By some accounts, 2020 represents something of a lull in terms of drugs expected to lose patent protection.
A 2017 report by Evaluate Pharma estimated that this year, $17 billion in worldwide sales are at risk due to patent expirations. By contrast, last year, $41 billion in sales were at risk, and companies were anticipated to lose $19 billion.
Nevertheless, the year will see its fair share of U.S. patents on drugs and biologics expiring, and some of those drugs will see generic or biosimilar versions launched this year and next.
The list of 12 pharmaceutical drugs going off patent in 2020 came from National Pharmaceutical Services. These were cross-referenced with the Food and Drug Administration’s Orange Book, which lists approved pharmaceutical drugs’ patents, patent expiration dates and in many cases summarizes what those patents cover. The agency’s Drugs@FDA site was then searched for information such as when the drugs were approved and whether any generic versions had received approval. If they hadn’t, OptumRx’s latest quarterly RxOutlook report was examined to find whether a possible near-term generic launch was anticipated. Company earnings reports were used to find the latest annual sales figures.
But there are a few caveats to bear in mind. For one, the expiration of a patent this year does not mean there are not additional patents that may be protecting a branded drug, let alone that a generic will become available in 2020. Another confusing factor is that under the provisions of the Hatch-Waxman Act, the 1984 law that created an abbreviated approval pathway for generics, it’s common for generic companies to launch ahead of patent expiration under deals with brand-name drugs’ manufacturers. Sales figures for some drugs were also unavailable because they are made by private companies or are not included in financial filings because they don’t generate enough revenue.
For biologics, finding patent data is much less straightforward than with pharmaceutical drugs. The NPS’ list doesn’t list any biologics facing patent expiration in 2020, but a 2019 article in the Generics and Biosimilars Initiative Journal lists six. However, because the FDA Orange Book does not include information for biologics, it is much more difficult to cross-reference its entries, some of which appear to be inaccurate – notably the entry for Novartis’ autoimmune disease drug Cosentyx. In addition, the list states that they are losing patent protection or exclusivity, but does not specify which is the case for each individual drug. The entries in GaBI’s list were checked against multiple sources like company reports and DrugPatentWatch.com, although the latter requires a subscription.
Only one of the biologics listed, Roche and Royalty Pharma’s Mircera, is anticipated to face biosimilar competition, according to OptumRx’s report, and not until late next year. However, other information, like sales numbers, was readily available.
Pharmaceuticals
(Source: NPS)
Atrovent HFA (ipratropium hfa)
Company: Boehringer Ingelheim
Approved: 2004
Indication(s): chronic obstructive pulmonary disease
Sales: N/A
Generic(s) approved? No
Patent expiration date in 2020: May 26
Bydureon (exenatide)
Company: AstraZeneca
Approved: 2012
Indication(s): Type 2 diabetes
Sales: $584 million (2018)
Generic(s) approved? No
Patent expiration dates in 2020: Jan. 14; May 25; Oct. 4 (treatment of Type 2 diabetes, treatment in combination with exenatide)
Note: OptumRx’s report does not include Bydureon, but does state a generic version of Byetta – a formulation of exenatide with more frequent dosing – may be launched this year.
Chantix (varenicline)
Company: Pfizer
Approved: 2006
Indication(s): smoking cessation
Sales: $282 million (2019)
Generic(s) approved? No
Patent expiration dates in 2020: May 10 (aid to smoking cessation); Nov. 10
Possible generic launch date: December 2021
Dexilant (dexlansoprazole)
Company: Takeda
Approved: 2009
Indication(s): gastroesophageal reflux disease
Sales: $688 million (FY2017)
Generic(s) approved? Yes (1)
Patent expiration dates in 2020: June 15 (healing of esophagitis, treatment of GERD); Dec. 15 (pediatric use)
Possible generic launch date: June 2020
Inlyta (axitinib)
Company: Pfizer
Approved: 2012
Indication(s): kidney cancer
Sales: $161 million (2019)
Generic(s) approved? No
Patent expiration date in 2020: June 30 (treatment of renal cell carcinoma)
Namenda (memantine)
Company: Allergan
Approved: 2003
Indication(s): Alzheimer’s-type dementia
Sales: $71 million (2018)
Generic(s) approved? Yes (19)
U.S. patent expiration date: N/A
An oral solution is also available, but without generic equivalents
Safyral (drospirenone, ethinyl estradiol, levomefolate)
Company: Bayer
Approved: 2010
Indication(s): Birth control
Sales: N/A
Generic(s) approved? Yes (2)
Patent expiration date in 2020: April 17, 2020
Note: Patent covering prevention of pregnancy expires March 3, 2022.
