- This acquisition gives us a strategic entry into the specialty and branded prescription products: Pranav Amin, Managing Director of Alembic Pharmaceuticals Limited
- We are thrilled that Alembic Pharmaceuticals understands the clinical and commercial value of PIVYA and will bring this proven treatment to female patients in need across the US: Tom Hadley, President and CEO of UTILITY Therapeutics
- Since 2015, Alembic Pharmaceuticals US has grown its generics business to over 160 molecules and 413 products: Craig Salmon, President of Alembic Pharmaceuticals, Inc
- Alembic announces USFDA final approval for Doxorubicin Hydrochloride Liposome Injection
NE HEALTH BUREAU
MUMBAI, JULY 3
Alembic Pharmaceuticals, Inc., the U.S. subsidiary of Alembic Pharmaceuticals Ltd., on Thursday announced it has acquired Utility Therapeutics Ltd. in a $12 million deal to strengthen its presence in the U.S. market. Alembic will begin the commercialization of Utility’s recently FDA approved product Pivya® (pivmethecillam) for the treatment of uncomplicated urinary tract infections. Pivya® was approved by the FDA in April 2024.
Commenting on the acquisition, Pranav Amin, Managing Director of Alembic Pharmaceuticals Limited, said: “This acquisition gives us a strategic entry into the specialty and branded prescription products. This will give us exposure to the branded pharmaceutical market with a near term commercial launch.”
The acquisition of Pivya is an important step in Alembic’s ability to provide branded pharmaceutical product to the US Healthcare market. It will further enhance Alembic’s ability to build long-term value by combining global research, regulatory, and manufacturing strengths with a sharpened focus on specialty segments.
“We are thrilled that Alembic Pharmaceuticals understands the clinical and commercial value of PIVYA and will bring this proven treatment to female patients in need across the U.S.,” said Tom Hadley, President and CEO of UTILITY Therapeutics. “With current therapies failing and the armament of uUTI antibiotics perilously thin, PIVYA provides U.S. clinicians with a new and effective treatment option that has a long safety record.”
Craig Salmon, President of Alembic Pharmaceuticals, Inc. said “Since 2015, Alembic Pharmaceuticals US has grown its generics business to over 160 molecules and 413 products including generic dermaceutical, ophthalmic, general injectable, and oncology products. Entering the branded product market is the next phase of our US growth.
Pivya represents an important and much needed treatment option for patients with uncomplicated urinary tract infections. It has an excellent history for safety, effectiveness and low levels of bacterial resistance in Europe for 40 years of real-world experience. The acquisition of Utility broadens Alembic Inc’s footprint beyond generic pharmaceuticals and will allow Alembic to build out its capabilities in the large US branded pharmaceutical market. We plan to have PIVYA available in the US in Q4, 2025”
Alembic announces USFDA final approval for Doxorubicin Hydrochloride Liposome Injection
Alembic Pharmaceuticals Limited (Alembic) announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) Single-Dose Vials. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Doxil Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL), of Baxter Healthcare Corporation.
Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of Ovarian Cancer, AIDS-Related Kaposi’s Sarcoma, and Multiple Myeloma. Refer label for a detailed indication.
Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2mg/mL) Single-Dose Vials have an estimated market size of US$ 29 million for twelve months ending March 2025 according to IQVIA.
Alembic has a cumulative total of 224 ANDA approvals (201 final approvals and 23 tentative approvals) from USFDA.
