STRATTERA Drug Patent Profile
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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 16th, 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 |
Recent Clinical Trials for STRATTERA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Brown University | Phase 2 |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Phase 2 |
Takeda Development Center Americas, Inc. | Phase 4 |
Pharmacology for STRATTERA
Drug Class | Norepinephrine Reuptake Inhibitor |
Mechanism of Action | Norepinephrine Uptake Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for STRATTERA
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Lilly | STRATTERA | atomoxetine hydrochloride | CAPSULE;ORAL | 021411-007 | Feb 14, 2005 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Lilly | STRATTERA | atomoxetine hydrochloride | CAPSULE;ORAL | 021411-004 | Nov 26, 2002 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Lilly | STRATTERA | atomoxetine hydrochloride | CAPSULE;ORAL | 021411-008 | Feb 14, 2005 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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 STRATTERA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Lilly | STRATTERA | atomoxetine hydrochloride | CAPSULE;ORAL | 021411-007 | Feb 14, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Lilly | STRATTERA | atomoxetine hydrochloride | CAPSULE;ORAL | 021411-003 | Nov 26, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Lilly | STRATTERA | atomoxetine hydrochloride | CAPSULE;ORAL | 021411-004 | Nov 26, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Lilly | STRATTERA | atomoxetine hydrochloride | CAPSULE;ORAL | 021411-001 | Nov 26, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for STRATTERA
See the table below for patents covering STRATTERA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Mexico | 9705117 | USO DE TOMOXETINA PARA LA FABRICACION DE UN MEDICAMENTO PARA EL TRATAMIENTO DEL DESORDEN DE DEFICIT DE LA ATENCION/HIPERACTIVIDAD. (TREATMENT OF ATTENTION-DEFICIT/HYPERACTIVITY DISORDER.) | ⤷ Try a Trial |
Slovenia | 0721777 | ⤷ Try a Trial | |
Turkey | 9700627 | ⤷ Try a Trial | |
Austria | 222757 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for STRATTERA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0721777 | SPC/GB04/033 | United Kingdom | ⤷ Try a Trial | 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 | C00721777/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: ATOMOXETIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58245 08.04.2009 |
0721777 | PA2006006 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ATOMOXETINUM HYDROCHLORICUM; REG. NO/DATE: PL 00006/0374-0379 20040527 |
0721777 | SZ 18/2006 | Austria | ⤷ Try a Trial | PRODUCT NAME: ATOMOXETIN, GEGEBENENFALLS IN FORM EINES SALZES, WIE ALS HYDROCHLORID |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |