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Serving leading biopharmaceutical companies globally:

UBS
Boehringer Ingelheim
Federal Trade Commission
Cipla
Deloitte
Medtronic
McKesson
Chinese Patent Office
Moodys
Dow

Generated: January 18, 2018

DrugPatentWatch Database Preview

Granisetron - Generic Drug Details

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What are the generic drug sources for granisetron and what is the scope of granisetron patent protection?

Granisetron
is the generic ingredient in six branded drugs marketed by Kyowa Kirin, Heron Theraps Inc, Akorn Inc, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Bionpharma Inc, Cipla Ltd, Fresenius Kabi Usa, Hikma Farmaceutica, Luitpold, Mylan Labs Ltd, Sagent Agila, Sagent Strides, Sandoz Inc, Teva Pharms Usa, West-ward Pharms Int, Wockhardt Usa, Roche, Pediatrx, Apotex Inc, Barr, Dr Reddys Labs Ltd, Epic Pharma Llc, Mylan, Natco Pharma, Orchid Hlthcare, Taro Pharm, and Teva Pharms, and is included in fifty NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Granisetron has fifty-six patent family members in thirty-two countries.

There are twenty-six drug master file entries for granisetron. Three suppliers are listed for this compound.
Pharmacology for granisetron
Medical Subject Heading (MeSH) Categories for granisetron

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
Sandoz Inc GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078531-001 Apr 30, 2009 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Labs Ltd GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 203454-002 Apr 4, 2017 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
West-ward Pharms Int GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 077187-001 Jun 30, 2008 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
West-ward Pharms Int GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 077177-001 Dec 31, 2007 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-003 Sep 17, 2004 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Wockhardt Usa GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078564-001 Jun 30, 2008 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Barr GRANISETRON HYDROCHLORIDE granisetron hydrochloride TABLET;ORAL 078221-001 Dec 31, 2007 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Orchid Hlthcare GRANISETRON HYDROCHLORIDE granisetron hydrochloride TABLET;ORAL 078678-001 Feb 13, 2008 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Hikma Farmaceutica GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078629-002 Dec 23, 2009 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Luitpold GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 091274-001 Sep 22, 2010 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for granisetron

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,861,068 Pharmaceutical compositions using semi-solid delivery vehicle ➤ Subscribe
8,252,306 Process for preparing a semi-solid delivery vehicle comprising granisetron ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for granisetron

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Daiichi Sankyo
Chinese Patent Office
UBS
Chubb
US Army
Covington
Argus Health
Deloitte

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 verifification 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.

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