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Serving leading biopharmaceutical companies globally:

Fuji
Dow
McKinsey
Farmers Insurance
AstraZeneca
Cantor Fitzgerald
Covington
Cipla
Deloitte
Teva

Generated: January 24, 2018

DrugPatentWatch Database Preview

NEXIUM Drug Profile

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Which patents cover Nexium, and what generic alternatives are available?

Nexium is a drug marketed by Astrazeneca Pharms and Astrazeneca Lp and is included in six NDAs. There are eight patents protecting this drug and five Paragraph IV challenges.

This drug has one hundred and eighty-one patent family members in forty-six countries.

The generic ingredient in NEXIUM is esomeprazole sodium. There are seventy drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.

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 Lp NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655-001 Mar 28, 2014 OTC Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-001 Oct 20, 2006 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium TABLET, DELAYED RELEASE;ORAL 207920-001 Nov 23, 2015 OTC Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca Pharms NEXIUM IV esomeprazole sodium INJECTABLE;INTRAVENOUS 021689-002 Mar 31, 2005 AP RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022101-001 Feb 27, 2008 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-001 Oct 20, 2006 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-001 Oct 20, 2006 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-001 Feb 20, 2001 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-003 Dec 15, 2011 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-004 Dec 15, 2011 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for NEXIUM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-003 Dec 15, 2011 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-001 Oct 20, 2006 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-002 Oct 20, 2006 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-001 Feb 20, 2001 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-002 Feb 20, 2001 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-001 Feb 20, 2001 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-002 Feb 20, 2001 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-004 Dec 15, 2011 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-001 Feb 20, 2001 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-002 Feb 20, 2001 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for NEXIUM
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Delayed-release for Oral Suspension 20 mg and 40 mg ➤ Subscribe 8/1/2013
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe 9/9/2016
➤ Subscribe Delayed-release Capsules 20 mg ➤ Subscribe 4/24/2014
➤ Subscribe For Injection 20 mg/vial and 40 mg/vial ➤ Subscribe 11/23/2009
➤ Subscribe Delayed-release 20 mg and 40 mg ➤ Subscribe 8/5/2005

Non-Orange Book US Patents for NEXIUM

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,677,455 Potassium salt of S-omeprazole ➤ Subscribe
6,747,155 Process ➤ Subscribe
7,745,466 Form of S-omeprazole ➤ Subscribe
8,076,361 Form of S-omeprazole ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for NEXIUM

Supplementary Protection Certificates for NEXIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2012 00035 Denmark ➤ Subscribe
0483 Netherlands ➤ Subscribe PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYDRAAT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105
11/016 Ireland ➤ Subscribe PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
2011005,C0984957 Lithuania ➤ Subscribe PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
0984957/02 Switzerland ➤ Subscribe PRODUCT NAME: ESOMEPRAZOL + ACETYLSALICYLSAEURE ; REGISTRATION NO/DATE: SWISSMEDIC 62119 26.06.2012
2011005 Lithuania ➤ Subscribe PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
871 Luxembourg ➤ Subscribe 91871, EXPIRES: 20230525
2012 00008 Denmark ➤ Subscribe
00517 Netherlands ➤ Subscribe PRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
2012000051 Germany ➤ Subscribe PRODUCT NAME: KOMBINATIONSPRODUKT UMFASSEND NAPROXEN UND ESOMEPRAZOL-MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Baxter
Healthtrust
Teva
Chubb
Cipla
Fuji
Queensland Health
Julphar

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 verifification 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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