Top 10 Drugs Losing U.S. Market Exclusivity in 2019: Key Players and Product Overview
Apr 22, 2019 10:51
CST Updated
10:51
Roche
Oncology Drug Research, Development, and Manufacturing
【Pharmaceutical Station Industry Dynamics] Recently, FiercePharma released a list of 10 drugs set to lose exclusivity in the United States in 2019, comprising 10 products from seven pharmaceutical companies. According to the list, Roche, the oncology powerhouse, is among the most significantly affected. The 10 products include rituximab, pregabalin, trastuzumab, bevacizumab, sofosbuvir/velpatasvir and sofosbuvir/ledipasvir, cinacalcet, fluticasone/salmeterol, cyclosporine, ambrisentan, and buprenorphine/naloxone.
Rituximab Roche
Rituximab Injection is indicated for the treatment of relapsed or refractory follicular center cell lymphoma (B-cell non-Hodgkin’s lymphoma, subtypes B, C, and D according to the International Working Formulation). In the United States and other countries, rituximab is used off-label for multiple sclerosis (MS) and shares similarities with ocrelizumab. Both drugs target CD20-positive B cells rather than T cells. Previously, the FDA approved ocrelizumab for the treatment of relapsing and primary progressive MS.
Pregabalin Pfizer
Pregabalin is a medication jointly approved in the United States and Europe for the treatment of two types of neuropathic pain, and was named one of the "Top 10 Medical Breakthroughs of 2007" by TIME magazine. Since its market launch, pregabalin has gained widespread recognition from physicians and the market due to its significant efficacy. With continuous approvals of new indications, global sales have maintained an overall growth trend, and the drug is currently marketed in dozens of countries and regions.
Trastuzumab - Roche
Trastuzumab is a HER2-targeted therapy approved for marketing in 2013. It is an antibody-drug conjugate (ADC) approved as a single agent for the treatment of patients with HER2-positive metastatic breast cancer who have previously received trastuzumab and taxane chemotherapy (either separately or in combination). The drug consists of trastuzumab (the active pharmaceutical ingredient of Herceptin) linked to ImmunoGen’s cytotoxic agent DM1 via a stable linker, forming a conjugate that delivers DM1 to HER2-positive breast cancer cells.
Bevacizumab (Roche)
Bevacizumab, based on the ECOG 4599 study, achieved a median overall survival exceeding 12 months in the treatment of non-small cell lung cancer (NSCLC) when combined with paclitaxel and carboplatin, marking a significant advancement in NSCLC therapy. Subsequent studies, including the AVAIL trial (gemcitabine plus platinum combined with bevacizumab) and the AVAPERL trial (pemetrexed plus platinum combined with bevacizumab), also demonstrated favorable efficacy. Bevacizumab has been used for the treatment of NSCLC abroad for many years.
Sofosbuvir/Velpatasvir and Sofosbuvir/Ledipasvir - Gilead
Sofosbuvir and Velpatasvir Tablets, also known as the third-generation new antiviral drug for hepatitis C developed by Gilead Sciences, or "Gilead's Third Generation," is an original research drug. According to Gilead China, the cost is 69,600 yuan for three bottles (a 12-week course). Salvage therapy requires two courses, and this price is less than one-tenth of the local price in the United States.
Dr. Norbert Bischofberger, Chief Scientific Officer of Gilead Sciences, stated that ledipasvir/sofosbuvir has achieved high cure rates in both global clinical studies and real-world use, with the added benefits of convenient once-daily dosing and good tolerability.
Cinacalcet Amgen
Cinacalcet is the first drug in a new class of compounds known as calcimimetics, which activate calcium-sensing receptors in the parathyroid glands, thereby reducing the secretion of parathyroid hormone (PTH). Experts have stated that the emergence of cinacalcet (a calcimimetic agent acting on calcium-sensing receptors) has brought substantial progress to the management of chronic kidney disease–mineral and bone disorder (CKD-MBD).
Fluticasone/Salmeterol GSK
In fact, GSK lost patent protection for this drug as early as 2010; however, due to the absence of generic competition, the product still generated £5.27 billion in sales revenue for GSK in 2013, with sales reaching £2.4 billion in 2018. The delayed market entry of generics, despite the expiration of patent protection years earlier, was partly attributable to the difficulty in replicating the Diskus inhaler technology and the fact that intellectual property rights for the device itself remained in force until 2016.
Cyclosporine Allergan
In 2017, Allergan transferred the patent for Restasis to the Saint Regis Mohawk Tribe, a Native American tribe in the United States, and then had the patent re-licensed back to Allergan through the tribe. This “sham transaction” drew widespread criticism, with market observers quickly noting that it cast a negative light on the industry at a time when drug pricing was making headlines.
Ambrisentan Gilead
Ambrisentan has long been one of Gilead’s key revenue drivers, generating $943 million in U.S. sales last year. Despite Gilead’s preparations for competition, the outlook remains unfavorable. To mitigate future competitive pressures, Gilead has been offering substantial rebates to secure prescription volumes.
