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. Four 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 DEVA HOLDING AS on March 6th, 2017.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for NEXIUM?
- What are the global sales for NEXIUM?
- What is Average Wholesale Price for NEXIUM?
Summary for NEXIUM
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 6 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 165 |
| Patent Applications: | 3,910 |
| 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 |
|---|---|
| Livzon Pharmaceutical Group Inc. | PHASE3 |
| Bio-innova Co., Ltd | PHASE1 |
| Alexandria University | Phase 3 |
Pharmacology for NEXIUM
| Drug Class | Proton Pump Inhibitor |
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
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 | ⤷ Get Started Free | ⤷ Get Started Free | ⤷ Get Started Free | |||
| Astrazeneca | NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957-002 | Oct 20, 2006 | AB | RX | Yes | Yes | ⤷ Get Started Free | ⤷ Get Started Free | ⤷ Get Started Free | |||
| Astrazeneca | NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957-004 | Dec 15, 2011 | AB | RX | Yes | No | ⤷ Get Started Free | ⤷ Get Started Free | ⤷ Get Started Free | |||
| Astrazeneca Lp | NEXIUM 24HR | esomeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 204655-001 | Mar 28, 2014 | OTC | Yes | Yes | ⤷ Get Started Free | ⤷ Get Started Free | ⤷ Get Started Free | ||||
| Astrazeneca | NEXIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 021153-002 | Feb 20, 2001 | AB | RX | Yes | Yes | ⤷ Get Started Free | ⤷ Get Started Free | ⤷ Get Started Free | |||
| Astrazeneca | NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957-003 | Dec 15, 2011 | AB | RX | Yes | No | ⤷ Get Started Free | ⤷ Get Started Free | ⤷ Get Started Free | |||
| >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
International Patents for NEXIUM
See the table below for patents covering NEXIUM around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Germany | 69426254 | ⤷ Get Started Free | |
| European Patent Office | 0956857 | ⤷ Get Started Free | |
| Brazil | 9406941 | ⤷ Get Started Free | |
| Slovakia | 285137 | ⤷ Get Started Free | |
| Spain | 2191682 | ⤷ Get Started Free | |
| Finland | 791219 | ⤷ Get Started Free | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NEXIUM
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0984957 | 430 | Finland | ⤷ Get Started Free | |
| 0984957 | 300483 | Netherlands | ⤷ Get Started Free | PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYDRAAT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105 |
| 0984957 | C300517 | Netherlands | ⤷ Get Started Free | PRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812 |
| 0005129 | SPC/GB99/015 | United Kingdom | ⤷ Get Started Free | SPC/GB99/015, EXPIRES: 20021115 |
| 0124495 | SPC/GB01/006 | United Kingdom | ⤷ Get Started Free | PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727 |
| 0984957 | SPC/GB11/013 | United Kingdom | ⤷ Get Started Free | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Nexium (Esomeprazole): An In-Depth Analysis
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