KYTRIL Drug Patent Profile
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When do Kytril patents expire, and when can generic versions of Kytril launch?
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.
Summary for KYTRIL
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 116 |
Clinical Trials: | 19 |
Patent Applications: | 4,160 |
Formulation / Manufacturing: | see details |
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 |
---|---|
University of Colorado, Denver | N/A |
Memorial Sloan Kettering Cancer Center | N/A |
Rutgers University | N/A |
Anatomical Therapeutic Chemical (ATC) Classes for KYTRIL
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Roche | KYTRIL | granisetron hydrochloride | TABLET;ORAL | 020305-002 | Jun 15, 1998 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Roche | KYTRIL | granisetron hydrochloride | INJECTABLE;INJECTION | 020239-002 | Mar 11, 1994 | DISCN | Yes | 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 KYTRIL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Roche | KYTRIL | granisetron hydrochloride | INJECTABLE;INJECTION | 020239-004 | Mar 11, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
Roche | KYTRIL | granisetron hydrochloride | INJECTABLE;INJECTION | 020239-004 | Mar 11, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
Roche | KYTRIL | granisetron hydrochloride | INJECTABLE;INJECTION | 020239-001 | Dec 29, 1993 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 | ⤷ Try a Trial | |
Japan | H0478636 | ⤷ Try a Trial | |
Spain | 2188611 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |