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, Aurobindo Pharma, Endo Operations, Intellipharmaceutics, Lupin Ltd, Macleods Pharms Ltd, Novast Labs, 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, Ipca Labs Ltd, Jubilant Generics, Norvium Bioscience, Sandoz, Sun Pharm, Teva Pharms, Torrent Pharms Ltd, and Zennova. and is included in thirty-seven NDAs.
The generic ingredient in QUETIAPINE FUMARATE is quetiapine fumarate. There are fifty-three drug master file entries for this compound. Forty-eight 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.
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Summary for QUETIAPINE FUMARATE
See drug prices 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 202152-006 | Mar 27, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Dr Reddys Labs Ltd | QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 077380-002 | Mar 27, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Novast Labs | QUETIAPINE FUMARATE | quetiapine fumarate | TABLET, EXTENDED RELEASE;ORAL | 208947-005 | Nov 29, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lupin Ltd | QUETIAPINE FUMARATE | quetiapine fumarate | TABLET, EXTENDED RELEASE;ORAL | 204203-005 | May 17, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Torrent Pharms Ltd | QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 200363-004 | Mar 27, 2012 | DISCN | 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 | |||
| Alkem Labs Ltd | QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 201504-001 | Feb 12, 2013 | 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 |
