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   December 2013 News Archive news archive  


03/12/2013  Canada approves generic Oxycodone despite urging from U.S. to ban it news archive
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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03/12/2013  Jubilant receives ANDA approval for Quetiapine fumarate tablet news archive
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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03/12/2013  Novartis says Accord can't make, sell generic bone drug Zometa news archive
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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03/12/2013  Wockhardt's main drug factory faces FDA ban after lapses news archive
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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03/12/2013  AstraZeneca awarded damages in Prilosec patent litigation news archive
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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03/12/2013  Shire enters into agreement to supply Adderall XR authorised generic news archive
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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03/12/2013  Purdue patent case can't be split into two phases, judge rules news archive
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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04/12/2013  Idenix files patent infringement and interference lawsuits against Gilead news archive
Idenix announced that it has filed two lawsuits against Gilead Sciences...
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06/12/2013  Purdue Pharma announces resolution of OxyContin tablets CII patent lawsuit with Impax Laboratories news archive
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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06/12/2013  Another view: Ambrose wrong on generic OxyContin news archive
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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06/12/2013  Apotex defeats Sanofi bid to block generic Arava in Australia news archive
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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08/12/2013  Lupin launches generic Trilipix delayed-release capsules 45 mg & 135 mg in the US news archive
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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08/12/2013  Alvotech plans multimillion biosimilars investment news archive
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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08/12/2013  Teva and Takeda announce agreement for Glatiramer acetate for multiple sclerosis treatment in Japan news archive
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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08/12/2013  Mylan launches Cabergoline tablets news archive
Mylan today announced that its U.S.-based subsidiary has launched Cabergoline tablets USP, 0.5 mg...
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08/12/2013  Mylan completes acquisition of Agila to create leading global injectables platform news archive
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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08/12/2013  Auxilium announces court grants Upsher-Smith Lab motion for summary judgment news archive
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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08/12/2013  Teva launches Imiquimod cream news archive
Teva' U.S. subsidiary has launched a generic drug for treating warts and skin lesions...
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09/12/2013  Glenmark announces launch of Hydrocortisone butyrate cream in the US news archive
Glenmark announces the exclusive launch of Hydrocortisone butyrate cream USP, 0.1% in the United States...
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09/12/2013  "Pay-for-delay" generic drug deals fall after EU crackdown news archive
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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09/12/2013  Boehringer unit taps BofA to explore sale of generics business news archive
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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10/12/2013  EU pharma patent settlements continuing to rise news archive
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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10/12/2013  Idenix announces declaration of senior party in a second patent interference by the USPTO news archive
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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10/12/2013  EU regulators fine J&J;, Novartis for generic drug deal news archive
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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10/12/2013  CVS Caremark and Cardinal Health announce creation of largest generic sourcing entity in U.S news archive
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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10/12/2013  Eli Lilly enters branded generics; launches four cancer drugs news archive
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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10/12/2013  Lupin receives FDA approval for generic Trizivir tablets news archive
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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11/12/2013  Citron Pharma launches a generic version of Cymbalta, delayed release capsules news archive
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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12/12/2013  Teva Pharm sees 2014 profit drop if Copaxone competition launched news archive
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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12/12/2013  FDA clears first generics of Lilly's $5bn-a-year Cymbalta news archive
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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12/12/2013  Lupin launches Generic Cymbalta delayed-release capsules 20 mg, 30 mg and 60 mg strengths in the US news archive
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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13/12/2013  Actavis announces tentative agreement related to Asacol HD patent challenge litigation news archive
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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13/12/2013  Aurobindo Pharma gains on USFDA nod for a generic medicine news archive
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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13/12/2013  Daiichi Sankyo launches four new generic drugs through its Daiichi Sankyo Espha subsidiary news archive
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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15/12/2013  Cadila Healthcare in an out of court settlement with Warner Chilcott news archive
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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16/12/2013  Cadence to file suit over ANDA submission for generic Ofirmev news archive
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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16/12/2013  US generic drug fee relief plan might benefit Indian firms news archive
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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16/12/2013  Recipharm subsidiary files infectious disease drug application in European markets news archive
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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16/12/2013  Stada expands its business activities into Myanmar news archive
Products from the German pharmaceutical producer Stada are now also available in Myanmar (Burma)...
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17/12/2013  U.S.-based Alvogen agrees to buy Taiwan's Lotus for $200 mln-paper news archive
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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17/12/2013  Teva settles Viagra patent litigation with Pfizer news archive
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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17/12/2013  AstraZeneca statement in response to reports of a launch of Esomeprazole strontium product in the US news archive
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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17/12/2013  Mylan announces settlement agreement for first-to-file generic version of Targretin news archive
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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17/12/2013  Update on patent ruling on ViiV healthcare's Epzicom and Trizivir news archive
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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17/12/2013  Biogen Idec and Samsung bioepis announce agreement to market anti-TNF biosimilar product candidates in Europe news archive
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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19/12/2013  Hanmi does not infringe AstraZeneca's Nexium: U.S.court news archive
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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19/12/2013  French watchdog fines Merck, Reckitt in Subutex generics dispute news archive
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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19/12/2013  Patent war spills over to non-cancer drugs news archive
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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23/12/2013  Sagent Pharmaceuticals announces the launch of Octreotide Acetate injection news archive
Sagent Pharmaceuticals today announced the launch of Octreotide Acetate Injection, a Somatostatin Analog, in five vial presentations...
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24/12/2013  Actavis confirms generic NuvaRing patent challenge news archive
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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31/12/2013  Glenmark confirms patent challenge for Bendamustine Hydrochloride news archive
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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