Content about Oral contraceptive formulations

April 15, 2014

Actavis on Tuesday announced that it has entered into an agreement with Mylan and Famy Care to settle all outstanding patent litigation related to Mylan's generic version of Generess FE (norethindrone, ethinyl estradiol and ferrous fumarate chewable tablets).

DUBLIN — Actavis on Tuesday announced that it has entered into an agreement with Mylan and Famy Care to settle all outstanding patent litigation related to Mylan's generic version of Generess FE (norethindrone, ethinyl estradiol and ferrous fumarate chewable tablets).

Under the terms of the agreement, Actavis will grant Mylan a license to market its generic version of Generess FE under its pending abbreviated new drug application beginning on April 1, 2015.

January 21, 2014

Actavis 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).

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.

November 8, 2013

Generic drug maker Amneal Pharmaceuticals will launch its version of a contraceptive product at the beginning of January, the drug maker said.

BRIDGEWATER, N.J. — Generic drug maker Amneal Pharmaceuticals will launch its version of a contraceptive product at the beginning of January, the drug maker said.

Amneal said it would launch its version of 24 Fe (norethindrone acetate and ethinyl estradiol tablets; ferrous fumarate tablets) in the 1 mg/20 mcg and 75 mg strength. As the first company to successfully file for Food and Drug Administration approval of the drug, Amneal's product will have 180 days in which to compete exclusively against the branded version.

October 22, 2013

The Food and Drug Administration has approved a generic contraceptive drug made by Famy Care, agency records show.

SILVER SPRING, Md. — The Food and Drug Administration has approved a generic contraceptive drug made by Famy Care, agency records show.

The agency approved Famy's levonorgestrel and ethinyl estradiol tablets in the 0.02-mg/0.1-mg strengths.

The drug is a generic version of Aviane-28, made by Teva Women's Health, a division of Israeli drug maker Teva Pharmaceutical Industries that previously went under the name Duramed.

 

September 30, 2013

Amneal Pharmaceuticals has bought rights to four generic drugs from Actavis, Amneal said Monday.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has bought rights to four generic drugs from Actavis, Amneal said Monday.

July 16, 2013

Mylan has launched a generic contraceptive therapy, the drug maker said Tuesday.

PITTSBURGH — Mylan has launched a generic contraceptive therapy, the drug maker said Tuesday.

Mylan, through its Mylan Pharmaceuticals subsidiary, announced the launch of norethindrone tablets in the 0.35-mg strength. The drug is a generic version of Actavis' Nor-Q.D. tablets, which are taken on a 28-day cycle to prevent pregnancy. Mylan is partnering with Famy Care, which filed for and received Food and Drug Administration approval for the drug.

June 26, 2013

Mylan has launched a generic version of a Johnson & Johnson contraceptive, the company said Wednesday.

PITTSBURGH — Mylan has launched a generic version of a Johnson & Johnson contraceptive, the company said Wednesday.

Mylan announced the launch of norethindrone tablets in the 0.35 mg strength. The drug is a generic version of Micronor, made by J&J subsidiary Janssen Pharmaceuticals. A company partnering with Mylan on the drug, Famy Care, received approval from the Food and Drug Administration for the drug.

Various versions of the drug had sales of about $57.2 million during the 12-month period that ended in March, according to IMS Health.

May 14, 2013

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.

April 23, 2013

The Food and Drug Administration has approved a new contraceptive drug made by Warner Chilcott, the drug maker said.

DUBLIN — The Food and Drug Administration has approved a new contraceptive drug made by Warner Chilcott, the drug maker said.

Warner Chilcott announced the approval of Minastrin 24 FE (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) for prevention of pregnancy.

The drug maker said an unnamed third-party company would manufacture the drug, but it did not expect to launch it this year.

 

April 12, 2013

The Food and Drug Administration has approved a contraceptive therapy made by Lupin Pharmaceuticals, the Indian drug maker said Friday.

MUMBAI, India — The Food and Drug Administration has approved a contraceptive therapy made by Lupin Pharmaceuticals, the Indian drug maker said Friday.

Lupin announced the approval of Daysee (levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets) in the 0.15-mg/0.03-mg and 0.01-mg strengths.

The drug is a generic version of Teva's Seasonique. Various versions of the drug had sales of $161 million in 2012, according to IMS Health.

