The dip in ANDA approvals that we witnessed in 2020 continued further in 2021 with a total of 631 final ANDA approvals granted during the calendar year, declining by further 16 per cent from the previous year. Additionally, 117 tentative approvals were also granted during the calendar year 2021, in the same range as tentative approvals during 2020 (123).
ANDA applicants were mapped to the parent company as recorded in the FDA database and the location/headquarter of the parent company was used for analysing the regional trends. As always, Indian companies dominated the ANDA approvals, with 267 or 42 per cent of total ANDA approvals. This was followed by the US, China, Europe and Israel in that order. Chinese companies (without Taiwan and Hong Kong) garnered 66 approvals during the year, maintaining their strong interest in playing in the forward integrated space of formulations as well. There was one approval also for Bangladesh-based Beximco Pharmaceuticals. With at least a couple more companies from Bangladesh targetting the US market, we can see a small stream of ANDAs continuing from this country in the future. Taiwan is another geography with eight ANDA approvals for products filed by five different companies.
Oral dosage forms get the highest share of approvals as always, followed by injectables and topicals
With 394 approvals, oral dosage forms held about 62 per cent of ANDA approvals granted in 2021, followed by injectables with 146 and topicals with 44 approvals. Within the oral dosage forms, 79 are extended-release/delayed-release formulations and 55 approvals are for liquid formulations. Separately, one buccal film (Buprenorphine) and three sub-lingual formulations also got approval. In injectables, Paliperidone Palmitate approval to Teva, Ferumoxytol approval to Sandoz, Calcitonin (Salmon) approval to Custopharm and Liposomal Amphotericin B to Sun Pharma are some of the notable ones. Within inhalations, most approvals were for inhalation solution vials except Budesonide suspension vials to Sun Pharma and Advair diskus generic to Teva. Ophthalmic category saw some of the more complex product approvals, including Loteprednol gel for Akorn, Brinzolamide suspension for Bausch Health, Difluprednate emulsion for Amneal and Cipla, and Tobradex suspension to Amneal. Another complex dosage form, vaginal ring, saw two approvals for Teva and DRL, both for Nuvaring generic taking the total of generics to this complex product to three.
ANDA approvals in 2021, dosage forms
First-time generics and CGT approvals: Indian companies again hold a significant share.
There were 88 first-time generics approved in 2021 and 52 approvals through the Competitive Generic Therapy (CGT) route. For the first-time generics approvals, 12 approvals were only for Droxidopa and five for Pregabalin extended-release tablets; 32 of the 88 first-time Gxapprovals were garnered by the Indian companies, mostly for oral solid dosage forms (24). Teva, with nine approvals, is the leading company targetting the first-time-generics products, followed by Fresenius with seven approvals. Zydus and Sun Pharma with six approvals each are the top Indian companies with maximum first-time-generics approvals in 2021.
The US-based companies led the table for CGT approvals, getting 22 of the 52 approvals followed closely by the Indian companies with 20 approvals. Novitium Pharma, with its liquids capability, is the leading player for five CGT approvals in 2021, followed by Glenmark and Amneal with four each.
Several ANDAs continue to be discontinued in the approval year itself, increasing significantly by the following year
About nine per cent (55 of 633) ANDAs are already listed as discontinued in the approval year itself, in line with the trends seen in the previous years. Indian companies discontinued relatively fewer proportion of ANDAs. While in overall approvals, Indian companies hold 42 per cent share, for discontinued ANDAs, the share is about 31 per cent (17). Interestingly, 13 first-time-generics approvals are already showing as status “discontinued” within the approval year. One product approved through CGT route is also showing up as discontinued already.
Checking for ANDAs approved in 2020, about 21 per cent are already discontinued by now (154 of 751). The same number for 2019-approved ANDA is showing status as discontinued (152). So, about 10 per cent of ANDAs get discontinued in the same year and about 20 per cent by the next two years.
Seven of the top 15 parent companies are from India
Hetero, with 28 approvals (including its affiliates Annor Pharma and Ascent Pharmaceuticals Inc), topped the overall list of companies getting final ANDA approvals in 2021 followed by Aurobindo (Including Eugia Pharma) with 24 and Teva (including Watson, Actavis and Arrow International) with 23 approvals. Fosun (Gland Pharma) was the leading Chinese parent company with 14 approvals which are expectedly mostly injectables.
‘Among the top 15, Teva had the highest number of first-time generic approvals (nine) followed by Sun Pharma and Zydus with six each.
All the approvals for Hetero were for oral dosage forms, including some for oral liquids. On the other hand, the other Indian companies in the top 15 had a much-varied presence across dosage forms, including complex dosage forms as well.
Harman Finochem (one ANDA – Metformin tablets), AET Pharma (two ANDAs Posaconazole DR Tablets, Leflunomide tablets) and Enaltec Labs (two ANDAs- Chlorpromazine tablets, Fluphenazine tablets) are the Indian companies that got first-time ANDA approvals in 2021.
As generic players become more selective, preferring the more complex and low-competition products, over higher number of filings, a slowing trend in ANDA approval is becoming evident, as we predicted in our analysis of 2019 approvals.
The changing market landscape and increasing costs of filing and maintaining ANDAs appears to be the more important driver of this change than the ongoing pandemic. We anticipate this trend to continue in the near future as well as companies continue to choose their investments carefully.
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