Saphris (asenapine)
Company: Allergan
Approved: 2009
Indication(s): schizophrenia, bipolar disorder
Sales: $139.7 million (2018)
Generic(s) approved? No
Patent expiration dates in 2020: June 9 (treatment of schizophrenia and bipolar disorder); Dec. 9 (pediatric use)
Possible generic launch date: 1H 2020
Silenor (doxepin)
Company: Currax
Approved: 2010
Indication(s): insomnia
Sales: N/A
Generic(s) approved? Yes (1)
Patent expiration date in 2020: Feb. 17 (treatment of insomnia)
Possible generic launch date: January 2020
Note: Additional patents covering treatment of insomnia expire throughout the decade and into 2030.
Sprycel (dasatinib)
Company: Bristol-Myers Squibb
Approved: 2006
Indication(s): Philadelphia chromosome-positive chronic myeloid leukemia and acute lymphoblastic leukemia
Sales: $2 billion (2018)
Generic(s) approved? No
Patent expiration dates in 2020: April 13 (treatment of CML); June 28 (treatment of protein tyrosine kinase-associated disorder and cancer); Oct. 13 (pediatric use); Dec. 28 (pediatric use)
Tykerb (lapatinib)
Company: Novartis
Approved: 2007
Indication(s): HER2-positive metastatic breast cancer
Sales: N/A
Generic(s) approved? No
Patent expiration date in 2020: Sept. 29 (treatment of HER2-positive metastatic breast cancer)
Possible generic launch date: September 2020
Vigamox (moxifloxacin)
Company: Novartis
Approved: 2003
Indication(s): bacterial conjunctivitis
Sales: N/A
Generic(s) approved? Yes (6)
Patent expiration date in 2020: March 29 (pediatric use)
Biologics
(Source: GaBI Journal)
Simulect (basiliximab)
Company: Novartis
Approved: 1998
Indication(s): organ transplant
Sales: N/A
Biosimilar approved? No
Estimated patent/exclusivity expiration date: 2020 (Source: Novartis)
Cosentyx (secukinumab)
Company: Novartis
Approved: 2015
Indication(s): plaque psoriasis, psoriatic arthritis, ankylosing spondylitis
Sales: $3.6 billion (2019)
Biosimilar approved? No
Estimated patent/exclusivity expiration: 2028 (Source: Novartis)
Note: Given that Cosentyx was approved only five years ago, and no information could be found corroborating its inclusion among biologics losing patent protection in 2020, it may have been included in the GaBI Journal list in error.
Lucentis (ranibizumab)
Companies: Roche, Novartis
Approved: 2006
Indication(s): age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, myopic choroidal neovascularization
Sales: $4 billion (2019)
Biosimilar approved? No
Estimated patent/exclusivity expiration: Unclear for U.S. (Japan, E.U. patents to expire 2020-2022) (Source: Novartis)
Vectibix (panitumumab)
Company: Amgen
Approved: 2006
Indication(s): wild-type RAS metastatic colorectal cancer
Sales: $744 million (2019)
Biosimilar approved? No
Estimated patent/exclusivity expiration date: April 8, 2020 (Source: Amgen)
Kineret (anakinra)
Company: Sobi
Approved: 2001
Indication(s): rheumatoid arthritis, cryopyrin-associated periodic syndromes
Sales: $118.6 million (2017)
Biosimilar approved? No
Estimated patent/exclusivity expiration date: July 29, 2020 (Source: DrugPatentWatch.com)
Mircera (methoxy polyethylete glycol, epoetin alfa)
Company: Roche, Royalty Pharma
Approved: 2007
Indication(s): anemia associated with chronic kidney disease
Sales: $610 million (2019)
Biosimilar approved? No
Estimated patent/exclusivity expiration date: Unclear
Possible biosimilar launch date: November 2021
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