onglyza Drug Patent Profile
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Which patents cover Onglyza, and what generic alternatives are available?
Onglyza is a drug marketed by Astrazeneca Ab and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has fifty-seven patent family members in thirty-two countries.
The generic ingredient in ONGLYZA is saxagliptin hydrochloride. There are fifteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the saxagliptin hydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Onglyza
Onglyza was eligible for patent challenges on July 31, 2013.
There have been sixteen 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.
There is one tentative approval for the generic drug (saxagliptin hydrochloride), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
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Questions you can ask:
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Summary for onglyza
International Patents: | 57 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 134 |
Clinical Trials: | 68 |
Patent Applications: | 4,141 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for onglyza |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for onglyza |
What excipients (inactive ingredients) are in onglyza? | onglyza excipients list |
DailyMed Link: | onglyza at DailyMed |
Recent Clinical Trials for onglyza
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Ain Shams University | N/A |
Beni-Suef University | Phase 4 |
Sabyasachi Sen | Phase 4 |
Pharmacology for onglyza
Drug Class | Dipeptidyl Peptidase 4 Inhibitor |
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Paragraph IV (Patent) Challenges for ONGLYZA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ONGLYZA | Tablets | saxagliptin hydrochloride | 2.5 mg and 5 mg | 022350 | 8 | 2013-07-31 |
US Patents and Regulatory Information for onglyza
onglyza is protected by one US patents.
Patents protecting onglyza
Coated tablet formulation and method
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca Ab | ONGLYZA | saxagliptin hydrochloride | TABLET;ORAL | 022350-001 | Jul 31, 2009 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Astrazeneca Ab | ONGLYZA | saxagliptin hydrochloride | TABLET;ORAL | 022350-002 | Jul 31, 2009 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 onglyza
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astrazeneca Ab | ONGLYZA | saxagliptin hydrochloride | TABLET;ORAL | 022350-001 | Jul 31, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca Ab | ONGLYZA | saxagliptin hydrochloride | TABLET;ORAL | 022350-002 | Jul 31, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca Ab | ONGLYZA | saxagliptin hydrochloride | TABLET;ORAL | 022350-002 | Jul 31, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca Ab | ONGLYZA | saxagliptin hydrochloride | TABLET;ORAL | 022350-001 | Jul 31, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for onglyza
See the table below for patents covering onglyza around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20120064141 | COATED TABLET FORMULATION AND METHOD | ⤷ Sign Up |
Colombia | 5280198 | INHIBIDORES A BASE DE PIRROLIDINA FUSIONADA CON CICLOPROPILO DE DIPEPTIDIL PEPTIDASA IV Y METODO | ⤷ Sign Up |
Mexico | PA06013711 | FORMULACION DE TABLETA REVESTIDA Y METODO. (COATED TABLET FORMULATION AND METHOD.) | ⤷ Sign Up |
Denmark | 1753406 | ⤷ Sign Up | |
Cyprus | 1117813 | ⤷ Sign Up | |
Taiwan | 201204414 | Coated tablet formulation and method | ⤷ Sign Up |
Argentina | 049062 | FORMULACION DE TABLETA REVESTIDA QUE CONTIENE UN INHIBIDOR DPP4, COMO SAXAGLIPTINA, Y METODO | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for onglyza
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1261586 | 91985 | Luxembourg | ⤷ Sign Up | 91985, EXPIRES: 20260305 |
1261586 | 12C0028 | France | ⤷ Sign Up | PRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124 |
1261586 | 2012C/016 | Belgium | ⤷ Sign Up | PRODUCT NAME: UNE COMBINAISON DE PRODUITS DE SAXAGLIPTINE ET DE METFORMINE AINSI QUE TOUT SELS PHARMACEUTIQUEMENT ACCEPTABLES, DONT LES SELS DE CHLORHYDRATE DE SAXAGLIPTINE ET DE METFORMINE; AUTHORISATION NUMBER AND DATE: EU/1/11/731/001 20111128 |
1084705 | C01084705/03 | Switzerland | ⤷ Sign Up | PRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 59390 05.02.2010 |
1261586 | C01261586/01 | Switzerland | ⤷ Sign Up | FORMER OWNER: BRISTOL-MYERS SQUIBB COMPANY, US |
2139494 | 132020000000115 | Italy | ⤷ Sign Up | PRODUCT NAME: SAXAGLIPTIN E DAPAGLIFLOZIN(QTERN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1108, 20160719 |
1261586 | CA 2010 00007 | Denmark | ⤷ Sign Up | PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER SAXAGLIPTIN HCL |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |