Indian pharma companies grab 290 final ANDA approvals from US FDA in 2018

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Indian Pharmaceutical companies and their subsidiaries have established strong presence in US during last couple of years with higher ANDA approvals. The loss of patent exclusivity and cost cutting measures adopted by several nations pushed the demand for generic segment. Indian pharma companies enhanced their investments in research and development (R&D) and successfully received higher approvals from US FDA during last decade. Out of total 5,350 ANDA approvals between 2009 to 2018, Indian companies have secured 34.4% of these approvals and received total 1,842 ANDA final approvals. Further, out of total 1,310 tentative approvals, Indian companies grab 500 tentative approvals from US FDA which worked out to over 38.2%.

During 2018, Indian pharma companies received 290 ANDA approvals from US FDA. The US FDA approved total final 813 ANDAs in 2018, slightly lower than previous year figure of 846. Thus, Indian pharma companies captured 35.7% of total approvals in 2018. Similarly, US FDA approved total 194 tentative products during 2018 as against 174 products in the last year and Indian companies secured 77 tentative approvals in 2018 as compared to 61 in the 2017. The overall performance was under pressure due to US FDA actions against several Indian pharma companies regarding quality and issued warning letters. However, these companies started receiving approvals after successfully resolving warning letter problem.

Cadila Healthcare and its US based division Zydus Pharmaceuticals (USA) Inc. received highest number of ANDA approvals among Indian companies during 2018. Zydus Group has received 48 final ANDA approvals followed by Aurobindo Pharma 44 and Cipla 24. Lupin got 19 ANDA approvals and Dr Reddy’s Laboratories, Glenmark Pharmaceuticals and Strides Pharma received 17 approvals each in 2018. Sun Pharma and Taro Pharmaceutical received total 20 ANDA approvals. Among the tentative approvals, Aurobindo Pharma remained on top with 10 approvals, followed by Zydus Pharma 9 and Lupin 7. Cipla and Ajanta pharma received 6 tentative approvals during 2018.

Cadila Healthcare has incurred R&D expenditure of Rs.690 crore during 2017-18 and it received 77 approval for new products for the US market. Zydus Group has created exciting pipeline coming in the next few years including several first-to-file and 505B2 opportunities, nasal sprays, dermatological, injectable, oncology products, and metered dose inhalers. Launch of mesalamine 1.2 g DR tablets (generic version of Lialda) in July 2017 with 180 days exclusivity was the first large First to File opportunity. It recently launched Zypitamag tablets, the first product filed through the 505(b)(2) route.

Cadila’s purchase of Nesher Pharmaceuticals in St. Louis, Missouri, it is also providing controlled substances and additional difficult to manufacture extended release products. Zydus has develop innovative medicines, including small molecule NCEs, biosimilars novel bioloics, vacines and novel formulations.

Aurobindo Pharma, a second largest pharma company in India with consolidated net sales of Rs.16,200 crore plus, has invested Rs.667 crore during the year ended March 2018. It launched 38 products in US, including six injectables. The company has identified 79 oncology and hormonal products for development. It received its first penem injectable during 2017-18. It has developed he process of manufacturing 14 peptides and two more molecules are in the process of development. The company’s its product portfolio spans seven major therapeutic product areas, including antibiotics, ARVs, CVS, CNS gastroenterologicals, anti-diabetics and anti-allelrgics.

Cipla, a Rs.14,750 crore pharma giant, has continued to invest in building a strong product pipeline through R&D, which contributed significant growth in US revenues. Its annual R&D investment cross Rs.1,000 crore and reached at Rs.1,074 crore during 2018. R&D spending worked out to 7.1% of its revenues. It launched 80 new products globally during 2017-18 and its cumulative ANDA filing reached at 249. The company launched 11 new products in US during 2017-18. The API pipeline consists of over 50 complex developments in the therapy areas of oncology, Hep C, ARV, diabetology, respiratory, etc. Further, it filed 35 patent applications, of which 24 were successfully granted.

