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Last Updated: March 28, 2024

Granisetron hydrochloride - Generic Drug Details


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What are the generic sources for granisetron hydrochloride and what is the scope of freedom to operate?

Granisetron hydrochloride is the generic ingredient in four branded drugs marketed by Am Regent, Amneal, Baxter Hlthcare Corp, Bionpharma, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Mylan Asi, Mylan Labs Ltd, 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 NDAs. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for granisetron hydrochloride. Seven suppliers are listed for this compound.

Recent Clinical Trials for granisetron hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 4
Guangxi Medical UniversityPhase 3
Heron TherapeuticsPhase 4

See all granisetron hydrochloride clinical trials

Pharmacology 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
Rising GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 079078-002 Sep 14, 2009 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Labs Ltd GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 203454-001 Apr 4, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roche KYTRIL granisetron hydrochloride SOLUTION;ORAL 021238-001 Jun 27, 2001 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Labs Ltd GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 203453-001 Jan 31, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 077177-001 Dec 31, 2007 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma GRANISETRON HYDROCHLORIDE granisetron hydrochloride TABLET;ORAL 077842-001 Dec 31, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Asi GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 091136-001 Apr 9, 2010 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche KYTRIL granisetron hydrochloride TABLET;ORAL 020305-001 Mar 16, 1995 ⤷  Try a Trial ⤷  Try a Trial
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-003 Sep 17, 2004 ⤷  Try a Trial ⤷  Try a Trial
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-002 Mar 11, 1994 ⤷  Try a Trial ⤷  Try a Trial
Roche KYTRIL granisetron hydrochloride TABLET;ORAL 020305-002 Jun 15, 1998 ⤷  Try a Trial ⤷  Try a Trial
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-001 Dec 29, 1993 ⤷  Try a Trial ⤷  Try a Trial
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-002 Mar 11, 1994 ⤷  Try a Trial ⤷  Try a Trial
Roche KYTRIL granisetron hydrochloride SOLUTION;ORAL 021238-001 Jun 27, 2001 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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