NewsBytes — Generics, 9/24/12
NEW YORK — Generic drug makers Hospira, Sagent Pharmaceuticals and Teva Pharmaceutical Industries have launched generic versions of a chemotherapy drug made by Sanofi, the three companies said last month.
The drug makers announced the launch of oxaliplatin injection, which Sanofi markets under the brand name Eloxatin. Eloxatin had sales of $1.7 billion during the 12-month period ended in June, according to IMS Health. Hospira and Sagent launched their versions of the drug on Aug. 9, while Teva Health Systems, an Irvine, Calif.-based division of the Israeli drug maker, launched the drug on Aug. 15.
Hospira originally launched generic oxaliplatin in August 2009 after a court ruled in its favor in a patent-infringement suit filed by Sanofi. Sanofi and Hospira later settled the suit in 2010, requiring Hospira to suspend sales of the drug in June 2010, but allowing it to relaunch ahead of the expiration of Sanofi’s patent. The patents on Eloxatin expire between January 2013 and February 2016, according to Food and Drug Administration records.
ALLEGAN, Mich. — The FDA has approved an oral painkiller made by Perrigo, the drug maker said.
Perrigo announced the approval of morphine sulfate oral solution in the 100-mL/5% strength. The drug is a schedule II controlled substance and is used to treat moderate to severe acute and chronic pain. Sales of the drug are about $26 million per year, according to Wolters Kluwer Health. Perrigo said it would ship the drug immediately.
PRINCETON, N.J. — Sandoz has launched a generic version of a topical medication used to treat psoriasis, the company said.
Sandoz, the generics arm of Swiss drug maker Novartis, announced the launch of calcipotriene cream in the 0.005% strength, calling it the first generic version of Leo Pharma’s Dovonex. Dovonex had sales of about $118.8 million during the 12-month period ended in May, according to IMS Health.
BRIDGEWATER, N.J. — Generic drug maker Amneal Pharmaceuticals will spend $120 million to expand three of its plants, the privately owned drug maker said. Amneal said it would spend the money over a two-year period lasting through 2014 to “significantly” grow operations at research-and-development, manufacturing and distribution plants in New York, New Jersey and Kentucky. The company, which employs more than 1,100 people in the United States, said the expansion would create 500 more jobs.
“We clearly understand the value of, and are fully committed to, investing and growing within the market we serve, significantly expanding our number of ‘Made in the USA’ products,” Amneal president Chirag Patel said. “Generic pharmaceuticals ensure the lowest cost of medications to help make health care more affordable to all consumers.”
PARSIPPANY, N.J. — Teva Pharmaceutical Industries, Mylan and Ranbaxy Labs launched generic versions of a Type 2 diabetes drug made by Takeda Pharmaceutical last month, as Watson Pharmaceuticals sued the FDA after the agency prevented it from launching its own version.
Watson said it was entitled to share market exclusivity for a generic version of Takeda’s Type 2 diabetes drug Actos (pioglitazone). Under the Hatch-Waxman Act of 1984, the first company to file a complete regulatory approval application with the FDA for a generic version of a drug is entitled to 180 days in which to compete exclusively with the branded version upon approval. In some cases, multiple companies share exclusivity, and a 2010 settlement with Takeda would allow Watson, Teva Pharmaceutical Industries, Mylan and Ranbaxy Labs to launch generic versions of Actos.
Watson said the FDA denied its claim of shared exclusivity based on the timing of its reinstatement of several of its original paragraph IV certifications, a type of challenge to a branded drug maker’s patent commonly issued by generic drug companies. Watson said it had converted its paragraph IV certification to a different type of challenge at the FDA’s direction, later reinstating the paragraph IV certification after it settled a patent-infringement suit with Takeda. The FDA’s denial of Watson’s claim would delay its launch of the drug by six months, the company said.
“When we learned of [the] FDA’s position regarding our application, we made efforts to work cooperatively with [the] FDA to resolve the situation,” Watson president and CEO Paul Bisaro said. “[The] FDA has refused to grant shared exclusivity and seeks to unnecessarily delay the launch of Watson’s generic Actos product, with potential harm to consumers who may face constraints on supply as a result of this action.”
Actos had sales of about $2.7 billion during the 12-month period ended in May, according to IMS Health. The lawsuit remained unresolved at press time.
PITTSBURGH — Mylan has launched a generic drug used to treat sleep disorders, the company said. The generic drug maker announced the launch of modafinil tablets in the 100-mg and 200-mg strengths. The drug is a generic version of Provigil, made by Cephalon — a company that Teva Pharmaceutical Industries acquired last year — and is used to treat narcolepsy, obstructive sleep apnea and shift work disorder.
There has been some contention surrounding the drug since the FDA determined in April that Teva was the first company to file for regulatory approval of the generic, thus entitling it to 180 days in which to compete with the branded version, as provided for under the Hatch-Waxman Act of 1984.
But under an agreement with the Federal Trade Commission related to Teva’s acquisition of Cephalon in October 2011, Par Pharmaceutical launched the generic version on April 6, while Teva launched an authorized generic, a term used to refer to the branded drug marketed under its generic name at a reduced price. Mylan responded by suing the FDA, asserting that Teva was disqualified from submitting a regulatory filing challenging Provigil’s patent protection because a company could not infringe its own patent, and that Mylan should be considered the first-to-file company.
Mylan CEO Heather Bresch said she was “pleased” that Mylan would be launching the drug prior to the expiration of the 180-day exclusivity period. Branded and generic versions of the drug had sales of about $1.3 billion during the 12-month period ended in June, according to IMS Health.
