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.
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Summary for NILOTINIB HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 40 |
| Clinical Trials: | 200 |
| Patent Applications: | 153 |
| DailyMed Link: | NILOTINIB HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for NILOTINIB HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Life Molecular Imaging GmbH | Phase 3 |
| Augusta University | Phase 2 |
| Worldwide Clinical Trials | 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 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apotex | NILOTINIB HYDROCHLORIDE | nilotinib hydrochloride | CAPSULE;ORAL | 203640-002 | Jan 5, 2024 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apotex | NILOTINIB HYDROCHLORIDE | nilotinib hydrochloride | CAPSULE;ORAL | 203640-003 | Jan 5, 2024 | DISCN | No | 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 |
