Content about Actavis

November 19, 2012

Generic Drug Report 2012

The year 2012 is coming to an end, and it's been a big year for generic drugs. It's the year that the most lucrative drug of all time became commoditized. It's the year that Watson bought Actavis for $5.6 billion. And it's the year the FDA released draft guidance for biosimilars regulations. All of these events speak to some of the most important trends in the world of generics — trends that are often interrelated.

June 17, 2013

Supreme Court issues 'pay-for-delay' ruling

Patent settlements between brand and generic drug makers commonly referred to as "pay-for-delay" settlements are not necessarily against the law, the Supreme Court ruled Monday.

NEW YORK — Patent settlements between brand and generic drug makers commonly referred to as "pay-for-delay" settlements are not necessarily against the law, the Supreme Court ruled Monday.

June 13, 2013

Actavis partners with Medicines360 to sell low-cost IUDs in public clinics

Drug maker Actavis is working with nonprofit pharmaceutical company Medicines360 to make low-cost intrauterine devices available to women, the two said.

PARSIPPANY, N.J. — Drug maker Actavis is working with nonprofit pharmaceutical company Medicines360 to make low-cost intrauterine devices available to women, the two said.

June 7, 2013

Actavis seeks approval for two generics

Actavis is hoping to become the first to market generic versions of a contraceptive and a sedative, the drug maker said.

PARSIPPANY, N.J. — Actavis is hoping to become the first to market generic versions of a contraceptive and a sedative, the drug maker said.

May 31, 2013

Reports: Sun to buy Meda for up to $6 billion

India-based Sun Pharmaceutical Industries may buy Sweden-based Meda for $5 billion to $6 billion, according to published reports.

NEW YORK — India-based Sun Pharmaceutical Industries may buy Sweden-based Meda for $5 billion to $6 billion, according to published reports.

Reuters reported that the two companies were in talks for Sun to buy Meda in order to boost its generics business in developed markets.

May 30, 2013

States consider 'carve-out'-style laws for biosimilars

While the passage of the Patient Protection and Affordable Care Act of 2010 was a milestone in a number of respects, it also was one of the biggest moments in the history of the generic drug industry since the 1984 passage of the Hatch-Waxman Act, which created an abbreviated regulatory approval pathway for generic pharmaceutical drugs.

May 28, 2013

Court blocks Actavis asthma generic

A federal court has blocked Actavis from distributing its generic version of a drug for treating asthma, the company said.

PARSIPPANY, N.J. — A federal court has blocked Actavis from distributing its generic version of a drug for treating asthma, the company said.

Actavis said the U.S. Court of Appeals for the Federal Circuit had issued an injunction against Actavis' distribution of budesonide inhalation suspension at the request of AstraZeneca, which sells the drug under the trade name Pulmicort Respules.

May 20, 2013

Actavis, Warner Chilcott reach acquisition deal

Actavis will acquire Warner Chilcott for $8.5 billion, the drug maker said.

PARSIPPANY, N.J. — Actavis will acquire Warner Chilcott for $8.5 billion, the drug maker said Monday.

May 14, 2013

Actavis issues regulatory filing to comply with Irish company-takeover rules

Actavis is continuing to pursue a plan to buy Irish drug maker Warner Chilcott, as the U.S.-based company announced Tuesday its total number of shares and share-purchase options in order to comply with Ireland's merger-and-acquisition rules.

PARSIPPANY, N.J. — Actavis is continuing to pursue a plan to buy Irish drug maker Warner Chilcott, as the U.S.-based company announced Tuesday its total number of shares and share-purchase options in order to comply with Ireland's merger-and-acquisition rules.

Actavis listed about 133.3 million ordinary shares, 1.5 billion restricted shares and 1.26 options to purchase ordinary shares.

May 14, 2013

Actavis seeks FDA approval for contraceptive patch

The Food and Drug Administration will review an experimental contraceptive patch made by Actavis, the drug maker said Tuesday.

PARSIPPANY, N.J. — The Food and Drug Administration will review an experimental contraceptive patch made by Actavis, the drug maker said Tuesday.

