Generics Industry News Search
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December 2013 News Archive |
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Health Canada recently approved a generic, addictive form of Oxycodone just as U.S. officials were urging their Canadian counterparts to ban such formulations of the powerful painkiller...
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Jubilant, announced today that it has received Abbreviated New Drug Application approval from the US Food and Drug Administration for: Quetiapine fumarate tablet, 25 mg (base), the generic version of AstraZeneca's Seroquel...
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Novartis hit Accord with a patent infringement lawsuit, saying Accord asked the U.S. Food and Drug Administration to approve generic versions of Novartis' bone drug Zometa prior to the expiration of a patent that protects it...
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Wockhardt was banned from selling some medicines to the U.S. from a
second factory in India after regulators added it to a list of
restricted facilities...
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AstraZeneca today announced a ruling by the US District Court for the Southern District of New York which ordered Apotex and Torpharm to pay AstraZeneca approximately $76 million in damages...
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Shire announces that its subsidiary has entered into an agreement to
supply an authorised generic version of its product Adderall XR...
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Depomed's patent-infringement case against Purdue Pharma can't be split into two phases, a federal judge in Trenton, N.J., ruled...
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Idenix announced that it has filed two lawsuits against Gilead Sciences...
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Purdue Pharma and Impax Laboratories, announced
today that the companies have agreed to resolve the patent infringement
lawsuits between them now pending in the United States District Court for the
Southern District of New York concerning certain Purdue patents, including
patents for abuse-deterrent technology, protecting OxyContin (oxycodone HCl
controlled-release) Tablets CII...
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Federal Health Minister Rona Ambrose
should pay close attention to her provincial counterparts' warnings on
the risks of allowing the current generic forms of the drug OxyContin
into Canada...
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Apotex Pty defeated Sanofi (SAN), France's
biggest drugmaker, in an Australian patent dispute over the
rheumatoid arthritis drugs Arava and Arabloc, with the country's
highest court ruling for the first time on the patentability of
medical treatments for humans...
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Pharma Major Lupin announced today that its US subsidiary, has launched
its generic Fenofibric acid delayed?release capsules 45 mg and 135 mg...
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Alvotech, plans to invest $250 million to develop and manufacture biosimilar assets that include follow-on versions of monoclonal antibodies molecules, which will be brought to market by 2018...
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Teva and Takeda today announced the signing earlier this year of an agreement in which Teva licensed to Takeda the right to commercialise Teva's innovative Glatiramer acetate formulation for the treatment of multiple sclerosis, in Japan...
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Mylan today announced that its U.S.-based subsidiary has launched Cabergoline tablets USP, 0.5 mg...
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Mylan today announced that it has completed the acquisition of the Agila injectables businesses from Strides Arcolab for up to $1.75 billion, which includes $250 million in contingent consideration...
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Auxilium announced today that the United States District Court for the District of Delaware granted Upsher-Smith Laboratories, a motion for summary judgment with respect to its attempts to bring a Testosterone gel product to market via its 505(b)(2) NDA using Auxilium's Testim product as its reference listed drug...
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Teva' U.S. subsidiary has launched a generic drug for treating warts and skin lesions...
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Glenmark announces the exclusive launch of Hydrocortisone butyrate cream USP, 0.1% in the United States...
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A crackdown by regulators on deals between drug-makers that unfairly delay the launch of cheap generic medicines appears to be working, with data on Monday showing firms in Europe are avoiding settlements involving pay-offs...
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Ben Venue Laboratories, a Bedford, Ohio-based subsidiary of German
drugmaker Boehringer Ingelheim has tapped Bank of America Merrill Lynch
to explore a possible sale of its generic sterile injectable drugs
business...
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183 patent settlements between originator and generic drugmakers were concluded in the European Union (EU) in 2012, compared to 120 in 2011, but last year's total drops to 125 when those relating to new legal provisions in Portugal are excluded...
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Idenix, a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that the United States Patent and Trademark Office declared a patent interference between Idenix's U.S. Patent 7,608,600 and Gilead Sciences's U.S. Patent Application 11/854,218, both related to the use of certain 2'-methyl, 2'-fluoro nucleoside compounds to treat hepatitis C virus infections...
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European Union regulators have fined drugmakers Johnson & Johnson and Novartis 16.3 million euros ($22 million) for blocking the sale of a cheaper generic rival to their painkiller Fentanyl?...
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CVS Caremark and Cardinal Health today announced the signing of an agreement to form the largest generic sourcing entity in the U.S., which is the world's largest generic drug market...
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Drug firm Eli Lilly and Company India today said it has entered into
branded generics segment in the country with the launch of four cancer
drugs to treat patients with breast and colo-rectal cancer respectively...
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Pharma Major Lupin announced today that it has received final approval for its Abacavir sulfate, Lamivudine, and Zidovudine tablets, 300 mg (base) / 150 mg / 300 mg from the United States Food and Drugs Administration to market a generic version of ViiV Healthcare's Trizivir tablets, 300 mg (base) / 150 mg / 300mg...
