Generics Industry News Search
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June 2008 News Archive |
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In the battles between brand-name drugmakers and generics companies, Abbott Labs appears to have pulled an entirely new rabbit out of its hat, according to two lawsuits and an antitrust investigation. ...
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Generic drug companies have joined the rush to seek patents for drugs in India. A host of global and Indian generic drug majors, who have traditionally focused on manufacturing off-patent drugs, have claimed exclusivity for a large number of drugs, even more than a few global discovery firms....
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Lannett Company, Inc. (AMEX:LCI), a manufacturer of generic pharmaceuticals, today said that it expects to commence marketing Amantadine Hydrochloride Soft Gel Capsules 100mg, within the next several months. According to Wolters Kluwer, annual sales in 2007 of both the generic and brand product totaled $30 million.
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Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that it has received final approval from the U.S. Food and Drug Administration ("FDA") of its Abbreviated New Drug Application (ANDA) for Omeprazole Delayed-Release Capsules USP in the 10mg, 20mg and 40mg strengths. ...
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BOSTON (Thomson Financial) - Mylan Inc. Monday said it has acquired Merck KGaA's Central and Eastern Europe generics businesses, which include operations in Poland, Hungary, Slovakia, Slovenia and the Czech Republic....
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Boca Pharmacal, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Pamlab's Palgic(R) 4mg Tablet (Carbinoxamine Maleate 4 mg Tablet). The Company plans to launch its product immediately....
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Cephalon, Inc. today announced that it and its wholly-owned subsidiary CIMA LABS INC. have filed a lawsuit in U.S. District Court in Delaware against Watson Pharmaceuticals, Inc. and its wholly-owned subsidiary, Watson Laboratories, Inc., for infringement of U.S. Patent Nos. 6,200,604 and 6,974,590, which cover methods of use for the Cephalon product FENTORA(R) (fentanyl buccal tablet) [C-II]....
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Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the market for HIV therapies will experience robust 5.4 percent annual growth through 2012, driven by the use of premium-priced branded products. ...
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Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that generic erosion will significantly constrain the prostate cancer drug market, resulting in annual market growth of less than 2 percent through 2012....
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The Treatment Action Campaign (TAC) has claimed another victory in the fight for cheaper anti-AIDS drugs, with news that a multi-national pharmaceutical company has given the go-ahead for generic production of one of the country's first-line anti-retrovirals....
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Health Canada has released a draft guidance document entitled "Information and Submission Requirements for Subsequent Entry Biologics (SEBs)." This document outlines the regulatory review process that Health Canada will use for a biologic that is similar to an approved innovator biologic....
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Mylan Inc. today confirmed that its majority-owned subsidiary, Matrix Laboratories Ltd., has been sued by Daiichi Sankyo in connection with Amlodipine Besylate/Olmesartan Medoxomil Tablets, 5 mg/20 mg, 10 mg/20 mg, 5 mg/40 mg and 10 mg/40 mg, the generic version of Daiichi Sankyo's Azor Tablets....
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Tough cholesterol targets will be impossible to hit unless GPs ignore a new benchmark demanding 77% of drugs used to treat it are generic, a new analysis concludes....
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In a national survey released today by the Alliance of Minority Medical Associations (AMMA), Americans noted that their highest health care priority is reducing the cost of prescription drugs....
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Generic drug manufacturers across the globe, especially from India, experts in making copycat versions, will suffer major losses with the amicus curae of the US Federal Circuit court, Washington Legal Foundation (WLF), urging the court to rehear a case in which Caraco, Sun Pharma's US subsidiary, is involved....
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Coloradans have saved millions of dollars with the availability of a wide range of 4 dollar prescription drugs. Today, Governor Bill Ritter will sign legislation that will allow Wal-Mart to expand the number of 4 dollar prescriptions available to Colorado citizens....
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Sun Pharmaceutical Industries Ltd. today sent a letter to the Board of Directors of Taro Pharmaceutical Industries Ltd. regarding Taro's comments about its Irish subsidiary, in the Company's press release dated May 28, 2008, which Sun believes indicate that Taro intends to pursue a sale of these operations.
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Teva Pharmaceuticals is pleased to announce the introduction and availability of Zaleplon Capsules, CIV....
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Roxane Laboratories, Inc. announced today the approval of their Abbreviated New Drug Application for Zaleplon Capsules CIV, 5mg and 10mg. ...
