These 5 Drugs are Losing Patent Protection

Several generic versions of widely used medications may be hitting the market this year, including treatments for chronic obstructive pulmonary disease (COPD), HIV, and smoking cessation.

The FDA has sought to approve record numbers of generics in recent years in an effort to lower drug prices, and with several tentative approvals already in the books, manufacturers may see increased competition in 2020.

Here are 5 drugs that are losing patent protection in 2020:

1. ROFLUMILAST

Manufactured by AstraZeneca under the name Daliresp, roflumilast tablets are a prescription medication indicated for patients with severe COPD to reduce the number of episodes or worsening of COPD exacerbations.¹ The FDA originally approved Daliresp in May 2011, and the drug had a market value of $211 million for the fiscal year ended August 31, 2018.²

Breckenridge Pharmaceutical, Inc, announced the final FDA approval for its roflumilast tablets, 500 mcg, in October 2018, and entered into a confidential settlement agreement with AstraZeneca and Ferrer soon after.² Micro Labs USA has also received tentative FDA approval for a generic version of Daliresp,³ suggesting that competition may be stiff, since the patents expired on January 27, 2020.

2. POSACONAZOLE

As an antifungal medication used to prevent fungal infections in patients with weak immune systems resulting from diseases such as HIV or treatments such as chemotherapy,⁴ a generic version of Merck’s brand name Noxafil could be vital to improving accessibility for these vulnerable patient populations. The FDA approved the oral suspension in 2013,⁴ and Merck had $595 million in sales of the drug in 2016.⁵

Sinotherapeutics received FDA approval for posaconazole delayed-release tablets in August 2019,⁶ followed soon after by the launch of an authorized generic produced by Endo in September.⁷

3. VARENICLINE

Originally approved under the brand name Chantix in 2006 for smoking cessation,⁸ the cash price for the drug increased by 106% between 2013 and 2018.⁹ Although the drug has been reported to have some serious adverse effects, such as amnesia, nightmares, and suicidal thoughts, a study by Pfizer reported that 44% of its subjects successfully quit smoking after 12 weeks of taking the medication.⁹

The patent protection for Chantix expires in May 2020, meaning that a generic version could potentially be available by June 2020.⁸

4. ASENAPINE

Manufactured by Allergan under the brand name Saphris, asenapine is an atypical antipsychotic drug for the treatment of patients with schizophrenia or bipolar I disorder. The FDA approved it in 2009,¹⁰ and the patent expires in June 2020.¹¹

In 2017, INC Research received tentative FDA approval for asenapine sublingual tablets, 5 and 10 mg, but the full approval was not granted because of the ongoing patent protection for Saphris.¹² Given the tentative approval, it is entirely possible that a generic option will be available in 2020.

5. EMTRICITABINE/TENOFOVIR

Although Gilead Sciences has dominated the HIV antiviral market with Truvada, a recent legal decision will allow Teva Pharmaceuticals to begin selling its own triple-combination therapy in the United States a year ahead of schedule in 2020.¹³ Gilead quietly announced the development in a filing with the Securities and Exchange Commission in May 2019.

With the global HIV market estimated to grow to $22.5 billion by 2025,¹⁴ generic versions of the most common HIV antivirals will certainly change the market.

REFERENCES

• AstraZeneca. Daliresp (roflumilast) website. daliresp.com/. Accessed November 13, 2019.
• Breckenridge announces final approval of its ANDA for roflumilast tablets (Daliresp^) [news release]. Boca Raton, FL; October 5, 2018: MarketWatch. marketwatch.com/press-release/breckenridge-announces-final-approval-of-its-anda-for-roflumilast-tablets-daliresp-2018-10-05. Accessed Nov. 13, 2019.
• FDA. ANDA tentative approval. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208180Orig1s000TALtr.pdf. Accessed Nov. 13, 2019.
• FDA approves Merck’s NOXAFIL^ (posaconazole) delayed-release tablets [news release]. Whitehouse Station, NJ; November 26, 2013: Merck Sharp & Dohme Corp. mrknewsroom.com/news-release/research-and-development-news/fda-approves-mercks-noxafil-posaconazole-delayed-release-. Accessed November 13, 2019.
• United States Securities and Exchange Commission. Form 10-K — Merck & Co sec.gov/Archives/edgar/data/310158/000031015817000010/mrk1231201610k.htm. February 28, 2017. Accessed November 13, 2019.
• FDA. Drugs@FDA: FDA-approved drug products. accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212411. Accessed November 13, 2019.
• Endo launches authorized generic version of Noxafil^ (posaconazole) delayed-release tablets in the United States [news release]. Dublin, Ireland; September 3, 2019: BioSpace. biospace.com/article/releases/endo-launches-authorized-generic-version-of-noxafil-posaconazole-delayed-release-tablets-in-the-united-states/. Accessed November 13, 2019.
• FDA. Drugs@FDA: FDA-approved drug products. accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021928. Accessed November 14, 2019.
• Marsh T. Prices for smoking cessation drug Chantix increase by 106% in just five years. GoodRx. June 25, 2018. goodrx.com/blog/prices-for-smoking-cessation-drug-chantix-increase-by-106-in-just-five-years/. Accessed November 14, 2019.
• US Department of Health & Human Services. NDA approval. FDA website. accessdata.fda.gov/drugsatfda_docs/appletter/2009/022117s000ltr.pdf. August 13, 2009. Accessed November 14, 2019.
• Generic Saphris availability. Drugs.com website. drugs.com/availability/generic-saphris.html. Accessed November 14, 2019.
• US Department of Health & Human Services. ANDA tentative approval. FDA website. accessdata.fda.gov/drugsatfda_docs/appletter/2017/206098Orig1s000TAltr.pdf. August 11, 2017. Accessed November 14, 2019.
• United States Securities and Exchange Commission. Gilead Sciences Inc Form 10-Q. investors.gilead.com/static-files/0ff8d741-b9eb-4162-bcb4-f16094d37254. May 7, 2019. Accessed November 14, 2019.
• HIV market will see modest growth to $22.5 billion by 2025 [news release]. April 26, 2017: GlobalData. globaldata.com/hiv-market-will-see-modest-growth-to-22-5-billion-by-2025-says-globaldata/. Accessed November 14, 2019.