsor	Phase
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2
Brown University	Phase 2
Takeda Development Center Americas, Inc.	Phase 4

See all STRATTERA clinical trials

Pharmacology for STRATTERA

Drug Class	Norepinephrine Reuptake Inhibitor
Mechanism of Action	Norepinephrine Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for STRATTERA

N06BA	Centrally acting sympathomimetics
N06B	PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for STRATTERA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
STRATTERA	Capsules	atomoxetine hydrochloride	10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg	021411	10	2007-05-29

US Patents and Regulatory Information for STRATTERA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-001	Nov 26, 2002		DISCN	No	No
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-007	Feb 14, 2005	AB	RX	Yes	No
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-004	Nov 26, 2002	AB	RX	Yes	No
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-008	Feb 14, 2005	AB	RX	Yes	No
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-002	Nov 26, 2002	AB	RX	Yes	No
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-003	Nov 26, 2002	AB	RX	Yes	No
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-006	Nov 26, 2002	AB	RX	Yes	Yes

Expired US Patents for STRATTERA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-007	Feb 14, 2005
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-003	Nov 26, 2002
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-004	Nov 26, 2002
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-001	Nov 26, 2002
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-008	Feb 14, 2005
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-006	Nov 26, 2002
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-005	Nov 26, 2002

International Patents for STRATTERA

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9621430
Hungary	227306	USE OF TOMOXETIN FOR THE PRODUCTION OF MEDICAMENTS AGAINST ATTENTION-DEFICIT/HYPERACTIVITY DISORDER
China	1168095
Spain	2181845
Czech Republic	292226	Léčivo pro léčení poruchy nedostatku pozornosti/hyperaktivity (Medicament for the treatment of attention deficit/hyperactivity disorder)
Luxembourg	91238
Netherlands	300180

Supplementary Protection Certificates for STRATTERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0721777	CA 2006 00030	Denmark		PRODUCT NAME: ATOMOXETIN, EVENTUELT I FORM AF ET SALT DERAF, SASOM HYDROCHLORIDET
0721777	PA2006006,C0721777	Lithuania		PRODUCT NAME: ATOMOXETINUM HYDROCHLORICUM; NAT. REGISTRATION NO/DATE: LT/1/06/0431/001-LT/01/06/0431/024 20060621; FIRST REGISTRATION: PL 00006/0374-PL 00006/0379 20040527
0721777	10C0041	France		PRODUCT NAME: ATOMOXETINE OPTIONNELLEMENT SOUS FORME D'UN SEL TEL QUE LE CHLORHYDRATE; NAT. REGISTRATION NO/DATE: NL36369 20100628; FIRST REGISTRATION: GB - PL 00006/0374 20040527
0721777	SPC/GB04/033	United Kingdom		PRODUCT NAME: ATOMOXETINE, OPTIONALLY IN THE FORM OF A SALT, SUCH AS THE HYDROCHLORIDE; REGISTERED: UK PL 00006/0374 20040527; UK PL 00006/0375 20040527; UK PL 00006/0376 20040527; UK PL 00006/0377 20040527; UK PL 00006/0378 20040527; UK PL 00006/0379 20040527
0721777	SZ 18/2006	Austria		PRODUCT NAME: ATOMOXETIN, GEGEBENENFALLS IN FORM EINES SALZES, WIE ALS HYDROCHLORID
0721777	91238	Luxembourg		91238, EXPIRES: 20190527
0721777	SPC012/2006	Ireland		SPC012/2006: 20061020, EXPIRES: 20190526