See also: Generic Nexium IV
Nexium is a brand name of esomeprazole, approved by the FDA in the following formulation(s):
NEXIUM (esomeprazole magnesium - capsule, delayed rel pellets; oral)
Manufacturer: ASTRAZENECA
Approval date: February 20, 2001
Strength(s): EQ 20MG BASE, EQ 40MG BASE [RLD]
NEXIUM (esomeprazole magnesium - for suspension, delayed release; oral)
Manufacturer: ASTRAZENECA
Approval date: October 20, 2006
Strength(s): EQ 20MG BASE/PACKET, EQ 40MG BASE/PACKET [RLD]
Manufacturer: ASTRAZENECA
Approval date: February 27, 2008
Strength(s): EQ 10MG BASE/PACKET
Has a generic version of Nexium been approved?
No. There is currently no therapeutically equivalent version of Nexium available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Nexium. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
Related Patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
Pharmaceutical formulation of omeprazole
Patent 5,690,960
Issued: November 25, 1997
Inventor(s): Bengtsson; Inga Siv & Lovgren; Kurt Ingmar
Assignee(s): Astra Aktiebolag
A new oral pharmaceutical formulation containing a novel physical form of a magnesium salt of omeprazole, a method for the manufacture of such a formulation, and the use of such a formulation in medicine.Patent expiration dates:
- November 25, 2014✓✓
- November 25, 2014✓✓
- November 25, 2014✓✓
- November 25, 2014✓✓
- November 25, 2014✓✓
- November 25, 2014✓✓
- May 25, 2015✓✓
- May 25, 2015✓
- November 25, 2014
Compositions
Patent 5,714,504
Issued: February 3, 1998
Inventor(s): Lindberg; Per Lennart & Von Unge; Sverker
Assignee(s): Astra Aktiebolag
The novel optically pure compounds Na.sup.+, Mg.sup.2+, Li.sup.+, K.sup.+, Ca.sup.2+ and N.sup.+ (R).sub.4 salts of (+)-5-methoxy-2-››(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl!sulfinyl!-1H- benzimidazole or (-)-5-methoxy-2-››(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl!sulfinyl!-1H- benzimidazole, in particular sodium and magnesium salt form thereof, where R is an alkyl with 1-4 carbon atoms, processes for the preparation thereof and pharmaceutical preparations containing the compounds as active ingredients, as well as the use of the compounds in pharmaceutical preparations and intermediates obtained by preparing the compounds.Patent expiration dates:
- February 3, 2015✓✓
- February 3, 2015✓✓
- February 3, 2015✓✓
- February 3, 2015✓✓
- February 3, 2015✓✓
- February 3, 2015✓✓
- August 3, 2015✓✓
- August 3, 2015✓
- February 3, 2015
Method for the treatment of gastric acid-related diseases and production of medication using (-) enantiomer of omeprazole
Patent 5,877,192
Issued: March 2, 1999
Inventor(s): Lindberg; Per & Weidolf; Lars
Assignee(s): Astra Aktiebolag
A method for treatment of gastric acid related diseases by inhibition of gastric acid secretion comprising administering to a mammal in need of treatment a therapeutically effective amount of the (-)-enantiomer of 5-methoxy-2-››(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl!sulfinyl!-1H-benz imidazole or a pharmaceutically acceptable salt thereof, so as to effect decreased interindividual variation in plasma levels upon administration. The use of the (-)-enantiomer of omeprazole to receive increased average plasma levels (AUC) upon administration of the same doses of the (-)-enantiomer of omeprazole compared to those of racemic omeprazole is also claimed, as well as an improved antisecretory effect and a better clinical effect.Patent expiration dates:
- May 27, 2014✓✓
- May 27, 2014✓✓
- May 27, 2014✓✓
- May 27, 2014✓
- May 27, 2014✓
- May 27, 2014✓
- May 27, 2014✓
- November 27, 2014✓✓
- November 27, 2014✓
- May 27, 2014
Omeprazole magnesium salt form
Patent 5,900,424
Issued: May 4, 1999
Inventor(s): Kallstrom; Lars .ANG.ke & Nygren; Monica Annelie
Assignee(s): Astra Aktiebolag
A novel compound form of magnesium omeprazole useful in the manufacture of pharmaceutical formulations, the use of the product and the process for its production are described.Patent expiration dates:
- May 4, 2016✓✓
- May 4, 2016✓✓
- May 4, 2016✓✓
- May 4, 2016✓✓
- May 4, 2016✓✓
- May 4, 2016✓✓
- November 4, 2016✓✓
- November 4, 2016✓
- May 4, 2016
Omeprazole process and compositions thereof
Patent 6,147,103
Issued: November 14, 2000
Inventor(s): Anousis; Nick & McManus; James W. & Banks; Benjamin Newton & Zhou; Lingwen
Assignee(s): Merck & Co., Inc.
