Amneal Announces Launch of Esomeprazole strontium 49.3 mg Delayed-Release Capsules Authorized Generic
Company to market generic equivalent of recently-launched brand
BRIDGEWATER, N.J.--(BUSINESS WIRE)--Amneal Pharmaceuticals LLC today announced the launch of generic Esomeprazole strontium delayed-release capsules 49.3 mg. This new esomeprazole therapy is the generic equivalent of the recently launched brand Esomeprazole strontium. It contains the same active moiety (esomeprazole) in a different salt form as found in the leading PPI brand Nexium® (esomeprazole magnesium) and presents a potentially more affordable treatment option for GERD in adult patients.
“Introducing generic esomeprazole strontium offers a new, cost-effective treatment option for adult GERD sufferers. It’s another example of how Amneal’s innovative growth strategy has helped to bring economical generic medications to market and benefit all stakeholders in the healthcare equation—patients, prescribers, pharmacists and payers.”
Available in a 49.3 mg strength, each esomeprazole strontium capsule provides the equivalent of 40 mg of esomeprazole1 – the same amount of esomeprazole that is present in the 40 mg Nexium® capsule. Esomeprazole strontium capsules will be sold in 30-count bottles and are the authorized generic equivalent for their branded counterpart by the same name (Esomeprazole strontium delayed-release capsules 49.3 mg), which Amneal launched in December 2013.
Amneal Co-CEO & Chairman Chirag Patel explains, “Introducing generic esomeprazole strontium offers a new, cost-effective treatment option for adult GERD sufferers. It’s another example of how Amneal’s innovative growth strategy has helped to bring economical generic medications to market and benefit all stakeholders in the healthcare equation—patients, prescribers, pharmacists and payers.”
Esomeprazole strontium will be sold through wholesalers and distributors as well as directly to the trade. The product begins shipping today.
Indications and Usage
Esomeprazole strontium is a proton pump inhibitor (PPI) indicated for adults for:
- Treatment of gastroesophageal reflux disease (GERD)
- Risk reduction of NSAID-associated gastric ulcer
- H. pylori eradication to reduce the risk of duodenal ulcer recurrence
- Pathological hypersecretory conditions, including Zollinger-Ellison syndrome
The safety and effectiveness of esomeprazole strontium have not been established in pediatric patients. Esomeprazole strontium is not recommended for use in pediatric patients.
The safety of esomeprazole strontium has not been studied in patients with severe renal impairment. Esomeprazole strontium is not recommended for use in patients with severe renal impairment.
Nursing mothers should consider discontinuing esomeprazole strontium.
There are no studies in pregnant women. Esomeprazole strontium should be used during pregnancy only if the potential benefits justify the potential risk to the fetus.
Important Safety Information
Esomeprazole strontium is contraindicated in patients with known hypersensitivity to PPIs. Hypersensitivity reactions, e.g., angioedema and anaphylactic shock have been reported with esomeprazole use.
Symptomatic response to therapy does not preclude the presence of gastric malignancy.
Atrophic gastritis has been noted occasionally in biopsies from patients treated long-term with omeprazole.
PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea.
Avoid concomitant use of esomeprazole strontium with clopidogrel, because the metabolism of clopidogrel can be impaired. When using esomeprazole strontium consider alternative anti-platelet therapy.
Long-term and multiple daily dose PPI therapy may be associated with an increased risk of osteoporosis-related fractures of the hip, wrist, or spine.
Hypomagnesemia has been reported rarely with prolonged treatment with PPIs. Serious events included tetany, arrhythmias, and seizures, and may require discontinuation of the PPI.
Most common adverse reactions in adults (≥18 years) (incidence ≥1%) are headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth.
Avoid concomitant use of esomeprazole strontium with drugs which induce CYP2C19 or CYP3A4, such as with St. John’s wort or rifampin, due to the potential substantial reduction in esomeprazole levels.
Patients treated with PPIs and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time. Esomeprazole may interfere with the absorption of drugs for which gastric pH affects bioavailability (e.g., ketoconazole, iron salts, and digoxin).
Drug-induced decreases in gastric acidity may increase serum chromogranin A (CgA) levels and may cause false positive results in diagnostic investigations for neuroendocrine tumors. Providers should temporarily stop esomeprazole treatment before assessing CgA levels.
Concomitant use with atazanavir and nelfinavir is not recommended; Concomitant use of saquinavir with PPIs is expected to increase saquinavir concentrations, which may increase toxicity.
Please click here to see the full prescribing information for Esomeprazole strontium delayed-release capsules.
About Amneal Pharmaceuticals LLC
Amneal Pharmaceuticals LLC is a U.S.-based manufacturer of generic pharmaceuticals. Known as “Generic’s New Generation”, Amneal prides itself on its unwavering commitment to quality, meaningful business relationships, and innovative approach to maximizing value for all stakeholders. Extensive investment in R&D, an intelligently aggressive expansion strategy, and focus on vertical integration are key contributors to the company’s impressive growth over the past several years. Amneal is headquartered in Bridgewater, New Jersey with manufacturing, R&D, packaging, sales and distribution facilities throughout the U.S., as well as abroad. For more information, visit www.amneal.com.
All trademarks are property of their respective owners.
1 Esomeprazole strontium delayed-release capsules Full Prescribing Information, section 11