The Final Score: 2018 Drug & Biologic Patent Approvals

Posted on 01/15/2019 by Brittany Knight, in Articles, Biologics/biosimilars, Patent Trends & Activity

The past year was a big year for FDA approved new drugs and biologics – 59 in fact, compared to 46 in 2017 and a mere 22 in 2016. From the published list of approvals on the FDA website Novel Drug Approvals for 2018, we compiled data on the listed patents associated with these drugs. As a whole, the 59 drugs included 42 “conventional”, i.e. small molecule drugs, of which 35 were new chemical entities (NCEs approved via a New Drug Application or NDA), and 17 were biological molecules (approved via a Biological License Application or BLA). For background, “conventional” drugs are small (i.e. generally under 1000 molecular weight), synthetically manufactured chemical entities that are chemically and molecularly well-characterized. Currently, these drugs make up the majority of approved drugs. Information regarding patents and exclusivity for these “conventional” drugs is referenced in the Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the ‘Orange Book[i].

On the other hand, biological molecules or ‘biologics’ are a newer class of drugs that are either produced in living organisms or contain biological materials.  Compared to their small molecule chemical counterparts, biologics are not as easily characterized. Examples of biologics include, vaccines, gene therapies, cellular biologics, and recombinant proteins. More limited information regarding biologic drug products can be located in the ‘Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations’, also known as the ‘Purple Book[ii]. However, since this book was established in 2014, information regarding pertinent patent and exclusivity of biologics remains a challenge to access. Although the Purple book is still relatively new, the FDA should consider including this patent information in the future. In the table below, each of the 59 approved drugs are listed and for each of the 42 conventional drugs we compiled the listed patents.

In summary, a total of 216 patents are listed for the 42 approved conventional drugs.  Nine of these drugs have no listed patents. This turns out to average just over 5 patents per drug. With the most listed patents – a whopping 21 – is Alnylam’s drug Onpattro (active ingredient- patisiran) for the treatment of hereditary transthyretin-mediated amyloidosis or Familial amyloid polyneuropathy (FAP). FAP is a fatal neurodegenerative disease that affects approx. 50,000 people worldwide. Second highest with 18 patents was Vitrakvi (larotrectinib) by Loxo and Bayer to treat TRK fusion-related cancers. TRK fusion proteins are known to promote tumor formation in a variety of cancers that affect adults and children. And in third place, with 17 associated patents, is Vertex’s Symdeko (tezacaftor; ivacaftor) for the treatment of Cystic fibrosis.

In addition, 2018 was also noteworthy for the approval of GW Pharma’s Epidiolex (cannabidiol), a cannabis-related drug (with 8 patents listed). This was an exciting and perhaps controversial approval considering the stigmas, public policy considerations, and current laws regarding marijuana in the United States. Late last year, Surgeon General Jerome Adams asked the U.S. government to reconsider the classification of marijuana. Currently, as it stands marijuana is a schedule I drug with no currently acceptable medical use with high likelihood for abuse. However, the potential health and economic benefits associated with cannabis have yet to wait upon these impending changes to national policy.  Additionally, it will be interesting to follow future R&D and intellectual property trends as more approvals are likely to follow in the cannabinoid area in the future. Never the less it was interesting to see the relatively large number of patents listed for Epidiolex.

Summary Table of 2018 Drug Approvals
Note: Drugs are delineated by their approval via New Drug Application (NDA) or Biologics License Application (BLA)

