SEROQUEL Drug Patent Profile
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Which patents cover Seroquel, and what generic alternatives are available?
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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Questions you can ask:
- What is the 5 year forecast for SEROQUEL?
- What are the global sales for SEROQUEL?
- What is Average Wholesale Price for SEROQUEL?
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: | 5,318 |
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 |
![SEROQUEL drug patent expirations Drug patent expirations by year for SEROQUEL](/p/graph/s/t/SEROQUEL-patent-expirations.png)
![Drug Prices for SEROQUEL](/p/graph/drug-price/SEROQUEL.png)
![Drug Sales Revenue Trends for SEROQUEL](/p/graph/drug-sales-revenues/SEROQUEL.png)
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 | |||
Astrazeneca | SEROQUEL | quetiapine fumarate | TABLET;ORAL | 020639-007 | Oct 4, 2005 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Astrazeneca | SEROQUEL | quetiapine fumarate | TABLET;ORAL | 020639-002 | Sep 26, 1997 | 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 | 020639-004 | Dec 20, 1998 | ⤷ 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 |
Astrazeneca | SEROQUEL | quetiapine fumarate | TABLET;ORAL | 020639-007 | Oct 4, 2005 | ⤷ Sign Up | ⤷ Sign Up |
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 |
>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 |
---|---|---|---|
German Democratic Republic | 259403 | VERFAHREN ZUR HERSTELLUNG EINER DIHENZOTHIOZEPINVERBINDUNG | ⤷ Sign Up |
Japan | H064606 | ⤷ Sign Up | |
Zambia | 2987 | THIAZEPINE COMPOUNDS | ⤷ Sign Up |
Germany | 10075016 | ⤷ Sign Up | |
Malawi | 2087 | THIAZEPINE COMPOUNDS | ⤷ Sign Up |
Denmark | 158587 | ⤷ Sign Up | |
United Kingdom | 8607684 | ⤷ 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 | 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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |