Generics lineup: Highlighting top companies in generics

Alembic
In 2020, Bridgewater, N.J.-based Alembic launched a number of products, including desonide lotion, tizanidine HCl, adapalene gel, clobetasol cream, clobetasol shampoo, bimatoprost topical, timolol maleate gel, azithromycin and doxycycline hyclate. 

“Alembic continues to make significant investments into its pipeline and capabilities,” said Eric Purcell, vice president of sales and marketing. In 2019, Alembic invested over 14% of global group sales into research and development, with most of that investment targeting the U.S. market.  

In addition to product development, Alembic has invested significantly into dedicated facilities for solid oral dose, dermatology products, ophthalmics, injectables and oncology injectables, as well as three facilities that produce active ingredients for the U.S. market. 

“Alembic is laser focused on building on its reputation as a strong supplier to its customers with high levels of service. This is built on a foundation of vertical integration, strong and flexible manufacturing capabilities, as well as adequate inventory levels and strong planning in the United States,” Purcell said. “We’ve also worked with customers to provide assistance to patients that may have trouble affording their medications.”

Generics will continue to be a critical component to health care in the United States, he said.   

“Generic products help to control costs for payers and patients, and spur investment by innovators into new therapies that ultimately benefit patients,” Purcell said. “Generics manufacturers must hold themselves to ever higher quality standards to garner the trust of regulators, doctors and patients that is critical to success.”

Amneal
Since July, Amneal Pharmaceuticals has launched more than seven generic drugs, including fluphenazine tablets, metyrosine capsules, atazanavir sulfate capsules, naproxen oral suspension, methotrexate tablets, pilocarpine ophthalmic solution and dimethyl fumarate delayed-release capsules.

Bridgewater, N.J.-based Amneal also received Food and Drug Administration approval for olopatadine nasal spray and lidocaine patch.

“Amneal is bolstering all levels of the supply chain, while working with customers on demand forecasts to ensure we have sufficient quantities of critical products to meet needs of patients as the pandemic continues,” said Andy Boyer, executive vice president and chief commercial officer of generics. “Generics continue to be part of the solution when it comes to affordable, accessible health care. These products increase patient access to therapies otherwise priced beyond most people’s reach. Nobody can ever know what the future holds, but the safe bet is that generics will only play a greater role as time rolls on.”

Ascend Labs
Ascend Laboratories recently obtained FDA approvals for several generics, including dimethyl fumarate,  tolvaptan, azathioprine and colchicine.

“We are continuing our inventory infrastructure by building on-hand inventory to higher levels and enhancing our product dating through an ongoing continuing stability studies to lengthen expiration dates,” said John Dillaway, executive vice president at Parsippany, N.J.-based Ascend Labs.

Dillaway also said, “Generics will continue to be a high demand alternative to expensive branded products as their safety, efficacy and money-saving positions will continue to attract conversions from off-patent products.”

Aurobindo
Aurobindo Pharma has increased its generics portfolio with the following approvals in recent months: methotrexate tablets; flucytosine capsules; azelastine hydrochloride, Aurobindo’s first nasal spray; and imatinib mesylate tablets.   

Paul McMahon, senior vice president of commercial operations, said that amid the COVID-19 pandemic, the organization worked harder with their global teams to take all measures to keep product flowing as seamlessly as possible in terms of production and logistics, so that East Windsor, N.J.-based Aurobindo’s customers could continue to rely on the firm’s outstanding production and delivery services even during what has been a very challenging time. 

“As the world is beginning to open up, Aurobindo strives to come out of this even stronger than before, and having garnered a stronger relationship with customers for how the company was able to step up, deliver and keep their service levels high throughout the pandemic,” McMahon said.

In the coming months, Aurobindo plans to launch many new products as it continues to expand its portfolio, which currently includes more than 516 abbreviated new drug applications approved by the FDA, McMahon said.

Its portfolio growth has been accompanied by ongoing investments in its infrastructure, particularly in plant and capacity expansions, as well as the creation of new facilities to fuel growth in the years ahead. McMahon also said that Aurobindo remains focused on strengthening the company’s existing businesses and developing a differentiated and specialty-driven product portfolio.

“Aurobindo continues to perform well across the organization’s key geographies, while providing excellent customer service,” he said. “The size, scope and commitment to driving value establishes Aurobindo Pharma as the partner of choice for some of the largest retail and wholesale customer organizations worldwide, all of which has contributed to Aurobindo continually being ranked as one of the fastest-growing generic manufacturers year after year. The future is bright in generics and we will continue to set ourselves apart and perform well, which is key to the company’s success.”

Camber Pharmaceuticals
Camber has made several product launches, including dimethyl fumarate DR capsules, as well as the 30-day Starter Kit that contains a 120 mg 14-count and 240 mg 46-count bottle, silodosin capsules and venlafaxine hydrochloride ER capsules. 

Upcoming launches include antifungal itraconazole oral solution; zafirlukast tablets; rospirenone and ethinyl estradiol; and daptomycin lyophilized injection. 

“At Camber, we pride ourselves in learning about the needs of our customers to anticipate and mitigate potential supply issues. Our ongoing commitment to build ‘safety stock’ is only one example of how our proactive approach helps us all succeed,” the company said in a statement. “We are diversifying our portfolio to include more complex generics and have a commitment to a robust injectables product line. Due to our strong vertical integration, Camber is adept at managing global supply chain events. Adaptability helps us overcome even the most challenging obstacles. From sales and marketing to customer service and finance, Camber strives for flexible and transparent communication to quickly solve even the most complex problems.”

Dr. Reddy’s Labs
Dr. Reddy’s currently is waiting for FDA approval or feedback on more than 100 abbreviated new drug applications. By the end of the fiscal year next March, Dr. Reddy’s said it expects to launch more than 30 new products in multiple disease categories. Many of these products will be complex or difficult to make, and they will fall in the limited competition space. Additionally, Princeton, N.J.-based Dr. Reddy’s is growing significantly in the oncology space, with the introduction of several complex injectable products. The company continues to leverage its relationships with oncology treatment centers and hospitals. In October, Dr. Reddy’s launched sapropterin dihydrochloride tablets for oral use and cinacalcet tablets.

“We have a very close relationship with our trade partners, and we are excited about the prospect of bringing new products to our customers and strengthening our relationship with them,” said Marc Kikuchi, CEO of Dr. Reddy’s North America generics.

Part of Dr. Reddy’s strategy has it focusing on building a reliable and flexible supply chain for its products. 

“We remain committed to supporting our customer through demand surges and helping them be successful, and serve patients with an uninterrupted supply of medicines,” Kikuchi said. “We are well-positioned for sustained profitable growth given our strong base business and proven capability in complex generics with strategic investments in R&D for proprietary products and biologics. Our core business performance remains strong. Our growth levers are proven, vigorously executed and continue to deliver. We will continue to make strategic investments for long-term, sustainable growth. At the same time, we will continue to explore selective business integration and opportunities to augment growth.”

Upsher-Smith Labs
Upsher-Smith  Labs kicked off 2020 with three generic product launches and kept the momentum going throughout the year. In August, the Maple Grove, Minn.-based company also announced that it entered into an exclusive agreement with a pharmaceutical partner to develop and market corticotropin injection in the United States.

The company recently launched fluvoxamine maleate tablets, haloperidol tablets, clonidine hydrochloride extended-release tablets, propafenone hydrochloride extended-release capsules and ethacrynic acid tablets.

“Upsher-Smith’s commitment to go above and beyond normal expectations for our customers is at the core of everything we do,” said Mike McBride, vice president of partner relations. “The company’s history of quality product supply and enduring customer relationships are playing key roles in navigating the COVID-19 pandemic. We remain focused on the health and safety of our employees and building inventory on key products to ensure that we continue to deliver a consistent, reliable supply to customers and patients.”

McBride said he believes that the U.S. generics market remains challenging with continued competitive pressures. “This market experienced dramatic price deflation between 2017 and 2019, driven by a significant increase in the number of generic competitors, an increase in FDA approvals of new generic drugs and further purchasing consolidation,” he said.

Finally, McBride said that Upsher-Smith is committed to continuing investment in its organic pipeline as a foundation for future growth. “We are focused on adding more new product development programs and more complex programs — both generic and niche brands — to our portfolio. While this adds some complexity, it also adds the opportunity to drive stronger and diverse growth,” he said. “Upsher-Smith remains committed to investing in our ability to efficiently produce generic products in our U.S. facility and to be among our customers’ top suppliers for the products we supply. Our team’s commitment throughout the organization to consistent product supply has earned our place in this challenging market, and this also will allow us to compete well in the future.”