NILOTINIB HYDROCHLORIDE Drug Patent Profile
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Which patents cover Nilotinib Hydrochloride, and when can generic versions of Nilotinib Hydrochloride launch?
Nilotinib Hydrochloride is a drug marketed by Apotex and is included in one NDA.
The generic ingredient in NILOTINIB HYDROCHLORIDE is nilotinib hydrochloride. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nilotinib hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Nilotinib Hydrochloride
A generic version of NILOTINIB HYDROCHLORIDE was approved as nilotinib hydrochloride by APOTEX on January 5th, 2024.
Summary for NILOTINIB HYDROCHLORIDE
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 40 |
Clinical Trials: | 200 |
Patent Applications: | 153 |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for NILOTINIB HYDROCHLORIDE
Paragraph IV (Patent) Challenges 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apotex | NILOTINIB HYDROCHLORIDE | nilotinib hydrochloride | CAPSULE;ORAL | 203640-001 | Jan 5, 2024 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Apotex | NILOTINIB HYDROCHLORIDE | nilotinib hydrochloride | CAPSULE;ORAL | 203640-002 | Jan 5, 2024 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Apotex | NILOTINIB HYDROCHLORIDE | nilotinib hydrochloride | CAPSULE;ORAL | 203640-003 | Jan 5, 2024 | AB | 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 |