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 |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Phase 2 |
| Brown University | 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 | |||
| >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 | 021411-005 | Nov 26, 2002 | ⤷ 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 | 021411-001 | 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 |
|---|---|---|---|
| Hungary | 9801283 | ⤷ Try a Trial | |
| Hungary | 227306 | USE OF TOMOXETIN FOR THE PRODUCTION OF MEDICAMENTS AGAINST ATTENTION-DEFICIT/HYPERACTIVITY DISORDER | ⤷ Try a Trial |
| China | 1781480 | ⤷ 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 | SZ 18/2006 | Austria | ⤷ Try a Trial | PRODUCT NAME: ATOMOXETIN, GEGEBENENFALLS IN FORM EINES SALZES, WIE ALS HYDROCHLORID |
| 0721777 | C00721777/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: ATOMOXETIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58245 08.04.2009 |
| 0721777 | SPC012/2006 | Ireland | ⤷ Try a Trial | SPC012/2006: 20061020, EXPIRES: 20190526 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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