Top 10 drugs that lost U.S. patents in 2021

Top 10 drugs that lost U.S. patents in 2021. When drugmakers are responding to the COVID-19 pandemic by developing vaccines, drugs, and biologics, many drugmakers are losing patent protection for once profitable drugs.

Every year, many of the leading products of the pharmaceutical industry take the lead in the market, which provides many opportunities for generic drug manufacturers so that they can seize market share with cheaper generic drugs.

The expected loss of products that are about to expire in the United States this year includes Roche’s macular degeneration drug Lucentis, AbbVie’s two drugs, and Pfizer’s anticancer drug.

Roche, Pfizer, AbbVie and other drugs will lose their exclusive agency rights in the US market this year.

Not all products are guaranteed to face generic competition in 2021. Due to the development of regulations, the supervision of generic drug companies or other unforeseen events, some products may avoid these patent protections, while some are already facing competitors. But this list is based on the ranking of U.S. sales in 2020 to determine those top drugs that may face new generics or biosimilars this year.

1. Lucentis

• U.S. sales in 2020: $1.61 billion
• Diseases: age-related wet macular degeneration, macular edema after retinal vein occlusion, diabetic macular edema and diabetic retinopathy
• Expected time to market for imitation products: the second half of 2021

Roche’s Lucentis faces competition from Novartis’ biosimilars.

When Novartis launched Beovu in October 2019, Roche’s age-related wet macular degeneration (AMD) wet medicine Lucentis faced new competition. But this year, such drugs may face a whole new challenge: biosimilars.

In November last year, Samsung Bioepis stated that the FDA agreed to review the biosimilar license application for SB11, which is a biosimilar product that references Lucentis. Samsung Bioepis executive Hee Kyung Kim said at the time that this acceptance “brings us closer to the goal of providing affordable treatment options for patients with retinal vascular diseases.”

A Samsung Bioepis spokesperson said the drug will be reviewed within 12 months.

The company stated in a recent investor presentation that Biogen owns 49.9% of Samsung Bioepis and will commercialize biosimilars in the United States and other major markets. Although this is unlikely to happen this year, Biogen will also sell biosimilars to Regeneron’s Eylea.

In its annual report, Roche stated that “the expiration date of a patent for Lucentis in the United States is approaching, which may affect the sales of the product in 2021.” Due to COVID-19, patients delayed or cancelled treatment. The drug last year 1.44 billion Swiss francs (1.61 billion U.S. dollars) were generated in the United States, a decrease of 16% from 2019.

Other experts have also seen biosimilars that may be launched in 2021. OptumRx said that the introduction of generic drugs in the second half of the year is reasonable, and Piper Sandler analyst Christopher Raymond predicted in a report last October that Lucentis biosimilars may be launched in 2021.

2. Bystolic

• Sales in the U.S. in 2020: Undisclosed ($600 million in sales in 2019)
• Disease: Hypertension
• The imitation product is expected to go on the market: September 17

AbbVie acquired Bystolic through the Allergan merger.

When AbbVie signed a major Allergan acquisition plan in 2019, the company tried to consolidate its future after the Humira patent. Although Humira’s loss of exclusivity is putting pressure on the drugmaker, the Allergan drug selected by the company in this acquisition will face generic drugs this fall.

Bystolic, approved for the treatment of hypertension, lost the protection of its last patent on December 17. According to the settlement agreement reached with many generic drug manufacturers in 2013, generic products will be able to be launched three months before the expiration of the patent (September 17). One of the original developers of Bytstolic reached a patent agreement before reaching a series of mergers and acquisitions to bring the drug to AbbVie.

According to the Bystolic patent settlement agreement, Actavis, Alkem, Amerigen, Glenmark, Hetero, Indchemie, and Torrent will be licensed to sell their generic drugs, provided their imitators can win FDA approval. According to agency records, Hetero Labs has received preliminary approval from the FDA for its generic drugs.

For drug giant AbbVie, losing part of Bystolic’s annual US sales to generic drugs is not a big problem. In fact, the company’s annual report submitted to the SEC in 2020 did not exceed Bystolic’s sales. The statement pointed out that “except for Humira-related patents, licenses, and trademarks, there is no single patent, license, or trademark.” The company’s business is of great significance. Overall. “The drug generated US$600 million in revenue for Allergan in the United States in 2019.

3. Vascepa

• 2020 sales in the U.S.: $598 million
• Diseases: hypertriglyceridemia and cardiovascular disease
• Expected time to market for imitation products: November 2020

Vascepa lost its U.S. exclusive rights in November 2020.

Amarin’s cardiac drug Vascepa has made it one of the hottest players in the biopharmaceutical industry. Then, when the drug was used in combination with statins, impressive data was released in 2018, showing that patients with abnormally high triglyceride levels have a significantly reduced cardiovascular risk.

