Content about Generic drug

June 18, 2013

The Food and Drug Administration's Center for Drug Evaluation and Research has collected 84% of the fees it intends to collect this year under a law passed last year to collect user fees from generic drug members, according to a memo sent out to CDER staff Tuesday.

NEW YORK — The Food and Drug Administration's Center for Drug Evaluation and Research has collected 84% of the fees it intends to collect this year under a law passed last year to collect user fees from generic drug members, according to a memo sent out to CDER staff Tuesday.

CDER director Janet Woodcock wrote that the FDA had collected more than $255 million under the Generic Drug User Fee Amendments to the 2012 Prescription Drug User Fee Act reauthorization. The agency plans to collect $299 million in fiscal year 2013.

June 18, 2013

Half a loaf, the saying goes, is better than none. For the generic drug industry, that means that the Supreme Court handed it a partial victory Monday by ruling that “pay for delay” patent settlements between brand name and generic drug companies aren’t necessarily illegal and should be considered on a case-by-case, “rule of reason” approach by the Federal Trade Commission, which staunchly opposes the practice.

Half a loaf, the saying goes, is better than none. For the generic drug industry, that means that the Supreme Court handed it a partial victory Monday by ruling that “pay for delay” patent settlements between brand name and generic drug companies aren’t necessarily illegal and should be considered on a case-by-case, “rule of reason” approach by the Federal Trade Commission, which staunchly opposes the practice.

June 17, 2013

Patent settlements between brand and generic drug makers commonly referred to as "pay-for-delay" settlements are not necessarily against the law, the Supreme Court ruled Monday.

NEW YORK — Patent settlements between brand and generic drug makers commonly referred to as "pay-for-delay" settlements are not necessarily against the law, the Supreme Court ruled Monday.

June 5, 2013

South Korean drug maker Hanmi Pharmaceutical Co. and U.S. partner Amneal Pharmaceuticals have made an agreement in federal court concerning a generic heartburn drug.

SEOUL, South Korea — South Korean drug maker Hanmi Pharmaceutical Co. and U.S. partner Amneal Pharmaceuticals have made an agreement in federal court concerning a generic heartburn drug that they said clears a major hurdle to its launch.

June 4, 2013

The House of Representatives voted Monday to pass a bill that would establish national standards for the pharmaceutical supply chain.

WASHINGTON — The House of Representatives voted Monday to pass a bill that would establish national standards for the pharmaceutical supply chain.

June 3, 2013

Dr. Reddy's Labs and Fujifilm have terminated a deal to market generic drugs in Japan, Dr. Reddy's said.

HYDERABAD, India — Dr. Reddy's Labs and Fujifilm have terminated a deal to market generic drugs in Japan, Dr. Reddy's said Monday.

The two had signed a memorandum of understanding in June 2011 to establish a joint venture for developing and manufacturing generics in Japan. The ending of the deal was the result of Fujifilm changing its long-term strategy for the drug business, but Dr. Reddy's said they would continue looking into opportunities for partnerships and alliances in other drug businesses.

May 30, 2013

When does the double-edged sword of generic drug price reductions begin to cut the government agency or health system holding the sword?

That's the question many pharmacy leaders in Canada have for the provincial health system policy-makers who have embarked on a crusade to whack pharmacy reimbursement levels for many lower-cost generic medicines sold under the nation's publicly funded health system.

When does the double-edged sword of generic drug price reductions begin to cut the government agency or health system holding the sword?

That's the question many pharmacy leaders in Canada have for the provincial health system policy-makers who have embarked on a crusade to whack pharmacy reimbursement levels for many lower-cost generic medicines sold under the nation's publicly funded health system. The effort has drawn the ire of pharmacy advocates even as proponents in government and health policy circles tout its cost-saving benefits.

May 30, 2013

This summer, the Supreme Court will decide on a case that could determine whether generic drug makers can be held liable when patients suffer harmful side effects from taking their drugs.

This summer, the Supreme Court will decide on a case that could determine whether generic drug makers can be held liable when patients suffer harmful side effects from taking their drugs.

May 30, 2013

The year is only halfway done, but 2013 is already proving to be a year of particular importance for generic drugs as the industry awaits two important decisions from the Supreme Court and continues to wait for federal biosimilar regulations while fending off efforts to limit the scope of their use at the state level.