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Hyderabad, June 7 In pursuance of its ongoing litigation on cardio drug Nexium (Esomeprazole), pharma major Dr Reddy’s Laboratories Ltd filed for a declaratory judgment on its patents in a US court....
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Perrigo Company today announced that it has filed an Abbreviated New Drug Application (ANDA) for Fluocinonide Cream 0.1%, a generic version of VANOS(R) Cream 0.1%. The Company believes that it is the first to file an ANDA with a Paragraph IV certification against VANOS(R). ...
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Mylan Inc. today announced that its subsidiary, Genpharm ULC, has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Zaleplon Capsules, 5 mg and 10 mg. ...
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A South Korean judge dismissed claims brought by French drugmaker Sanofi-Aventis SA in a patent lawsuit against Boryung Pharmaceutical Co. over its treatment for colorectal cancer, according to Boryung on Monday....
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By 2012, generics is projected to account for about 26% of total Canadian pharmaceutical market as the penetration of generics is growing rapidly in the country, says RNCOS research.
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Mylan, Inc. announced today that it has signed a license and supply agreement with NATCO Pharma, Ltd. for NATCO's glatiramer acetate pre-filled syringes, a generic version of Teva's Copaxone, which is used to treat multiple sclerosis....
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Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Zaleplon Capsules 5mg and 10mg....
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Generic drug manufacturers are spreading misinformation about amendments to patent regulations in order to draw attention away from the real story. According to the Competition Bureau of Canada and other independent studies, provincial governments and Canadians at large are paying among the highest prices in the world for generic drugs....
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Cadila Healthcare's 70 per cent stake buy in South African-based Simayla Pharmaceuticals gives it a larger presence, well spread marketing network and a product basket that is skewed towards the generic medicines catering to the chronic segment....
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Wyeth has brought a patent infringement suit to prevent approval of Sandoz's generic version of the oral contraceptive Lybrel....
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Mylan, Inc. announced today that the U.S. Court of Appeals for the Federal Circuit has affirmed a May 2007 District Court ruling stating that Mylan's 10 mg and 20 mg Omeprazole delayed-release capsules do not infringe patents asserted against Mylan by AstraZeneca....
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Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by TAP Pharmaceuticals Inc. in connection with its Prevacid(R) SoluTab(TM) Delayed-Release Orally Disintegrating Tablets (lansoprazole), 15mg and 30mg....
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TOKYO - Japanese pharmaceutical company Daiichi Sankyo Co. said Wednesday it will buy a controlling stake in India's largest drug maker Ranbaxy Laboratories Ltd. for as much as $4.6 billion. ...
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Lannett Co. Inc. is challenging the patent rights associated with PrimaCare One, a prenatal vitamin product marketed by KV Pharmaceutical Co.'s Ther-Rx branded pharmaceutical business unit. ...
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Teva Pharmaceutical (Nasdaq: TEVA) is getting a taste of its own medicine. The generic-drug maker, which also makes branded drugs, including multiple sclerosis drug Copaxone, has some generic competition headed its way....
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Israeli pharmaceutical company Teva Pharmaceutical Industries Ltd. said Thursday the U.S. Food and Drug Administration tentatively approved the company's application to market a generic version of hypertension drug Diovan....
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Generic drug developers will continue taking advantage of global demand for lower-priced drugs, with industry giant Teva Pharmaceutical Industries Ltd. poised to maintain its lead position, according to a Goldman Sachs analyst....
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Bentley Pharmaceuticals, Inc. (NYSE: BNT) approved the spin-off of its drug delivery business into a new publicly traded company to be called CPEX Pharmaceuticals, Inc. ...
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There's one big reason why Pfizer might want to swipe the Indian generic drug company Ranbaxy Laboratories from under the nose of Japan's Daiichi Sankyo, and it's called Lipitor.
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Canadians are getting gouged more than ever on generic prescription drugs, a study by the Fraser Institute reported Monday.
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Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Irbesartan and Hydrochlorothiazide Tablets, 150 mg/12.5 mg and 300 mg/12.5 mg....
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The Mumbai based leading pharmaceutical company Ipca Laboratories has received US FDA marketing approval for metoclopramide tablets DSP 5mg and 10mg. Ipca is marketing this product in alliance with Ranbaxy Pharmaceutical Ltd, a US subsidiary of Ranbaxy Laboratories. ...