Proprietary Name Active Ingredient App. Type Exclusivity Code Company Indication No. of Patents[i]
1 Lutathera Lutetium Lu 177 dotatate NDA NCE Advanced Accelerator Applications Gastroenteropancreatic neuroendocrine tumors  0
2 Biktarvy  bictegravir, embitcitabine, tenofovir alafenamide NDA NCE Gilead HIV 9
3 Symdeko tezacaftor; ivacaftor NDA NCE Vertex Cystic fibrosis 17
4 Erleada apalutamide NDA NCE J&J Prostate cancer 7
5 Trogarzo ibalizumab-uiyk BLA TaiMed Biologics HIV  –
6 Ilumya tildrakizumab BLA Sun Pharma Plaque psoriasis  –
7 Tavalisse fostamatinib NDA NCE RIGEL PHARMACEUTICALS INC Thrombocytopenia 13
8 Crysvita burosumab-twza BLA Ultragenyx and Kyowa Hakko Kirin X-linked hypophosphatemia  –
9 Akynzeo fosnetupitant and palonosetron NDA NCE Helsinn Anti-nausea med for chemo 12
10 Lucemyra lofexidine hydrochloride NDA NCE US WorldMeds opioid withdrawal  0
11 Aimovig erenumab-aooe BLA Amgen; Novartis Migraines  –
12 Lokelma ZS-9 NDA NCE AstraZeneca Hyperkalemia 7
13 Doptelet avatrombopag NDA NCE Dova Pharma Thrombocytopenia 2
14 Palynziq pegvaliase BLA BioMarin Phenylketonuria  –
15 Olumiant baricitinib NDA NCE Eli Lilly; Incyte Rheumatoid arthritis 2
16 Moxidectin moxidectin NDA NCE Medicines Development for Global Health River blindness  0
17 Epidiolex cannabidiol NDA NCE GW Pharma Lennox-Gastaut syndrome, Dravet syndrome 8
18 Zemdri plazomicin NDA NCE Achaogen Complicated urinary tract infections 4
19 Mektovi binimetinib NDA NCE Array Biopharma Melanoma 11
20 Braftovi encorafenib NDA NCE Array Biopharma Melanoma 11
21 Tpoxx tecovirimat NDA NCE Siga Technologies Smallpox 6
22 Tibsovo ivosidenib NDA NCE Agios Acute myeloid leukemia 3
23 Krintafel tafenoquine NDA GlaxoSmithKline Plasmodium vivax malaria  0
24 Orilissa elagolix NDA NCE AbbVie Endometriosis 6
25 Omegaven fish oil triglycerides NDA NCE Fresenius Kabi Parenteral nutrition-associated cholestasis 2
26 Mulpleta lusutrombopag NDA NCE Shionogi Thrombocytopenia 4
27 Poteligeo mogamulizumab BLA Kyowa Hakko Kirin Non-Hodgkin lymphoma  –
28 Onpattro patisiran ME NCE Alnylam Hereditary transthyretin-mediated amyloidosis 21
29 Annovera segesterone acetate and ethinyl estradiol vaginal system NDA NCE TherapeuticsMD Birth control
30 Galafold migalastat NDA NCE Amicus Therapeutics Fabry disease 7
31 Diacomit stiripentol NDA NCE Biocodex Dravet syndrome  0
32 Oxervate cenegermin BLA Dompé Neurotrophic keratitis  –
33 Takhzyro lanadelumab BLA Shire Hereditary angioedema  –
34 Xerava eravacycline NDA NCE Tetraphase Complicated intra-abdominal infections  0
35 Pifeltro doravirine NDA NCE Merck HIV 1
36 Lumoxiti moxetumomab pasudotox-tdfk BLA AstraZeneca Hairy cell leukemia  –
37 Ajovy fremanezumab BLA Teva Migraine  –
38 Copiktra duvelisib NDA NCE Verastem Lymphoma 4
39 Emgality galcanezumab BLA Lilly Migraine  –
40 Vizimpro dacomitinib NDA NCE Pfizer Lung cancer 2
41 Libtayo cemiplimab BLA Sanofi; Regeneron Squamous cell carcinoma  –
42 Seysara sarecycline NDA NCE Paratek Pharma Acne 4
43 Nuzyra omadacycline NDA NCE Paratek Pharma CABP and ABSSSI 3
44 Revcovi elapegademase BLA Leadiant Biosciences ADA-SCID/Bubble boy disease
45 Tegsedi inotersen NDA NCE Ionis; Akcea TTR amyloidosis 6
46 Talzenna talazoparib NDA Pfizer Breast Cancer 4
47 Xofluza baloxavir marboxil NDA Roche Influenza 3
48 Lorbrena Lorlatinib NDA NCE Pfizer metastatic non-small cell lung cancer 1
49 Yupelri revefenacin NDA NCE Theravance, Mylan COPD 10
50 Aemcolo rifamycin NDA Cosmo Pharmaceuticals Travelers’ diarrhea 4
51 Gamifant emapalumab-lzsg BLA Sobi, Novimmune Primary hemophagocytic lymphohistiocytosis  –
52 Daurismo glasdegib NDA NCE Pfizer Frontline acute myeloid leukemia 2
53 Vitrakvi larotrectinib NDA Loxo, Bayer Site agnostic, TRK fusion cancers 18
54 Firdapse amifampridine NDA NCE Catalyst Pharmaceuticals Lambert-Eaton myasthenic syndrome  0
55 Xospata gilteritinib NDA Astellas Acute myeloid leukemia with a FLT3 mutation 2
56 Motegrity prucalopride NDA Shire (Takeda) Chronic idiopathic constipation  0
57 Asparlas calaspargase pegol-mknl BLA Servier Acute lymphoblastic leukemia  –
58 Elzonris tagraxofusp-erzs BLA Stemline Therapeutics Blastic plasmacytoid dendritic cell neoplasm  –
59 Ultomiris Ravulizumab BLA Alexion Paroxysmal nocturnal hemoglobinuria  –

Brittany Knight  & Dr. Anthony Sabatelli

Brittany Knight is a Ph.D. Candidate in the Biomedical Sciences Ph.D. Program in the Neuroscience Department at the University of Connecticut. Her thesis research focuses on understanding how proteins involved in wound healing can also prevent the onset of pain following inflammation. In addition to conducting research and mentoring students, Brittany has maintained several leadership positions in the Graduate school. Prior to attending UCONN, Brittany obtained her B.S. in Psychology and a minor in Biology with Global Honors with Distinction from Lock Haven University of Pennsylvania.

[i] The first print copy of Approved Drug Products with Therapeutic Equivalence Evaluations was published around Halloween in 1980 thus, inspiring the orange cover and the nickname.

[ii]Since “Orange” became a single-color nickname for Approved Drug Products with Therapeutic Equivalence Evaluations, the FDA named the book of licensure for biological molecules as the Purple Book.  Ironically, this is not a book of conventional sorts and it does not have a Purple cover.

[iii] Patent information for drugs approved via a Biologics License Application (BLA) is not included in the table.


This article is for informational purposes, is not intended to constitute legal advice, and may be considered advertising under applicable state laws. The opinions expressed in this article are those of the author only and are not necessarily shared by Dilworth IP, its other attorneys, agents, or staff, or its clients.