Lupin’s R&D expenditure declined by 19.9% to Rs.1,851 crore during the year ended March 2018 from Rs.2,310 crore in the previous year and worked out to 11.9% of sales. It filed 36 ANDAs and received 24 approvals from the US FDA during 2017-18. It filed total 398 products and received 235 approvals from US FDA. Cumulative DMF filings stand at 193. It also filed 2 MAA and received 5 approvals from European authority during the year. Cumulative filings with European authorities now stands at 62 with company having received 59 approvals to date. The company is well position globally with nine R&D sites in six countries and over 1,700 scientists. Its patent filing cross 3,000 globally.

Besides, these top three companies, Dr Reddy’s Laboratories, Glenmark Pharma, Sun Pharma and Strides Pharma received final ANDA approvals over 15 products each during 2018 from US FDA. Hetero Laboratories and Micro Laboratories got approvals for 9 products and 8 products each during 2018. Further, Ajanta Pharma, Alembic Pharma, Gland Pharma Macleods Pharma and Torrent Pharma received 7 ANDA each during 2018. Alkem Laboratories and Granules India received approval for 6 and 5 products each from US FDA.

US FDA ANDA approvals during Jan-Dec 2018

Company Jan-Mar April-June July-Sept Oct-Dec Total 2018
ZYDUS PHARMS USA INC 4 12 16 16 48
AUROBINDO PHARMA LTD 11 11 12 10 44
CIPLA LTD 4 7 9 4 24
LUPIN LTD 5 3 4 7 19
DR REDDYS LABS LTD 3 4 3 7 17
GLENMARK PHARMS 1 6 2 8 17
STRIDES PHARMA 6 6 1 4 17
SUN PHARMA 0 3 2 6 11
HETRO LABS LTD III 3 2 1 3 9
TARO 3 2 0 4 9
MICRO LABS LTD INDIA 1 2 1 4 8
AJANTA PHARMA 0 1 4 2 7
ALEMBIC PHARMA 0 3 0 4 7
GLAND PHARMA LTD 1 3 1 2 7
MACLEODS PHARMS LTD 2 2 1 2 7
TORRENT PHARMS LTD 1 2 4 0 7
ALKEM LABS LTD 1 1 1 3 6
GRANULES INDIA LTD 1 2 1 1 5
PIRAMAL HEALTHCARE 0 0 2 2 4
ACCORD HEALTHCARE 0 0 0 3 3
UNICHEM LABS 0 1 1 1 3
JUBILANT GENERICS 1 1 0 0 2
LAURUS LABS PVT 1 0 1 0 2
VIVIMED GLOBAL 2 0 1 0 3
AUROLIFE PHARMA 0 0 0 1 1
EMCURE PHARMA 0 0 0 1 1
MSN LABS 0 0 0 1 1
SHILPA MEDICARE 0 0 0 1 1
Indian Cos recd Approvals 47 62 68 97 290
Total ANDA Approvals 112 211 212 278 813

Tentative approvals Jan-Dec 2018

Company Jan-Mar April-June July-Sept Oct-Dec Total 2018
Aurobindo Pharma 1 5 2 2 10
Zudus Pharma 0 0 0 9 9
Lupin 1 2 2 2 7
Cipla 2 0 1 3 6
Ajanta Pharma 0 2 2 2 6
Taro Pharma 0 2 1 2 5
Alembic Pharma 0 0 3 2 5
Alkem Labs 0 1 1 2 4
Zydus Pharma 0 1 3 0 4
Gland Pharma 0 1 0 2 3
Dr Reddy’s Labs 0 0 1 2 3
Micro Labs 0 0 2 1 3
Micro Labs 2 0 0 0 2
Sun Pharma 0 2 0 0 2
Hetero Labs 0 0 2 0 2
Torrent Pharma 0 0 1 1 2
Accord Healthcare 0 0 0 1 1
Glenmark Pharma 0 0 0 1 1
Macleods Pharma 0 0 0 1 1
Shilpa Medicare 0 0 0 1 1
Indian Cos recd Approvals 6 16 21 34 77
Total Tentative approvals 23 48 57 66 194

US FDA Approvals of ANDAs during 2009 to 2018

         Year Total ANDA’s Indian Cos Tentative Indian Cos
Approvals approvals
2018 813 290 194 77
2017 846 304 171 61
2016 598 201 156 70
2015 564 167 147 48
2014 385 130 100 32
2013 400 154 86 38
2012 476 178 94 42
2011 431 144 117 49
2010 418 142 121 49
2009 419 132 124 34
Total 5350 1842 1310 500

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