DrugPatentWatch Database Preview
KAZANO Drug Profile
When do Kazano patents expire, and what generic alternatives are available?
Kazano is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and seven patent family members in thirty-nine 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.
Summary for KAZANO
| International Patents: | 107 |
| US Patents: | 7 |
| 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 |
Recent Litigation for KAZANO
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| TAKEDA PHARMACEUTICAL COMPANY LTD. v. INDOCO REMEDIES LTD. | 2018-01-03 |
| TAKEDA PHARMACEUTICAL COMPANY LTD. v. INDOCO REMEDIES LTD. | 2017-09-20 |
| TAKEDA PHARMACEUTICAL COMPANY LTD. v. TORRENT PHARMACEUTICALS LTD. | 2017-05-05 |
Pharmacology for KAZANO
| Drug Class | Dipeptidyl Peptidase 4 Inhibitor Biguanide |
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Synonyms for KAZANO
| Alogliptin / metformin |
| Alogliptin / metformin hydrochloride |
| Alogliptin and metformin hydrochloride |
| Alogliptin mixture with metformin |
| Alogliptin mixture with metformin hydrochloride |
| S900006100 |
| SYR-322 + metformin hydrochloride |
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 | 203414-002 | 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 | 203414-001 | 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for KAZANO
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 12.5 mg/500 mg and 12.5 mg/1000 mg | ➤ Subscribe | Start Trial |
International Patents for KAZANO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Ecuador | SP109979 | Start Trial |
| Israel | 220480 | Start Trial |
| European Patent Office | 2574336 | Start Trial |
| Germany | 602004015067 | Start Trial |
| Spain | 2603879 | 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 00066 | Denmark | Start Trial | PRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130923 |
| 1586571 | 92374 | Luxembourg | Start Trial | PRODUCT NAME: ALOGLIPTIN SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE. FIRST REGISTRATION: 20130923 |
| 1586571 | 1490014-6 | Sweden | Start Trial | PERIOD OF VALIDITY (FROM - UNTIL): 2024-12-22 TILL - 2028-09-22 |
| 1084705 | PA2014045 | Lithuania | Start Trial | PRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919 |
| 1586571 | C300640 | Netherlands | Start Trial | PRODUCT NAME: ALOGLIPTINE IN ALLE VORMEN ZOALS BESCHERMD DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/13/844/001-007 20130923 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