The year is only halfway done, but 2013 is already proving to be a year of particular importance for generic drugs as the industry awaits two important decisions from the Supreme Court and continues to wait for federal biosimilar regulations while fending off efforts to limit the scope of their use at the state level.

May 30, 2013

While the passage of the Patient Protection and Affordable Care Act of 2010 was a milestone in a number of respects, it also was one of the biggest moments in the history of the generic drug industry since the 1984 passage of the Hatch-Waxman Act, which created an abbreviated regulatory approval pathway for generic pharmaceutical drugs.

While the passage of the Patient Protection and Affordable Care Act of 2010 was a milestone in a number of respects, it also was one of the biggest moments in the history of the generic drug industry since the 1984 passage of the Hatch-Waxman Act, which created an abbreviated regulatory approval pathway for generic pharmaceutical drugs.

May 29, 2013

Texas has become the latest state to defeat a bill that critics say would limit the reach of knock-off versions of biotech drugs.

WASHINGTON — Texas has become the latest state to defeat a bill that critics say would limit the reach of knock-off versions of biotech drugs.

May 29, 2013

The Food and Drug Administration has approved a generic drug for incontinence made by Perrigo Co., the drug maker said.

ALLEGAN, Mich. — The Food and Drug Administration has approved a generic drug for incontinence made by Perrigo Co., the drug maker said Wednesday.

Perrigo announced the approval of trospium chloride extended-release capsules in the 60 mg strength, a once-daily treatment for overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency. The drug is a generic version of Allergan's Sanctura XR, which has annual sales of $54 million, according to Symphony Health Solutions.

May 22, 2013

Generic drug maker Par Pharmaceutical Cos. has started shipping an authorized generic version of a heart-disease medication made by AstraZeneca.

WOODCLIFF LAKE, N.J. — Generic drug maker Par Pharmaceutical Cos. has started shipping an authorized generic version of a heart-disease medication made by AstraZeneca.

Par said it had entered into an agreement with AstraZeneca to supply authorized generic Atacand (candesartan cilexetil) and had begun shipping the drug in the 4 mg, 8 mg, 16 mg and 32 mg strengths. Atacand has annual sales of about $113 million, according to IMS Health, and is used to treat certain kinds of heart failure and high blood pressure in children and adults.

May 21, 2013

Impax Labs has launched an authorized generic drug for migraine headaches under a partnership with AstraZeneca, Impax said.

HAYWARD, Calif. — Impax Labs has launched an authorized generic drug for migraine headaches under a partnership with AstraZeneca, Impax said.

Impax said its generics division, Global Pharmaceuticals, began shipping authorized generic zolmitriptan tablets and orally disintegrating tablets in the 2.5 mg and 5 mg strengths. The drug is a version of AstraZeneca's Zomig.

Zomig had sales of about $196 million during the 12-month period that ended in April, according to IMS Health.

May 13, 2013

The Generic Pharmaceutical Association has promoted Jason Money to associate VP federal government affairs, the trade group said Monday.

WASHINGTON — The Generic Pharmaceutical Association has promoted Jason Money to associate VP federal government affairs, the trade group said Monday.

Money, who has worked for the GPhA for six years, was previously the organization's senior director for federal affairs. In the new position, he will continue lobbying on behalf of the generic drug industry in Congress.

May 10, 2013

Actavis is looking into the possibility of buying Warner Chilcott, the generic drug maker said.

PARSIPPANY, N.J. — Actavis is looking into the possibility of buying Warner Chilcott, the generic drug maker said Friday.

Actavis, the world's third-largest generic drug maker, said it had entered into early-stage discussions with Warner Chilcott about a potential combination of the two, but that no agreement had been reached, and that it wouldn't issue further comment about the matter.

May 9, 2013

Declining use overall of healthcare services drove down spending on medicines in the United States by 3.5% per capita last year, according to a new study.

PARSIPPANY, N.J. — Declining use overall of healthcare services drove down spending on medicines in the United States by 3.5% per capita last year, according to a new study.

May 9, 2013

The November 2011 expiration of Pfizer's patent on the cholesterol drug Lipitor and Ranbaxy Labs' release of the generic version received significant play in the media, particularly due to the theretofore status of Lipitor (atorvastatin calcium) as the drug with the highest sales in the country, $7.7 billion in the United States, according to healthcare analytics firm IMS Health.

