BAJAJ BROKING

Notification
No new Notification messages
Ather Energy IPO is Open!
Apply for the Ather Energy IPO through UPI in just minutes.
Open a Free Demat Account
Pay ZERO maintenance charges for the first year, get free stock picks daily, and more.
Trade Now, Pay Later with up to 4x
Never miss a good trading opportunity due to low funds with our MTF feature.
Track Market Movers Instantly
Stay updated with real-time data. Get insights at your fingertips.

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

888.250.20 (0.02 %)

Updated - 30 April 2025
901.85day high
DAY HIGH
883.00day low
DAY LOW
907542
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

Share this article: 

Read More Blogs

Disclaimer :

The information on this website is provided on "AS IS" basis. Bajaj Broking (BFSL) does not warrant the accuracy of the information given herein, either expressly or impliedly, for any particular purpose and expressly disclaims any warranties of merchantability or suitability for any particular purpose. While BFSL strives to ensure accuracy, it does not guarantee the completeness, reliability, or timeliness of the information. Users are advised to independently verify details and stay updated with any changes.

The information provided on this website is for general informational purposes only and is subject to change without prior notice. BFSL shall not be responsible for any consequences arising from reliance on the information provided herein and shall not be held responsible for all or any actions that may subsequently result in any loss, damage and or liability. Interest rates, fees, and charges etc., are revised from time to time, for the latest details please refer to our Pricing page.

Neither the information, nor any opinion contained in this website constitutes a solicitation or offer by BFSL or its affiliates to buy or sell any securities, futures, options or other financial instruments or provide any investment advice or service.

BFSL is acting as distributor for non-broking products/ services such as IPO, Mutual Fund, Insurance, PMS, and NPS. These are not Exchange Traded Products. For more details on risk factors, terms and conditions please read the sales brochure carefully before investing.

Investments in the securities market are subject to market risk, read all related documents carefully before investing. This content is for educational purposes only. Securities quoted are exemplary and not recommendatory.

[ Read More ]

For more disclaimer, check here : https://www.bajajbroking.in/disclaimer

Our Secure Trading Platforms

Level up your stock market experience: Download the Bajaj Broking App for effortless investing and trading

Bajaj Broking App Download

9.5 lakh+ Users

icon-with-text

4+ App Rating

icon-with-text

4 Languages

icon-with-text

₹4400+ Cr MTF Book

icon-with-text