Generics Industry News Search
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November 2008 News Archive |
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For centuries, innovation inducement prizes have been suggested as a mechanism to stimulate investments in a wide range of topics. (See, for example, Selected Innovation Prizes and reward Programs, KEI Research Note 2008:1). During most of this period, the patent system has also existed.
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The lawsuit claims that Orchid is trying to market the generic version before Roche's patent expires...
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Barr Pharmaceuticals, Inc. today announced that its subsidiary, PLIVA - Lachema a.s., has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of Pfizer Inc.'s Camptosar(R) (c) Injection, 20 mg/mL, packaged in 40 mg/2 mL and 100 mg/5 mL vials. The Company plans to launch its product in the fourth quarter of 2008. Barr's U.S. generic injectable portfolio now totals nine products. ...
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Akorn-Strides, LLC today announced that the U.S. Food and Drug Administration has granted approval for an Abbreviated New Drug Application (ANDA) for Pamidronate Disodium Injection, 3 mg/mL and 9 mg/mL in 10 mL vials. Akorn-Strides, LLC is a Joint Venture that was formed in 2004 by Akorn, Inc. and Strides Arcolab Limited. The primary mission for the Joint Venture is to develop liquid, lyophilized and dry powder formulations of generic injectable products targeting several therapeutic markets with a major focus on anti-infectives, analgesics and CNS medicines. ...
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Akorn, Inc. today announced that the U.S. Food and Drug Administration has granted approval for Akorn’s Abbreviated New Drug Application (ANDA) for Adenosine Injection USP, 3 mg/mL. ...
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On October 31, 2008, Caraco Pharmaceutical Laboratories, Ltd. received a warning letter from the FDA. The letter was issued as a follow up to the last FDA inspection of the Company's manufacturing facility in Detroit, Michigan which was initiated in May 2008. ...
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Drug major Wockhardt has challenged the US patent of Stalevo, a new generation combination drug for the treatment of Parkinson's disease, originated by Finland-based Orion Corporation and marketed by Novartis....
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets, 250 mg, 500 mg and 750 mg. Levetiracetam Tablets are the generic version of UCB Pharma's Keppra....
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Sun Pharmaceutical Industries Ltd. announced that USFDA has granted approval for the Abbreviated New Drug Application to market generic Sinemet, carbidopa and levodopa tablets....
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Santarus, Inc. today announced that Chief Judge Gregory M. Sleet of the U.S. District Court for the District of Delaware has ruled in favor of Santarus and the University of Missouri following the Markman hearing held November 5, 2008...
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Caraco Pharmaceutical Laboratories, Ltd. announced today, that it has launched Carbidopa and Levodopa tablets on behalf of Sun Pharmaceutical Industries Ltd...
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Glenmark Generics Limited has announced that its European subsidiary has launched its first product in Western Europe via initiation of sales of Perindopril tablets in the United Kingdom...
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Healthcare payers around the world are desperate to find ways to contain pharmaceutical expenditures without compromising the quality of the services they provide...
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The Supreme Court of Canada has dispensed a major victory to drug companies that conduct original research, strengthening their patent protection against generic knock-offs....
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Mylan Inc.'s specialty business, Dey L.P., announced today that the Centers for Medicare & Medicaid Services (CMS) has established a unique billing code, or J-code, for Perforomist Inhalation Solution, which is a product that was approved by the U.S. Food and Drug Administration in 2007 for long-term, twice-daily maintenance treatment of bronchoconstriction in patients with Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis and emphysema....
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The Supreme Court of Canada blocked the sale of a generic version of a popular blood-thinning drug in a ruling Thursday that reinforced patent protection to encourage brand-name pharmaceutical companies and other businesses to invest time and money into research...
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Ethex Corporation announced today that it has voluntarily recalled to the consumer level specific lots of five generic /non-branded products that it markets. These lots have been recalled as a precaution, due to the possibility that they may contain oversized tablets...
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Ranbaxy Laboratories Limited and Daiichi Sankyo Company Limited today announced the successful closure of their transformational deal with the execution of the final transfer of the remaining equity shares of the Singh family, in Ranbaxy. ...
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Par Pharmaceutical Companies, Inc. announced that it will begin shipping generic versions of Imitrex injection (sumatriptan succinate injection) 4 mg and 6 mg starter kits and 4 mg and 6 mg prefilled syringe cartridges to the trade immediately. In addition, Par anticipates launching the 6mg vials early next year.
