NEXIUM Drug Patent Profile
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When do Nexium patents expire, and when can generic versions of Nexium launch?
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. Five 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.
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Questions you can ask:
- What is the 5 year forecast for NEXIUM?
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- 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: | 44 |
| Clinical Trials: | 160 |
| Patent Applications: | 4,306 |
| 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 |
| IQVIA RDS Inc. | 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Astrazeneca | NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957-002 | Oct 20, 2006 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Astrazeneca | NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957-004 | Dec 15, 2011 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| 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 | NEXIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 021153-002 | Feb 20, 2001 | AB | RX | 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
| 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 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957-003 | Dec 15, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | NEXIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 021153-001 | Feb 20, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | NEXIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 021153-002 | Feb 20, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | NEXIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 021153-001 | Feb 20, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Saudi Arabia | 821 | ملح magnesium نقي ضوئياً لمركب pyridinylmethyl sulfinyl- 1H- benzimidazole | ⤷ Sign Up |
| Slovenia | 0984957 | ⤷ Sign Up | |
| Israel | 109684 | OPTICALLY PURE CRYSTALLINE SALTS OF THE (-)-ENANTIOMER OF OMEPRAZOLE, PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM | ⤷ Sign Up |
| Mexico | 9405217 | PROCESO PARA LA FABRICACION DE SAL DE MAGNESIO DE OMEPRAZOL, PRODUCTOOBTENIDO A PARTIR DEL MISMO Y COMPOSICION FARMACEUTICA QUE CONTIENE DICHOPRODUCTO. | ⤷ Sign Up |
| Lithuania | 2275 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NEXIUM
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1020461 | 91870 | Luxembourg | ⤷ Sign Up | |
| 0984957 | CA 2012 00008 | Denmark | ⤷ Sign Up | |
| 0984957 | 430 | Finland | ⤷ Sign Up | |
| 1411900 | SPC/GB11/015 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
| 0984957 | PA2011005 | Lithuania | ⤷ Sign Up | PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126 |
| >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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