The present invention describes an improved process for the preparation, isolation, and purification of the anti-ulcer agent omeprazole whereby the sulfide precursor pyrmetazole is reacted subsurfacely with exactly one molar equivalent of meta-chloroperoxybenzoic acid in methylene chloride or toluene solution; residual organic solvent is removed from the aqueous layer by vacuum distillation; crude product is obtained by reactive crystallization with an alkyl formate and seeding; and pure product is isolated by recrystallization in methanol-water containing aqueous NaOH by subsurface addition of aqueous acetic acid to pH 9.0, seeding, filtration, washing, and drying. Compositions of omeprazole containing no chromatographically detectable levels of residual non-alcoholic organic reaction solvent are also described.Patent expiration dates:
- October 9, 2018
- April 9, 2019✓
- October 9, 2018
Omeprazole process and compositions thereof
Patent 6,166,213
Issued: December 26, 2000
Inventor(s): Anousis; Nick & McManus; James W. & Banks; Benjamin Newton & Zhou; Lingwen & Liu; Hui
Assignee(s): Merck & Co., Inc.
The present invention describes an improved process for the preparation, isolation, and purification of the anti-ulcer agent omeprazole whereby the sulfide precursor pyrmetazole is reacted subsurfacely with exactly one molar equivalent of meta-chloroperoxybenzoic acid in methylene chloride or toluene solution; residual organic solvent is removed from the aqueous layer by vacuum distillation; crude product is obtained by reactive crystallization with an alkyl formate and seeding; and pure product is isolated by recrystallization in methanol-water containing aqueous NaOH by subsurface addition of aqueous acetic acid to pH 9.0, seeding, filtration, washing, and drying. Compositions of omeprazole containing no chromatographically detectable levels of residual non-alcoholic organic reaction solvent are also described.Patent expiration dates:
- October 9, 2018
- April 9, 2019✓
- October 9, 2018
Omerazole process and compositions thereof
Patent 6,191,148
Issued: February 20, 2001
Inventor(s): McManus; James W. & Anousis; Nick & Banks; Benjamin Newton & Liu; Hui & Zhou; Lingwen
Assignee(s): Merck & Co., Inc.
The present invention describes an improved process for the preparation, isolation, and purification of the anti-ulcer agent omeprazole whereby the sulfide precursor pyrmetazole is reacted subsurfacely with exactly one molar equivalent of meta-chloroperoxybenzoic acid in a chlorinated aliphatic hydrocarbon or aromatic hydrocarbon solvent, such as methylene chloride or toluene; residual organic solvent is removed from the aqueous layer by vacuum distillation; crude product is obtained by reactive crystallization with an alkyl formate or formic acid solution and seeding; and pure product is isolated by recrystallization in methanol-water containing aqueous NaOH by subsurface addition of aqueous acetic acid to pH 9.0, seeding, filtration, washing, and drying. Omeprazole and compositions of omeprazole containing no chromatographically detectable levels of residual non-alcoholic organic reaction solvent and diminished levels of alcoholic solvent are also described.Patent expiration dates:
- October 9, 2018
- April 9, 2019✓
- October 9, 2018
Form of S-omeprazole
Patent 6,369,085
Issued: April 9, 2002
Inventor(s): Hanna; Cotton & Anders; Kronström & Anders; Mattson & Eva; Möller
Assignee(s): AstraZeneca AB
The present invention relates to a novel form of the (−)-enantiomer of 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)-methyl]sulfinyl]-1H-benzimidazole, i.e. S-omeprazole. More specifically, it relates to a novel form of the magnesium salt of the S-enantiomer of omeprazole trihydrate. The present invention also relates to processes for preparing such a form of the magnesium salt of S-omeprazole and pharmaceutical compositions containing it. Furthermore, the present invention also relates to new intermediates used in the process.Patent expiration dates:
- May 25, 2018✓✓✓
- May 25, 2018✓✓✓
- May 25, 2018✓✓✓
- May 25, 2018✓✓✓
- May 25, 2018✓✓✓
- November 25, 2018✓
