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Milestones

FDA approves Sucralfate Suspension

On March 18, 2024, Abon received FDA approval of its ANDA for a generic version of Carafate® (sucralfate) Oral Suspension, 1 g/10 ml. “We are pleased to announce our approval of this complex product. We are preparing to launch it shortly,” said Salah Ahmed, CSO, President and CEO of Abon. According to IQVIA™, U.S market annual sales for sucralfate oral suspension is estimated to be approximately $146 million.

Atovaquone Suspension Launched

On November 14, 2023, Abon launched a generic version of Mepron® (atovaquone) Oral Suspension, 750 mg/5 ml. “This is one of a series of oral suspension products we would be launching during the next few quarters” said Salah Ahmed, CSO, President and CEO of Abon. According to IQVIA™, U.S market annual sales for atovaquone oral suspension is estimated to be approximately $53 million.

Abon opens new facility in Chestnut Ridge, New York

On May 1, 2023 Abon opened a new facility in Chestnut Ridge, New York. In addition to a state of the art pilot plant, analytical laboratory and GMP manufacturing suite, this will house the corporate office as well. “We are excited with the new facility that will allow us to bring certain manufacturing operation in house" said Salah Ahmed, CSO, President and CEO of Abon.

FDA approves Atovaquone Suspension

On October 25, 2021 FDA approved Abon's ANDA for a generic version of Mepron® (atovaquone) Oral Suspension, 750 mg/5 ml. “This is the first of a series of oral suspension products Abon intends to bring to market at lower cost” said Salah Ahmed, CSO, President and CEO of Abon.

FDA approves Clofarabine Injection

On May 9, 2017 Abon received FDA approval of its ANDA for a generic version of Clolar® Injection, 20 mg/20 mL (1 mg/mL). “We are excited to announce the approval of this anticancer injectable product. We are preparing to launch it shortly with our marketing partner Fresenius Kabi,” said Salah Ahmed, CSO, President and CEO of Abon. Clofarabine Injection, 20 mg/20 mL (1 mg/mL), Single-use Vial, is bioequivalent and, therefore, therapeutically equivalent to the reference listed drug (RLD), Clolar® Injection, 20 mg/20 mL (1 mg/mL) of Genzyme Corporation (Genzyme).

Genzyme et al Settles Patent Litigation with Abon

On July 25, 2014, Abon Pharmaceuticals, LLC, a specialty pharmaceutical company, announced that Southern Research Institute, Genzyme Corporation and sanofi-aventis U.S. LLC, settled the patent litigation related to U.S. Patent No. 5,661,136. According to the agreement, Abon is allowed to launch this product on or after February 15, 2017.

Abon first to file for Clofarabine Injection

On July 31, 2012, Abon Pharmaceuticals, LLC, a specialty pharmaceutical company, announced that Genzyme filed suit against Abon on July 27, 2012, in the United States District Court for the District of New Jersey seeking to prevent Abon from commercializing its product prior to the expiration of U.S. Patent No. 5,661,136. Based on available information, Abon believes it may be the "first applicant" to file an ANDA for the generic version of CLOLAR® Injection and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity. Total US sales for the twelve month period ending in June 2012 were approximately $77.5 million, according to IMS Health.

Abon files ANDA for Clofarabine Injection

On February 23, 2012, Abon Pharmaceuticals, LLC, a specialty pharmaceutical company, filed an Abbreviated New Drug Application (ANDA), with a paragraph IV certification, with the U.S. Food and Drug Administration (FDA) seeking approval to market its Clofarabine Injection, 1 mg/ml. Abon's Clofarabine Injection is a generic equivalent of Genzyme's CLOLAR® Injection. CLOLAR® injection is a prescription medicine indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. for a generic version of Clolar® Injection, 20 mg/20 mL (1 mg/mL) of Genzyme Corporation. Total US sales for the twelve month period ending in June 2012 were approximately $77.5 million, according to IMS Health.

"This filing is an important milestone for Abon. It establishes our capability to expedite development of generic products facing significant barriers to entry," said Dr. Salah U. Ahmed, President, CEO and founder of Abon Pharmaceuticals, LLC. While several ANDAs for products developed by Abon have been filed with the FDA by its strategic partners, the Clofarabine Injection ANDA is the first to be filed and owned by Abon.

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