Content about Endo Pharmaceuticals

April 11, 2014

Mylan on Friday confirmed that a federal district court has granted its request to enforce a settlement agreement between Endo Pharmaceuticals and Mylan settling patent litigation in connection with Mylan's filing of an abbreviated new drug application with the Food and Drug Administration for frovatriptan succinate tablets, 2.5 mg.

PITTSBURGH — Mylan on Friday confirmed that a federal district court has granted its request to enforce a settlement agreement between Endo Pharmaceuticals and Mylan settling patent litigation in connection with Mylan's filing of an abbreviated new drug application with the Food and Drug Administration for frovatriptan succinate tablets, 2.5 mg. This product is the generic version of Frova, which is used to treat acute migraine headaches in adults. 

September 16, 2013

Actavis has launched a generic drug for post-shingles pain under an agreement with the branded drug's manufacturers, the company said Monday.

PARSIPPANY, N.J. — Actavis has launched a generic drug for post-shingles pain under an agreement with the branded drug's manufacturers, the company said Monday.

Actavis announced the launch of generic lidocaine topical patches in the 5% strength under a settlement agreement with Endo Pharmaceuticals and Teikoku Seiyaku Co. The drug is a generic version of Lidoderm, and Actavis said it was likely the first company to win approval for the generic from the Food and Drug Administration, thus entitling it to 180 days in which to compete exclusively against the branded version.

July 17, 2013

New, abuse-deterrent formulations of two opioid painkillers have not necessarily reduced doctors' unease with prescribing them, according to a new study.

 BURLINGTON, Mass. — New, abuse-deterrent formulations of two opioid painkillers have not necessarily reduced doctors' unease with prescribing them, according to a new study.

May 30, 2013

The year is only halfway done, but 2013 is already proving to be a year of particular importance for generic drugs as the industry awaits two important decisions from the Supreme Court and continues to wait for federal biosimilar regulations while fending off efforts to limit the scope of their use at the state level.

The year is only halfway done, but 2013 is already proving to be a year of particular importance for generic drugs as the industry awaits two important decisions from the Supreme Court and continues to wait for federal biosimilar regulations while fending off efforts to limit the scope of their use at the state level.

May 13, 2013

A ruling by the Food and Drug Administration means that generic versions of an opioid painkiller made by Endo Pharmaceuticals can stay on the market, drawing criticism from the drug maker.

SILVER SPRING, Md. — A ruling by the Food and Drug Administration means that generic versions of an opioid painkiller made by Endo Pharmaceuticals can stay on the market, drawing criticism from the drug maker.

April 16, 2013

Purdue Pharma's patent for OxyContin expired Tuesday, opening up the opioid painkiller to generic competition, but authorities have raised concerns about what they call the potential for generic versions to be abused.

NEW YORK — Purdue Pharma's patent for OxyContin expired Tuesday, opening up the opioid painkiller to generic competition, but authorities have raised concerns about what they call the potential for generic versions to be abused.

March 5, 2013

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.

January 9, 2013

One of the most serious drug abuse problems in the country doesn't involve heroin, methamphetamine or crack, but abuse of legal prescription drugs, particularly opioid painkillers, a problem that the Food and Drug Administration aims to change with draft guidance released Wednesday.

SILVER SPRING, Md. — One of the most serious drug abuse problems in the country doesn't involve heroin, methamphetamine or crack, but abuse of legal prescription drugs, particularly opioid painkillers, a problem that the Food and Drug Administration aims to change with draft guidance released Wednesday.

December 21, 2012

A federal court decision means that a nontamper-resistant formulation of a painkiller made by Endo Health Solutions can enter the market early next month, the drug maker said.

CHADDS FORD, Pa. — A federal court decision means that a nontamper-resistant formulation of a painkiller made by Endo Health Solutions can enter the market early next month, the drug maker said.

The U.S. District Court for the District of Columbia dismissed a case filed by Endo subsidiary Endo Pharmaceuticals against the Food and Drug Administration, in which the company had argued that the FDA failed meet a legal obligation to determine whether the original formulation of Opana ER (oxymorphone) extended-release tablets was withdrawn from the market for safety reasons.

