Mylan N.V. announced that it has launched tadalafil tablets — the first generic version of the reference branded drug, Eli Lilly and Company's (LLY - Free Report) Adcirca.
Along with the final approval from the FDA for its Abbreviated New Drug Application for the generic version of Adcirca, Mylan was awarded 180 days of marketing exclusivity for this product.
Adcirca is indicated for the treatment of pulmonary arterial hypertension to improve exercise ability.
The addition of generic Adcirca tablets strengthened Mylan’s cardiovascular portfolio.
New generic approvals should boost Mylan’s generic business in the United States. Mylan has 192 ANDAs pending FDA approval, representing approximately $88.3 billion in annual brand sales, as per IQVIA. Among these, 44 of the pending ANDAs are potential first-to-file opportunities, representing $44.9 billion in annual brand sales for the 12 months ending Dec 31, 2017, according to IQVIA.
Last month, Mylan had announced that it launched the generic version of Novartis’ (NVS - Free Report) Exelon patch, which is indicated for the treatment of dementia associated with mild, moderate and severe Alzheimer's disease and the treatment of mild to moderate dementia associated with Parkinson's disease.
However, the generic business in the United States continues to experience pricing and competitive pressure. The competitive pressure for EpiPen has increased further along with supply issues. The company earlier suffered a setback when the FDA refused to approved its Abbreviated New Drug Application for the generic version of GlaxoSmithKline’s (GSK - Free Report) asthma drug, Advair Diskus.
Mylan’s second-quarter results were dismal as challenges in North America persist prompting the management to evaluate strategic alternatives. Mylan lowered its outlook as a result of the change in expected complex product launch, utilization assumptions, resizing of product opportunities in the United States, and the negative impact on operations of the restructuring and remediation program in Morgantown. While the biosimilar business continues to gain traction buoyed by new approvals, these new approvals might not be enough to combat the persistent decline in North America.
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Mylan N.V. announced that it has launched tadalafil tablets — the first generic version of the reference branded drug, Eli Lilly and Company's (LLY - Free Report) Adcirca.
Along with the final approval from the FDA for its Abbreviated New Drug Application for the generic version of Adcirca, Mylan was awarded 180 days of marketing exclusivity for this product.
Adcirca is indicated for the treatment of pulmonary arterial hypertension to improve exercise ability.
The addition of generic Adcirca tablets strengthened Mylan’s cardiovascular portfolio.
New generic approvals should boost Mylan’s generic business in the United States. Mylan has 192 ANDAs pending FDA approval, representing approximately $88.3 billion in annual brand sales, as per IQVIA. Among these, 44 of the pending ANDAs are potential first-to-file opportunities, representing $44.9 billion in annual brand sales for the 12 months ending Dec 31, 2017, according to IQVIA.
Last month, Mylan had announced that it launched the generic version of Novartis’ (NVS - Free Report) Exelon patch, which is indicated for the treatment of dementia associated with mild, moderate and severe Alzheimer's disease and the treatment of mild to moderate dementia associated with Parkinson's disease.
However, the generic business in the United States continues to experience pricing and competitive pressure. The competitive pressure for EpiPen has increased further along with supply issues. The company earlier suffered a setback when the FDA refused to approved its Abbreviated New Drug Application for the generic version of GlaxoSmithKline’s (GSK - Free Report) asthma drug, Advair Diskus.
Mylan’s second-quarter results were dismal as challenges in North America persist prompting the management to evaluate strategic alternatives. Mylan lowered its outlook as a result of the change in expected complex product launch, utilization assumptions, resizing of product opportunities in the United States, and the negative impact on operations of the restructuring and remediation program in Morgantown. While the biosimilar business continues to gain traction buoyed by new approvals, these new approvals might not be enough to combat the persistent decline in North America.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
See the pot trades we're targeting>>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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