Latest news with #TicagrelorTablets
The Hindu
02-05-2025
- Health
- The Hindu
Alembic Pharma's generic Ticagrelor tablets gets U.S. FDA nod
Alembic Pharmaceuticals has received U.S. Food and Drug Administration final approval for an abbreviated new drug application for Ticagrelor Tablets 90 mg and tentative approval for Ticagrelor Tablets 60 mg. The approved ANDA is therapeutically equivalent to the reference listed drug Brilinta Tablets, 60 mg and 90 mg, of AstraZeneca. Ticagrelor tablets are indicated to reduce the risk of cardiovascular death, myocardial infarction (MI) and stroke in patients with acute coronary syndrome or a history of MI. For Ticagrelor Tablets 90 mg, Alembic was one of the first to submit a substantially complete ANDA with a paragraph IV certification. The estimated market size of Ticagrelor Tablets 90 mg was $1,062 million for twelve months ending March 2025. Ticagrelor Tablets 60 mg had an estimated market size of $242 million during the same period, the company said citing IQVIA numbers. The tablet is also indicated to reduce the risk of stent thrombosis in patients who have been stented for treatment of ACS; to reduce risk of a first MI or stroke in patients with coronary artery disease; and to reduce the risk of stroke in patients with acute ischemic stroke.
Business Standard
02-05-2025
- Business
- Business Standard
Alembic Pharma receives USFDA approval for Ticagrelor tablets
Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ticagrelor Tablets, 90 mg, and tentative approval for Ticagrelor Tablets, 60 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Brilinta Tablets (60 mg and 90 mg), of AstraZeneca Pharmaceuticals LP (AstraZeneca). Ticagrelor tablets are indicated to: i) Reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. ii) Reduce the risk of stent thrombosis in patients who have been stented for treatment of ACS. iii) Reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. iv) Reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score <5) or high-risk transient ischemic attack (TIA). For Ticagrelor Tablets, 90 mg, Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification. Alembic was among the first ANDA applicants to file a substantially complete application with a Paragraph IV certification for Ticagrelor Tablets, 90 mg. According to IQVIA, Ticagrelor Tablets, 90 mg, have an estimated market size of US$1,062 million for the twelve months ending March 2025, while the 60 mg variant is estimated at US$242 million for the same period. With this approval, Alembic's total USFDA-approved ANDAs now stand at 222, including 197 final and 25 tentative approvals. The companys consolidated net profit tumbled 23.29% to Rs 138.42 crore in Q3 FY25, compared with Rs 180.45 crore posted in Q3 FY24. Revenue from operations was at Rs 1,692.74 crore in the third quarter of FY25, up 3.81% year on year (YoY). Shares of Alembic Pharmaceuticals shed 0.31% to Rs 873.65 on the BSE.
Business Standard
02-05-2025
- Health
- Business Standard
Alembic Pharmaceuticals receives USFDA final approval for Ticagrelor Tablets
Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ticagrelor Tablets, 90 mg and tentative approval for Ticagrelor Tablets, 60 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Brilinta Tablets, 60 mg and 90 mg, of AstraZeneca Pharmaceuticals LP (AstraZeneca). Ticagrelor tablets are indicated for: i) to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. Ticagrelor tablets also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. ii) to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events, and iii) to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score <5) or high-risk transient ischemic attack (TIA). For Ticagrelor Tablets, 90 mg, Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification. Ticagrelor Tablets, 90 mg have an estimated market size of US$ 1,062 million for twelve months ending March 2025 according to IQVIA. Ticagrelor Tablets, 60 mg have an estimated market size of US$ 242 million for twelve months ending March 2025 according to IQVIA.
Time of India
02-05-2025
- Business
- Time of India
Alembic gets USFDA nod for generic drug
Alembic Pharmaceuticals on Friday said it has received approval from the US health regulator to market a generic medication for the prevention of heart attack and stroke. The company has received final approval from the US Food & Drug Administration ( USFDA ) for its abbreviated new drug application (ANDA) for Ticagrelor Tablets , 90 mg and tentative approval for Ticagrelor Tablets, 60 mg, Alembic Pharma said in a statement. #Pahalgam Terrorist Attack India's Rafale-M deal may turn up the heat on Pakistan China's support for Pakistan may be all talk, no action India brings grounded choppers back in action amid LoC tensions The company's approved ANDA is therapeutically equivalent to AstraZeneca Pharmaceuticals's Brilinta Tablets, 60 mg and 90 mg, it added. Ticagrelor tablets are indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome. Play Video Pause Skip Backward Skip Forward Unmute Current Time 0:00 / Duration 0:00 Loaded : 0% 0:00 Stream Type LIVE Seek to live, currently behind live LIVE Remaining Time - 0:00 1x Playback Rate Chapters Chapters Descriptions descriptions off , selected Captions captions settings , opens captions settings dialog captions off , selected Audio Track Picture-in-Picture Fullscreen This is a modal window. Beginning of dialog window. Escape will cancel and close the window. Text Color White Black Red Green Blue Yellow Magenta Cyan Opacity Opaque Semi-Transparent Text Background Color Black White Red Green Blue Yellow Magenta Cyan Opacity Opaque Semi-Transparent Transparent Caption Area Background Color Black White Red Green Blue Yellow Magenta Cyan Opacity Transparent Semi-Transparent Opaque Font Size 50% 75% 100% 125% 150% 175% 200% 300% 400% Text Edge Style None Raised Depressed Uniform Drop shadow Font Family Proportional Sans-Serif Monospace Sans-Serif Proportional Serif Monospace Serif Casual Script Small Caps Reset restore all settings to the default values Done Close Modal Dialog End of dialog window. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Villas For Sale in Dubai Might Surprise You Villas In Dubai | Search Ads Get Rates Undo For Ticagrelor Tablets, 90 mg, Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification, the drug firm said. According to IQVIA, Ticagrelor Tablets (90 mg) have an estimated market size of USD 1,062 million for twelve months ending March 2025. Live Events Ticagrelor Tablets, 60 mg have an estimated market size of USD 242 million for twelve months ending March 2025. Alembic shares were trading 0.03 per cent down at Rs 876.10 apiece on BSE.
Business Upturn
02-05-2025
- Business
- Business Upturn
Alembic Pharma gets USFDA final nod for Ticagrelor 90 mg, tentative approval for 60 mg
Alembic Pharmaceuticals Limited announced on May 2, 2025, that it has received final approval from the US Food and Drug Administration (USFDA) for its Ticagrelor Tablets, 90 mg, and tentative approval for Ticagrelor Tablets, 60 mg. The 90 mg dosage has been approved as a therapeutically equivalent generic to AstraZeneca's Brilinta, and is indicated to reduce the risk of cardiovascular death, myocardial infarction (MI), stroke, and stent thrombosis in certain high-risk patients. The 60 mg variant has also received tentative approval pending patent expiry or exclusivity clearance. Alembic was among the first ANDA applicants to file for the 90 mg dosage with a Paragraph IV certification, indicating it is contesting the innovator's patent. According to IQVIA data, the estimated market size in the U.S. for the 90 mg Ticagrelor tablets is approximately US$ 1,062 million, and for the 60 mg tablets is around US$ 242 million, for the twelve months ending March 2025. With this development, Alembic's cumulative USFDA approvals now stand at 222 ANDAs, comprising 197 final approvals and 25 tentative approvals. The company reaffirmed its long-standing focus on regulated markets, with robust R&D and vertically integrated manufacturing capabilities. Alembic continues to expand its presence in global generics with a strong pipeline and established regulatory track record. News desk at