 

March 20, 2013

The Food and Drug Administration has approved and launched two generic contraceptives made by Sandoz, the drug maker said.

PRINCETON, N.J. — The Food and Drug Administration has approved and launched two generic contraceptives made by Sandoz, the drug maker said.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval of Estarylla (norgestimate and ethinyl estradiol tablets) and Tri-Estarylla (norgestimate and ethinyl estradiol tablets), generic versions of Johnson & Johnson's Ortho Cyclen and Ortho Tri-Cyclen, respectively. Sandoz said the launches brought the total number of oral contraceptives it has launched since the beginning of 2011 to six.

January 22, 2013

The Food and Drug Administration has approved a generic contraceptive made by Lupin Pharmaceuticals, the drug maker said Tuesday.

BALTIMORE — The Food and Drug Administration has approved a generic contraceptive made by Lupin Pharmaceuticals, the drug maker said Tuesday.

Lupin announced the approval of levonorgestrel and ethinyl estradiol tablets in the 0.1 mg/0.02 mg strength, a generic version of Watson Labs' Lutera.

Lutera had sales of about $103.6 million during the 12-month period that ended in September 2012, according to IMS Health.

December 28, 2012

Mylan on Friday announced that its partner Famy Care has received final approval from the Food and Drug Administration for its abbreviated new drug application for levonorgestrel and ethinyl estradiol Tablets USP in the 0.15mg/0.03mg strength.

PITTSBURGH — Mylan on Friday announced that its partner Famy Care has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for levonorgestrel and ethinyl estradiol tablets USP in the 0.15mg/0.03mg strength.

The product is a generic version of Teva Branded Pharmaceutical Products' Nordette 28 Tablets, a form of oral contraception. The new product will be distributed in the United States by Mylan Pharmaceuticals, and the company is shipping the product immediately.

October 18, 2012

The Food and Drug Administration has approved a generic contraceptive made by Indian drug maker Lupin, the company said Thursday.

MUMBAI, India — The Food and Drug Administration has approved a generic contraceptive made by Indian drug maker Lupin, the company said Thursday.

Lupin announced the approval of Kurvelo (levonorgestrel and ethinyl estradiol) tablets in the 0.15 mg/0.03 mg strength.

The drug is a generic version of Teva's branded Nordette. Nordette had sales of about $59 million during the 12-month period ended in June, according to IMS Health.

August 13, 2012

The Food and Drug Administration is reviewing a regulatory application from Teva for a contraceptive drug, the company said Monday.

FRAZER, Pa. — The Food and Drug Administration is reviewing a regulatory application from Teva for a contraceptive drug, the company said Monday.

Teva Women's Health, part of Israeli drug maker Teva Pharmaceutical Industries, announced the FDA's acceptance of its application for Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol), which the company called the first ascending-dose, extended regimen oral contraceptive for preventing pregnancy.

July 3, 2012

The Food and Drug Administration has approved a generic contraceptive drug made by Lupin Pharmaceuticals, the company said Tuesday.

BALTIMORE — The Food and Drug Administration has approved a generic contraceptive drug made by Lupin Pharmaceuticals, the company said Tuesday.

Lupin announced the approval of norgestimate and ethinyl estradiol tablets in the 0.18/0.025-mg, 0.215/0.025-mg and 0.25/0.025-mg strengths.

The drug is a generic version of Ortho Tri-Cyclen Lo, made by Johnson & Johnson subsidiary Janssen Pharmaceuticals. The branded version of the drug had sales of about $421 million during the 12-month period ended in March, according to IMS Health.

May 18, 2012

Generic drug maker Watson Pharmaceuticals is challenging the patent protection of a contraceptive drug made by Warner Chilcott, Watson said Friday.

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals is challenging the patent protection of a contraceptive drug made by Warner Chilcott, Watson said Friday.

The company announced that it had filed a regulatory application with the Food and Drug Administration for norethindrone acetate and ethinyl estradiol tablets in the 1-mg/0.01-mg strength and ethinyl estradiol and ferrous fumarate tablets in the 0.01-mg/75-mg strength. The treatment is a generic version of Warner Chilcott's Lo Loestrin Fe.

March 15, 2012

The Food and Drug Administration has approved a drug that the manufacturer called the first oral contraceptive that also treats heavy menstrual bleeding.

