Generic Hepatitis C Drugs Begin to Emerge

The cost of hepatitis C virus (HCV) antivirals has been at the forefront of health care spending conversations for years. Although it has slowed, spending on the blockbuster drugs remains high. Despite the curative ability of the treatments, it is likely that a significant need for antiviral drugs will remain into the foreseeable future due the prevalence of undiagnosed HCV cases.
A recent Vizient Drug Price Forecast outlined the top drivers of specialty pharmacy spending, one of which being HCV. The cost of HCV drugs is projected to increase 2.02% in 2018, which is slower than the past few years due to increasing competition and lower-cost options.
Natco Pharma recently announced it filed an Abbreviated New Drug Application (ANDA) for sofosbuvir tablets, 400-mg, according to a press release.
Sofosbuvir is currently marketed by Gilead Sciences under the brand name Sovaldi. Sofosbuvir was the first blockbuster HCV drug to receive approval in December 2013, shortly followed by Gilead’s ledipasvir/sofosbuvir (Harvoni) in October 2014.
Natco said it is the first to have filed a complete ANDA and expects to receive 180 days of exclusivity after final approval.
Between December 2016 and December 2017, Gilead said Sovaldi garnered $130 million in sales, which would drop significantly if a generic version received approval.
In August 2017, the FDA approved glecaprevir/pibrentasvir (Mavyret) to treat adults with HCV genotypes 1 through 6. The approval sent shockwaves through the market due to the significantly lower cost of $26,400 for a full course of treatment. Comparatively, Sovaldi was launched at a list price of $84,000.
If approved, the sofosbuvir generic has the potential to threaten big-name manufacturers that have invested heavily into HCV antivirals even more so than the approval of a lower cost brand.

Stay up to date on the latest news in specialty pharmacy by getting Specialty Pharmacy Times in your mailbox or inbox for free!

Click here to sign up for free for the bi-monthly Specialty Pharmacy Times print journal delivered to your address.

Click here to sign up for our email newsletters delivered every Monday, Wednesday, and Friday, in addition to breaking news alerts.

Click here to follow us on Facebook. 

Click here to follow us on Twitter. 

Click here to join our LinkedIn group. 

Related Articles

In addition to a natural variation in genetic makeup, approximately 1 in 1000 people inherit a damaged or mutated copy of the BRCA1 gene from a parent.
Top news of the day from across the health care landscape.
Photobiomodulation therapy found effective for the prevention of oral mucositis caused by radiation therapy.
Company Profile >
Industry Guide >
Market News >
Peer Exchange >
Conferences >
Subscribe >
Specialty Times Resources
About Us
Contact Us
Terms & Conditions
MJH Associates >
Pharmacy Times
American Journal of Managed Care
MD Magazine
Targeted Oncology
Physicians' Education Resource
Pharmacy & Healthcare Communications, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-716-4747

Copyright Specialty Pharmacy Times 2006-2019
Pharmacy & Healthcare Communications, LLC. All Rights Reserved.