Amarin executives believe that if the FDA adds data to the label, the company can greatly increase sales, and in 2019, the agency did just that. But the patent loss in court in 2020 poses a challenge for the drug maker in 2021.

Amarin’s Vascepa’s U.S. sales in 2020 was 598 million U.S. dollars, an increase of 40% over the previous year. Following the court’s decision in March 2020 that the Amarin patent was lost and the appeal failed in September, Hikma launched its generic drug in November. This launch will threaten Amarin’s Vascepa growth plan, which received the original FDA approval in 2012.

After the listing of generic drugs, Cantor Fitzgerald analyst Louise Chen told customers in a report in February that her team heard: “Some retail pharmacy chains have slowed down purchases of the brand Vascepa because generic drugs are already on the market.”

4. Northera

• 2020 sales in the U.S.: $416 million
• Disease: Neurogenic postural hypotension
• Expected time to market for imitation products: February 2021

As Northera lost its patent protection, Lundbeck is busy marketing its migraine prevention drug Vyepti.

While driving sales growth of the new migraine prevention drug Vyepti, Lundbeck is facing its
Northera raises concerns about the fate of neurogenic orthostatic hypotension drugs. Lundbeck stated in its annual report that the drug was approved in 2014 and is expected to lose its exclusive rights in February 2021.

Northera is approved for the treatment of dizziness, dizziness, or “feeling that you are about to pass out” in adult patients with symptomatic neurogenic orthostatic hypotension. Lundbeck said that despite the COVID-19 pandemic, by 2020, the drug “still achieved solid sales growth.”

But this growth is coming to an end. Lundbeck predicts that with the introduction of multiple generic drugs in 2021, sales will fall by 50%.

Last year, Northera received $416 million in revenue in North America, an increase of 10% over the previous year. This is 14% of the company’s total revenue, which makes generic drugs a huge threat to the company’s performance in 2021.

5. Narcan

• 2020 sales in the U.S.: $311 million
• Disease: Opioid overdose
• Expected time to market for imitation products: the second half of 2021

Emergent Biosolutios has become an active manufacturing partner for COVID-19 vaccine and drug manufacturers.

It is often impossible to accurately predict when generics of top-brand drugs will enter the market. But signs indicate that Emergent Biosolutions’ opioid generic drug Narcan may appear in 2021.

The generic drug giant Teva was nominated by the FDA for its Narcan generic drug as early as 2019, but the patent protection of this drug has prevented the generic drug from being put on the market since then. In June last year, Teva won the court, when a New Jersey federal judge ruled that the claims against multiple Narcan patents were invalid.

In order to protect Narcan’s US$311 million in sales in the United States, Emergent and its partner Opiant Pharmaceuticals filed an appeal, and the Federal Circuit Court of Appeals is likely to rule on the issue in the second half of 2021. Wells Fargo analyst Jacob Hughes and Emergent CEO Bob Kramer wrote a letter stating that it is “very unlikely” that Teva will launch a generic drug while the lawsuit is pending.

Nevertheless, the Wells Fargo team does not want to win the case in an emergency “based on the opinions of two patent experts.”

The executives of emerging companies seem to be realistic about their chances of winning in patent disputes. In a conference call with analysts in mid-February, Kramer stated that Emergent expects that “after the appeal process is complete, a generic product will enter the market.” CFO Rich Lindahl added that nonetheless , The company “still has a strong appeal, and we are doing everything we can to reverse this situation.”

6. Brovana

• U.S. sales forecast for 2020: approximately $275 million
• Disease: Chronic Obstructive Pulmonary Disease
• Expected time to market for imitation products: the second half of 2021

Brovana generics will compete for market share later this year.

Sunovion’s maintenance COPD drug, Brovana, has always stood the test of many competitors, but by 2021, competition will likely be further intensified by generic drugs.

All Brovana patents will expire in 2021, and some generic drug manufacturers have obtained provisional approval from the FDA. According to the FDA, they include Teva, Cipla and Lupin.

GoodRx believes that it is possible to launch generic generic drugs in September 2021, while OptumRx believes that the competition may start in November.

Although there are many competitors in the crowded COPD market, Sunovion’s parent company Sumitomo Dainippon expects Brovana’s revenue in North America to be $275 million in 2020. The company has not announced its full-year results.

7. Sutent

• 2020 US sales: 2.23 million
• Diseases: gastrointestinal stromal tumors, advanced renal cell carcinoma and pancreatic neuroendocrine tumors
• Expected time for imitation products to be on the market: August 2021

Pfizer’s anti-cancer drug Sutent will lose patent protection this summer, and it is not clear whether a generic drug will be available immediately.

