Content about Generic drug

April 19, 2011

The main trade group for the generic drug industry is heralding a new cost analysis by the IMS Institute for Healthcare Informatics showing that generic drugs can reduce co-payments by up to 80%.

WASHINGTON — The main trade group for the generic drug industry is heralding a new cost analysis by the IMS Institute for Healthcare Informatics showing that generic drugs can reduce co-payments by up to 80%.

According to the analysis, contained in the report “The Use of Medicines in the United States: Review of 2010,” the average co-payment for a generic drug was $6.06 per prescripton last year, compared with $23.65 to $34.77 for preferred and nonpreferred brand drugs.

April 19, 2011

U.S. spending on drugs grew 2.3% to $307.4 billion in 2010, according to a new report by the IMS Institute for Healthcare Informatics, part of industry research firm IMS Health.

PARSIPPANY, N.J. — U.S. spending on drugs grew 2.3% to $307.4 billion in 2010, according to a new report by the IMS Institute for Healthcare Informatics, part of industry research firm IMS Health.

April 18, 2011

The Food and Drug Administration has approved a topical treatment for skin conditions made by Israeli generic drug maker Taro Pharmaceutical Industries.

HAWTHORNE, N.Y. — The Food and Drug Administration has approved a topical treatment for skin conditions made by Israeli generic drug maker Taro Pharmaceutical Industries.

Taro announced Monday the approval of imiquimod cream in the 5% strength. The drug is used to treat actinic keratosis and external genital warts, and is a generic version of Graceway Pharmaceuticals’ Aldara.

Imiquimod cream has annual sales of around $340 million in the United States, according to Taro.

April 14, 2011

The Food and Drug Administration has approved Dr. Reddy's version of an allergy medication that recently received Rx-to-OTC switch approval, the generic drug maker said.

HYDERABAD, India — The Food and Drug Administration has approved Dr. Reddy's version of an allergy medication that recently received Rx-to-OTC switch approval, the generic drug maker said.

Dr. Reddy's fexofenadine HCl tablets are bioequivalent versions of Sanofi-Aventis’ Allegra, which received Rx-to-OTC switch approval from the FDA in January.

The fexofenadine HCl Rx market had branded and generic sales of approximately $452 million for the 12 months ended last December, according to IMS Health.

April 11, 2011

Another generic drug maker is seeking to market its version of a popular opioid painkiller.

HAYWARD, Calif. — Another generic drug maker is seeking to market its version of a popular opioid painkiller.

Impax said it had filed applications with the Food and Drug Administration seeking approval for a generic version of Purdue Pharma’s Oxycontin (oxycodone) controlled-release tablets in the 10-, 15-, 20-, 30-, 40-, 60- and 80-mg strengths.

Purdue filed suit against Impax on April 8 in the U.S. District Courts for the Southern District of New York, seeking to prevent Impax from marketing its version before the expiration of Purdue's patents.

April 8, 2011

Watson announced that its subsidiary is seeking approval to market a generic version of a bacterial conjunctivitis treatment.

PARSIPPANY, N.J. — Watson announced that its subsidiary is seeking approval to market a generic version of a bacterial conjunctivitis treatment.

Watson Labs filed an abbreviated new drug application with the Food and Drug Administration for moxifloxacin hydrochloride ophthalmic solution USP in the 0.5% strength. The antibiotic solution is a generic version of Alcon's Vigamox, which had total U.S. sales of about $281 million ended in February, according to IMS Health.

April 5, 2011

Generic drug maker Impax Labs is hoping to become the first to market a version of a gastroesophageal reflux disease treatment made by Takeda Pharmaceutical.

HAYWARD, Calif. — Generic drug maker Impax Labs is hoping to become the first to market a version of a gastroesophageal reflux disease treatment made by Takeda Pharmaceutical.

Impax said Tuesday that it had filed an approval application with the Food and Drug Administration for dexlansoprazole delayed-release capsules in the 30-mg and 60-mg strengths. The drug is a version of Takeda’s Dexilant.

March 31, 2011

Indian generic drug maker Aurobindo has received two approvals from the Food and Drug Administration.

HYDERABAD, India — Indian generic drug maker Aurobindo has received two approvals from the Food and Drug Administration.

