Generics Industry News Search
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July 2008 News Archive |
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An increasing number of patients with Medica prescription drug benefit coverage can receive a 30 day course of therapy at no cost to the patient. The increase is due to a recent expansion in a partnership with MedVantx that includes more than 300 providers in 35 participating offices in Minnesota....
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Company to Move Forward with Plan to be Acquired by Teva Pharmaceutical Industries Ltd....
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Normally, issuing final approvals for Abbreviated New Drug Applications (ANDAs) at the FDA is just another day on the job. But the ANDA granted to Teva Pharmaceuticals yesterday for its generic version of Johnson & Johnson's Risperdal must have stung just a little.
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AstraZeneca today announced that the US District Court for the District of New Jersey has granted the company's Motion for Summary Judgment of No Inequitable Conduct....
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Generic drug maker Mylan Inc. said Thursday it received tentative approval from the Food and Drug Administration to market its 600 milligram linezolid tablets.
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APP Pharmaceuticals Inc. said Thursday it received final approval from the Food and Drug Administration to market its granisetron hydrochloride injection, the generic version of Hoffmann-LaRoche's Kytril injection for chemo-induced nausea....
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Glenmark Pharmaceuticals Ltd. (India) on Wednesday announced that its European organisation, acting through its Czech subsidiary Medicamenta, has signed agreements with Actavis (the international generic pharma company from Iceland) and Biovena (an affiliate of Actavis in Poland) to acquire 7 pharma brands in Poland. ...
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Bentley Pharmaceuticals, Inc. announced that the aggregate cash purchase price for its acquisition by Teva Pharmaceutical Industries Ltd. has been adjusted in accordance with the merger agreement after completion of the previously announced taxable spin-off of its drug delivery business, CPEX Pharmaceuticals, Inc....
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Within days of Japanese company Daiichi Sankyo acquiring Ranbaxy Laboratories, another innovator company Sanofi Aventis of France said it is making a bid to acquire Czech generics company Zentiva. Does this signal a paradigm shift in the global pharmaceutical space?...
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The Indian patent office will provide drug innovators a chance to explain their views before a decision to grant compulsory licences against their patented medicines is taken....
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APP Pharmaceuticals, Inc., a leading provider of hospital-based injectable pharmaceutical products, and Fresenius SE, a global health care group with approximately $18 billion of sales in products and services for hospital, dialysis and in home medical care, today announced that they have entered into a definitive merger agreement pursuant to which Fresenius will acquire APP....
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Dierbergs Markets will roll out new pricing Tuesday for more than 350 generic medications, the supermarket chain said Monday. Dierbergs is among the latest grocers to offer expanded generic drug programs to compete with Wal-Mart and Target, which expanded there programs in May....
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Stater Bros. has announced that its Stater Bros. Super Rx Pharmacy locations will begin offering generic drugs for $4 per prescription beginning Wednesday, July 9, 2008. Over 300 of the most commonly prescribed generic drugs will now be available for the low price of $4 for a 30-day supply and $10 for a 90-day supply....
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Others in Big Pharma may be stepping up their investment in generics, but GlaxoSmithKline's new CEO isn't going there....
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Dr. Reddy's Laboratories announced today that it has signed a global distribution agreement for Ibuprofen API with Albemarle Corporation, a US-based specialty chemicals company. The agreement shall come into effect immediately....
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Unitaid, the international agency created in 2006 to buy medicine to counter AIDS, tuberculosis and malaria, has taken the first step toward establishing a mechanism to deal with a vexing problem of drugs so expensive they are out of reach for most poor people....
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India's drugs regulator has decided to abandon his own proposal to link marketing approvals for non-patented versions of a drug to its patent status, called patent linkage, dropping a plan that led to heated debate and intense lobbying from industry factions and public health advocates....
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Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the generic availability of Shire/Janssen/Ortho McNeil's Razadyne (galantamine) in December 2008 will have the greatest impact on Eisai/Pfizer's Aricept as surveyed primary care physicians (PCPs) estimate that after the launch of generic galantamine, prescriptions of Aricept for the treatment of Alzheimer's disease will drop by up to 20 percent....
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The Federal Circuit today affirmed a finding on summary judgment by the District Court for the Northern District of California that U.S. Patent No. 5,110,493, which is owned by Plaintiff-Appellee Roche Palo Alto LLC, is valid and infringed by Defendants-Appellants Apotex, Inc. and Apotex Corp....
