It’s no secret that big pharma is big business. Americans spend hundreds of billions on prescription medications every year, with that figure projected to keep growing. And now a new report shows that the top-selling brand-name prescription drugs in the U.S. earn more than $60 billion a year for their manufacturers, with the biggest money-maker topping $13 billion per year in sales on its own.
Axios compiled a handy chart of the top 20 top-selling drugs in the U.S. in 2016, based on data from the QuintilesIMS Institute.
The figures, Axios notes, are pure gross figures, and so don’t reflect what individuals or their insurers are paying, and don’t include any negotiations, discounts, rebates, coupons, or promotions. Still, they show a clear pattern of how many billions of dollars the top blockbuster drugs are bringing in.
Below is some more information on the ten biggest earners in the U.S. prescription drug business. Combined, they represent more than $60 billion a year in sales. Only three of these drugs have generic versions available; some of them have generic versions that could be released but are being held up by lawsuits. In terms of the ailments treated by these pharmaceutical money-makers, rheumatoid arthritis shows up most frequently, followed by diabetes.
1. Humira (adalimumab): $13.6 billion
Manufacturer: AbbVie
Introduced: 2003 (granted FDA approval Dec. 31, 2002)
Treats: First introduced to treat rheumatoid arthritis; now also prescribed for psoriatic arthritis, juvenile ideopathic arthritis, ankylosing spondylitis, plaque psoriasis, ulcerative colitis, and Crohn’s disease.
Currently costs: $49,752 – $58,044 per year [PDF]
Generic available? No.
The FDA approved a biosimilar drug, Amjevita, from Amgen in late 2016. However, AbbVie sued Amgen over it, claiming patent infringement. Due to that ongoing litigation Amgen executives have said not to expect their product to ship until 2018 at the earliest.
2. Harvoni (ledipasvir/sofosbuvir): $10 billion
Manufacturer: Gilead
Introduced: 2014 (granted FDA approval Oct. 10, 2014)
Treats: Hepatitis C
Currently costs: $94,500 for 12-week regimen; $113,400 – $226,800 per year [PDF]
Generic available?: No.
Harvoni is the specific combination of two drugs, ledipasvir and sofosbuvir. Generica drug company Mylan, after entering a deal with Gilead, has launched a generic equivalent in India, but it is not currently approved or for sale in the U.S.
3. Enbrel (etanercept): $7.4 billion
Manufacturer: Amgen
Introduced: 1998 (granted FDA approval Nov. 2, 1998)
Treats: First introduced as to treat rheumatoid arthritis; now also prescribed for psoriatic arthritis, juvenile ideopathic arthritis, ankylosing spondylitis, and plaque psoriasis.
Currently costs: $49,762 – $62,202 per year [PDF]
Generic available?: No.
In Aug. 2016, the FDA approved a biosimilar drug (Erelzi) made by Novartis. However, as with the generic version of Humira, this drug is being held up because Novartis is being sued for alleged patent infringement by Amgen. That legal action is expected to delay any biosimilar to Enbrel from hitting the market until 2018 at the earliest, and possibly not until 2029.
4. Lantus Solostar (insulin glargine): $5.7 billion
Manufacturer: Sanofi-Aventus
Introduced: 2000 (granted FDA approval Apr. 20, 2000; Solostar is specifically an automatic pen-style delivery mechanism)
Treats: Diabetes
Currently costs: Approx. $75 per pen (annual dosing varies widely; one pen may last from less than a day to more than a week)
Generic available? Yes.
The FDA approved the biosimilar Basaglar, made by Eli Lilly, in Dec. 2015. At launch, Basaglar was priced at 15% less than Lantus.
5. Remicade (infliximab): $5.3 billion
Manufacturer: Johnson & Johnson
Introduced: 1998 (granted FDA approval Aug. 24, 1998)
Treats: Crohn’s disease, ulcerative colitis, psoriasis, psoriatic arthritis, ankylosing spondylitis, and rheumatoid arthritis.
Currently costs: $39,223 per year [PDF]
Generic available?: Yes.
The FDA has approved two biosimilars to Remicade: Inflectra, in Apr. 2016, and Renflexis, in Apr. 2017. The two are made by Pfizer and Merck, respectively.
6. Januvia (sitagliptin), $4.8 billion
Manufacturer: Merck
Introduced: 2006 (gained FDA approval Oct. 17, 2006)
Treats: Diabetes
Currently costs: Price varies widely by dose; anywhere from $8 to $15 per pill
Generic available?: No.
7. Advair Diskus (fluticasone/salmeterol), $4.7 billion
Manufacturer: GSK
Introduced: 2000 (gained FDA approval Aug. 24, 2000)
Treats: Asthma, COPD, and other respiratory issues
Currently costs: Price varies widely depending on formulation, and dosage varies from person to person. Price for one inhaler is approximately between $230 and $370.
Generic available?: No.
Competitor Hikma did apply for approval for a generic; however, its application was denied earlier this year, as was another potential generic version from Mylan. Neither is expected to reach market before 2018 at the earliest.
8. Lyrica (pregabalin): $4.4 billion
Manufacturer: Pfizer
Introduced: 2005 (gained FDA approval Dec. 30, 2004)
Treats: Nerve pain, including from fibromyalgia, diabetes, or shingles; epilepsy; generalized anxiety disorders
Currently costs: Price varies; 60-capsule supply runs approx. $500.
Generic available?: No.
In 2014, Pfizer won a lawsuit blocking the entry of a generic competitor to Lyrica onto the market until Dec. 2018 at the earliest.
9. Crestor (rosuvastatin): $4.2 billion
Manufacturer: AstraZeneca
Introduced: 2003 (gained FDA approval Aug. 13, 2003)
Treats: High cholesterol (statin)
Currently costs: Price varies; an average of around $170 for 30 tablets.
Generic available?:Yes.
The FDA approved the first generic version of Crestor in Apr, 2016.
10. Neulasta (pegfilgrastim): $4.2 billion
Manufacturer: Amgen
Introduced: 2002 (gained FDA approval Jan. 31, 2002)
Treats: Reduces the chance of infection in patients undergoing chemotherapy
Currently costs: $23,5900 per year [PDF]
Generic available?: No.
Novartis applied to have a biosimilar drug approved, but that application was rejected in 2016.
[Sales figures via Axios.com]
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