GRANISETRON HYDROCHLORIDE Drug Patent Profile
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Which patents cover Granisetron Hydrochloride, and what generic alternatives are available?
Granisetron Hydrochloride is a drug marketed by Am Regent, Amneal, Baxter Hlthcare Corp, Bionpharma, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Mylan Asi, Norvium Bioscience, Rising, Sandoz, Sandoz Inc, Teva Pharms Usa, Wockhardt Usa, Yung Shin Pharm, Apotex Inc, Aurobindo Pharma Usa, Barr, Chartwell Molecular, Dr Reddys Labs Ltd, Natco Pharma, Orbion Pharms, Taro, and Teva Pharms. and is included in forty-six NDAs.
The generic ingredient in GRANISETRON HYDROCHLORIDE is granisetron hydrochloride. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Granisetron Hydrochloride
A generic version of GRANISETRON HYDROCHLORIDE was approved as granisetron hydrochloride by AMNEAL on December 31st, 2007.
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Summary for GRANISETRON HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 27 |
| NDAs: | 46 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 116 |
| Clinical Trials: | 125 |
| Patent Applications: | 2,030 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for GRANISETRON HYDROCHLORIDE |
| DailyMed Link: | GRANISETRON HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for GRANISETRON HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Phase 4 |
| Guangxi Medical University | Phase 3 |
| Heron Therapeutics | Phase 4 |
Pharmacology for GRANISETRON HYDROCHLORIDE
| Drug Class | Serotonin-3 Receptor Antagonist |
| Mechanism of Action | Serotonin 3 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for GRANISETRON HYDROCHLORIDE
Paragraph IV (Patent) Challenges for GRANISETRON HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| KYTRIL | Injection | granisetron hydrochloride | 0.1 mg/mL, 1 mL single dose vial | 020239 | 1 | 2007-03-08 |
| KYTRIL | Injection | granisetron hydrochloride | 1 mg/mL, 4 mL multi-dose vials | 020239 | 1 | 2004-07-19 |
| KYTRIL | Injection | granisetron hydrochloride | 1 mg/mL, 1 mL vials | 020239 | 1 | 2004-06-01 |
US Patents and Regulatory Information for GRANISETRON HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Yung Shin Pharm | GRANISETRON HYDROCHLORIDE | granisetron hydrochloride | INJECTABLE;INJECTION | 202647-001 | Mar 6, 2020 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sandoz | GRANISETRON HYDROCHLORIDE | granisetron hydrochloride | INJECTABLE;INJECTION | 078808-001 | Apr 29, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Epic Pharma Llc | GRANISETRON HYDROCHLORIDE | granisetron hydrochloride | TABLET;ORAL | 078260-001 | Dec 31, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aurobindo Pharma Usa | GRANISETRON HYDROCHLORIDE | granisetron hydrochloride | TABLET;ORAL | 078725-001 | Jan 30, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma | GRANISETRON HYDROCHLORIDE | granisetron hydrochloride | TABLET;ORAL | 077842-001 | Dec 31, 2007 | DISCN | 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 |
