NILOTINIB HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for nilotinib hydrochloride and what is the scope of patent protection?
Nilotinib hydrochloride
is the generic ingredient in two branded drugs marketed by Apotex and Novartis, and is included in two NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Nilotinib hydrochloride has two hundred and ninety patent family members in fifty-two countries.
There are seven drug master file entries for nilotinib hydrochloride. One supplier is listed for this compound.
Summary for NILOTINIB HYDROCHLORIDE
International Patents: | 290 |
US Patents: | 7 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Drug Master File Entries: | 7 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 40 |
Clinical Trials: | 200 |
Patent Applications: | 237 |
Formulation / Manufacturing: | see details |
DailyMed Link: | NILOTINIB HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for NILOTINIB HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Sun Pharmaceuticals Industries Limited | Phase 3 |
KeifeRx, LLC | Phase 3 |
Life Molecular Imaging GmbH | Phase 3 |
Pharmacology for NILOTINIB HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TASIGNA | Capsules | nilotinib hydrochloride | 50 mg | 022068 | 1 | 2019-10-17 |
TASIGNA | Capsules | nilotinib hydrochloride | 150 mg and 200 mg | 022068 | 1 | 2013-11-08 |
US Patents and Regulatory Information for NILOTINIB HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-001 | Oct 29, 2007 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-002 | Jun 17, 2010 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-002 | Jun 17, 2010 | RX | 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 NILOTINIB HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-001 | Oct 29, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-003 | Mar 22, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-002 | Jun 17, 2010 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NILOTINIB HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Peru | 20070241 | SALES DE 4-METIL-N-[3-(4-METIL-IMIDAZO-1-LIL)-5-TRIFLUROMETIL-FENIL]-3-(4-PIRIDI-3-NIL-PIRIMIDI-2-NILAMINO)-BENZAMIDA | ⤷ Sign Up |
Poland | 374583 | Inhibitory kinaz tyrozynowych (INHIBITORS OF TYROSINE KINASES) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2007015871 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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