Future Focus: The industry’s top five biggest drug patent expirations in 2016

pharmafile | October 21, 2015 | Feature | Manufacturing and Production, Research and Development biosimilars, blockbuster, generics, patent cliff, patents 

From Humira to Cubicin, some multi-billion dollar drugs are set to be hit hard by patent expiries next year, and companies will be hit hard unless they take drastic action now.

5. Kaletra, (Iopinavir/ritonavir), Abbvie

It is shaping up to be a difficult year for Abbvie in 2016. Not only will the company be watching the calendar until Humira goes off-patent in December, but it will also have to contend with the same problem for HIV antiviral Kaletra six months earlier, in June 2016. Revenues already appear to be in decline, with the drug taking in $167 million global sales in Q2, down from the $180 million in Q1.

4. Cubicin (daptomycin), Merck (formerly owned by Cubist Pharmaceuticals)

Cubist Pharmaceuticals suffered a blow when it was blocked from preventing rival Hospira from producing a generic version of the treatment for skin infections beyond June 2016. A US district judge found that four patents covering the drug and expiring in 2019 and 2020 were invalid, paving the way for generics from next year.

This decision came too late for Merck to reconsider a $9.5 billion takeover of the US-based company last year, yet the new owner claimed to be unfazed by the looming expiration. The drug brought in $293 million revenues in Q2 2015.

3. Benicar (olmesartan medoxomil), Daiichi Sankyo

With patent expiration looming in October 2016, Daiichi will want to get the best from its top-selling hypertension medication before this time. Mylan is already waiting in the wings with a 180-day exclusivity period for its generic, which is ready to hit shelves in late 2016. Sales were worth $2.4 billion to the Japanese company in the 2014 fiscal year, despite long-term legal headaches and safety concerns following the death of a 74 year-old patient, allegedly from gastrointestinal issues caused by Benicar.

2. Crestor (rosuvastatin calcium), Astra Zeneca,

Actavis is eyeing the end of AZ’s Crestor patent next year, and already has a generic version ready for launch in 2016. It will however have to pay the London-based drugmaker 39% royalties on all sales in advance of July 8, after AstraZeneca was granted a six-month patent extension under the US paediatric trials incentive programme. Q2 sales this year for cholesterol-buster Crestor were $1.3 billion (down 3%), but for the time being it remains one of the most lucrative drugs on the market.

1. Humira, (adalimumab), Abbvie

Rheumatoid arthritis treatment Humira has long been a crucial source of revenue for AbbVie: the world’s biggest-selling drug accounted for 63% of its 2014 revenue at $12.54 billion. Sales remained strong in Q1 2015, but took a hit in Q2, with a 7.6% fall from the previous year.

Although Humira’s US patent is not set to expire until 2016, Zydus Cadala launched a biosimilar in India for a fifth of the US price in late 2014, and Janssen’s Remicade is believed to already be impacting Humira sales. AbbVie investors are hopeful that the challenge of obtaining regulatory approval in the US for a biosimilar will prevent additional rivals in the country until towards the end of the decade. 

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