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Par Pharmaceutical Companies, Inc. today announced that it will commence shipment of 12.5mg and 25mg meclizine HCl tablets immediately. At this time, Par believes it is the exclusive supplier of the AB-rated generic product....
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With the passage of new patent laws in their countries, India and China will be well-poised to accelerate their pharmaceutical industries, especially biopharmaceuticals, says the author of a new research study of emerging non-US pharmaceutical markets. ...
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Swaziland will import generic AIDS drugs from Uganda from next month, New Vision reported, citing Moses Mathedelene, the Swazi foreign minister....
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Taro Pharmaceutical Industries Ltd. said today that its Board of Directors (with Drs. Barrie Levitt and Daniel Moros and Ms. Tal Levitt neither participating in the deliberations nor voting) has unanimously concluded that Sun's offer is financially inadequate and is a 'sham' offer, because we believe Sun knows that it will not be accepted by the shareholders....
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Actavis today announced the launch of Bicalutamide tablets in the United Kingdom, Germany and France. Actavis' Bicalutamide is the first generic version of the oncology drug to be made available in the three markets....
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Shares of Teva Pharmaceutical Industries Ltd. fell Friday as Momenta Pharmaceuticals Inc. turned the tables on the generic drug developer by challenging the patent on its lucrative multiple sclerosis drug....
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Akorn-Strides, LLC today announced the first commercial product launch for the Joint Venture, Rifampin for Injection USP, 600 mg/vial. Rifampin is used in the treatment of all forms of tuberculosis in conjunction with Isoniazid and Ethambutol....
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The U.S. Food and Drug Administration has filed a motion in a U.S. court seeking documents from Indian drugmaker Ranbaxy Laboratories Ltd as part of an ongoing investigation, a Ranbaxy spokesman said on Sunday....
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On July 1st, the U.S. District Court for the District of New Jersey granted AstraZeneca's motion for summary judgment that its patent on quetiapine fumarate, the active ingredient in Seroquel, is not unenforceable for inequitable conduct. The decision disposed of the last remaining issue in the case, as Teva and Sandoz, which are challenging the patent, had already conceded infringement and validity....
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Insmed has indeed demonstrated bioequivalency for its biogeneric white blood booster, but the FDA is unlikely to approve the drug until a regulatory pathway is in place, legal and scientific sources told Pharmawire, drawing a distinction between the science and politics that are shaping the biosimilar debate....
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Branded Pharmaceutical companies are painfully aware of the astronomical growth of Generics competition. By the end of this year, Branded drug patents accounting for sales of more than $80 Billion will expire, resulting in major losses in company profits....
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The Founders might have used quill pens, but they would roll their eyes at how, in this supposedly technology-minded era, we're undermining their intention to encourage innovation. The U.S. is stumbling in the transition from their Industrial Age to our Information Age, despite the charge in the Constitution that Congress "promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries."...
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Sun Pharmaceutical Industries Ltd. today announced its subsidiary, Alkaloida Chemical Company Exclusive Group Ltd., has extended the Expiration Date of the Tender Offer for purchase of all outstanding Ordinary Shares of Taro Pharmaceutical Industries Ltd....
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Two days after it became public that Ranbaxy Laboratories Ltd is the target of a US litigation that has federal investigators charging that the company did not follow standards in drugs manufacturing and fabricated data in filings with that country's drugs regulator, it has emerged that the company might be at a much bigger risk: expensive class action suits in the world’s most litigious nation....
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Want to know how quickly generic drug competition can eat into sales of the original? Risperdal, an anti-psychotic drug sold by Johnson&Johnson;, came off patent protection in June and the effect on sales of the original drug was immediate: Risperdal sales fell 16% year over year. That's with only a few weeks of generic competition....
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Shire has brought patent infringement lawsuits against Nostrum Pharmaceuticals and Apotex for filing applications to market generic versions of its anti-seizure drug Carbatrol....
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Sources inform "Globes" that Teva Pharmaceutical Industries Ltd is in talks to acquire NYSE-traded Barr Pharmaceuticals. ...
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IMPAX Laboratories Inc. today announced that all conditions of a settlement of the U.S. patent infringement litigation pertaining to IMPAX's proposed generic capsule formulation of Wyeth's EFFEXOR XR anti-depressant have been approved by the United States District Court for the District of Delaware....
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Like a zombie in a horror flick, the issue of compulsory licensing has emerged again in Thailand and just won't die....
