Alembic Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Ticagrelor Tablets 90 mg, along with tentative approval for the 60 mg version. The approval marks a significant milestone for the company in expanding its cardiovascular medication portfolio in the U.S. market.
The approved generic drug is therapeutically equivalent to AstraZeneca's reference listed drug Brilinta Tablets. For the 90 mg tablets, Alembic was among the first companies to submit a substantially complete ANDA with a paragraph IV certification, positioning it advantageously in the competitive generic pharmaceutical landscape.
Therapeutic Applications and Market Potential
Ticagrelor tablets are primarily indicated to reduce the risk of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction. The medication also serves several additional critical functions, including:
- Reducing the risk of stent thrombosis in patients who have been stented for ACS treatment
- Reducing the risk of first MI or stroke in patients with coronary artery disease
- Reducing stroke risk in patients with acute ischemic stroke
According to IQVIA data cited by Alembic, the estimated market size for Ticagrelor Tablets 90 mg is approximately $1.062 billion for the twelve-month period ending March 2025. The 60 mg version has an estimated market value of $242 million for the same period, representing a substantial commercial opportunity for the company.
Clinical Significance
Ticagrelor belongs to a class of medications known as P2Y12 platelet inhibitors, which work by preventing blood platelets from sticking together to form clots. This mechanism is crucial for patients at high risk of cardiovascular events, particularly those who have experienced acute coronary syndrome or have undergone coronary stenting procedures.
The approval of generic versions of this important cardiovascular medication may potentially increase accessibility and affordability for patients requiring long-term antiplatelet therapy. Cardiovascular diseases remain the leading cause of mortality globally, with coronary artery disease accounting for a significant proportion of these deaths.
Company Impact and Market Position
This approval strengthens Alembic Pharmaceuticals' position in the U.S. generic pharmaceutical market, particularly in the cardiovascular therapeutic area. The company's shares were trading at Rs 876.10 on the BSE following the announcement.
The approval comes at a time when healthcare systems worldwide are increasingly focused on cost-effective treatment options for chronic conditions. Generic medications play a crucial role in this ecosystem by providing therapeutically equivalent alternatives at potentially lower costs.
For patients with acute coronary syndrome or history of myocardial infarction, the availability of generic Ticagrelor represents an important addition to the treatment armamentarium, potentially improving adherence through greater affordability while maintaining the clinical benefits of the reference product.
