Sandoz In-Licenses Brand And Authorized Generic Of Respiratory Medicine Proventil® HFA (Albuterol Sulfate) Inhalation Aerosol From Kindeva Drug Delivery, With Immediate Generic Availability In US

• Albuterol sulfate is used to treat or prevent bronchospasm in patients four years and older with reversible obstructive airway disease, such as asthma, and to prevent exercise-induced bronchospasm¹
• Immediate launch of our authorized generic will help ensure a reliable supply of albuterol medicines, as respiratory products see increased demand over past year
• Deal allows Sandoz to further grow respiratory portfolio and availability of our authorized generic ensures patients have access to an important medicine at an affordable price

Princeton, New Jersey — Sandoz Inc. today announced the in-licensing of commercial distribution rights to the brand and authorized generic of respiratory inhalation medicine Proventil^® HFA (albuterol sulfate) Inhalation Aerosol from Kindeva Drug Delivery, a global contract development and manufacturing organization supplying the product. Our albuterol sulfate authorized generic is immediately available to patients in the US.

There has been a surge in demand for albuterol medicines over the past year. Hospitals increasingly switched to using metered-dose albuterol inhalers rather than nebulizers to treat the growing number of COVID-19 patients. Pharmacies also saw increased demand for albuterol inhalers after the CDC recommended that Americans stock up on necessary medications.²

“With the commercial distribution rights to the brand and authorized generic of Proventil^® HFA, we are excited to work to increase supply and help ensure patients who need albuterol have access to this important medicine,” said Keren Haruvi, President, Sandoz Inc. “This deal delivers on our strategy to grow our respiratory portfolio and brings us closer to our ambition to be the world’s leading and most valued generic company.”

Albuterol sulfate is used to treat patients four years and older suffering from bronchospasm, a condition where the muscular coat of the bronchial tubes contracts, resulting in a narrowing of the breathing airways.³ Exercise or other physical activities can also bring on symptoms in most people who have asthma and may occur either during or right after being active.⁴

“We are pleased to partner with Sandoz on the distribution of the authorized generic of Proventil from our manufacturing site in Northridge, California,” said Aaron Mann, CEO of Kindeva Drug Delivery. “Combining Kindeva’s long track record of formulating, developing and manufacturing complex combination drug products with the Sandoz legacy of successfully commercializing critical drug therapies will help more patients access this important medicine.”

Millions of patients worldwide rely on Sandoz to consistently produce and deliver the medicines they need. The comprehensive, resilient and geographically diverse nature of our supply chain network helps Sandoz to ensure reliability in manufacturing and access to high-quality medicines for clinicians and patients. The brand and authorized generic of Proventil^® HFA are both manufactured in California.

About Sandoz

Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical need. Our ambition is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines, covering all major therapeutic areas, accounted for 2020 sales of USD 9.6 billion.

Sandoz on social media

LinkedIn: https://www.linkedin.com/company/sandoz/
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CEO Richard Saynor on LinkedIn: https://www.linkedin.com/in/richard-saynor/

About Kindeva Drug Delivery

Headquartered in St. Paul, Minnesota, Kindeva Drug Delivery is a leading global contract development and manufacturing organization (CDMO) in the pharmaceutical industry. Kindeva provides unique technologies and quality services to its customers, ranging from formulation and product development to commercial manufacturing. Kindeva focuses on complex drug programs, and its current offering spans inhalation drug delivery, transdermal drug delivery, microstructured transdermal systems (microsystems), and connected drug delivery. Kindeva employs over 1,000 people worldwide. For more information, visit www.kindevadd.com.

References:

1. Albuterol Sulfate aerosol. Prescribing Information.
2. Allergic Living. COVID-19 and Albuterol Shortage: 6 Strategies for Asthma Patients. Available at: https://www.allergicliving.com/2020/03/30/covid-19-and-albuterol-shortage-6-strategies-for-asthma-patients/. Accessed February 15, 2021.
3. American Academy of Allergy Asthma and Immunology. Bronchospasm Defined. Available at: https://www.aaaai.org/conditions-and-treatments/conditions-dictionary/bronchospasm. Accessed February 15, 2021.
4. FDA. FDA Approves First Generic of a Commonly Used Albuterol Inhaler to Treat and Prevent Bronchospasm. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-commonly-used-albuterol-inhaler-treat-and-prevent-bronchospasm. Accessed February 15, 2021.