August 24, 2012

The Food and Drug Administration has approved a generic medicated patch for treating pain made by Watson Pharmaceuticals, the company said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic medicated patch for treating pain made by Watson Pharmaceuticals, the company said.

Watson announced the approval of lidocaine topical patch in the 5% strength. The drug is a generic version of Endo Pharmaceuticals' Lidoderm, which had sales of about $1.2 billion during the 12-month period ended in June 2012, according to IMS Health.

May 29, 2012

Generic drug maker Watson Pharmaceuticals has entered a settlement that will allow it to launch a generic patch used to treat post herpetic neuralgia, a pain disorder associated with shingles.

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals has entered a settlement that will allow it to launch a generic patch used to treat post herpetic neuralgia, a pain disorder associated with shingles.

Watson announced Tuesday a settlement through one of its subsidiaries with Endo Pharmaceuticals and Teikoku Seiyaku Co. over its generic version of Lidoderm (lidocaine) topical patch. Lidoderm had sales of $1.2 billion during the 12-month period ended in March 2012, according to IMS Health.

May 24, 2012

The parent company of Endo Pharmaceuticals has changed its name, the company said.

CHADDS FORD, Pa. — The parent company of Endo Pharmaceuticals has changed its name, the company said.

Shareholders of Endo Pharmaceutical Holdings voted at the company's annual shareholder meeting Wednesday to change the company's name to Endo Health Solutions. The company said the name change would more accurately reflect its new business model, which aggregates four operating businesses into one enterprise.

March 14, 2012

Endo Pharmaceuticals is hoping the Food and Drug Administration will back tougher regulatory approval requirements for generic versions of one of its drugs.

CHADDS FORD, Pa. — Endo Pharmaceuticals is hoping the Food and Drug Administration will back tougher regulatory approval requirements for generic versions of one of its drugs.

March 1, 2012

Endo's parent company is looking to change its name and will integrate four of its operating units, the drug maker said Thursday.

CHADDS FORD, Pa. — Endo's parent company is looking to change its name and will integrate four of its operating units, the drug maker said Thursday.

Endo said the company, currently called Endo Pharmaceutical Holdings, would ask shareholders to approve changing the name to Endo Health Solutions at its annual shareholder meeting in May.

January 9, 2012

Endo Pharmaceuticals announced a short-term supply constraint of analgesic products, including Opana ER, due to the temporary shutdown of a manufacturing facility operated by Novartis Consumer Health.

CHADDS FORD, Pa. — Endo Pharmaceuticals announced a short-term supply constraint of analgesic products, including Opana ER, due to the temporary shutdown of a manufacturing facility operated by Novartis Consumer Health.

December 12, 2011

The Food and Drug Administration has approved a new formulation of a painkiller made by Endo Pharmaceuticals designed to thwart drug abuse, Endo said Monday.

CHADDS FORD, Pa. — The Food and Drug Administration has approved a new formulation of a painkiller made by Endo Pharmaceuticals designed to thwart drug abuse, Endo said Monday.

Endo announced the FDA's approval of a crush-resistant version of Opana ER (oxymorphone). Drug abusers often crush opioid pills in order to smoke, inhale or inject them. Endo developed the new formulation of the drug, scheduled for launch in 2012, using Grunenthal's Intac technology. The new version will otherwise be identical to the old one.

November 2, 2011

The Food and Drug Administration has approved a drug made by Endo Pharmaceuticals for high blood pressure.

CHADDS FORD, Pa. — The Food and Drug Administration has approved a drug made by Endo Pharmaceuticals for high blood pressure.

Endo announced Wednesday the approval of felodipine extended-release tablets in the 2.5-mg, 5-mg and 10-mg strengths. Endo's generic drugs division, Qualitest Pharmaceuticals, will manufacture and distribute the product.

The drug is a generic version of AstraZeneca's Plendil extended-release tablets. Felodipine had sales of about $84 million during the 12-month period ended in June, according to IMS Health.

September 16, 2011

Qualitest Pharmaceuticals, an Endo Pharmaceuticals subsidiary, issued a voluntary, nationwide recall of multiple lots of oral contraceptives at the retail level.

