PONATINIB HYDROCHLORIDE Drug Patent Profile
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When do Ponatinib Hydrochloride patents expire, and when can generic versions of Ponatinib Hydrochloride launch?
Ponatinib Hydrochloride is a drug marketed by Apotex and is included in one NDA.
The generic ingredient in PONATINIB HYDROCHLORIDE is ponatinib hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ponatinib hydrochloride profile page.
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Questions you can ask:
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Summary for PONATINIB HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 37 |
| Clinical Trials: | 62 |
| Patent Applications: | 256 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PONATINIB HYDROCHLORIDE |
| DailyMed Link: | PONATINIB HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for PONATINIB HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| German Federal Ministry of Education and Research | Phase 2 |
| Deutsche Leukämie- & Lymphom-Hilfe | Phase 2 |
| Goethe University | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for PONATINIB HYDROCHLORIDE
Paragraph IV (Patent) Challenges for PONATINIB HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ICLUSIG | Tablets | ponatinib hydrochloride | 10 mg and 30 mg | 203469 | 1 | 2022-12-12 |
| ICLUSIG | Tablets | ponatinib hydrochloride | 15 mg and 45 mg | 203469 | 1 | 2021-03-31 |
US Patents and Regulatory Information for PONATINIB HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | PONATINIB HYDROCHLORIDE | ponatinib hydrochloride | TABLET;ORAL | 215893-001 | Jul 14, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apotex | PONATINIB HYDROCHLORIDE | ponatinib hydrochloride | TABLET;ORAL | 215893-002 | Jul 14, 2023 | 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 |
