Granisetron - Generic Drug Details
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What are the generic drug sources for granisetron and what is the scope of freedom to operate?
Granisetron
is the generic ingredient in six branded drugs marketed by Cumberland, Heron Theraps Inc, 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, Roche, Intra Sana Labs, Apotex Inc, Aurobindo Pharma Usa, Barr, Chartwell Molecular, Dr Reddys Labs Ltd, Natco Pharma, Orbion Pharms, Taro, and Teva Pharms, and is included in fifty-two NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Granisetron has fifty-eight patent family members in thirty-two countries.
There are twenty-six drug master file entries for granisetron. Two suppliers are listed for this compound.
Summary for granisetron
International Patents: | 58 |
US Patents: | 6 |
Tradenames: | 6 |
Applicants: | 31 |
NDAs: | 52 |
Drug Master File Entries: | 26 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 51 |
Clinical Trials: | 125 |
Patent Applications: | 7,564 |
Drug Prices: | Drug price trends for granisetron |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for granisetron |
What excipients (inactive ingredients) are in granisetron? | granisetron excipients list |
DailyMed Link: | granisetron at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for granisetron
Generic Entry Date for granisetron*:
Constraining patent/regulatory exclusivity:
Dosage:
FILM, EXTENDED RELEASE;TRANSDERMAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for granisetron
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
Drug Class | Serotonin-3 Receptor Antagonist |
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for granisetron
Anatomical Therapeutic Chemical (ATC) Classes for granisetron
Paragraph IV (Patent) Challenges for GRANISETRON
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
SANCUSO | Transdermal System | granisetron | 3.1 mg/24 hrs | 022198 | 1 | 2015-10-09 |
US Patents and Regulatory Information for granisetron
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Eugia Pharma | GRANISETRON HYDROCHLORIDE | granisetron hydrochloride | INJECTABLE;INJECTION | 204238-001 | Jul 6, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Chartwell Molecular | GRANISETRON HYDROCHLORIDE | granisetron hydrochloride | TABLET;ORAL | 078037-001 | Feb 27, 2008 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Rising | GRANISETRON HYDROCHLORIDE | granisetron hydrochloride | INJECTABLE;INJECTION | 079078-001 | Sep 14, 2009 | AP | 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 granisetron
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Heron Theraps Inc | SUSTOL | granisetron | INJECTABLE;SUBCUTANEOUS | 022445-001 | Aug 9, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Heron Theraps Inc | SUSTOL | granisetron | INJECTABLE;SUBCUTANEOUS | 022445-001 | Aug 9, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Heron Theraps Inc | SUSTOL | granisetron | INJECTABLE;SUBCUTANEOUS | 022445-001 | Aug 9, 2016 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for granisetron
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Kyowa Kirin Holdings B.V. | Sancuso | granisetron | EMEA/H/C/002296 Prevention of nausea and vomiting in patients receiving moderately or highly emetogenic chemotherapy, with or without cisplatin, for up to five consecutive days.Sancuso may be used in patients receiving their first chemotherapy regimen or in patients who have previously received chemotherapy. |
Authorised | no | no | no | 2012-04-20 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for granisetron
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 6057972 | ⤷ Sign Up | |
Poland | 218351 | ⤷ Sign Up | |
China | 1747724 | Transdermal granisetron | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.