19 February 2014Big Pharma

Expiring soon: products up for grabs

Copaxone (glatiramer acetate)

By far Teva’s biggest selling drug, Copaxone has received challenges from generic makers Sandoz, Momenta, Mylan and Natco all vying to launch their own versions of the multiple sclerosis drug.

In an effort to extend the life of the drug, which is worth $4.3 billion a year, Teva formulated a new formulation for the drug, which was approved by the US Food and Drug Administration (FDA) in January.

It will now be working to convert as many patients as possible to the three-times-weekly injection before the patent expires in May.

“2013 was an important year for Teva and its shareholders,” said Eyal Desheh, Teva’s former acting president and chief executive.

“Many seeds were planted to ensure our long-term success and prosperity. 2014 will be a pivotal year in terms of execution and further enhancement of our strategic direction.”

A spokesperson for Teva told LSIPR: “We do not know whether a generic form of Copaxone will be approved and we do not believe a generic glatiramer acetate should be approved without appropriate clinical trial testing.

“Copaxone is a very complex synthetic mixture of an enormous number of polypeptide sequences with a higher order structure and unidentified active sequences. As such, it is our position that untested versions of Copaxone should not be prescribed without demonstrating efficacy and safety in patients with relapsing forms of multiple sclerosis.”

Among those aiming to launch a Copaxone generic on May 24 is India-based Natco Pharma, which plans to release the drug through its marketing partner Mylan.

"the company's pipeline has 11 new molecular entities in Phase II or registration-almost double last year's total"

Nexium (esomeprazole magnesium)

Due to lose patent exclusivity in November this year, heartburn drug Nexium is the second biggest selling drug in the world, making AstraZeneca $3.8 billion in 2013.

However, the effect of Nexium’s impending expiry has already been felt, as this figure was down from more than $3.9 billion in 2012.

AstraZeneca’s chief executive Pascal Soriot said that in the short term, the impact from the loss of “key brands” would be challenging, although he expects 2017’s revenues to be “broadly in line” with those of 2013.

In a statement, he said that the company’s pipeline has 11 new molecular entities in Phase II or registration—almost double last year’s total. AstraZeneca recently acquired Bristol-Myers Squibb’s diabetes portfolio and will be working to maximise its potential.

“I’m pleased with the momentum we have built in 2013,” he said. “We continue to focus our organisation on the areas that will drive growth, redeploying our resources to fund the promising late-stage pipeline.”

In 2011, Ranbaxy, Mylan and Teva launched generic versions of Nexium in the UK, and after the patent expires on May 27, they are likely to enter the US market.

Cymbalta (duloxetine hydrochloride)

Indiana-based Eli Lilly has been preparing for a double-hit with two of its blockbuster drugs facing the so-called patent cliff. Last spring it started laying off hundreds of sales staff, and posted disappointing financial results at the end of the year.

Still Lilly’s biggest selling drug, antidepressant Cymbalta brought in more than $880 million in the last quarter of 2013, though this was down by 38 percent compared with the same period in 2012.

Immediately after the drug lost exclusivity last December, six generic makers including Teva, Lupin and Sun Pharma rushed into the market. Another one of Lilly’s Cymbalta patents, covering the formulation of duloxetine in pellets, will expire in July this year.

“Lilly’s fourth-quarter 2013 results reflect the initial impact from the US patent expiration for Cymbalta,” said Lilly’s chairman, president and chief executive John Lechleiter.

“The loss of the Cymbalta patent, along with the expiration of the US patent for Evista in March of this year will result in a substantial decline in revenue and earnings in 2014.

“Yet, far from seeing 2014 as a tough year for Lilly, we see it as a moment of tremendous opportunity. We expect to launch several new medicines this year and returning our company to growth in 2015 and beyond,” he added.

Lilly says it expects revenue declines following patent expiries to be partially offset by “growth from a portfolio of other products including [diabetes treatment] Humalog”.

Evista (raloxifene hydrochloride)

An osteoporosis drug that has also been approved to reduce the risk of breast cancer, at the end of 2013 Lilly’s Evista was still going strong, with global sales reaching $1 billion in 2013—an increase of 4 percent on the previous year.

Due to lose exclusivity in March, its main competitor will likely be Teva’s generic offering.

In 2010, the US Court of Appeals for the Federal Circuit dismissed Teva’s appeal against a district court’s permanent injunction preventing any manufacture of distribution of a generic version of Evista.

Lilly’s strategy for weathering its big patent losses is developing new medicines. It has entered into an agreement with Pfizer to develop and commercialise tanezumab, a monoclonal antibody under consideration for the treatment of moderate-to-severe chronic osteoarthritis pain, chronic low back pain, and cancer-related bone pain.

It has also announced that a new drug application for long-acting insulin filed with alliance partner Boehringer Ingelheim has been accepted by the FDA.

Micardis (telmisartan)

The hypertension drug worth $274 million annually to Boehringer Ingelheim slipped off the patent cliff in January, with Actavis receiving FDA approval for its generic version immediately after.

As the first filer of an Abbreviated New Drug Application (ANDA) with the FDA, Actavis has been granted 180 days of generic exclusivity on the market.

However, Boehringer has a backup with its MicardisPlus formulation, a combination of active ingredient telmisartan and diuretic hydrochlorothiazide. A supplementary protection certificate (SPC) covering the product will extend its life to 2017, although this has been challenged by Actavis in a case that was referred by the UK Patents Court to the Court of Justice of the European Union (CJEU) late last year.

Boehringer is waiting for the CJEU to decide whether it may keep its SPC on the combination product; decisions on three cases handed down in December could provide a window as to which way the court will go.

Restasis (cyclosporine)

Allergan’s Restasis eye drop solution for chronic dry eye will lose exclusivity in May, although in January the US Patent and Trademark Office issued three new patents covering the formulation and method of using the drug.

Hoping to secure first-filer status to enter the generic market is Actavis, which in January confirmed that its subsidiary Watson Laboratories had submitted an ANDA to the FDA. After issuing guidelines related to the approval of generic versions of Restasis products, the FDA informed Actavis that its application had been refused.

Actavis then notified Allergan that it had amended its application to include a Paragraph IV certification to the newly issued patent. Actavis is currently discussing the filing status of its application with the FDA.

Restasis made $940 million in worldwide sales in 2013. Allergan expects this to reach $1 billion by end of 2014.

Nasonex (mometasone furoate monohydrate)

Nasonex has proven something of a cash cow for Merck, which acquired the product when it bought company Schering-Plough in 2009. By the end of 2013, worldwide sales of the hayfever nasal spray were still climbing, from $1.268 billion in 2012 to $1.335 billion.

Two of the patents covering use of mometasone furoate expired at the end of January, and Merck has six months to hone its strategy before paediatric exclusivity runs out in July.

Nasonex has already experienced some competition—in 2012, a US district court decided that Canadian pharmaceutical company Apotex did not infringe Merck’s patent covering the active ingredient, which expires in 2017.

Even though the court found the composition of matter patent to be valid, Merck appealed against the ruling of non-infringement to the ruling to the US Court of Appeals for the Federal Circuit, which dismissed the case.

2014's patent expiries at a glance

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