Mylan also announced the launch of lithium carbonate extended-release tablets, a drug used to treat manic episodes of bipolar disorder. Various versions of the drug had sales of about $15.2 million during the 12-month period ended in June, according to IMS Health.
JERUSALEM — Teva Select Brands has launched a new drug used to treat schizophrenia. The company, a subsidiary of Israeli drug maker Teva Pharmaceutical Industries, announced late last month the launch of clozapine orally disintegrating tablets in the 12.5-mg, 25-mg and 100-mg strengths.
The drug is a generic version of Jazz Pharmaceuticals’ FazaClo.
Generics saved U.S. $1 trillion in 9 years
A trillion of anything is difficult to wrap one’s head around, whether it’s the number of grains of sand on a beach or stars in the sky. It’s so much easier for the human mind to look at such a quantity as the sum of its parts rather than on the basis of its individual components.
With more than $1 trillion in savings on generic drugs, it’s important to look at what such a number comprises just to realize how important it really is. According to a study released last month by the Generic Pharmaceutical Association, that’s how much money the country saved thanks to the use of generic drugs between 2002 and 2011. That translates into $1 billion every other day, and almost $193 billion in 2011 alone.
“There’s been significant cost savings for the U.S. pharmaceutical market due to the adoption of generics,” IMS Health VP industry relations Doug Long told Drug Store News. “So that’s been good for pharmacy; it’s been good for wholesalers; it’s good for the payers. It’s rather difficult for the brands, but I think that the brands will really succeed based on innovation.”
The study, commissioned by the GPhA and conducted by IMS Health’s research division, also found that 2011 had the highest year-over-year increase in savings from generics since 1998, as savings increased 22%, compared with 2010. Savings from generics that have entered the market since 2002 have increased as well, totaling $481 billion over the decade. Nearly 80% of the 4 billion prescriptions written in 2011 were for generics, while accounting for only 27% of drug spending.
What makes the $1 trillion figure particularly significant is how it figures into national healthcare spending overall. According to the most recent National Health Expenditure Accounts report by the government, total healthcare spending reached $2.6 trillion in 2010, or $8,402 per person and about 18% of the country’s gross domestic product. The federal government financed 29% of the total, and state and local governments financed another 16%. By contrast, the federal government financed about 23% of the total in 2007. The NHEA also projected that the average growth in annual healthcare spending will hit 6.2% through 2018, even as the overall economy grows 4.1%. By that year, healthcare spending will be $4.4 billion, more than one-fifth of the country’s GDP, reaching half the country’s GDP within 15 years.
According to the report, of the total $1.07 trillion in savings, $588 billion came from generic drugs that were already on the market and had been approved by the Food and Drug Administration before 2002, while $481 billion came from newly introduced generic versions of branded drugs, which have been steadily rising over the past several years.
In 2011, the largest percentage of savings, 57%, came from central nervous system and cardiovascular drugs, which together delivered more than $100 billion in total savings. Generics for central nervous system indications themselves grew 10% in savings in 2011 compared with 2010. Metabolism drugs reduced costs by a further $27 billion, representing 500% growth in savings since 2002. Together, the three categories accounted for almost three-fourths of savings from generic drugs in 2011. The biggest increase in year-over-year savings came from generic cancer drugs, which produced $10 in savings in 2011, compared with $3 billion in 2010.
“This is the first time the 10-year number has been more than a trillion dollars,” Long said. “2012 being a bigger generic year than 2011, you’re going to see a big jump next year.”
PDUFA, GDUFA make 2012 milestone year
2012 is turning out to be a pretty important year for generic drugs, important enough that some of the things happening over the past several months have begged comparison to 1984, probably the biggest milestone year for the industry.
In July, Congress passed, and President Barack Obama signed, the Prescription Drug User Fee Act, which included the Generic Drug User Fee Amendments, known respectively as PDUFA and GDUFA. Following the signing, Generic Pharmaceutical Association president and CEO Ralph Neas called it “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act,” referring to the law that created an abbreviated regulatory approval pathway for generic pharmaceutical drugs.
The amendments create a system of user fees that generic drug companies will pay to the Food and Drug Administration when they apply for approval of a drug. These fees are projected to raise about $299 million per year over five years. That money will go toward hiring extra staff who will help clear the FDA’s estimated backlog of 2,500 generic drug approval applications awaiting review. Many of those applications are for drugs for which multiple versions already exist, as opposed to entirely new generic versions of branded drugs.
The wave of major branded drugs losing patent protection has continued as well. Pfizer’s cholesterol drug Lipitor (atorvastatin calcium) was the most noteworthy example, having gone generic in November 2011 with the introduction of Ranbaxy Labs’ generic version; Ranbaxy’s own 180-day period of market exclusivity, which it received as the first company to successfully file for FDA approval of a generic version of the drug, ended in May of this year, allowing other generic companies to make their own versions. Other major drugs facing patent expiry this year have been Bristol-Myers Squibb’s and Sanofi’s blood-thinning drug Plavix (clopidogrel), AstraZeneca’s psychiatric drug Seroquel (quetiapine), Merck’s respiratory drug Singulair (montelukast) and Takeda’s Type 2 diabetes drug Actos (pioglitazone).
“Right now, there’s plentiful generic opportunities,” IMS Health VP industry relations Doug Long told Drug Store News. “It’s almost a who’s-who list of patent expiries.”
In addition to generic drug makers themselves, retail pharmacies plan to benefit as well. “They generally make more margin for a generic product than they do for a branded product, particularly during the exclusivity period,” Long said.