The company said Wednesday that it received approval for galantamine tablets in the 4-, 8- and 12-mg strengths. The drug is a version of Johnson & Johnson’s Alzheimer’s treatment Razadyne; various versions of the drug had sales of $41 million during the 12 months ended in September 2010, according to IMS Health.

March 31, 2011

The American Enterprise Institute for Public Policy Research on Monday published a working paper that identified $329 million in overspending as a result of underutilization of generics.

WASHINGTON — The American Enterprise Institute for Public Policy Research on Monday published a working paper that identified $329 million in overspending as a result of underutilization of generics.

As total spending on 20 medicines with generic equivalents totaled approximately $1.5 billion, AEI concluded Medicaid overspent by 22% ($1.5 billion versus $1.17 billion) on these pharmaceuticals.

March 29, 2011

Indian generic drug maker Dr. Reddy’s Labs has launched a generic treatment for seasonal allergies, the company said Tuesday.

HYDERABAD, India — Indian generic drug maker Dr. Reddy’s Labs has launched a generic treatment for seasonal allergies, the company said Tuesday.

Dr. Reddy’s announced the launch of levocetirizine tablets in the 5-mg strength. The drug is a generic version of UCB’s and Sanofi-Aventis’ Xyzal.

Levocetirizine had sales of about $238 million during the 12-month period ended in September 2010, according to IMS Health.

March 29, 2011

Generic drug maker Watson Pharmaceuticals is hoping to become the first to market a version of a popular opioid painkiller.

MORRISTOWN, N.J. — Generic drug maker Watson Pharmaceuticals is hoping to become the first to market a version of a popular opioid painkiller.

Watson said it had filed applications with the Food and Drug Administration seeking approval for a generic version of Purdue Pharma’s OxyContin (oxycodone) extended-release tablets in the 10-, 15-, 20-, 30-, 40-, 60- and 80-mg strengths.

March 28, 2011

Ten states could reap significant savings by increasing the use of generic drugs in their state Medicaid programs, the Generic Pharmaceutical Association said Monday in response to a report by the American Enterprise Institute, a conservative think tank.

WASHINGTON — Ten states could reap significant savings by increasing the use of generic drugs in their state Medicaid programs, the Generic Pharmaceutical Association said Monday in response to a report by the American Enterprise Institute, a conservative think tank.

The report, “Overspending on Multi-Source Drugs in Medicaid,” by Alex Brill, identified states that overspend the most on their Medicaid programs, with California, Texas and Georgia topping the list.

March 28, 2011

Teva Pharmaceuticals has launched a chewable birth control pill, the generic drug maker said Friday.

NORTH WALES, Pa. — Teva Pharmaceuticals has launched a chewable birth control pill, the generic drug maker said Friday.

Teva announced the launch of Zeosa (norethindrone and ethinyl estradiol) tablets.

The drug is chemically equivalent to Warner Chilcott’s Femcon Fe tablets and is available in the 0.4 mg/0.035 mg strength.

 

March 23, 2011

Though more than 7-in-10 drugs dispensed in the United States today are generics, and the Food and Drug Administration holds generics to the same standards as branded drugs, misgivings among the general public still exist, fed by the occasional media report of patients experiencing bad side effects after taking certain generic drugs.

PITTSBURGH — Though more than 7-in-10 drugs dispensed in the United States today are generics, and the Food and Drug Administration holds generics to the same standards as branded drugs, misgivings among the general public still exist, fed by the occasional media report of patients experiencing bad side effects after taking certain generic drugs.

March 21, 2011

The generic drug industry’s main lobby in Washington is hoping to head off cuts to the Food and Drug Administration’s Office of Generic Drugs, which it said could have a “devastating impact” on those who rely on generics.

WASHINGTON — The generic drug industry’s main lobby in Washington is hoping to head off cuts to the Food and Drug Administration’s Office of Generic Drugs, which it said could have a “devastating impact” on those who rely on generics.

Republicans in Congress have sought to reduce government spending by making large cuts to various domestic programs and agencies, including the FDA, which critics of the plan said could jeopardize food and drug safety.

March 15, 2011

Five senators have issued a letter to Food and Drug Administration commissioner Margaret Hamburg to expand Americans' access to affordable medications by avoiding the delay of generic drug approvals.

