KYTRIL Drug Patent Profile
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When do Kytril patents expire, and what generic alternatives are available?
Kytril is a drug marketed by Roche and is included in three NDAs.
The generic ingredient in KYTRIL 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 Kytril
A generic version of KYTRIL was approved as granisetron hydrochloride by AMNEAL on December 31st, 2007.
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Summary for KYTRIL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 116 |
| Clinical Trials: | 20 |
| Patent Applications: | 4,811 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for KYTRIL |
| DailyMed Link: | KYTRIL at DailyMed |
Recent Clinical Trials for KYTRIL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| The University of The West Indies | Early Phase 1 |
| Rutgers University | N/A |
| National Institute of General Medical Sciences (NIGMS) | N/A |
Paragraph IV (Patent) Challenges for KYTRIL
| 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 KYTRIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Roche | KYTRIL | granisetron hydrochloride | INJECTABLE;INJECTION | 020239-003 | Sep 17, 2004 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Roche | KYTRIL | granisetron hydrochloride | TABLET;ORAL | 020305-002 | Jun 15, 1998 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Roche | KYTRIL | granisetron hydrochloride | INJECTABLE;INJECTION | 020239-002 | Mar 11, 1994 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Roche | KYTRIL | granisetron hydrochloride | INJECTABLE;INJECTION | 020239-004 | Mar 11, 1994 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Roche | KYTRIL | granisetron hydrochloride | INJECTABLE;INJECTION | 020239-001 | Dec 29, 1993 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Roche | KYTRIL | granisetron hydrochloride | TABLET;ORAL | 020305-001 | Mar 16, 1995 | DISCN | Yes | 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 KYTRIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Roche | KYTRIL | granisetron hydrochloride | TABLET;ORAL | 020305-002 | Jun 15, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Roche | KYTRIL | granisetron hydrochloride | TABLET;ORAL | 020305-001 | Mar 16, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Roche | KYTRIL | granisetron hydrochloride | INJECTABLE;INJECTION | 020239-003 | Sep 17, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Roche | KYTRIL | granisetron hydrochloride | INJECTABLE;INJECTION | 020239-004 | Mar 11, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| Roche | KYTRIL | granisetron hydrochloride | INJECTABLE;INJECTION | 020239-001 | Dec 29, 1993 | ⤷ Sign Up | ⤷ Sign Up |
| Roche | KYTRIL | granisetron hydrochloride | INJECTABLE;INJECTION | 020239-002 | Mar 11, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for KYTRIL
See the table below for patents covering KYTRIL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Germany | 3687080 | ⤷ Sign Up | |
| South Africa | 8902737 | ⤷ Sign Up | |
| Japan | H0478636 | ⤷ Sign Up | |
| Israel | 109059 | Pharmaceutical compositions containing granisetron for the treatment of post-operative nausea and vomiting | ⤷ Sign Up |
| South Africa | 9401844 | ⤷ Sign Up | |
| African Regional IP Organization (ARIPO) | 511 | The use of granisetron in the manufacture of a medicament for the treatment of post-operative nausea advomiting (PONV). | ⤷ 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.
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