NEXIUM Drug Patent Profile
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When do Nexium patents expire, and what generic alternatives are available?
Nexium is a drug marketed by Astrazeneca and Astrazeneca Lp and is included in six NDAs.
The generic ingredient in NEXIUM 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
A generic version of NEXIUM was approved as esomeprazole sodium by SUN PHARM on March 18th, 2013.
Summary for NEXIUM
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 6 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 44 |
| Clinical Trials: | 160 |
| Patent Applications: | 4,583 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for NEXIUM |
| Drug Sales Revenues: | Drug sales revenues for NEXIUM |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NEXIUM |
| What excipients (inactive ingredients) are in NEXIUM? | NEXIUM excipients list |
| DailyMed Link: | NEXIUM at DailyMed |
Recent Clinical Trials for NEXIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Nanfang Hospital of Southern Medical University | Phase 4 |
| Liaocheng People's Hospital | Phase 1 |
| Medidata Solutions | Phase 3 |
Pharmacology for NEXIUM
| Drug Class | Proton Pump Inhibitor |
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for NEXIUM
Paragraph IV (Patent) Challenges for NEXIUM
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| NEXIUM | Delayed-release for Oral Suspension | esomeprazole magnesium | 2.5 mg and 5 mg | 021957 | 1 | 2018-09-24 |
| NEXIUM | Delayed-release for Oral Suspension | esomeprazole magnesium | 10 mg | 022101 | 1 | 2018-07-06 |
| NEXIUM | Delayed-release for Oral Suspension | esomeprazole magnesium | 20 mg and 40 mg | 021957 | 1 | 2013-08-01 |
| NEXIUM | Delayed-release Capsules | esomeprazole magnesium | 20 mg and 40 mg | 021153 | 1 | 2005-08-05 |
US Patents and Regulatory Information for NEXIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca | NEXIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 021153-001 | Feb 20, 2001 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Astrazeneca | NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957-002 | Oct 20, 2006 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Astrazeneca | NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957-004 | Dec 15, 2011 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| 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 | NEXIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 021153-002 | Feb 20, 2001 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Astrazeneca | NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957-003 | Dec 15, 2011 | RX | Yes | 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 |
Expired US Patents for NEXIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca | NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957-004 | Dec 15, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca | NEXIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 021153-001 | Feb 20, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca | NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957-003 | Dec 15, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca | NEXIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 021153-001 | Feb 20, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca | NEXIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 021153-001 | Feb 20, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca | NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957-001 | Oct 20, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NEXIUM
See the table below for patents covering NEXIUM around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 1020460 | Le sel sodique de l'énatiomère d'omeprazole (The sodium salt of the (-)-enantiomer of omeprazole) | ⤷ Try a Trial |
| Cyprus | 2224 | Optically pure salts of pyridinylmethyl sulfinyl-1H-benzimidazole compounds | ⤷ Try a Trial |
| Yugoslavia | 49065 | ⤷ Try a Trial | |
| Croatia | P920855 | PHARMACEUTICAL FORMULATIONS OF ACID LABILE SUBSTANCES FOR ORAL USE | ⤷ Try a Trial |
| Latvia | 5502 | Panemiens benzimidazola atvasinajumu vai to salu iegusanai | ⤷ Try a Trial |
| Spain | 2091971 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NEXIUM
| 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 |
| 0984957 | PA2011005,C0984957 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126 |
| 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 | 91870 | Luxembourg | ⤷ Try a Trial | |
| 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 |
| 0984957 | C300517 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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