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Teva Gets FDA Nod for First Generic Version of Mylan's EpiPen
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Shares of Teva Pharmaceutical Industries Limited (TEVA - Free Report) rose 7.3% on Thursday after the FDA announced approval for the Israeli drugmaker’s generic version of Mylan’s popular EpiPen (epinephrine) auto-injector for severe allergy treatment.
Teva’s shares have risen 15.4% this year so far compared with the industry’s increase of 4.9%.
The FDA approved the generic version of EpiPen and EpiPen Jr in 0.3 mg and 0.15 mg strengths to treat life-threatening allergic reactions like anaphylaxis in both adults and children.
The approval of this drug-device combination product is part of FDA’s efforts to improve access to cheaper copycat versions of complex yet critically important medicines/products like EpiPen.
Mylan ran into massive trouble in 2016 for raising the price of EpiPen by more than 400% since its acquisition in 2007, drawing immense flak from lawmakers, consumers and common people alike. As a result of the increased prices of EpiPen, Mylan launched the first authorized generic for EpiPen in December 2016, which cost almost half of the branded version. Meanwhile, cheaper FDA approved branded alternatives to EpiPen, Auvi-Q and Adrenaclick, are also available in the market. Also, Adamis Pharmaceuticals Corporation gained FDA approval for a competing low cost pre-filled epinephrine syringe called Symjepi in June 2017 but has not launched the product yet.
However, Teva’s product is the first true generic rival of EpiPen to be approved by the FDA. The FDA had previously rejected Teva’s generic version in 2016.
The approval comes as a relief for Teva, which is facing significant challenges in the form of accelerated generic competition for its key multiple sclerosis injection, Copaxone, new competition for branded products, pricing erosion in the U.S. generics business, lower-than-expected contribution from generic launches and a massive debt load.
Teva has not mentioned when it will launch the generic product as well as the price of the same. Teva may try to capture a sizable portion of the market by pricing its generic version even lower than Mylan’s authorized version. Also, Mylan is facing supply shortages for EpiPen.
Mylan’s manufacturing partner, Pfizer (PFE - Free Report) , continues to experience interruptions in the production of EpiPen and hence the latter’s supplies to Mylan are inconsistent and inadequate in meeting global demand, including the United States. This leaves open a significant market opportunity for Teva to capture.
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Teva Gets FDA Nod for First Generic Version of Mylan's EpiPen
Shares of Teva Pharmaceutical Industries Limited (TEVA - Free Report) rose 7.3% on Thursday after the FDA announced approval for the Israeli drugmaker’s generic version of Mylan’s popular EpiPen (epinephrine) auto-injector for severe allergy treatment.
Teva’s shares have risen 15.4% this year so far compared with the industry’s increase of 4.9%.
The FDA approved the generic version of EpiPen and EpiPen Jr in 0.3 mg and 0.15 mg strengths to treat life-threatening allergic reactions like anaphylaxis in both adults and children.
The approval of this drug-device combination product is part of FDA’s efforts to improve access to cheaper copycat versions of complex yet critically important medicines/products like EpiPen.
Mylan ran into massive trouble in 2016 for raising the price of EpiPen by more than 400% since its acquisition in 2007, drawing immense flak from lawmakers, consumers and common people alike. As a result of the increased prices of EpiPen, Mylan launched the first authorized generic for EpiPen in December 2016, which cost almost half of the branded version. Meanwhile, cheaper FDA approved branded alternatives to EpiPen, Auvi-Q and Adrenaclick, are also available in the market. Also, Adamis Pharmaceuticals Corporation gained FDA approval for a competing low cost pre-filled epinephrine syringe called Symjepi in June 2017 but has not launched the product yet.
However, Teva’s product is the first true generic rival of EpiPen to be approved by the FDA. The FDA had previously rejected Teva’s generic version in 2016.
The approval comes as a relief for Teva, which is facing significant challenges in the form of accelerated generic competition for its key multiple sclerosis injection, Copaxone, new competition for branded products, pricing erosion in the U.S. generics business, lower-than-expected contribution from generic launches and a massive debt load.
Teva has not mentioned when it will launch the generic product as well as the price of the same. Teva may try to capture a sizable portion of the market by pricing its generic version even lower than Mylan’s authorized version. Also, Mylan is facing supply shortages for EpiPen.
Mylan’s manufacturing partner, Pfizer (PFE - Free Report) , continues to experience interruptions in the production of EpiPen and hence the latter’s supplies to Mylan are inconsistent and inadequate in meeting global demand, including the United States. This leaves open a significant market opportunity for Teva to capture.
Teva currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Here's another stock idea to consider. Much like petroleum 150 years ago, lithium power may soon shake the world, creating millionaires and reshaping geo-politics. Soon electric vehicles (EVs) may be cheaper than gas guzzlers. Some are already reaching 265 miles on a single charge.
With battery prices plummeting and charging stations set to multiply, one company stands out as the #1 stock to buy according to Zacks research.
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