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Zydus Life Gets Final USFDA Approval for Eluxadoline Tablets

Synopsis:

Zydus Lifesciences Ltd. secures final USFDA approval for Eluxadoline Tablets, 75 mg and 100 mg, granting 180-day generic exclusivity. The drug, used for IBS-D treatment, saw annual US sales of $243.7 million. Zydus Lifesciences Ltd. share price settled at Rs 880.


Zydus Lifesciences Ltd. has received final approval from the US Food and Drug Administration to manufacture and market Eluxadoline tablets, 75 mg and 100 mg, in the United States. This approval allows the company to enter the market with 180 days of shared generic drug exclusivity. Eluxadoline is a mu-opioid receptor agonist used for the treatment of irritable bowel syndrome with diarrhoea in adults. The drug will be manufactured at Zydus Lifesciences Ltd.’s SEZ facility in Ahmedabad.

Also read: KEC International Secures Orders Worth Rs 1,267 Crores Across Sectors

ZYDUS LIFESCIENCES LTD

Trade

892.79.60 (1.08 %)

Updated - 17 March 2025
901.30day high
DAY HIGH
887.15day low
DAY LOW
960318
VOLUME (BSE)

Key takeaways

  • Final USFDA approval for Eluxadoline tablets, 75 mg and 100 mg

  • 180-day shared generic exclusivity granted to Zydus

  • Annual sales of Eluxadoline tablets in the US reached $243.7 million

  • Zydus Lifesciences Ltd. share price closed 1% lower at Rs 880

  • 419 total USFDA approvals and 483 ANDAs filed by Zydus since FY 2003-04

Also read: Dalmia Bharat Begins Production at 2.4 MTPA Cement Unit in Assam

Zydus gains competitive edge with ANDA approval

Zydus Lifesciences Ltd. was among the first applicants to file an abbreviated new drug application with a paragraph IV certification for Eluxadoline tablets, making it eligible for an exclusive launch window in the generic market. The drug’s US market value of $243.7 million presents a strong revenue opportunity for Zydus, further solidifying its presence in the gastrointestinal segment.

Zydus’ regulatory milestones and market impact

With this latest approval, Zydus Lifesciences Ltd. has strengthened its portfolio, marking 419 total approvals from the USFDA. The company has been actively expanding its presence in the US pharmaceutical market, having filed 483 abbreviated new drug applications since FY 2003-04. Despite this milestone, Zydus Lifesciences Ltd. share price saw a minor dip, closing at Rs 880 on Thursday.

Zydus Lifesciences Ltd. – USFDA approval summary

Approval details

Information

Drug name

Eluxadoline tablets

Strengths

75 mg, 100 mg

Indication

Irritable bowel syndrome with diarrhoea

Approval type

Final USFDA approval

Exclusivity period

180 days (shared)

Annual US market sales

$243.7 million

Manufacturing facility

Ahmedabad (SEZ), India

Zydus Lifesciences Ltd. continues its strong momentum in the US market with yet another key regulatory approval. The Eluxadoline tablets approval enhances its gastrointestinal drug portfolio and positions it well for revenue growth. However, Zydus Lifesciences Ltd. share price faced a slight decline despite the positive news, reflecting mixed investor sentiment.

Also read: Galaxy Surfactants Declares ₹18 Per Share Interim Dividend for FY25

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