WAYNE, N.J. — The Food and Drug Administration has approved a drug that the manufacturer called the first oral contraceptive that also treats heavy menstrual bleeding.

Bayer HealthCare Pharmaceuticals announced Wednesday the approval of Natazia (estradiol valerate and estradiol valerate and dienogest) tablets for heavy menstrual bleeding not caused by any conditions of the uterus. The drug was originally approved as an oral contraceptive in May 2010.

March 6, 2012

The Food and Drug Administration has approved a new formulation of a drug for postmenopausal women.

WAYNE, N.J. — The Food and Drug Administration has approved a new formulation of a drug for postmenopausal women.

Bayer HealthCare Pharmaceuticals said the FDA approved a lower-dose formulation of Angeliq (drospirenone and estradiol) tablets, used to treat moderate to severe vasomotor symptoms due to menopause in women who have a uterus. The new formulation contains 0.25-mg drospirenone and 0.5-mg estradiol, while the previously approved formulation contained 0.5-mg drospirenone and 1-mg estradiol.

February 8, 2012

Subsidiaries of Watson Pharmaceuticals and Johnson & Johnson have settled a lawsuit filed by the latter when Watson attempted to market a generic version of one of its contraceptive drugs.

PARSIPPANY, N.J. — Subsidiaries of Watson Pharmaceuticals and Johnson & Johnson have settled a lawsuit filed by the latter when Watson attempted to market a generic version of one of its contraceptive drugs.

February 1, 2012

A possible pill mix-up has prompted Pfizer to recall more than two dozen lots of a prescription contraceptive drug, the drug maker said.

NEW YORK — A possible pill mix-up has prompted Pfizer to recall more than two dozen lots of a prescription contraceptive drug, the drug maker said.

Pfizer announced the voluntary nationwide recall of 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol) tablets and 14 additional lots of the drug's generic version. Pfizer manufactured and packaged the drugs, while Akrimax Pharmaceuticals commercialized them, and they were sold under the Akrimax brand.

December 1, 2011

Generic drug maker Mylan and a partnering company are challenging the patent on a contraceptive drug.

PITTSBURGH — Generic drug maker Mylan and a partnering company are challenging the patent on a contraceptive drug.

Mylan said Thursday that it and Famy Care had been sued by Warner Chilcott in the U.S. District Court for the District of New Jersey following their filing of a regulatory approval application with the Food and Drug Administration for norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets, a generic version of Warner Chilcott's Generess Fe.

November 11, 2011

An appeals court has thrown out an attempt by Teva Pharmaceutical Industries to stop Watson Pharmaceuticals from selling a generic contraceptive, Watson said.

PARSIPPANY, N.J. — An appeals court has thrown out an attempt by Teva Pharmaceutical Industries to stop Watson Pharmaceuticals from selling a generic contraceptive, Watson said.

The U.S. Court of Appeals for the Federal Circuit affirmed a lower court's June 16 decision to deny Duramed Pharmaceuticals' request for an injunction that would stop Watson from selling a generic version of Seasonique (levonorgestrel and ethinyl estradiol [0.15 mg/0.03 mg] and ethinyl estradiol [0.01 mg]). Duramed originally was a subsidiary of Barr Pharmaceuticals, which Teva acquired in 2008.

October 19, 2011

Generic drug maker Mylan has settled with Warner Chilcott in a case concerning an oral contraceptive.

PITTSBURGH — Generic drug maker Mylan has settled with Warner Chilcott in a case concerning an oral contraceptive.

Mylan said Wednesday that it and Famy Care had entered into an agreement with Warner Chilcott resolving a lawsuit over Femcon Fe (norethindrone and ethinyl estradiol chewable tablets, ferrous fumarate tablets).

October 11, 2011

Indian generic drug maker Lupin has launched an authorized generic version of a birth control pill made by Warner Chilcott, according to published reports.

NEW YORK — Indian generic drug maker Lupin has launched an authorized generic version of a birth control pill made by Warner Chilcott, according to published reports.

Dow Jones reported that Lupin launched an authorized generic of Femcon (norethindrone and ethinyl estradiol tablets, ferrous fumarate tablets).

An authorized generic is a branded drug sold under its generic name at a reduced price, usually through a third-party company.