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Citron today announced that its New Jersey-based business has launched Duloxetine delayed-release capsules USP in 20 mg, 30 mg and 60 mg strengths...
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Teva Pharmaceutical Industries , the world's biggest generic
drug maker, forecast a big drop in profit in 2014 if cheap generic competition
to its blockbuster multiple sclerosis treatment Copaxone is launched...
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The US Food and Drug Administration has opened the door to the first
stream of generic formulations of Eli Lilly's antidepressant Cymbalta
(duloxetine), following the recent loss of its patent protection...
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Lupin announced today that its US subsidiary has launched its Duloxetine
hydrochloride delayed-release (HCl DR) capsules 20 mg, 30 mg and 60 mg
strengths...
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Actavis plc, a leading specialty pharmaceutical company, today announced that it its subsidiary, Warner Chilcott Company, LLC, has entered into an agreement in principle with Zydus Pharmaceuticals USA Inc. and Cadila Healthcare Limited to settle all outstanding patent litigation related to Zydus' generic version of Asacol HD (mesalamine) delayed-release tablets...
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Aurobindo Pharma said it has received the final approval from USFDA to
manufacture and market Duloxetine hydrochloride delayed-release capsules
in 3 strengths in the United States...
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Daiichi Sankyo announced that its Japan generics subsidiary, Daiichi Sankyo Espha, today launched two new generic drugs with two new active ingredients and two generic drugs with an additional standard...
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Cadila and Zydus have entered into an agreement in principle with Warner Chilcott to settle all outstanding patent litigation related to Asacol delayed-release tablets...
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On December 12, 2013, Cadence received a notice from Wockhardt, a New Jersey-based company, stating that Wockhardt filed an Abbreviated New Drug Application containing a "Paragraph IV" patent certification with the U.S. Food and Drug Administration for a generic version of Cadence's drug, Ofirmev (Acetaminophen) injection (1000 mg/100 mL, 10 mg/mL)...
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The US FDA could consider bringing some relief in payment of fees to small generic drug makers, including those from India, if a newly proposed legislation is enacted...
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RPH Pharmaceuticals AB a subsidiary of Recipharm AB announces the filing
of an application for an infectious disease drug product in a range of
European countries...
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Products from the German pharmaceutical producer Stada are now also available in Myanmar (Burma)...
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U.S. pharmaceutical company Alvogen has agreed to buy a 67 percent stake in Taiwan's Lotus for $200 million, a local newspaper reported on Tuesday...
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Teva announced today that its subsidiary in the USA has entered into an agreement with Pfizer to settle patent litigation related to Teva's generic version of Pfizer's Viagra (Sildenafil citrate) tablets...
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AstraZeneca is aware of reports that an 505(b)(2) NDA Esomeprazole
strontium product has been launched in the US by Hanmi Pharmaceutical
and affiliates and its US marketing partner Amneal
Pharmaceuticals...
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Mylan today announced that its subsidiary and partner, Banner (a wholly-owned subsidiary of Patheon), have entered into a settlement and license agreement with Eisai and Valeant that will resolve patent litigation related to Bexarotene capsules, 75 mg...
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GSK and ViiV Healthcare confirmed today that the US District Court for the District of Delaware upheld the validity of a patent covering the double combination of Lamivudine and Abacavir and the triple combination of Lamivudine, Abacavir and Zidovudine...
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Biogen Idec and Samsung Bioepis today announced that through their joint venture, Biogen Idec has exercised its right to enter into an agreement to commercialise anti-TNF biosimilar product candidates in Europe, including biosimilars for widely used therapies to treat conditions such as rheumatoid arthritis and Crohn's disease...
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The drug company AstraZeneca PLC lost a bid on Thursday to defend its widely used heartburn drug Nexium when an appeals court ruled that a new drug from Hanmi Pharmaceuticals did not infringe on Nexium patents
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The French competition authority said on Thursday it had fined Schering-Plough, now owned by Merck, 15.3 million euros ($21 million) over what it called a smear campaign against generic competition to Subutex, its drug for opioid addiction...
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The turf war between Big Pharma and generic companies, which was largely restricted to exorbitantly priced drugs for cancer and HIV, is now spilling over to chronic and lifestyle problems
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Sagent Pharmaceuticals today announced the launch of Octreotide Acetate Injection, a Somatostatin Analog, in five vial presentations...
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Actavis plc today confirmed that its subsidiary, Warner Chilcott Company LLC, has filed an ANDA with the U.S. FDA seeking approval to market Ethinyl Estradiol and Etonogestrel Vaginal Ring, 0.015 mg/24 hour and 0.12 mg/24 hour...
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Glenmark Pharmaceuticals and Glenmark Generics, USA confirms Cephalon has filed a patent infringement suit on 26 Dec 2013 in the U.S. District Court for the District of Delaware seeking to prevent Glenmark from commercializing its Abbreviated New Drug Application Bendamustine Hydrochloride product, their generic version of Treanda, prior to expiration of the Orange Book patents...
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