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, Mylan, Slate Run Pharma, 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. Five 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 EUGIA PHARMA on August 10th, 2016.
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Summary for ESOMEPRAZOLE SODIUM
| US Patents: | 0 |
| Applicants: | 7 |
| NDAs: | 7 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 180 |
| Clinical Trials: | 8 |
| Patent Applications: | 5,104 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ESOMEPRAZOLE SODIUM |
| DailyMed Link: | ESOMEPRAZOLE SODIUM at DailyMed |
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 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mylan | ESOMEPRAZOLE SODIUM | esomeprazole sodium | INJECTABLE;INTRAVENOUS | 202686-001 | May 17, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Eugia Pharma | ESOMEPRAZOLE SODIUM | esomeprazole sodium | INJECTABLE;INTRAVENOUS | 204657-002 | Aug 10, 2016 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan | ESOMEPRAZOLE SODIUM | esomeprazole sodium | INJECTABLE;INTRAVENOUS | 202686-002 | May 17, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Deva Holding As | ESOMEPRAZOLE SODIUM | esomeprazole sodium | INJECTABLE;INTRAVENOUS | 207181-001 | Mar 6, 2017 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Eugia Pharma | ESOMEPRAZOLE SODIUM | esomeprazole sodium | INJECTABLE;INTRAVENOUS | 204657-001 | Aug 10, 2016 | DISCN | 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 |