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Daiichi-Sankyo, which announced that it was buying the promoter's stake in India's largest drug maker Ranbaxy Laboratories last week, has been granted two product patents by the Kolkata Patent Office.
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Johnson and Johnson's Janssen unit sued Novartis AG's Sandoz Inc. to prevent it from selling a generic version of the Alzheimer's drug Razadyne ER until a patent expires in 2019....
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The release of generic versions of cholesterol drug Lipitor in the U.S. will be delayed to Nov. 30, 2011 under the settlement of a patent dispute between Pfizer and India's Ranbaxy Laboratories....
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Ethex, a subsidiary of generic drugmaker KV Pharmaceutical, recalled one lot of morphine sulfate 60 mg because of a report that a tablet was twice the appropriate thickness, potentially indicating the drug contains twice the amount of active ingredient.
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A Barr Pharmaceuticals subsidiary is being sued after filing an ANDA to market generic 15- and 30-mg strengths of TAP Pharmaceutical's heartburn drug Prevacid SoluTab. ...
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Perrigo Company today announced that it has received final approval from the US FDA to manufacture and market Cetirizine hydrochloride syrup (Rx only) 1 mg/ml. ...
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On June 19, 2008, FDA granted tentative approval to fixed dose combination lamivudine/stavudine tablets, 30mg/6mg & 60mg/12mg for oral suspension for pediatric use, manufactured by Cipla Limited of Mumbai, India. The application was reviewed under expedited review provisions for the President's Emergency Plan for AIDS Relief...
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Glenmark Generics Limited (GGL), a subsidiary of Glenmark Pharmaceuticals Ltd. (Glenmark), has received ANDA approval from the United States Food and Drug Administration (U.S. FDA) for Trandolapril tablets USP 1 mg, 2 mg and 4 mg and will immediately commence marketing and distribution of these products in the U.S. market....
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India has rejected German drug major Boehringer Ingelheim's application for a pediatric form of anti-AIDS drug nevirapine bowing to objections from the country's civil society group and also to help local companies continue selling the medicine....
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Mylan Inc. announced that its subsidiary, Mylan Pharmaceuticals Inc., has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for venlafaxine hydrochloride (HCl) tablets 25 mg (base), 37.5 mg (base), 50 mg (base), 75 mg (base) and 100 mg (base).
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If you liked the heparin, dog food, lead-painted toys toothpaste and truck tires from China, you'll be happy to hear that Chinese-made generic drugs are making their way to the U.S....
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Walgreen Co. said Monday its third-quarter profit rose 2%, helped by higher sales of generic prescription drugs as well as tight control over expenses....
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Alchemia Ltd. announces the granting of the first two patents in the 'Synthetic Heparin Oligosaccharide' family of patents....
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Taro Pharmaceutical Industries Ltd. reported today that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for prescription Cetirizine Hydrochloride Syrup, 1 mg/1 ml....
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Teva Pharmaceuticals is pleased to announce the introduction and availability of Ramipril Capsules. This product is AB rated and bioequivalent to Altace Capsules. Ramipril Capsules are available in 2.5 mg, 5 mg, and 10 mg strengths, in bottle sizes of 100....
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Bayer AG. said it agreed to supply a generic version of its Yasmin contraceptive to Barr Pharmaceuticals Inc. but will continue to pursue an appeal against a court decision in favour of Barr, which voided Bayer's U.S. patent on Yasmin....
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Sun Pharmaceutical Industries Ltd. yesterday sent a letter to Dr. Barrie Levitt, Chairman of the Board of Directors of Taro Pharmaceutical Industries Ltd. in response to Dr. Levitt's letter of June 19, 2008 to Taro's shareholders, his letter of June 15, 2008 to Sun Pharma and the Initiating Motion filed by Taro in the Tel-Aviv District Court on the same day....
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On April 1, in a 2-1 decision in Caraco v. Forest, the Federal Circuit held that an ANDA applicant may in some circumstances bring a declaratory judgment action for non-infringement even if the patentee has granted the applicant a covenant not to sue....
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Ranbaxy Laboratories Limited (RLL), announced today that the company has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Valganciclovir Hydrochloride Tablets, 450 mg....
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Last month King Pharmaceuticals filed a citizen petition that could delay final approval of numerous ANDAs for generic versions of Altace (ramipril), which were set to earn final approval on June 7....