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Court of Appeals for the Federal Circuit has affirmed a March 31, 2008 decision by the District Court, which had found TAP Pharmaceutical Products Inc.'s U.S. Patent No. 4,628,098 valid and enforceable. As a result of today's decision, Teva expects to market its generic version of TAP's Prevacid (Lansoprazole) Delayed Release Capsules, 15 mg and 30 mg no later than November 10, 2009, when the patent is otherwise set to expire....
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Research and Markets has announced the addition of the "Apotex Generics Company Intelligence Report" company profile to their offering...
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Actavis Group and ASKA Pharmaceutical announce that the companies have concluded a preliminary agreement concerning the establishment of a joint company: Actavis ASKA Co., Ltd. - planning to enter the Japanese generic pharmaceutical market in April 2009. ...
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Orion Corporation filed a patent infringement lawsuit in the United States to enforce its U.S. Patent No. 5,446,194 against Sun Pharma Global, Inc., who seeks to market a generic version of Orion Corporation's proprietary drug, Comtan in the United States. ...
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US appeals against measure, calling it the "only problem in Finnish-US relations"
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Perrigo Company announced today that it has acquired Unico Holdings for approximately $49 million in cash. Based in Lake Worth, Florida, privately-held Unico is the leading manufacturer of store brand pediatric electrolytes, enemas and feminine hygiene products for retail customers in the US. The acquisition is expected to add nearly $50 million of annual sales and be accretive to earnings in the first twelve months....
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Actavis UK Ltd has launched Clamelle Azithromycin 500mg Tablets and Clamelle Chlamydia Test Kits are now available for pharmacy distribution, following the POM to P reclassification of azithromycin...
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The filing comes as the company continues to work to address compliance issues stemming from an inspection of the Actavis Totowa facilities by the FDA earlier this year. Since May 2008, the company has focused entirely on ensuring the quality and integrity of its manufacturing and quality systems.
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Gilead Sciences, Inc. today announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration requesting permission to manufacture and market a generic version of Truvada....
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With many biologic drugs used to treat increasingly common diseases such as cancer and arthritis, the demand for biologics is set to increase. However, due to their high price and the need to constrain pharmaceutical expenditure in Europe and the US, biosimilars are emerging as a cheaper alternative...
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Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Venlafaxine Hydrochloride (HCl) Extended-release (ER) Capsules, 37.5 mg (base), 75 mg (base) and 150 mg (base)....
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Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fluoxetine Capsules USP, 10 mg and 20 mg....
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Drugmaker Eli Lilly and Co. is suing four generic drugmakers to protect patents covering its second-best selling drug, the antidepressant Cymbalta....
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IMPAX Laboratories, Inc. today announced Eli Lilly and Company has filed suit alleging infringement U.S. Patent No. 5,023,269 (the "269 patent") in the United States District Court for the Southern District of Indiana based on the Company's submission of Abbreviated New Drug Application ("ANDA") for duloxetine hydrochloride delayed-release capsules (20, 30, and 60 mg), generic of Cymbalta, to the Food and Drug Administration. In connection with this ANDA, IMPAX provided notice that its submission includes a Paragraph IV certification stating the Company believes its product does not infringe any valid claim of the '269 patent. The Company is aware of at least three additional lawsuits containing similar patent infringement claims based on the filing of ANDAs containing a Paragraph IV certification to the '269 patent. The Company's ANDA was submitted August 4, 2008, and the Company believes all filers of ANDAs submitted on that date will be entitled to 180 days of exclusivity under the applicable regulations.
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Sanofi-aventis announced today the signature of agreements to settle the U.S. patent infringement suits related to Barr Pharmaceuticals and Teva Pharmaceuticals' generic version of Allegra, as well as the U.S. patent infringement suits related to Barr's proposed generic versions of Allegra D-12 Hour and Nasacort AQ. In each case, the settlement agreement is subject to review by the Federal Trade Commission and U.S. state Attorneys General.
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application to market its generic version of AstraZeneca's Pulmicort (Budesonide) Respules...
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Par Pharmaceutical Companies, Inc. today announced that it has entered into a supply and distribution agreement with AstraZeneca in the U.S. to market budesonide inhalation suspension, which is a generic form of AstraZeneca's Pulmicort Respules...
