GRANISETRON - Generic Drug Details
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What are the generic drug sources for granisetron and what is the scope of patent protection?
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hikma | GRANISETRON HYDROCHLORIDE | granisetron hydrochloride | INJECTABLE;INJECTION | 077187-001 | Jun 30, 2008 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Fresenius Kabi Usa | GRANISETRON HYDROCHLORIDE | granisetron hydrochloride | INJECTABLE;INJECTION | 078090-001 | Jun 30, 2008 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Heron Theraps Inc | SUSTOL | granisetron | INJECTABLE;SUBCUTANEOUS | 022445-001 | Aug 9, 2016 | RX | Yes | Yes | ⤷ 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 | ||||
Heron Theraps Inc | SUSTOL | granisetron | INJECTABLE;SUBCUTANEOUS | 022445-001 | Aug 9, 2016 | RX | Yes | Yes | ⤷ 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 |
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 |
---|---|---|---|
Austria | 368454 | ⤷ Sign Up | |
Taiwan | I407966 | ⤷ Sign Up | |
Norway | 331441 | ⤷ Sign Up | |
Canada | 2579297 | VEHICULE D'ADMINISTRATION SEMI-SOLIDE ET COMPOSITIONS PHARMACEUTIQUES (SEMI-SOLID DELIVERY VEHICLE AND PHARMACEUTICAL COMPOSITIONS) | ⤷ Sign Up |
Russian Federation | 2005127599 | ТРАНСДЕРМАЛЬНЫЙ ГРАНИЗЕТРОН | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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