DANZITEN Drug Patent Profile
Which patents cover Danziten, and what generic alternatives are available?
Danziten is a drug marketed by Azurity and is included in one NDA. There are four patents protecting this drug.
The generic ingredient in DANZITEN is nilotinib tartrate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the nilotinib tartrate profile page.
DrugPatentWatch® Generic Entry Outlook for Danziten
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 18, 2040. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for DANZITEN?
- What are the global sales for DANZITEN?
- What is Average Wholesale Price for DANZITEN?
Summary for DANZITEN
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Applications: | 3,672 |
| What excipients (inactive ingredients) are in DANZITEN? | DANZITEN excipients list |
| DailyMed Link: | DANZITEN at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DANZITEN
Generic Entry Date for DANZITEN*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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.
Pharmacology for DANZITEN
US Patents and Regulatory Information for DANZITEN
DANZITEN is protected by four US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of DANZITEN is ⤷ Start Trial.
This potential generic entry date is based on patent ⤷ Start Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Azurity | DANZITEN | nilotinib tartrate | TABLET;ORAL | 219293-001 | Nov 7, 2024 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Azurity | DANZITEN | nilotinib tartrate | TABLET;ORAL | 219293-002 | Nov 7, 2024 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Azurity | DANZITEN | nilotinib tartrate | TABLET;ORAL | 219293-001 | Nov 7, 2024 | 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 DANZITEN
When does loss-of-exclusivity occur for DANZITEN?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
China
Patent: 3573712
Estimated Expiration: ⤷ Start Trial
Patent: 2351243
Estimated Expiration: ⤷ Start Trial
European Patent Office
Patent: 14252
Estimated Expiration: ⤷ Start Trial
Patent: 09123
Estimated Expiration: ⤷ Start Trial
Japan
Patent: 11644
Estimated Expiration: ⤷ Start Trial
Patent: 22510732
Estimated Expiration: ⤷ Start Trial
Spain
Patent: 93251
Estimated Expiration: ⤷ Start Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering DANZITEN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 113573712 | 尼洛替尼的药物组合物 (PHARMACEUTICAL COMPOSITIONS OF NILOTINIB) | ⤷ Start Trial |
| China | 122351243 | 尼洛替尼的药物组合物 (Pharmaceutical composition of nilotinib) | ⤷ Start Trial |
| European Patent Office | 3914252 | COMPOSITION PHARMACEUTIQUE DU NILOTINIB (PHARMACEUTICAL COMPOSITIONS OF NILOTINIB) | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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