QUETIAPINE FUMARATE Drug Patent Profile
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When do Quetiapine Fumarate patents expire, and what generic alternatives are available?
Quetiapine Fumarate is a drug marketed by Accord Hlthcare, Alignscience Pharma, Amneal Pharms, Anchen Pharms, Aurobindo Pharma, Intellipharmaceutics, Lupin Ltd, Macleods Pharms Ltd, Novast Labs, Par Pharm, Pharmadax Inc, Prinston Inc, Rising, Sciegen Pharms Inc, Unichem, Actavis Grp Ptc, Alembic, Alkem Labs Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma, Jubilant Generics, Mylan Pharms Inc, Sandoz, Sun Pharm, Teva Pharms, Torrent Pharms Ltd, and Zennova. and is included in thirty-six NDAs.
The generic ingredient in QUETIAPINE FUMARATE 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 Quetiapine Fumarate
A generic version of QUETIAPINE FUMARATE was approved as quetiapine fumarate by ACCORD HLTHCARE on March 27th, 2012.
Summary for QUETIAPINE FUMARATE
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Actavis Grp Ptc | QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 201762-001 | Feb 27, 2013 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Dr Reddys Labs Ltd | QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 077380-003 | Mar 27, 2012 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Par Pharm | QUETIAPINE FUMARATE | quetiapine fumarate | TABLET, EXTENDED RELEASE;ORAL | 090482-005 | May 9, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Novast Labs | QUETIAPINE FUMARATE | quetiapine fumarate | TABLET, EXTENDED RELEASE;ORAL | 208947-001 | Nov 29, 2017 | AB | RX | No | 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 |