ALOGLIPTIN BENZOATE - Generic Drug Details
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What are the generic drug sources for alogliptin benzoate and what is the scope of freedom to operate?
Alogliptin benzoate
is the generic ingredient in three branded drugs marketed by Takeda Pharms Usa and is included in three NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Alogliptin benzoate has sixty-nine patent family members in thirty-seven countries.
There are ten drug master file entries for alogliptin benzoate. Five suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for ALOGLIPTIN BENZOATE
International Patents: | 69 |
US Patents: | 6 |
Tradenames: | 3 |
Applicants: | 1 |
NDAs: | 3 |
Drug Master File Entries: | 10 |
Finished Product Suppliers / Packagers: | 5 |
Raw Ingredient (Bulk) Api Vendors: | 67 |
Clinical Trials: | 6 |
Patent Applications: | 644 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ALOGLIPTIN BENZOATE |
DailyMed Link: | ALOGLIPTIN BENZOATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ALOGLIPTIN BENZOATE
Generic Entry Date for ALOGLIPTIN BENZOATE*:
Constraining patent/regulatory exclusivity:
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 ALOGLIPTIN BENZOATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Yonsei University | Phase 4 |
Takeda | Phase 4 |
Celltrion Pharm, Inc. | Phase 4 |
Generic filers with tentative approvals for ALOGLIPTIN BENZOATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 6.25MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | EQ 25MG BASE | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | EQ 12.5MG BASE | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for ALOGLIPTIN BENZOATE
Drug Class | Dipeptidyl Peptidase 4 Inhibitor |
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ALOGLIPTIN BENZOATE
Paragraph IV (Patent) Challenges for ALOGLIPTIN BENZOATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
NESINA | Tablets | alogliptin benzoate | 6.25 mg, 12.5 mg and 25 mg | 022271 | 5 | 2017-01-25 |
US Patents and Regulatory Information for ALOGLIPTIN BENZOATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426-005 | Jan 25, 2013 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-001 | Jan 25, 2013 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426-004 | Jan 25, 2013 | DISCN | Yes | 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 |
Expired US Patents for ALOGLIPTIN BENZOATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Takeda Pharms Usa | NESINA | alogliptin benzoate | TABLET;ORAL | 022271-001 | Jan 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | NESINA | alogliptin benzoate | TABLET;ORAL | 022271-002 | Jan 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | NESINA | alogliptin benzoate | TABLET;ORAL | 022271-003 | Jan 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ALOGLIPTIN BENZOATE
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Takeda Pharma A/S | Vipidia | alogliptin benzoate | EMEA/H/C/002182 Vipidia is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations). |
Authorised | no | no | no | 2013-09-18 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ALOGLIPTIN BENZOATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 2124901 | PRÉPARATION DE COMPRIMÉ NE PROVOQUANT PAS DE PROBLÈME DE PASTILLAGE (TABLET PREPARATION WITHOUT CAUSING A TABLETING TROUBLE) | ⤷ Sign Up |
Malaysia | 146290 | DIPEPTIDYL PEPTIDASE INHIBITORS | ⤷ Sign Up |
China | 102140090 | Dipeptidyl peptidase inhibitors | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ALOGLIPTIN BENZOATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1586571 | 300640 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ALOGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/844/001-007 20130923 |
1586571 | C01586571/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: AUTORISATION SWISSMEDIC 62955 22.11.2013 |
1084705 | CR 2014 00066 | Denmark | ⤷ Sign Up | PRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130923 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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