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Teva Pharmaceutical Industries Ltd. announces that further to its press release dated November 19, 2008, the United States District Court for the District of New Jersey has granted AstraZeneca's request for a temporary order restraining further sales of Teva's generic version of AstraZeneca's Pulmicort (Budesonide) Respules pending the Court's decision on AstraZeneca's motion for a preliminary injunction...
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Glenmark Generics Ltd's US subsidiary has gained full marketing rights through an exclusive partnership to begin distributing Azathioprine 50mg Tablets in the United States....
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Akorn, Inc., a specialty pharmaceutical company and an undisclosed healthcare company have entered into a five-year contract manufacturing supply agreement. ...
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Glenmark Generics Ltd's, US subsidiary (GGI) has received ANDA approval from the United States Food and Drug Administration (U.S. FDA) for Ranitidine 150 mg and 300 mg tablets and will soon commence marketing and distribution of these products in the U.S. market....
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Pharmaceutical and medical products maker Abbott Laboratories Inc. has announced settlements totaling about $184 million for a federal court case involving class action claims over its popular cholesterol medication TriCor...
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Barr Pharmaceuticals, Inc. today announced that its shareholders overwhelmingly approved the proposals submitted to them relating to the acquisition of Barr by Teva Pharmaceuticals Industries Ltd....
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Synthon has successfully completed multiple decentralised procedures for its latest product Pramipexole. Regulatory clearance has been obtained for Synthon's product in thirteen European countries...
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King Pharmaceuticals, Inc. and Alpharma Inc. today announced that the two companies have signed a definitive merger agreement under which King will acquire all of the outstanding shares of Class A Common Stock of Alpharma for $37.00 per share in cash for a total equity value of approximately $1.6 billion. The Boards of Directors of both companies have unanimously approved the transaction....
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Akorn, Inc. today announced that it has signed a memorandum of understanding with Bioluz S.A., a privately held French company, for five premix products. The estimated market size of the five products, based on recent IMS data, is approximately $175 million. Premix medications are ready to use intravenous drug products which eliminate compounding steps in the pharmacy or at the point of care. ...
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Dr. Reddy's Laboratories today announced that it has launched the authorised generic version of GlaxoSmithKline's Imitrex (sumatriptan succinate) tablets 25mg, 50mg, and 100mg in the United States...
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today announced a definitive agreement to acquire a portfolio of generic pharmaceutical products that are being divested as a result of the proposed merger between Teva Pharmaceutical Industries, Ltd. and Barr Pharmaceuticals, Inc...
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A European report on competition in the pharmaceuticals sector will criticise drug companies for the way they prolong drug patents and conduct litigation, an EU source familiar with the investigation said on Tuesday...
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AstraZeneca today announced it has entered into a settlement agreement in its Pulmicort Respules patent infringement litigation against Ivax Pharmaceuticals, Inc., a wholly owned subsidiary of Teva Pharmaceuticals USA...
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Canadian consumers, taxpayers and businesses are already benefiting from competition in the generic drug manufacturing and pharmacy sectors, according to the Canadian Association of Chain Drug Stores...
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Cephalon isn't going to let generic competitors take over its turf without a fight. ...
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today announced that its subsidiary, Watson Laboratories, Inc., has received final approval today from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Bupropion Hydrochloride Extended-Release Tablets (XL) in the 150 mg strength. Bupropion Hydrochloride Extended-Release Tablets is the generic equivalent to GlaxoSmithKline's Wellbutrin XL(R) product, which is indicated for the treatment of major depressive disorder. Watson intends to launch the product immediately.
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Anchen Pharmaceuticals, Inc. announced today today the launch its Bupropion HCl ER 150mg tablets. Shipment of the product will begin immediately. Anchen's Bupropion HCl ER tablets are the AB-rated generic equivalent of GSK's Wellbutrin XL product and are indicated for the treatment of major depressive disorder. Anchen manufactures its Buproprion HCL ER tablet products in Irvine, California....
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Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patent listed by Anesta in connection with its Amrix (cyclobenzaprine hydrochloride) extended-release capsules, 15mg and 30mg. ...
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Major drug companies are delaying or blocking the entry of cheaper generic medicines, pushing up bills for taxpayers and reducing the incentive for innovation, the European Commission said on Friday....
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AOK, Germany's largest health insurer, has picked 58 suppliers as part of its first Europe-wide tender for generic-drug procurement contracts in a long-awaited decision that could potentially reshape the industry in Germany....
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