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.
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Questions you can ask:
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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: | 3,936 |
| 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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Lilly | STRATTERA | atomoxetine hydrochloride | CAPSULE;ORAL | 021411-007 | Feb 14, 2005 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lilly | STRATTERA | atomoxetine hydrochloride | CAPSULE;ORAL | 021411-004 | Nov 26, 2002 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lilly | STRATTERA | atomoxetine hydrochloride | CAPSULE;ORAL | 021411-008 | Feb 14, 2005 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 | 021411-001 | Nov 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Lilly | STRATTERA | atomoxetine hydrochloride | CAPSULE;ORAL | 021411-004 | Nov 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Lilly | STRATTERA | atomoxetine hydrochloride | CAPSULE;ORAL | 021411-005 | Nov 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Lilly | STRATTERA | atomoxetine hydrochloride | CAPSULE;ORAL | 021411-008 | Feb 14, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Germany | 122005000011 | ⤷ Sign Up | |
| Romania | 118374 | UTILIZAREA TOMOXETINEI IN TRATAMENTUL TULBURARILOR DE TIP HIPERACTIVITATE CU DEFICIT DE ATENTIE (USE OF TOMOXETINE FOR THE TREATMENT OF THE HYPERACTIVITY-TYPE DISORDERS WITH ATTENTION DEFICIT) | ⤷ Sign Up |
| Netherlands | 300180 | ⤷ Sign Up | |
| 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.) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for STRATTERA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0721777 | SPC012/2006 | Ireland | ⤷ Sign Up | SPC012/2006: 20061020, EXPIRES: 20190526 |
| 0721777 | PA2006006,C0721777 | Lithuania | ⤷ Sign Up | 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 | C00721777/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: ATOMOXETIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58245 08.04.2009 |
| 0721777 | 300180 | Netherlands | ⤷ Sign Up | 300180, 20160109, 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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