NEXIUM IV Drug Patent Profile
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When do Nexium Iv patents expire, and what generic alternatives are available?
Nexium Iv is a drug marketed by Astrazeneca and is included in one NDA.
The generic ingredient in NEXIUM IV 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 Nexium Iv
A generic version of NEXIUM IV was approved as esomeprazole sodium by SUN PHARM on March 18th, 2013.
Summary for NEXIUM IV
Recent Clinical Trials for NEXIUM IV
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Nanfang Hospital of Southern Medical University | Phase 4 |
Liaocheng People's Hospital | Phase 1 |
Little Journey Ltd. | Phase 3 |
Pharmacology for NEXIUM IV
Drug Class | Proton Pump Inhibitor |
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for NEXIUM IV
Paragraph IV (Patent) Challenges for NEXIUM IV
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 NEXIUM IV
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca | NEXIUM IV | esomeprazole sodium | INJECTABLE;INTRAVENOUS | 021689-001 | Mar 31, 2005 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Astrazeneca | NEXIUM IV | esomeprazole sodium | INJECTABLE;INTRAVENOUS | 021689-002 | Mar 31, 2005 | AP | RX | Yes | Yes | ⤷ 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 NEXIUM IV
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astrazeneca | NEXIUM IV | esomeprazole sodium | INJECTABLE;INTRAVENOUS | 021689-002 | Mar 31, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca | NEXIUM IV | esomeprazole sodium | INJECTABLE;INTRAVENOUS | 021689-002 | Mar 31, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca | NEXIUM IV | esomeprazole sodium | INJECTABLE;INTRAVENOUS | 021689-001 | Mar 31, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca | NEXIUM IV | esomeprazole sodium | INJECTABLE;INTRAVENOUS | 021689-001 | Mar 31, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NEXIUM IV
See the table below for patents covering NEXIUM IV around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hungary | T71888 | ⤷ Try a Trial | |
Singapore | 49283 | New compounds | ⤷ Try a Trial |
Czech Republic | 9500202 | ⤷ Try a Trial | |
China | 1055469 | ⤷ Try a Trial | |
Greece | 3035365 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NEXIUM IV
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0984957 | 2012/048 | Ireland | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812 |
1020461 | 91870 | Luxembourg | ⤷ Try a Trial | |
1411900 | 2011/016 | Ireland | ⤷ Try a Trial | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105 |
1411900 | 2011C/016 | Belgium | ⤷ Try a Trial | PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214 |
1020461 | C300482 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20101105 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |