Saxagliptin hydrochloride - Generic Drug Details
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What are the generic sources for saxagliptin hydrochloride and what is the scope of freedom to operate?
Saxagliptin hydrochloride
is the generic ingredient in two branded drugs marketed by Astrazeneca Ab, Amneal, Aurobindo Pharma, Glenmark Pharms Ltd, Mylan, and Sun Pharm, and is included in six NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Saxagliptin hydrochloride has fifty-seven patent family members in thirty-two countries.
There are eight drug master file entries for saxagliptin hydrochloride. Six suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for saxagliptin hydrochloride
| International Patents: | 57 |
| US Patents: | 1 |
| Tradenames: | 2 |
| Applicants: | 6 |
| NDAs: | 6 |
| Drug Master File Entries: | 8 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 38 |
| Clinical Trials: | 121 |
| Patent Applications: | 5 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for saxagliptin hydrochloride |
| DailyMed Link: | saxagliptin hydrochloride at DailyMed |
Recent Clinical Trials for saxagliptin hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Erlangen-Nürnberg Medical School | Phase 4 |
| Ain Shams University | N/A |
| Sabyasachi Sen | Phase 3 |
Generic filers with tentative approvals for SAXAGLIPTIN HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Try a Trial | ⤷ Try a Trial | EQ 5MG BASE | TABLET;ORAL |
| ⤷ Try a Trial | ⤷ Try a Trial | EQ 2.5MG 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 saxagliptin hydrochloride
| Drug Class | Dipeptidyl Peptidase 4 Inhibitor |
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Paragraph IV (Patent) Challenges for SAXAGLIPTIN HYDROCHLORIDE
| 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 saxagliptin hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glenmark Pharms Ltd | SAXAGLIPTIN | saxagliptin hydrochloride | TABLET;ORAL | 205994-002 | Jul 31, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Astrazeneca Ab | ONGLYZA | saxagliptin hydrochloride | TABLET;ORAL | 022350-001 | Jul 31, 2009 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Glenmark Pharms Ltd | SAXAGLIPTIN | saxagliptin hydrochloride | TABLET;ORAL | 205994-001 | Jul 31, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >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 saxagliptin hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca Ab | ONGLYZA | saxagliptin hydrochloride | TABLET;ORAL | 022350-002 | Jul 31, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca Ab | ONGLYZA | saxagliptin hydrochloride | TABLET;ORAL | 022350-002 | Jul 31, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca Ab | ONGLYZA | saxagliptin hydrochloride | TABLET;ORAL | 022350-001 | Jul 31, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for saxagliptin hydrochloride
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 2568391 | FORMULATION DE COMPRIME REVETU ET PROCEDE CORRESPONDANT (COATED TABLET FORMULATION AND METHOD) | ⤷ Try a Trial |
| Hungary | E029039 | ⤷ Try a Trial | |
| Israel | 179454 | COATED TABLET FORMULATION COMPRISING SAXAGLIPTIN AND METHOD FOR PREPARING THE SAME | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for saxagliptin hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1261586 | SPC/GB10/001 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: SAXAGLIPTIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF INCLUDING SAXAGLIPTIN HYDROCHLORIDE; REGISTERED: UK EU/1/09/545/001 20091001; UK EU/1/09/545/002 20091001; UK EU/1/09/545/003 20091001; UK EU/1/09/545/004 20091001; UK EU/1/09/545/005 20091001; UK EU/1/09/545/006 20091001; UK EU/1/09/545/007 20091001; UK EU/1/09/545/008 20091001; UK EU/1/09/545/009 20091001; UK EU/1/09/545/010 20091001 |
| 2498758 | 16/2020 | Austria | ⤷ Try a Trial | PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 (MITTEILUNG) 20191113 |
| 2139494 | 301054 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160719 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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. 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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