Quetiapine fumarate - Generic Drug Details
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What are the generic drug sources for quetiapine fumarate and what is the scope of patent protection?
Quetiapine fumarate
is the generic ingredient in three branded drugs marketed by Accord Hlthcare, Alignscience Pharma, Amneal Pharms, Aurobindo Pharma, Endo Operations, Intellipharmaceutics, Lupin Ltd, Macleods Pharms Ltd, Novast Labs, Pharmadax Inc, Prinston Inc, Rising, Sciegen Pharms Inc, Unichem, Astrazeneca, Actavis Grp Ptc, Alembic, Alkem Labs Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma, Ipca Labs Ltd, Jubilant Generics, Norvium Bioscience, Sandoz, Sun Pharm, Teva Pharms, and Torrent Pharms Ltd, and is included in thirty-nine NDAs. Additional information is available in the individual branded drug profile pages.There are forty-eight drug master file entries for quetiapine fumarate. Fifty-one suppliers are listed for this compound.
Summary for quetiapine fumarate
US Patents: | 0 |
Tradenames: | 3 |
Applicants: | 29 |
NDAs: | 39 |
Drug Master File Entries: | 48 |
Finished Product Suppliers / Packagers: | 51 |
Raw Ingredient (Bulk) Api Vendors: | 207 |
Clinical Trials: | 97 |
Patent Applications: | 4,253 |
Drug Prices: | Drug price trends for quetiapine fumarate |
Drug Sales Revenues: | Drug sales revenues for quetiapine fumarate |
What excipients (inactive ingredients) are in quetiapine fumarate? | quetiapine fumarate excipients list |
DailyMed Link: | quetiapine fumarate at DailyMed |
Recent Clinical Trials for quetiapine fumarate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
The University of Texas Health Science Center at San Antonio | Early Phase 1 |
Haining Health-Coming Biotech Co., Ltd. | Phase 2 |
Alphacait, LLC | Phase 2 |
Pharmacology for quetiapine fumarate
Drug Class | Atypical Antipsychotic |
Medical Subject Heading (MeSH) Categories for quetiapine fumarate
Anatomical Therapeutic Chemical (ATC) Classes for quetiapine fumarate
Paragraph IV (Patent) Challenges for QUETIAPINE FUMARATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
SEROQUEL XR | Extended-release Tablets | quetiapine fumarate | 150 mg | 022047 | 1 | 2008-11-17 |
SEROQUEL XR | Extended-release Tablets | quetiapine fumarate | 50 mg | 022047 | 1 | 2008-10-17 |
SEROQUEL XR | Extended-release Tablets | quetiapine fumarate | 400 mg | 022047 | 1 | 2008-06-18 |
SEROQUEL XR | Extended-release Tablets | quetiapine fumarate | 200 mg and 300 mg | 022047 | 1 | 2008-06-12 |
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 quetiapine fumarate
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 | 020639-005 | Jul 26, 2000 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Aurobindo Pharma | QUETIAPINE FUMARATE | quetiapine fumarate | TABLET, EXTENDED RELEASE;ORAL | 207655-004 | Nov 29, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Lupin Ltd | QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 201109-005 | Mar 27, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Teva Pharms | QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 077745-001 | Mar 27, 2012 | AB | RX | No | 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 quetiapine fumarate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astrazeneca | SEROQUEL | quetiapine fumarate | TABLET;ORAL | 020639-006 | Oct 4, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | SEROQUEL XR | quetiapine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022047-003 | May 17, 2007 | ⤷ 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 | 020639-007 | Oct 4, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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