{"id":207462,"date":"2026-08-17T15:15:57","date_gmt":"2026-08-17T09:45:57","guid":{"rendered":"https:\/\/univest.in\/blogs-2\/?p=207462"},"modified":"2026-08-17T15:15:59","modified_gmt":"2026-08-17T09:45:59","slug":"lupin-share-price-usfda-pitolisant-tablets-wakix-august-2026","status":"publish","type":"post","link":"https:\/\/univest.in\/blogs-2\/lupin-share-price-usfda-pitolisant-tablets-wakix-august-2026\/","title":{"rendered":"Lupin Share Price in Focus After USFDA Grants Final Approval for Pitolisant Tablets 4.45 mg and 17.8 mg as Bioequivalent to Wakix on 17 August 2026"},"content":{"rendered":"
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Lupin share price Rs 2,228.60 (-0.29%). USFDA final approval for Pitolisant Tablets 4.45mg and 17.8mg. Bioequivalent to Wakix. High Rs 2,243.50 (52W high). Vol 21,615 vs avg 86,200 (-74.92%).<\/em><\/p>\n

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Quick Answer<\/strong><\/p>\n

Lupin share price is in focus on 17 August 2026 after the company received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Pitolisant Tablets in 4.45 mg and 17.8 mg strengths, approved as bioequivalent to Wakix. The USFDA approval gives Lupin entry into the narcolepsy treatment generic market in the United States.<\/p>\n<\/div>\n

The Lupin<\/a> share price received a significant regulatory milestone on 17 August 2026: the US Food and Drug Administration has granted final approval for Lupin’s Abbreviated New Drug Application for Pitolisant Tablets in two strengths, 4.45 mg and 17.8 mg. The tablets have been approved as bioequivalent to Wakix, the branded narcolepsy treatment made by Harmony Biosciences. This USFDA approval gives Lupin entry into the US generic narcolepsy market, a segment where Wakix has been growing strongly.<\/p>\n

The Lupin share price reaction is interesting: the stock touched a new 52-week high of Rs 2,243.50 intraday before pulling back to Rs 2,228.60, a mild decline of 0.29 percent. This price action reflects the pattern common to ANDA approvals: the initial regulatory approval triggers a push to new highs as the news is absorbed, but the limited trading volume (21,615 shares versus the five-day average of 86,200, a 74.92 percent decline) means the move is happening in a thin post-holiday session. The Lupin share price’s 52-week high touch today is technically significant regardless of the mild price decline from that peak.<\/p>\n

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Lupin Share Price Data<\/th>\nValue<\/th>\n<\/tr>\n<\/thead>\n
CMP (17 Aug 2026)<\/td>\nRs 2,228.60 (-0.29% \/ -Rs 6.40)<\/td>\n<\/tr>\n
Intraday High (= 52-Week High)<\/td>\nRs 2,243.50<\/td>\n<\/tr>\n
Intraday Low<\/td>\nRs 2,219.75<\/td>\n<\/tr>\n
USFDA Approval<\/td>\nFinal ANDA approval for Pitolisant Tablets<\/td>\n<\/tr>\n
Dosage Strengths<\/td>\n4.45 mg and 17.8 mg<\/td>\n<\/tr>\n
Reference Brand<\/td>\nWakix (by Harmony Biosciences)<\/td>\n<\/tr>\n
Indication<\/td>\nNarcolepsy treatment<\/td>\n<\/tr>\n
Volume Today<\/td>\n21,615 shares<\/td>\n<\/tr>\n
5-Day Avg Volume<\/td>\n86,200 shares<\/td>\n<\/tr>\n
Volume vs Avg<\/td>\n-74.92%<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
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