SEROQUEL Drug Patent Profile
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When do Seroquel patents expire, and when can generic versions of Seroquel launch?
Seroquel is a drug marketed by Astrazeneca and is included in two NDAs.
The generic ingredient in SEROQUEL is quetiapine fumarate. There are fifty-three drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Seroquel
A generic version of SEROQUEL was approved as quetiapine fumarate by ACCORD HLTHCARE on March 27th, 2012.
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Summary for SEROQUEL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 81 |
| Clinical Trials: | 192 |
| Patent Applications: | 5,414 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SEROQUEL |
| Drug Sales Revenues: | Drug sales revenues for SEROQUEL |
| What excipients (inactive ingredients) are in SEROQUEL? | SEROQUEL excipients list |
| DailyMed Link: | SEROQUEL at DailyMed |
Recent Clinical Trials for SEROQUEL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ain Shams University | N/A |
| University of Miami | Phase 4 |
| Alzheimer's Association | Phase 4 |
Pharmacology for SEROQUEL
| Drug Class | Atypical Antipsychotic |
Paragraph IV (Patent) Challenges for SEROQUEL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| SEROQUEL | Tablets | quetiapine fumarate | 50 mg, 150 mg and 400 mg | 020639 | 1 | 2007-02-12 |
| SEROQUEL | Tablets | quetiapine fumarate | 100 mg, 200 mg and 300 mg | 020639 | 1 | 2006-02-21 |
| SEROQUEL | Tablets | quetiapine fumarate | 25 mg | 020639 | 1 | 2005-08-12 |
US Patents and Regulatory Information for SEROQUEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca | SEROQUEL | quetiapine fumarate | TABLET;ORAL | 020639-001 | Sep 26, 1997 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Astrazeneca | SEROQUEL | quetiapine fumarate | TABLET;ORAL | 020639-006 | Oct 4, 2005 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Astrazeneca | SEROQUEL | quetiapine fumarate | TABLET;ORAL | 020639-004 | Dec 20, 1998 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Astrazeneca | SEROQUEL XR | quetiapine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022047-004 | May 17, 2007 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Astrazeneca | SEROQUEL XR | quetiapine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022047-001 | May 17, 2007 | 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 SEROQUEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca | SEROQUEL | quetiapine fumarate | TABLET;ORAL | 020639-003 | Sep 26, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | SEROQUEL | quetiapine fumarate | TABLET;ORAL | 020639-005 | Jul 26, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | SEROQUEL | quetiapine fumarate | TABLET;ORAL | 020639-001 | Sep 26, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | SEROQUEL | quetiapine fumarate | TABLET;ORAL | 020639-006 | Oct 4, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | SEROQUEL | quetiapine fumarate | TABLET;ORAL | 020639-002 | Sep 26, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SEROQUEL
See the table below for patents covering SEROQUEL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | 58132 | ⤷ Sign Up | |
| South Korea | 900001868 | ⤷ Sign Up | |
| Japan | S638378 | DIBENZOTHIAZEPINE COMPOUND, MANUFACTURE AND PHARMACEUTICAL COMPOSITION HAVING ANTIPSYCHOTIC AND NEUROLEPTIC ACTIVITY | ⤷ Sign Up |
| Zimbabwe | 5787 | THIAZEPINE COMPOUNDS | ⤷ Sign Up |
| Germany | 3765969 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SEROQUEL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0240228 | SPC/GB97/086 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: QUETIAPINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY-ACCEPTABLE SALT; REGISTERED: UK 12619/0112 19970731; UK 12619/0113 19970731; UK 12619/0114 19970731 |
| 0240228 | 2000C/015 | Belgium | ⤷ Sign Up | PRODUCT NAME: QUETIAPINE FUMARAT (EQUIV. MET 25MG QUETIAPINE BASE); REGISTRATION NO/DATE: 624 S 309 F 3 20000207; FIRST REGISTRATION: GB PL 12619/0113 19970731 |
| 0240228 | 9/2000 | Austria | ⤷ Sign Up | PRODUCT NAME: QUETIAPIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ZULAESSIGEN SALZES; NAT. REGISTRATION NO/DATE: 1-23460, 1-23461 1-23463 20000113; FIRST REGISTRATION: GB 12619/0112 - 12619/0114 19970731 |
| 0240228 | C980022 | Netherlands | ⤷ Sign Up | PRODUCT NAME: QUETIAPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR DBAAR ZOUT, IN HET BIJZONDER QUETIAPINEFUMARAAT; NAT. REGISTRATION NO/DATE: RVG 20826 - RVG 20828 19980427; FIRST REGISTRATION: GB PL 12619/0112 - PL 12619/0114 19970731 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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