HUNTSVILLE, Ala. — Qualitest Pharmaceuticals, an Endo Pharmaceuticals subsidiary, issued a voluntary, nationwide recall of multiple lots of oral contraceptives at the retail level.

Qualitest said it recalled lots of the following birth control pills due to a packaging error, whereby select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date no longer visible. This error, the drug maker said, could leave women without adequate contraception and at risk for unintended pregnancy:

August 18, 2011

Endo Pharmaceuticals has ended its research program and collaboration with Grunenthal.

CHADDS FORD, Pa. — Endo Pharmaceuticals has ended its research program and collaboration with Grunenthal.

The announcement comes shortly after the companies revealed their mid-stage clinical trial results for axomadol — designed to treat chronic low back pain — did not meet the predetermined endpoint.

Endo licensed exclusive rights to develop and market axomadol in the United States and Canada from Grunenthal in February 2009.

August 17, 2011

Mylan announced Wednesday that it filed with the Food and Drug Administration for approval of a generic version of a drug for migraine headaches made by Endo Pharmaceuticals.

PITTSBURGH — Mylan announced Wednesday that it filed with the Food and Drug Administration for approval of a generic version of a drug for migraine headaches made by Endo Pharmaceuticals.

Mylan said it was the first to file for approval of a generic version of Frova (frovatriptan succinate EQ) tablets in the 2.5-mg strength. In response, Endo has filed a patent infringement lawsuit against Mylan in response to the filing.

Frova had sales of $68.2 million during the 12-month period ended in June, according to IMS Health.

June 24, 2011

The Food and Drug Administration has accepted a resubmission by Endo Pharmaceuticals of a regulatory application for an opioid pain drug designed to thwart abuse, Endo said.

CHADDS FORD, Pa. — The Food and Drug Administration has accepted a resubmission by Endo Pharmaceuticals of a regulatory application for an opioid pain drug designed to thwart abuse, Endo said.

The agency had declined to approve Endo’s Opana ER (oxymorphone hydrochloride) in January for reasons that the company did not specify, though the agency did not request additional clinical studies in its statement, known as a complete response letter.

June 22, 2011

Endo Pharmaceuticals has acquired a provider of devices and therapies for male and female pelvic health.

CHADDS FORD, Pa. — Endo Pharmaceuticals has acquired a provider of devices and therapies for male and female pelvic health.

Endo said its acquisition of American Medical Systems has boosted the drug maker's devices and services business segment, and the combination of AMS with Endo's existing platform will provide additional cost-effective solutions across the entire urology spectrum.

The company announced its definitive agreement to acquire AMS in a cash transaction valued for approximately $2.9 billion.

May 23, 2011

The FDA has approved a new treatment for Type 2 diabetes, the agency said. The FDA announced the approval of Tradjenta (linagliptin) made by Indianapolis-based Eli Lilly and German drug maker Boehringer Ingelheim.


SUPPLIER NEWS — The FDA has approved a new treatment for Type 2 diabetes, the agency said. The FDA announced the approval of Tradjenta (linagliptin) made by Indianapolis-based Eli Lilly and German drug maker Boehringer Ingelheim.


May 5, 2011

A generic drug maker has launched its version of a pain medication made by Endo Pharmaceuticals.

PITTSBURGH — A generic drug maker has launched its version of a pain medication made by Endo Pharmaceuticals.

Mylan and its subsidiary Mylan Pharmaceuticals launched oxycodone and aspirin tablets USP in the 4.8355-mg/325-mg strength, based on an agreement with licensing partner Coastal Pharmaceuticals. The drug, designed to treat moderate to severe pain, is a generic version of Percodan.

Oxycodone and aspirin tablets had U.S. sales of approximately $6.5 million for the 12 months ended Dec. 31, 2010, according to IMS Health.

April 11, 2011

Endo Pharmaceuticals will buy American Medical Systems for $2.9 billion, the drug maker said Monday.

CHADDS FORD, Pa. — Endo Pharmaceuticals will buy American Medical Systems for $2.9 billion, the drug maker said Monday.

Endo said it and AMS had reached an agreement whereby Endo would acquire the maker of devices and therapies for pelvic health for $30 per share. AMS’ business focuses on men’s health, women’s health and benign prostatic hyperplasia.