WASHINGTON — Five senators have issued a letter to Food and Drug Administration commissioner Margaret Hamburg to expand Americans' access to affordable medications by avoiding the delay of generic drug approvals.

March 15, 2011

Patients that opt to fill their prescriptions through a $4 generic program could help garner societal savings of nearly $6 billion, a new study found.

PITTSBURGH — Patients that opt to fill their prescriptions through a $4 generic program could help garner societal savings of nearly $6 billion, a new study found.

March 4, 2011

SUPPLIER NEWS — Impax Labs received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment. The drug maker said the FDA approved its 150-mg doxycycline monohydrate capsules, a drug used to treat bacterial infections and a generic version of Adoxa, made by Nycomed subsidiary PharmaDerm. The 150-mg strength of Adoxa had sales of about $25 million during the 12 months ended in December 2010, according to Wolters Kluwer.

March 3, 2011

The Food and Drug Administration has approved a generic drug for pain and inflammatory diseases made by Amneal Pharmaceuticals, Amneal said Thursday.

BRIDGEWATER, N.J. — The Food and Drug Administration has approved a generic drug for pain and inflammatory diseases made by Amneal Pharmaceuticals, Amneal said Thursday.

The FDA approved indomethacin extended-release capsules in the 75-mg strength. The drug is used to treat pain associated with rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, bursitis and tendonitis.

March 3, 2011

The head of a group representing the nation's pharmacy benefit managers got honors from the Generic Pharmaceutical Association.

WASHINGTON — The head of a group representing the nation's pharmacy benefit managers got honors from the Generic Pharmaceutical Association.

The Pharmaceutical Care Management Association announced Thursday that president and CEO Mark Merritt had received the GPhA’s Outstanding Contribution Award at the generic drug industry group’s annual meeting in Orlando, Fla. The organization has advocated increased generic drug utilization and found common cause with the generics industry in its support for follow-on biologics.

March 2, 2011

A group of drug makers have sued Mylan over its attempt to gain Food and Drug Administration approval for a generic menopause drug, Mylan said Tuesday.

PITTSBURGH — A group of drug makers have sued Mylan over its attempt to gain Food and Drug Administration approval for a generic menopause drug, Mylan said Tuesday.

February 24, 2011

Generic drug maker Par Pharmaceutical Cos. had sales of $227 million during fourth quarter 2010 and $1 billion for the year as a whole, according to an earnings statement Thursday.

WOODCLIFF LAKE, N.J. — Generic drug maker Par Pharmaceutical Cos. had sales of $227 million during fourth quarter 2010 and $1 billion for the year as a whole, according to an earnings statement Thursday.

Profits were $17.5 million for the quarter and $92.7 million for the year, compared with $10.7 million in fourth quarter 2009 and $76.9 million for 2009 as a whole.

February 22, 2011

Generic drug maker Hi-Tech Pharmacal has received Food and Drug Administration approval for its version of a drug used to treat neurological disorders, the company said Tuesday.

AMITYVILLE, N.Y. — Generic drug maker Hi-Tech Pharmacal has received Food and Drug Administration approval for its version of a drug used to treat neurological disorders, the company said Tuesday.

Hi-Tech announced the approval of gabapentin oral solution in the 250 mg/5 mL strength, a generic version of Pfizer’s Neurontin oral solution.

The drug is used to treat postherpetic neuralgia and epilepsy. Neurontin had sales of $15 million in 2010, according to IMS Health.

February 22, 2011

Generic drug maker Perrigo has filed for approval of a drug to treat psoriasis with the Food and Drug Administration.

ALLEGAN, Mich. — Generic drug maker Perrigo has filed for approval of a drug to treat psoriasis with the Food and Drug Administration.

Perrigo announced Tuesday that it had filed an application with the FDA for calcipotriene and betamethasone dipropionate in the 0.005%/0.064% strength. The drug is a generic version of Leo Pharma’s Taclonex and is used to treat psoriasis vulgaris in adults.

February 18, 2011

A whole slew of drugs will lose patent protection this year, opening up opportunities for generic drug makers to market their own versions. Most notable among these is Pfizer’s cholesterol-
lowering drug Lipitor (atorvastatin), the world’s top-selling drug, with U.S. sales of $7 billion during the 12 months ended September 2010, according to IMS Health.