SAXAGLIPTIN Drug Patent Profile
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Which patents cover Saxagliptin, and what generic alternatives are available?
Saxagliptin is a drug marketed by Amneal, Aurobindo Pharma, Glenmark Pharms Ltd, Mylan, and Sun Pharm. and is included in seven NDAs.
The generic ingredient in SAXAGLIPTIN is metformin hydrochloride; saxagliptin hydrochloride. There are forty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; saxagliptin hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Saxagliptin
A generic version of SAXAGLIPTIN was approved as metformin hydrochloride; saxagliptin hydrochloride by DR REDDYS LABS SA on August 9th, 2023.
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Summary for SAXAGLIPTIN
| US Patents: | 0 |
| Applicants: | 5 |
| NDAs: | 7 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 103 |
| Clinical Trials: | 121 |
| Patent Applications: | 4,141 |
| DailyMed Link: | SAXAGLIPTIN at DailyMed |
Recent Clinical Trials for SAXAGLIPTIN
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 |
Pharmacology for SAXAGLIPTIN
| Drug Class | Dipeptidyl Peptidase 4 Inhibitor |
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
US Patents and Regulatory Information for SAXAGLIPTIN
SAXAGLIPTIN is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting SAXAGLIPTIN
PATENT CHALLENGE
Exclusivity 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal | SAXAGLIPTIN | saxagliptin hydrochloride | TABLET;ORAL | 205941-001 | Jul 31, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mylan | SAXAGLIPTIN | saxagliptin hydrochloride | TABLET;ORAL | 205980-001 | Jul 31, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Aurobindo Pharma | SAXAGLIPTIN | saxagliptin hydrochloride | TABLET;ORAL | 205972-002 | Jul 31, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan | SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205981-003 | Jul 31, 2023 | AB | RX | No | 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 |
