North America generic drugs market is estimated to grow at a CAGR of nearly 7.2% during the forecast period. Significant initiatives by regulatory authorities to stimulate generic drug approvals are supporting to drive market growth. For instance, in October 2007, the US FDA introduced the Generic Initiative for Value and Efficiency (GIVE). As an initiative, GIVE will utilize existing resources to support the US FDA to advance and streamline the approval process of generic drugs. The initiative is intended to increase the availability of generic drugs. The increasing availability of generic-drug alternatives results in more cost-savings to consumers, as generic drugs cost nearly 30% to 80% lower compared to the brand name drugs.
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In 2019, the US FDA approved a total of over 1,000 generic drug final and tentative approvals. In 2019, the US FDA approvals comprised 107 applications for first generics of drugs that had no generic competition, which includes medicines for the treatment of depression, breast cancer, pulmonary arterial hypertension, seizures, and several infections and 110 complex generic drugs that are harder to develop and usually have lacked competition. The increasing availability of generic drugs will further bring down the cost of generics and thereby will accelerate market growth.
Scope of the North America Generic Drugs Market
Market Coverage
- Market number available for 2019-2026
- Base year- 2019
- Forecast period- 2020-2026
- Segment Covered- By Application and Route of Administration
- Countries Covered- US and Canada
- Competitive Landscape- Mylan N.V., Teva Pharmaceutical Industries Ltd., Lupin Ltd., Novartis International AG, and Sun Pharmaceutical Industries Ltd.
Recent Strategic Initiatives in the North America Generic Drugs Market
- In October 2020, Teva Pharmaceuticals USA, Inc. declared the availability of the first US FDA-approved generic versions of TRUVADA i and ATRIPLA i tablets. These products, along with over 10 HIV-related drugs are already on the WHO’s Essential Medicines List. By launching these new generic options for HIV treatment, Teva will further increase access to vital therapies and strengthen its position in the generic marketplace.
- In April 2020, Cipla Ltd. received the US FDA approval of the first generic of Proventil HFA (albuterol sulfate) metered-dose inhaler, 90 mcg/Inhalation. This is indicated for the treatment or prevention of bronchospasm in patients four years of age and older suffering from reversible obstructive airway disease, as well as the prevention of exercise-induced bronchospasm in this age group.
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North America Generic Drugs Market-Segmentation
By Application
- Cancer
- CVD
- Musculoskeletal Diseases
- Infectious Diseases
- Neurology
- Diabetes
- Others
By Route of Administration
- Oral
- Topical
- Injectable
- Inhaler
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