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TASIGNA Drug Profile
» See Plans and Pricing
When do Tasigna patents expire, and what generic alternatives are available?
Tasigna is a drug marketed by Novartis and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and seventy-two patent family members in fifty-one countries.
The generic ingredient in TASIGNA 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.
US ANDA Litigation and Generic Entry Outlook for Tasigna
Tasigna was eligible for patent challenges on October 29, 2011.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 7, 2032. This may change due to patent challenges or generic licensing.
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
Summary for TASIGNA
| International Patents: | 272 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 115 |
| Clinical Trials: | 59 |
| Patent Applications: | 4,467 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TASIGNA |
| DailyMed Link: | TASIGNA at DailyMed |
Generic Entry Opportunity Date for TASIGNA
Generic Entry Date for TASIGNA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for TASIGNA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Baylor College of Medicine | Phase 2 |
| Ohio State University Comprehensive Cancer Center | Phase 1 |
| National Institutes of Health (NIH) | Phase 2 |
Pharmacology for TASIGNA
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors |
Paragraph IV (Patent) Challenges for TASIGNA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| TASIGNA | CAPSULE;ORAL | nilotinib hydrochloride | 022068 | 2019-10-17 |
| TASIGNA | CAPSULE;ORAL | nilotinib hydrochloride | 022068 | 2013-11-08 |
US Patents and Regulatory Information for TASIGNA
| 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 | Start Trial | Start Trial | Start Trial | ||||
| Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-001 | Oct 29, 2007 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-001 | Oct 29, 2007 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-001 | Oct 29, 2007 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for TASIGNA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Guatemala | 200600315 | Start Trial |
| Croatia | P20110639 | Start Trial |
| Germany | 60324805 | Start Trial |
| Poland | 1912973 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
