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KAZANO Drug Profile
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» See Plans and PricingWhich patents cover Kazano, and what generic alternatives are available?
Kazano is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.
This drug has eighty-six patent family members in forty countries.
The generic ingredient in KAZANO is alogliptin benzoate; metformin hydrochloride. There are ten drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the alogliptin benzoate; metformin hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Kazano
Kazano was eligible for patent challenges on January 25, 2017.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be May 24, 2029. This may change due to patent challenges or generic licensing.
There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for KAZANO
| International Patents: | 86 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for KAZANO |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for KAZANO |
| DailyMed Link: | KAZANO at DailyMed |
Generic Entry Opportunity Date for KAZANO
Generic Entry Date for KAZANO*:
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.
Recent Clinical Trials for KAZANO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Takeda | Phase 3 |
Pharmacology for KAZANO
| Drug Class | Dipeptidyl Peptidase 4 Inhibitor Biguanide |
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Paragraph IV (Patent) Challenges for KAZANO
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| KAZANO | TABLET;ORAL | alogliptin benzoate; metformin hydrochloride | 203414 | 2017-01-25 |
US Patents and Regulatory Information for KAZANO
Expired US Patents for KAZANO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-001 | Jan 25, 2013 | Start Trial | Start Trial |
| Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-001 | Jan 25, 2013 | Start Trial | Start Trial |
| Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-002 | Jan 25, 2013 | Start Trial | Start Trial |
| Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-001 | Jan 25, 2013 | Start Trial | Start Trial |
| Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-002 | Jan 25, 2013 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for KAZANO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20080005162 | Start Trial |
| China | 1269528 | Start Trial |
| Taiwan | 200531695 | Start Trial |
| Eurasian Patent Organization | 201070164 | Start Trial |
| Netherlands | 300640 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for KAZANO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1084705 | CR 2014 00062 | Denmark | Start Trial | PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091005 |
| 1084705 | SPC/GB14/085 | United Kingdom | Start Trial | PRODUCT NAME: SAXAGLIPTIN; REGISTERED: UK EU/1/09/545/001-010 20091005 |
| 1174135 | 437 | Finland | Start Trial | |
| 1084705 | CR 2014 00063 | Denmark | Start Trial | PRODUCT NAME: SITAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SITAGLIPTIN PHOSPHAT MONOHYDRAT; REG. NO/DATE: EU/1/07/383/001-024 AND EU/1/07/382/001-024 20070323 |
| 1586571 | 511 | Finland | Start Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