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Novartis AG (NVS) said Thursday it was difficult to predict when a generic version of Sanofi AG's (SNY) blood-thinner Plavix can be launched in Germany, after the local regulator suspended an approval that it had given earlier because the French company had requested it.
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Merck & Co Inc won a fight with Apotex over the osteoporosis drug Fosamax when a patent appeals court ruled on Wednesday against the generic drugmaker on all counts.
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A pair of powerful House Democrats will investigate what U.S. regulators knew about allegations that drugmaker Ranbaxy lied about the quality of its products....
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PRICE rises might be infecting most consumer goods in Australia these days but there is good news for the sick: the cost of many popular prescribed medicines is coming down.
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Teva Pharmaceutical Industries Ltd. and Barr Pharmaceuticals, Inc. announced today that they have signed a definitive agreement under which Teva will acquire Barr, the fourth largest generic drug company worldwide. ...
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Anna Csapo, the manager of the Panacea Pharmacy in downtown Budapest, sells 10 different generic versions of Pfizer Inc.'s Norvasc because of the demand for low-cost copies of the blood-pressure medicine....
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A Federal lawsuit filed in Birmingham, Alabama July 18, 2008 charges pharmaceutical company Actavis Totowa with manufacturing and distributing defective Digitek heart drug pills that contained dangerously excessive doses of the drug's active ingredient, digoxin, causing life-threatening adverse drug reactions....
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Richard Gold, a professor at McGill University's faculty of law, helped conduct a feasibility study that would bring pharmaceutical companies together to create a patent pool for medicines....
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"There was no crisis at Teva. I'm not denigrating the position or scale of the public shareholders. The crisis was not at us," Teva Pharmaceutical Industries Ltd. chairman Eli Hurvitz said this morning in an interview with "IDF Radio". ...
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Investment bank Wachovia downgraded four of the largest generic drug companies Monday, indicating it expects them to perform about as well as the overall market....
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With respect to Eisai's patent infringement lawsuit against Teva Pharmaceuticals and Dr. Reddy's Laboratories concerning Aciphex(R) (rabeprazole sodium), Eisai Co., Ltd. and its U.S. subsidiary Eisai Inc. (collectively "Eisai") today announce that the United States Court of Appeals for the Federal Circuit has affirmed both the United States District Court for the Southern District of New York's summary judgment rulings on the validity of Eisai's composition of matter patent and its ruling on the enforceability of the composition of matter patent....
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Ranbaxy Laboratories Limited (Ranbaxy) announced that the UK Serious Fraud Office's (SFO) prosecution of its UK subsidiary, Ranbaxy (UK) Limited (RUKL), has been quashed by the English Crown Court. ...
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Teva Pharmaceutical Industries Ltd announced today that it has commenced commercial shipment of its generic version of Lamictal(R) (Lamotrigine) Tablets, 25mg, 100 mg, 150 mg, and 200 mg....
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Two members of the US House of Representatives Committee on Energy and Commerce began an investigation Tuesday into whether the Food and Drug Administration (FDA) allowed the continued sale of certain drugs that agency officials knew had been manufactured and sold using faulty data. ...
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GlaxoSmithKline Plc (GSK.L), the world's second largest drugmaker, took a bold step into the branded generics marketplace on Wednesday via an alliance with South Africa's Aspen Pharmacare Holdings (APNJ.J).
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Generic drug maker Impax Laboratories Inc. has been sued over its copy of a drug to treat prostate enlargement. ...
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Teva Pharmaceutical Industries Ltd. announced today that it has completed its acquisition of Bentley Pharmaceuticals, Inc. which will operate in Spain under the Teva name. At closing, Bentley consisted solely of its generic pharmaceutical operations, following the spin-off of its drug delivery business to its stockholders on June 30, 2008....
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Sagent Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, today announced that it has launched ceftazidime for injection, USP, a semisynthetic broad-spectrum, beta-lactam antibiotic....
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Drug developer Barr Pharmaceuticals Inc. said Thursday it is challenging Cephalon Inc.'s patent on the pain drug Fentora and in turn is being sued to prevent it from marketing a generic version....
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Ranbaxy Laboratories Limited (Ranbaxy) announced the Day-1 launch of its first independently developed generic product, Amlodipine tablets 2.5mg & 5mg in Japan . Amlodipine is currently the largest molecule which has gone off patent in Japan and represents the biggest generic opportunity so far in the Japanese generic market. The product has a market size of around USD 2 Billion....