- May 25, 2018
Pharmaceutical formulation comprising omeprazole
Patent 6,428,810
Issued: August 6, 2002
Inventor(s): Pontus; Bergstrand & Peter; Wang
Assignee(s): AstraZeneca AB
An enteric coated oral pharmaceutical formulation comprising as active ingredient a compound selected from the group of omeprazole, an alkaline salt of omeprazole, one of the single enantiomers of omeprazole and an alkaline salt of one of the single enantiomers of omeprazole, wherein the formulation comprises a core material that comprises the active ingredient and optionally an alkaline reacting compound, the active ingredient is in admixture with a pharmaceutically acceptable excipient, such as for instance a binding agent, and on said core material a separating layer and an enteric coating layer. A hydroxypropyl cellulose (HPC) with a specific cloud point is used in the manufacture of the claimed pharmaceutical formulations. Furthermore, the application describes the processes for their preparation and the use of the claimed formulations in medicine.Patent expiration dates:
- November 3, 2019✓✓
- November 3, 2019✓✓
- November 3, 2019✓✓
- November 3, 2019✓✓
- November 3, 2019✓✓
- November 3, 2019✓✓
- May 3, 2020✓✓
- May 3, 2020✓
- November 3, 2019
Compounds
Patent 6,875,872
Issued: April 5, 2005
Inventor(s): Lindberg; Per Lennart & Von Unge; Sverker
Assignee(s): AstraZeneca
The novel optically pure compounds Na+, Mg2+, Li+, K+, Ca2+ and N+(R)4 salts of (+)-5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole or (−)-5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole, in particular sodium and magnesium salt form thereof, where R is an alkyl with 1-4 carbon atoms, processes for the preparation thereof and pharmaceutical preparations containing the compounds as active ingredients, as well as the use of the compounds in pharmaceutical preparations and intermediates obtained by preparing the compounds.Patent expiration dates:
- May 27, 2014✓
- November 27, 2014✓
- May 27, 2014
Form of S-omeprazole
Patent 7,411,070
Issued: August 12, 2008
Inventor(s): Cotton; Hanna & Kronström; Anders & Mattson; Anders & Möller; Eva
Assignee(s): AstraZeneca AB
The present invention relates to a novel form of the (−)-enantiomer of 5-methoxy-2[[(4-methoxy-3,5-dimethyl-2-pyridinyl)-methyl]sulfinyl]-1H-benzimidazole, i.e. S-omeprazole. More specifically, it relates to a novel form of the magnesium salt of the S-enantiomer of omeprazole trihydrate. The present invention also relates to processes for preparing such a form of the magnesium salt of S-omeprazole and pharmaceutical compositions containing it. Furthermore, the present invention also relates to new intermediates used in the process.Patent expiration dates:
- May 25, 2018✓
- November 25, 2018✓
- May 25, 2018
Related Exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
- Exclusivity expiration dates:
- February 27, 2011 - NEW PATIENT POPULATION
- August 27, 2011 - PEDIATRIC EXCLUSIVITY
- June 18, 2012 - LABELING CHANGES SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST FOR INFANTS AGES BIRTH TO 11 MONTH INCLUSIVE REFLECTING LACK OF EFFICACY FOR GERD INDICATION FOR THIS PATIENT POPULATION
- December 18, 2012 - PEDIATRIC EXCLUSIVITY
See also...
- Nexium Consumer Information (Drugs.com)
- Nexium Delayed-Release Capsules Consumer Information (Wolters Kluwer)
- Nexium Delayed-Release Oral Suspension Consumer Information (Wolters Kluwer)
- Nexium Consumer Information (Cerner Multum)
- Nexium Advanced Consumer Information (Micromedex)
- Nexium Oral Advanced Consumer Information (Micromedex)
- Esomeprazole Consumer Information (Wolters Kluwer)
- Esomeprazole Delayed-Release Capsules Consumer Information (Wolters Kluwer)
- Esomeprazole Delayed-Release Oral Suspension Consumer Information (Wolters Kluwer)
- Esomeprazole Consumer Information (Cerner Multum)
- Esomeprazole Advanced Consumer Information (Micromedex)
- Esomeprazole Oral, Intravenous Advanced Consumer Information (Micromedex)
- Esomeprazole Magnesium AHFS DI Monographs (ASHP)
- Esomeprazole Sodium AHFS DI Monographs (ASHP)
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