Arformoterol tartrate



  1. Marketed by Sunovion Pharmaceuticals Inc., a U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd.
  2. Long-acting beta 2 adrenergic agonist (LABA) with bronchodilator activity used for symptomatic control of chronic obstructive pulmonary disease (COPD)

What to watch?

Will the declining market size discourage those with tentative approvals from launching, or will we see price erosion with multiple generics entering the market in 2021?


  1. First U.S. approval date – October 6, 2006
  2. Numerous patent expiries – June 22 – November 9, 2021 (U.S.)

About BROVANA® in the market

  1. Four tentative ANDA filings in the United States: Axar Pharmaceuticals Inc, Lupin Limited, Cipla Limited, Teva Pharmaceutical Industries Ltd
  2. According to the U.S. FDA, eligibility extinguished for the 180-day generic drug exclusivity for a generic version of BROVANA
  3. Despite the generic interest, declining U.S. market share (2017-2019):
    • -37% prescription count
    • -50% dose units count
    • Similar trend observed for other products in this therapeutic class since 2017

U.S. market share

About Sunovion Pharma

  1. Holder of 11 U.S. FDA NDA filings between 2000 and 2020
  2. Marketer of nine products in the United States: two under litigation (eslicarbazepine acetate and levalbuterol tartrate) and one to lose exclusivity on Dec 16, 2031 (apomorphine hydrochloride)
  3. December 2016: agreement to commercialize Novartis’ three COPD products, UTIBRON NEOHALER® (glycopyrronium; indacaterol maleate), SEEBRI NEOHALER® (glycopyrronium) and ARCAPTA NEOHALER® (indacaterol maleate), in the United States
  4. July 2017: divested U.S. marketing rights of ALVESCO®, OMNARIS® and ZETONNA® against asthma and allergic rhinitis to Covis Pharma

Patient impact

COPD is a chronic disease requiring lifelong treatment; as such, it is associated with high economic and patient burden due to lost productivity, healthcare expenditure and reduced quality of life.

Treatment with either a LABA or a long-acting muscarinic antagonist (LAMA) is the preferred first-line therapy. With worsening symptoms, polypharmacy, potentially requiring a multi-inhaler regimen, is common and can be expensive and difficult for patients to manage.

people have COPD in the key markets (United States, France, United Kingdom, Germany, Spain, Italy, Japan)

Based on Cortellis data, active pharmaceutical ingredients (API) are available for regulated markets from multiple manufacturers.

Source: Cortellis Generics Intelligence

Source: Cortellis Generics Intelligence

Data current as of April 14, 2021

The future of the generics landscape

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