Actavis’ Lo Loestrin Fe patent upheld
DUBLIN — Actavis last week confirmed that the U.S. District Court for the District of New Jersey found United States Patent No. 7,704,984 (the ‘984 Patent) to be valid and infringed by Lupin Pharmaceuticals and Amneal Pharmaceuticals Abbreviated New Drug Applications (ANDAs) for generic versions of Actavis’ Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets).
Lo Loestrin Fe is a prescription birth control pill used for the prevention of pregnancy.
"We are pleased that the Court has ruled in our favor and upheld the validity of our patent on Lo Loestrin Fe," said Paul Bisaro, chairman and CEO of Actavis. "The enforcement of our intellectual property rights is a critical tool in our ability to continue to invest in future treatments, and we intend to vigorously defend these rights against any future challenges or appeals."
Greenstone launches authorized generic of Pfizer’s Rapamune
PEAPACK, N.J. — Greenstone, a U.S.-based generic pharmaceutical subsidiary of Pfizer, on Tuesday announced the introduction of Sirolimus to its generic pharmaceutical product line. The product is offered in dosage strengths of 0.5mg x 100.
Greenstone’s Sirolimus product is the authorized generic of, and equivalent to, Pfizer’s Rapamune (sirolimus).
Sirolimus is indicated for the prophylaxis of organ rejection in patients ages 13 years or older receiving renal transplants. Therapeutic drug monitoring is recommended for all patients receiving sirolimus.
Actavis Pharma to sell seven Western European operations to Aurobindo Pharma
DUBLIN — Actavis Pharma recently announced that it intends to enter into an agreement for Aurobindo Pharma to acquire Actavis’ generics commercial operations in seven markets in Western Europe. The transaction is conditional on certain antitrust approvals and completion of employee consultation processes.
Aurobindo would acquire Actavis’ pharmaceutical commercial infrastructure in France, Italy, Spain, Portugal, Belgium, Germany and the Netherlands, including products, marketing authorizations and dossier license rights. The two companies would also enter into a long term strategic supply arrangement.
"We believe that the value created by the commercial operations in these seven markets will be better maximized by Aurobindo, which will gain scale, additional products and enhanced competitive market share position as a result of this transaction," stated Sigurdur Oli Olafsson, president, Actavis Pharma. "This transaction will permit Actavis to focus management time and resources to support accelerated investment in driving faster growth of other markets, including Central and Eastern Europe and Southeast Asia."
Until the transaction is completed, Actavis will continue to operate the commercial businesses in a business-as-usual mode, providing full support to manage the business, introduce new products and maximize its partnership with customers, the company stated.