The November 2011 expiration of Pfizer's patent on the cholesterol drug Lipitor and Ranbaxy Labs' release of the generic version received significant play in the media, particularly due to the theretofore status of Lipitor (atorvastatin calcium) as the drug with the highest sales in the country, $7.7 billion in the United States, according to healthcare analytics firm IMS Health.

May 6, 2013

Florida's state legislature approved a bill last week that will allow pharmacists to substitute biosimilars for brand name biotech drugs.

NEW YORK — Florida's state legislature approved a bill last week that will allow pharmacists to substitute biosimilars for brand name biotech drugs.

The bill, which was approved last Tuesday and is scheduled to take effect on July 1, institutes requirements for pharmacists to substitute biosimilars when they are determined to be biosimilar to and interchangeable with the brand name product, while also requiring the state board of pharmacy to maintain a current list of interchangeable products.

May 2, 2013

Rite Aid's same-store sales decreased 4% in April compared with April 2012 due to an earlier Easter and introductions of new generic drugs, the retail pharmacy chain said.

CAMP HILL, Pa. — Rite Aid's same-store sales decreased 4% in April compared with April 2012 due to an earlier Easter and introductions of new generic drugs, the retail pharmacy chain said Thursday.

The numbers released Thursday included a 3.5% decrease in sales on the front end and a 4.2% decrease in pharmacy sales, but the pharmacy figure included a 4.54% negative effect due to new generics. Same-store prescription count decreased by 0.2%.

Total sales for the month were $1.902 billion, a 4.6% decrease over April 2012's $1.993 billion.

April 30, 2013

The Food and Drug Administration has approved two generic drugs made by Aurobindo Pharma, the drug maker said.

HYDERABAD — The Food and Drug Administration has approved two generic drugs made by Aurobindo Pharma, the drug maker said.

The company announced Tuesday the approval of quinapril tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths. The drug is a generic version of Pfizer's Accupril and is used to treat high blood pressure. Various versions of the drug had sales of about $49 million during the 12-month period ending in September, according to IMS Health.

April 26, 2013

Generic drug maker Actavis is settling a patent-infringement suit with Purdue Pharma concerning the opioid painkiller OxyContin, Actavis said, saying it expected to make more than $100 million in the deal between 2014 and 2015.

PARSIPPANY, N.J. — Generic drug maker Actavis is settling a patent-infringement suit with Purdue Pharma concerning the opioid painkiller OxyContin, Actavis said Friday, saying it expected to make more than $100 million in the deal between 2014 and 2015.

April 24, 2013

Generic drug maker Hospira marked its fifth year marketing knock-off versions of biotech drugs in Europe Wednesday as it presented at the 2013 Biotechnology Industry Organization International Convention this week.

CHICAGO — Generic drug maker Hospira marked its fifth year marketing knock-off versions of biotech drugs in Europe Wednesday as it presented at the 2013 Biotechnology Industry Organization International Convention this week.

The drug maker said it delivered more than 5 million doses of biosimilar medicines to patients in Europe and Australia. The convention includes multiple sessions devoted to such topics as biosimilar regulatory approval, manufacturing and market formation, the company said.

April 21, 2013

Last month, the Supreme Court heard Federal Trade Commission v. Actavis, which could impact the future of the generic drug industry at a time when 80% of all prescriptions dispensed in the United States are generic.

Last month, the Supreme Court heard Federal Trade Commission v. Actavis, which could impact the future of the generic drug industry at a time when 80% of all prescriptions dispensed in the United States are generic.

April 19, 2013

A report released yesterday by the Bipartisan Policy Center, entitled “A Bipartisan Rx for Patient-Centered Care and System-Wide Cost Containment,” contains a smart, forward-looking and no-cost recommendation that could save the government billions, the Generic Pharmaceutical Association said.

WASHINGTON — A report released yesterday by the Bipartisan Policy Center, entitled “A Bipartisan Rx for Patient-Centered Care and System-Wide Cost Containment,” contains a smart, forward-looking and no-cost recommendation that could save the government billions, the Generic Pharmaceutical Association said today.