NEXIUM 24HR Drug Patent Profile
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Which patents cover Nexium 24hr, and when can generic versions of Nexium 24hr launch?
Nexium 24hr is a drug marketed by Astrazeneca Lp and is included in two NDAs.
The generic ingredient in NEXIUM 24HR is esomeprazole magnesium. There are seventy-four drug master file entries for this compound. One hundred and eleven suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Nexium 24hr
A generic version of NEXIUM 24HR was approved as esomeprazole magnesium by IVAX SUB TEVA PHARMS on January 26th, 2015.
Summary for NEXIUM 24HR
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 18 |
Clinical Trials: | 160 |
Patent Applications: | 1,278 |
Formulation / Manufacturing: | see details |
Drug Sales Revenues: | Drug sales revenues for NEXIUM 24HR |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NEXIUM 24HR |
What excipients (inactive ingredients) are in NEXIUM 24HR? | NEXIUM 24HR excipients list |
DailyMed Link: | NEXIUM 24HR at DailyMed |
Recent Clinical Trials for NEXIUM 24HR
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 24HR
Drug Class | Proton Pump Inhibitor |
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for NEXIUM 24HR
Paragraph IV (Patent) Challenges for NEXIUM 24HR
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
NEXIUM 24HR | Delayed-release Capsules | esomeprazole magnesium | 20 mg | 204655 | 2014-04-24 |
US Patents and Regulatory Information for NEXIUM 24HR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca Lp | NEXIUM 24HR | esomeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 204655-001 | Mar 28, 2014 | OTC | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Astrazeneca Lp | NEXIUM 24HR | esomeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 207920-001 | Nov 23, 2015 | OTC | 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 24HR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astrazeneca Lp | NEXIUM 24HR | esomeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 207920-001 | Nov 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Lp | NEXIUM 24HR | esomeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 204655-001 | Mar 28, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Lp | NEXIUM 24HR | esomeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 204655-001 | Mar 28, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Lp | NEXIUM 24HR | esomeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 204655-001 | Mar 28, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca Lp | NEXIUM 24HR | esomeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 204655-001 | Mar 28, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NEXIUM 24HR
See the table below for patents covering NEXIUM 24HR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 1124539 | FORMULATION PHARMACEUTIQUE CONTENANT DE L'OMEPRAZOLE (PHARMACEUTICAL FORMULATION COMPRISING OMEPRAZOLE) | ⤷ Try a Trial |
Australia | 7198294 | ⤷ Try a Trial | |
Slovenia | 0984957 | ⤷ Try a Trial | |
Canada | 2166483 | NOUVELLE FORMULATION PHARMACEUTIQUE (NEW PHARMACEUTICAL FORMULATION) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 9501783 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NEXIUM 24HR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0124495 | SPC/GB01/006 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727 |
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 |
0984957 | 1290006-4 | Sweden | ⤷ Try a Trial | PRODUCT NAME: ACETYLSALICYLSYRA OCH ESOMEPRAZOLMAGNESIUMTRIHYDRAT; NAT. REG. NO/DATE: MTNR 44371 20110930; FIRST REG.: PT 5402359MFL 20110812 |
0984957 | 122012000017 | Germany | ⤷ Try a Trial | PRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812 |
1020461 | 91870 | Luxembourg | ⤷ Try a Trial | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |