NILOTINIB Drug Patent Profile
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Which patents cover Nilotinib, and when can generic versions of Nilotinib launch?
Nilotinib is a drug marketed by Cipla, Apotex, Dr Reddys, Hetero Labs Ltd V, MSN, and Torrent. and is included in six NDAs.
The generic ingredient in NILOTINIB is nilotinib hydrochloride. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the nilotinib hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Nilotinib
A generic version of NILOTINIB was approved as nilotinib hydrochloride by APOTEX on January 5th, 2024.
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Questions you can ask:
- What is the 5 year forecast for NILOTINIB?
- What are the global sales for NILOTINIB?
- What is Average Wholesale Price for NILOTINIB?
Summary for NILOTINIB
| US Patents: | 0 |
| Applicants: | 6 |
| NDAs: | 6 |
| What excipients (inactive ingredients) are in NILOTINIB? | NILOTINIB excipients list |
| DailyMed Link: | NILOTINIB at DailyMed |
US Patents and Regulatory Information for NILOTINIB
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cipla | NILOTINIB D-TARTRATE | nilotinib d-tartrate | CAPSULE;ORAL | 218922-001 | Feb 19, 2025 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Dr Reddys | NILOTINIB HYDROCHLORIDE | nilotinib hydrochloride | CAPSULE;ORAL | 218350-001 | Nov 19, 2025 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Apotex | NILOTINIB HYDROCHLORIDE | nilotinib hydrochloride | CAPSULE;ORAL | 203640-001 | Jan 5, 2024 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Msn | NILOTINIB HYDROCHLORIDE | nilotinib hydrochloride | CAPSULE;ORAL | 218544-001 | Nov 19, 2025 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