Actavis said the FDA accepted for review its application for norethindrone transdermal delivery system. The patch, which does not yet have a brand name, is designed to provide continuous delivery of norethindrone during a once-weekly, seven-day dosing regimen.

May 10, 2013

Actavis in talks to combine with Warner Chilcott

Actavis is looking into the possibility of buying Warner Chilcott, the generic drug maker said.

PARSIPPANY, N.J. — Actavis is looking into the possibility of buying Warner Chilcott, the generic drug maker said Friday.

Actavis, the world's third-largest generic drug maker, said it had entered into early-stage discussions with Warner Chilcott about a potential combination of the two, but that no agreement had been reached, and that it wouldn't issue further comment about the matter.

May 3, 2013

Actavis sales up 24% in first quarter 2013

Actavis' had $1.9 billion in sales in first quarter 2013, the drug maker said.

PARSIPPANY, N.J. — Actavis' had $1.9 billion in sales in first quarter 2013, the drug maker said.

The latest figure represented a 24% increase from first quarter 2012's $1.52 billion. "The new Actavis is off to a strong start in 2013, and as a result, we are increasing our 2013 forecast based on the strong performance and execution against our objectives to date," president and CEO Paul Bisaro said.

May 1, 2013

Actavis to acquire rights to Valeant drug

Drug maker Actavis has acquired rights to a treatment for an experimental bacterial vaginosis from Valeant Pharmaceuticals International for about $55 million, the drug makers said.

PARSIPPANY, N.J. — Drug maker Actavis has acquired rights to a treatment for an experimental bacterial vaginosis from Valeant Pharmaceuticals International for about $55 million, the drug makers said Wednesday.

Actavis Specialty Brands' acquisition of Valeant's metronidazole vaginal gel is in the 1.3% strength. The deal includes an upfront payment, milestone payments and royalties for the first three years after the drug is commercialized. Actavis hopes to market the drug as early as the middle of next year.

April 29, 2013

Reports: Valeant, Actavis deal put on hold

A proposal by Canadian drug maker Valeant Pharmaceuticals International to purchase generic drug maker Actavis has fallen through, according to published reports.

NEW YORK — A proposal by Canadian drug maker Valeant Pharmaceuticals International to purchase generic drug maker Actavis has fallen through, according to published reports.

According to reports, Valeant was planning to pay more than $13 billion in stock to acquire Actavis, but the deal was put on hold because the companies could not agree to terms of the deal. The deal would create a company worth about $35 billion.

April 26, 2013

Actavis can launch generic OxyContin in January 2014 under settlement with Purdue

Generic drug maker Actavis is settling a patent-infringement suit with Purdue Pharma concerning the opioid painkiller OxyContin, Actavis said, saying it expected to make more than $100 million in the deal between 2014 and 2015.

PARSIPPANY, N.J. — Generic drug maker Actavis is settling a patent-infringement suit with Purdue Pharma concerning the opioid painkiller OxyContin, Actavis said Friday, saying it expected to make more than $100 million in the deal between 2014 and 2015.

April 25, 2013

Actavis to launch generic ADHD drug in December 2014

Actavis can launch a generic version of an attention deficit hyperactivity disorder drug made by Shire next year under an agreement between the two companies announced Thursday.

PARSAPPANY, N.J. — Actavis can launch a generic version of an attention deficit hyperactivity disorder drug made by Shire next year under an agreement between the two companies announced Thursday.

April 21, 2013

Future of pay-for-delay in hands of SCOTUS

Last month, the Supreme Court heard Federal Trade Commission v. Actavis, which could impact the future of the generic drug industry at a time when 80% of all prescriptions dispensed in the United States are generic.

Last month, the Supreme Court heard Federal Trade Commission v. Actavis, which could impact the future of the generic drug industry at a time when 80% of all prescriptions dispensed in the United States are generic.

April 18, 2013

Actavis relaunches generic contraceptive

A federal court ruling has allowed Actavis to relaunch a generic contraceptive drug, the company said.

PARSIPPANY, N.J. — A federal court ruling has allowed Actavis to relaunch a generic contraceptive drug, the company said.