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that its subsidiary has commenced commercial shipment of its Omeprazole Delayed-Release Capsules USP product in the 40mg strength from its Davie, Florida manufacturing facility....
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Lannett Company, Inc., a manufacturer of generic pharmaceuticals, today said that on June 6, 2008 it initiated a lawsuit against KV Pharmaceuticals, Inc. and its subsidiaries Drugtech Corporation and Ther-Rx Corporation in the U.S. District Court for the District of Delaware....
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NEW DELHI: The health ministers of India, Brazil and South Africa will meet here Monday and Tuesday to push forward their cooperation in the health sector. Minister for Health and Family Welfare Anbumani Ramadoss will also hold bilateral meetings with his Brazilian and South African counterparts....
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Mylan Inc said it won U.S. approval for the first generic version of Sciele Pharma Inc's blood-pressure drug Sular, and would ship its product immediately, sending Sciele shares to their lowest point in nearly two years....
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Ranbaxy Pharmaceuticals Inc (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Ltd (RLL) today said that under an agreement with AstraZeneca Pharmaceuticals it has launched an authorised generic of Omeprazole 40 mg capsules in the US healthcare system....
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Health Canada is warning consumers not to use Sandoz Canada's timolol ophthalmic solution in 0.25 percent and 0.5 percent strengths because some bottles may contain more of the active ingredient than indicated on the label.
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Lannett Company, Inc., a manufacturer of generic pharmaceuticals, today announced that its wholly owned subsidiary, Cody Laboratories (Cody), a manufacturer/supplier of bulk active pharmaceutical ingredients (API) acquired by Lannett in April 2007, has received approval for its import registration application from the U.S. Drug Enforcement Administration (DEA)....
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IMPAX Laboratories, Inc. today announced Endo Pharmaceuticals, Inc. and Penwest Pharmaceuticals, Co. have filed suit for patent infringement based on the Company's amendment to its existing Abbreviated New Drug Application for oxymorphone hydrochloride extended-release tablets CII, generic of Opana ER, adding new 7.5 mg, 15 mg and 30 mg strengths. ...
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Mylan Inc. and Watson Pharmaceuticals, Inc. announced today that Mylan has acquired Watson's 50 percent interest in the Somerset Pharmaceuticals, Inc. (Somerset) joint venture. Details of the transaction remain confidential....
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Teva Pharmaceuticals and Par Pharmaceutical are facing a lawsuit in which the plaintiff alleges the companies' generic pergolide, a treatment for Parkinson's disease and restless leg syndrome (RLS), caused her valvular heart disease.
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Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by Amgen Inc. in connection with its Sensipar(R) Tablets (cincalcet hydrochloride), 30mg, 60mg and 90mg....
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Teva Pharmaceuticals is pleased to announce the introduction and availability of Divalproex Sodium Delayed-Release Tablets USP....
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Sun Pharmaceutical Industries Ltd. announced that USFDA has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for generic Depakote, divalproex sodium delayed release tablets....
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Lupin Limited announced today that it has acquired Hormosan Pharma GmbH (Hormosan), a German Sales and Marketing generics company specialised in the supply of pharmaceutical products for the Central Nervous System (CNS)....
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Lupin Limited, announced today that its subsidiary in the US, Lupin Pharmaceuticals, Inc. (LPI) has received final approval for the Company's Abbreviated New Drug Application (ANDA) for Divalproex Sodium Delayed-Release Tablets, 125 mg, 250 mg and 500 mg from the U.S. Food and Drug Administration (USFDA). Commercial shipments of the product have already commenced....
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Barr Pharmaceuticals, Inc. today confirmed that its subsidiaries, Barr Laboratories, Inc. and PLIVA-Hrvatska D.O.O., have initiated a challenge of the patent listed by UCB Inc. in connection with its Xyzal(R) Tablets (levocetirizine dihydrochloride), 5mg....
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Japanese drug maker Daichii Sankyo, which has signed a share purchase agreement with Ranbaxy, today said its open offer for an additional 20 per cent stake in the domestic pharma major would undergo a change of schedule, pursuant to a delay in Sebi's approval....
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Handa Pharmaceuticals, LLC, a specialty pharmaceutical company based in Fremont, California, today confirmed that its Abbreviated New Drug Application or Quetiapine Fumarate Extended-Release Tablets, the generic version of AstraZeneca's Seroquel(R) XR, has been accepted for filing by the U.S. Food and Drug Administration....
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