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Barr Pharmaceuticals, Inc. today announced that U.S. District Court for Delaware has ruled in favor of its subsidiary, Barr Laboratories, Inc., in the challenge of the patent listed by Boehringer Ingelheim Pharmaceuticals, Inc. in connection with Boehringer Ingelheim's Mirapex(R) Tablets (pramipexole dihydrochloride) 0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg....
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Sun Pharmaceutical Industries Ltd. today announced that a subsidiary of Sun Pharma has exercised the Option under its Option Agreement to acquire all the shares held by the controlling shareholders of Taro Pharmaceuticals Industries Limited....
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Johnson & Johnson has not ruled out going into generic drugs, says its chief executive, noting the large opportunities from many medicines going off patent....
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More generic drugmakers are likely to become prey for large branded drugmakers, which are seeking to grow faster in emerging markets, analysts at Deutsche Bank said on Thursday....
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Akorn-Strides, LLC today announced the approvals of two ANDAs for Famotidine Injection USP, 20 mg/2mL Single-Dose Vials and 40 mg/4mL & 200 mg/20mL Multiple-Dose Vials. Akorn-Strides, LLC is a Joint Venture that was formed in 2005 by Akorn, Inc. and Strides Arcolab Limited....
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FDA granted approval for a generic Zidovudine Oral Solution USP, 50 mg/5 mL formulation manufactured by Cipla Limited of of Mumbai, India....
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Patients from Brazil have asked the Delhi patent office not to grant a patent pending on the HIV drug tenofovir because it would prevent the import of low-cost generic medicines from India they say are important for their national AIDS treatment programme, upon which 1,800,000 Brazilians depend....
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Pharmaceutical firms such as Cipla, Matrix and AIDS patient groups have filed separate post-grant oppositions against Swiss multinational Roche's patent on valganciclovir, a drug used during organ transplantation and by HIV/ AIDS patients....
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More and more doctors believe that health insurance companies are taking medical decisions out of their hands by dictating the medications a doctor can prescribe to patients....
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Retailer Kmart said on Monday it has expanded its generic prescription drug program to include more than 500 common medications from about 300 and cut prices for some products as of June 22....
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that, under a supply agreement with Solvay Pharmaceuticals, Inc., Watson has launched the authorized generic version of dronabinol in the 2.5, 5 and 10 mg once daily dosage strengths....
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Caraco Pharmaceutical Laboratories, Ltd., announced today that the US Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Applications for Amitriptyline Hydrochloride USP Tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg....
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Par Pharmaceutical Companies, Inc. today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for dronabinol, a generic version of Solvay Pharmaceutical's Marinol, a CIII controlled substance....
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Divi's Laboratories is a major manufacturer of generic active pharmaceutical ingredients (APIs) and is among the best players in the Indian contract research and manufacturing space (CRAMS). It has a focussed approach on developing new processes for the production of APIs and intermediates. Concentrating on generic API leadership, Divi's is expanding its high-margin custom manufacturing (CM) business....
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Sun Pharmaceutical Industries Ltd. today announced that Alkaloida Chemical Company Exclusive Group Ltd. (Alkaloida), a subsidiary of Sun Pharma, has commenced a tender offer for all outstanding Ordinary Shares of Taro Pharmaceutical Industries Ltd. (Taro) for USD 7.75 per share in cash....
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application to market its generic version of Janssen's antipsychotic agent Risperdal (Risperidone) Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg. Shipment of these products has commenced....
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Taro Pharmaceutical Industries Ltd. said today that it would have no formal comment on the unsolicited tender offer commenced today by a subsidiary of Sun Pharmaceutical Industries Ltd., for all shares of Taro common stock at a price of $7.75 per share until Taro's Board of Directors has an opportunity to review and evaluate the full details of the offer....
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For the past few months, Patent Docs has been following and reporting on biotech and pharma lobbying efforts. Our interest in this topic stems from the push by Congress over the past year to pass patent reform and follow-on biologics legislation, and corresponding efforts by corporations and organisations during that time to lobby on this legislation....
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Teva Health Systems is pleased to announce the introduction and availability of Granisetron Hydrochloride Injection in 4 mL multiple dose vials....
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Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., announced that it has launched an authorised generic version of Risperidal(R) (risperidone) through Patriot Pharmaceuticals, L.L.C. ...
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