ESOMEPRAZOLE SODIUM Drug Patent Profile
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When do Esomeprazole Sodium patents expire, and what generic alternatives are available?
Esomeprazole Sodium is a drug marketed by Accord Hlthcare, Deva Holding As, Eugia Pharma, Gland Pharma Ltd, Hainan Poly, Mylan, and Sun Pharm. and is included in seven NDAs.
The generic ingredient in ESOMEPRAZOLE SODIUM is esomeprazole sodium. There are seventy-four drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Esomeprazole Sodium
A generic version of ESOMEPRAZOLE SODIUM was approved as esomeprazole sodium by SUN PHARM on March 18th, 2013.
Summary for ESOMEPRAZOLE SODIUM
Recent Clinical Trials for ESOMEPRAZOLE SODIUM
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Livzon Pharmaceutical Group Inc. | Phase 3 |
BioPharma Services, Inc | Phase 1 |
Food and Drug Administration (FDA) | Phase 1 |
Pharmacology for ESOMEPRAZOLE SODIUM
Drug Class | Proton Pump Inhibitor |
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ESOMEPRAZOLE SODIUM
Paragraph IV (Patent) Challenges for ESOMEPRAZOLE SODIUM
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
NEXIUM IV | For Injection | esomeprazole sodium | 20 mg/vial and 40 mg/vial | 021689 | 1 | 2009-11-23 |
US Patents and Regulatory Information for ESOMEPRAZOLE SODIUM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Accord Hlthcare | ESOMEPRAZOLE SODIUM | esomeprazole sodium | INJECTABLE;INTRAVENOUS | 205379-001 | Sep 25, 2015 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Hainan Poly | ESOMEPRAZOLE SODIUM | esomeprazole sodium | INJECTABLE;INTRAVENOUS | 215732-001 | Feb 10, 2022 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Eugia Pharma | ESOMEPRAZOLE SODIUM | esomeprazole sodium | INJECTABLE;INTRAVENOUS | 204657-002 | Aug 10, 2016 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Mylan | ESOMEPRAZOLE SODIUM | esomeprazole sodium | INJECTABLE;INTRAVENOUS | 202686-001 | May 17, 2017 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Deva Holding As | ESOMEPRAZOLE SODIUM | esomeprazole sodium | INJECTABLE;INTRAVENOUS | 207181-001 | Mar 6, 2017 | AP | 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 |