When Pfizer won the headlines of the COVID-19 vaccine competition in 2020, investors did not focus on the company’s core research focus (including oncology). But with people’s attention to COVID treatments, it is difficult to ignore a major patent loss that Pfizer has faced this year in cancer.

Sutent was approved in 2006 for the treatment of certain patients with gastrointestinal stromal tumors, advanced renal cell carcinoma (RCC) and certain pancreatic neuroendocrine tumors. According to the agency’s records, although all patents for the drug expire in 2021, it is vulnerable to generic competitors, although no generic products have been approved by the FDA so far.

Glenmark has just launched a generic Sutent drug in India. Mylan submitted its Sutent generic drug to the FDA in 2010, prompting Pfizer to file a lawsuit against patent infringement. After a four-day trial in 2014, the court upheld Sutent’s 2021 patent.

Douglas Lankler, Pfizer’s general counsel, said at the time: “The defense of our intellectual property is critical to our ability to discover and develop innovative new drugs, and this is at the core of what we do.”

Many years after the patent dispute, Mylan and Pfizer joined forces to merge Pfizer’s Upjohn department with Mylan to form a new company, Viatris. The transaction was completed in November last year.

8. Saphris

• 2020 sales in the U.S.: Undisclosed (IQVIA estimates the market size to be 217 million U.S. dollars)
• Disease: Schizophrenia and Bipolar Disorder I
• The imitation product is expected to go on the market: December 11, 2020

AbbVie (AbbVie) acquired Saphris in the Allergan acquisition.

In addition to the high-blooded Bystolic generic drug competition later this year and the upcoming loss of exclusive rights to the $16 billion annual Humira, AbbVie will also see products imitating its antipsychotic Saphris in 2021.

Sabbris is inherited from AbbVie’s acquisition of Allergan and is used to treat schizophrenia and bipolar I disorder in some patients. OptumRX reports that Breckenridge, Alembic and Sigmapharm launched their generic drugs in mid-December. Alembic is “one of the first people to apply for generic drugs”, stating that it and other companies are eligible for 180 days of exclusive rights to share generic drugs.

AbbVie did not announce Saphris’ sales in its financial report, but Alembic cited data from IQVIA to estimate that in the 12 months ending in September 2020, the market was valued at $217 million.

Merck had previously sold it on Saphris, and then sold the ownership of the drug to Forest Laboratories for $240 million in December 2013. Forest eventually entered AbbVie through a series of biopharmaceutical M&A transactions.

9. Amitiza

• 2020 sales in the U.S.: approximately $180 million (estimated)
• Disease: Constipation and Irritable Bowel Syndrome
• The imitation product is expected to be on the market: January 4

With the progress of Mallinckrodt’s bankruptcy proceedings, its IBS drug Amitiza faces generic competition.

The troubled drugmaker Mallinckrodt has been in trouble due to opioid and Acthar lawsuits, but its constipation and irritable bowel syndrome drug Amitiza usually does not make headlines. This year, as the company faced bankruptcy proceedings, the drug succumbed to generic competition.

According to an agreement reached by Sucampo, the former owner of Amitiza, Par Pharmaceutical was allowed to launch its licensed generic drugs in the United States starting in early 2021. Mallinckrodt acquired Sucampo in 2018.

Par announced the launch of its imitation products on January 4. The generic label of Par is similar to that of Amitiza, which is approved for the treatment of chronic idiopathic constipation in adults, irritable bowel syndrome in women with constipation, and constipation caused by opioids.

10. Feraheme

• 2020 sales in the U.S.: (estimated) approximately $150 million
• Disease: Iron deficiency anemia
• Expected time to market for imitation products: July 2021

According to a patent settlement agreement, Novartis’ Sandoz may launch a generic Feraheme drug this summer.

When Covis Group acquired Amag Pharmaceuticals in November last year, it purchased Feraheme, a drug used to treat iron deficiency anemia. But before the merger, Amag and Sandoz reached a deal that may allow the generic drug manufacturer to launch its generic version of Feraheme this summer.

The transaction was reached after Amag reached a settlement with Sandoz in a patent infringement lawsuit in March 2018. The settlement allows Sandoz to obtain the FDA-approved generic Feraheme for its “generic drug” in July 2021. This date has not been publicly disclosed, but Sandoz scored in January the FDA approved its imitation.

The settlement also includes a provision that Sandoz can “initiate a settlement agreement of this nature earlier in certain circumstances.” The generic drug manufacturer agreed to pay Amag royalties until the last patent for the drug expires. According to FDA records, this will happen on June 30, 2023.

If Santos’ approval under the confidential settlement agreement is too late, the transaction will include a clause allowing the company to launch authorized generic drugs provided by Amag in July 2022.

(source:internet, reference only)

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