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 twelve 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.
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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 |
| IQVIA RDS Inc. | Phase 3 |
Pharmacology for NEXIUM 24HR
| Drug Class | Proton Pump Inhibitor |
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Astrazeneca Lp | NEXIUM 24HR | esomeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 207920-001 | Nov 23, 2015 | OTC | Yes | Yes | ⤷ 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 |
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 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca Lp | NEXIUM 24HR | esomeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 204655-001 | Mar 28, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca Lp | NEXIUM 24HR | esomeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 204655-001 | Mar 28, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca Lp | NEXIUM 24HR | esomeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 204655-001 | Mar 28, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca Lp | NEXIUM 24HR | esomeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 204655-001 | Mar 28, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Yugoslavia | 49199 | ⤷ Sign Up | |
| Sweden | 510650 | Ny förening | ⤷ Sign Up |
| Poland | 337180 | ⤷ Sign Up | |
| Finland | 960101 | ⤷ Sign Up | |
| Australia | 681686 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NEXIUM 24HR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1020461 | 91870 | Luxembourg | ⤷ Sign Up | |
| 0984957 | 92017 | Luxembourg | ⤷ Sign Up | 92017, EXPIRES: 20230525 |
| 0984957 | 2012/048 | Ireland | ⤷ Sign Up | 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 |
| 0984957 | C300483 | Netherlands | ⤷ Sign Up | PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYFRAAT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20110524 |
| 1411900 | 2011/016 | Ireland | ⤷ Sign Up | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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