Buprenorphine/Naloxone Indivior
Suboxone film has already faced the impact of generic competition. In early March, Indivior lost a lawsuit aimed at blocking Suboxone film. While Indivior held an injunction, Indian pharmaceutical company Dr. Reddy’s “ventured” to launch its generic version. The U.S. Court of Appeals for the Federal Circuit overturned this injunction and rejected Indivior’s request for reconsideration in early February.
Rituximab Roche
Rituximab Injection is indicated for the treatment of relapsed or refractory follicular center cell lymphoma (B-cell non-Hodgkin’s lymphoma, subtypes B, C, and D according to the International Working Formulation). In the United States and other countries, rituximab is used off-label for multiple sclerosis (MS) and shares similarities with ocrelizumab. Both drugs target CD20-positive B cells rather than T cells. Previously, the FDA approved ocrelizumab for the treatment of relapsing and primary progressive MS.
Pregabalin Pfizer
Pregabalin is a medication jointly approved in the United States and Europe for the treatment of two types of neuropathic pain, and was named one of the "Top 10 Medical Breakthroughs of 2007" by TIME magazine. Since its market launch, pregabalin has gained widespread recognition from physicians and the market due to its significant efficacy. With continuous approvals of new indications, global sales have maintained an overall growth trend, and the drug is currently marketed in dozens of countries and regions.
Trastuzumab - Roche
Trastuzumab is a HER2-targeted therapy approved for marketing in 2013. It is an antibody-drug conjugate (ADC) approved as a single agent for the treatment of patients with HER2-positive metastatic breast cancer who have previously received trastuzumab and taxane chemotherapy (either separately or in combination). The drug consists of trastuzumab (the active pharmaceutical ingredient of Herceptin) linked to ImmunoGen’s cytotoxic agent DM1 via a stable linker, forming a conjugate that delivers DM1 to HER2-positive breast cancer cells.
Bevacizumab (Roche)
Bevacizumab, based on the ECOG 4599 study, achieved a median overall survival exceeding 12 months in the treatment of non-small cell lung cancer (NSCLC) when combined with paclitaxel and carboplatin, marking a significant advancement in NSCLC therapy. Subsequent studies, including the AVAIL trial (gemcitabine plus platinum combined with bevacizumab) and the AVAPERL trial (pemetrexed plus platinum combined with bevacizumab), also demonstrated favorable efficacy. Bevacizumab has been used for the treatment of NSCLC abroad for many years.
Sofosbuvir/Velpatasvir and Sofosbuvir/Ledipasvir - Gilead
Sofosbuvir and Velpatasvir Tablets, also known as the third-generation new antiviral drug for hepatitis C developed by Gilead Sciences, or "Gilead's Third Generation," is an original research drug. According to Gilead China, the cost is 69,600 yuan for three bottles (a 12-week course). Salvage therapy requires two courses, and this price is less than one-tenth of the local price in the United States.
Dr. Norbert Bischofberger, Chief Scientific Officer of Gilead Sciences, stated that ledipasvir/sofosbuvir has achieved high cure rates in both global clinical studies and real-world use, with the added benefits of convenient once-daily dosing and good tolerability.
Cinacalcet Amgen
Cinacalcet is the first drug in a new class of compounds known as calcimimetics, which activate calcium-sensing receptors in the parathyroid glands, thereby reducing the secretion of parathyroid hormone (PTH). Experts have stated that the emergence of cinacalcet (a calcimimetic agent acting on calcium-sensing receptors) has brought substantial progress to the management of chronic kidney disease–mineral and bone disorder (CKD-MBD).
Fluticasone/Salmeterol GSK
In fact, GSK lost patent protection for this drug as early as 2010; however, due to the absence of generic competition, the product still generated £5.27 billion in sales revenue for GSK in 2013, with sales reaching £2.4 billion in 2018. The delayed market entry of generics, despite the expiration of patent protection years earlier, was partly attributable to the difficulty in replicating the Diskus inhaler technology and the fact that intellectual property rights for the device itself remained in force until 2016.
Cyclosporine Allergan
In 2017, Allergan transferred the patent for Restasis to the Saint Regis Mohawk Tribe, a Native American tribe in the United States, and then had the patent re-licensed back to Allergan through the tribe. This “sham transaction” drew widespread criticism, with market observers quickly noting that it cast a negative light on the industry at a time when drug pricing was making headlines.
Ambrisentan Gilead
Ambrisentan has long been one of Gilead’s key revenue drivers, generating $943 million in U.S. sales last year. Despite Gilead’s preparations for competition, the outlook remains unfavorable. To mitigate future competitive pressures, Gilead has been offering substantial rebates to secure prescription volumes.
Buprenorphine/Naloxone Indivior
Suboxone film has already faced the impact of generic competition. In early March, Indivior lost a lawsuit aimed at blocking Suboxone film. While Indivior held an injunction, Indian pharmaceutical company Dr. Reddy’s “ventured” to launch its generic version. The U.S. Court of Appeals for the Federal Circuit overturned this injunction and rejected Indivior’s request for reconsideration in early February.