April 5, 2013

Actavis to market, distribute authorized generic version of Valeant drug; Valeant to co-promote Actavis drug

Actavis will market and distribute an authorized generic version of a genital herpes ointment made by Valeant Pharmaceuticals International, the companies said Friday.

PARSIPPANY, N.J. — Actavis will market and distribute an authorized generic version of a genital herpes ointment made by Valeant Pharmaceuticals International, the companies said Friday.

The agreement centers around Zovirax, known generically as acyclovir, in the 5% strength. The Food and Drug Administration approved the generic version, made by Mylan, on Wednesday. Financial terms of the deal were not disclosed.

April 2, 2013

Federal court rules in favor of Actavis in generic asthma drug case

A court has ruled in favor of generic drug maker Actavis concerning its generic version of a drug to treat asthma in children, the company said.

PARSIPPANY, N.J. — A court has ruled in favor of generic drug maker Actavis concerning its generic version of a drug to treat asthma in children, the company said.

April 1, 2013

Actavis seeks approval for additional strength of generic testosterone gel

Just a week after the Supreme Court heard the Federal Trade Commission's lawsuit over its deal with AbbVie to sell a generic version of a testosterone-replacement therapy, Actavis is challenging the patent on another strength of the drug.

PARSIPPANY, N.J. — Just a week after the Supreme Court heard the Federal Trade Commission's lawsuit over its deal with AbbVie to sell a generic version of a testosterone-replacement therapy, Actavis is challenging the patent on another strength of the drug.

Actavis said Monday that it had filed with the Food and Drug Administration for approval of testosterone gel in the 1.62% strength. The drug is a generic version of AbbVie's AndroGel 1.62%. The case that went before the Supreme Court on March 25 concerns the 1% strength of AndroGel.

March 26, 2013

FDA approves Actavis drug for opioid dependence

The Food and Drug Administration has approved a drug for opioid dependence made by Actavis, the company said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a drug for opioid dependence made by Actavis, the company said.

Actavis announced the approval of buprenorphine hydrochloride and naloxone hydrochloride dehydrate sub-lingual tablets in the 2 mg/0.5 mg and 8 mg/2 mg strengths.

The drug is a generic version of Reckitt Benckiser's Suboxone, which had sales of about $625 million in 2012, according to IMS Health.

March 25, 2013

Actavis can launch generic version of Crestor in 2016, under deal with AstraZeneca

Generic drug maker Actavis has reached a deal with AstraZeneca that will allow it to launch a version of a drug used to treat cholesterol in three years, Actavis said Monday.

PARSIPPANY, N.J. — Generic drug maker Actavis has reached a deal with AstraZeneca that will allow it to launch a version of a drug used to treat cholesterol in three years, Actavis said Monday.

Under a deal to settle a patent-infringement lawsuit, Actavis will be allowed to launch its generic version of Crestor (rosuvastatin calcium) tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths 67 days before July 8, 2016, when the drug's market exclusivity for use in children expires, at a fee of 39% of net sales to AstraZeneca.

March 12, 2013

Actavis seeks approval for Alzheimer's patch

Actavis is challenging Novartis' patent on a patch used to treat Alzheimer's disease, Actavis said.

PARSIPPANY, N.J. — Actavis is challenging Novartis' patent on a patch used to treat Alzheimer's disease, Actavis said.

The generic drug maker said it had filed with the Food and Drug Administration an amendment to its regulatory application for rivastigmine transdermal system to include the 13.3 mg-per-24-hours dosage strength, a generic version of Novartis' Exelon. Novartis filed suit against Actavis on Thursday in the U.S. District Court for the District of Delaware seeking to prevent commercialization of the generic version.

March 5, 2013

Actavis seeks approval for testosterone-replacement gel

Drug maker Actavis is challenging the patent for a drug used to treat testosterone deficiency or absence in men, the company said.

PARSIPPANY, N.J. — Drug maker Actavis is challenging the patent for a drug used to treat testosterone deficiency or absence in men, the company said.

Actavis, formerly known as Watson Pharmaceuticals, said it had filed a regulatory approval application with the Food and Drug Administration for a generic version of Endo Pharmaceuticals' Fortesta (testosterone) gel in the 10 mg-per-0.5 g strength.