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February 06, 2016 9:34 PM ET

Pharmaceuticals

Company Overview of Lupin Pharmaceuticals, Inc.

Company Overview

Lupin Pharmaceuticals, Inc. engages in the development and manufacture of branded and generic pharmaceutical products. It offers generic pharmaceutical products for a range of therapeutic areas; and generic Gatifloxacin Ophthalmic Solution for the treatment of bacterial conjunctivitis. The company also engages in identifying, developing, and marketing prescription drugs for children through distributors in the United States; and manufactures oral and injectable cephalosporin APIs. In addition, it offers oral contraceptives for the prevention of pregnancy in women. Lupin Pharmaceuticals, Inc. was founded in 2003 and is based in Baltimore, Maryland. The company has plants in Mandideep, Auranga...

111 South Calvert Street

Harborplace Tower

21st Floor

Baltimore, MD 21202

United States

Founded in 2003

Phone:

410-576-2000

Fax:

410-576-2221

Key Executives for Lupin Pharmaceuticals, Inc.

Chief Executive Officer and Managing Director
Age: 47
Compensation as of Fiscal Year 2015.

Lupin Pharmaceuticals, Inc. Key Developments

Lupin Pharmaceuticals, Inc. Launches Generic Glumetza HCI ER Tablets in the US

Lupin Pharmaceuticals Inc. has launched its Metformin HCl ER Tablets, 500 mg and 1000 mg to market a generic equivalent of Santarus Inc.'s Glumetza® HCl ER Tablets, 500 mg and 1000 mg. Lupin's Metformin HCl ER Tablets, 500 mg and 1000 mg are the AB-rated generic equivalent of Santarus Inc.'s Glumetza® HCl ER Tablets, 500 mg and 1000 mg strengths. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type II diabetes mellitus. Lupin is eligible for 180 days of generic drug exclusivity for its Metformin HCl ER Tablets, 500 mg and 1000 mg. Glumetza® HCI ER Tablets had US sales of USD 450.4 million (IMS MAT September 2015).

Lupin Pharmaceuticals, Inc. Launches Generic Ortho Tri-Cyclen® Lo Tablets in the US

Lupin Pharmaceutical Inc. has launched its Tri-Lo-Marzia™ Tablets (Norgestimate and Ethinyl Estradiol Tablets USP, 0.180 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.250 mg/0.025 mg) having received approval from the United States Food and Drug Administration (FDA) to market a generic equivalent of Janssen Pharmaceuticals Inc. (Janssen) Ortho Tri-Cyclen® Lo Tablets, (Norgestimate and Ethinyl Estradiol Tablets USP, 0.180 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.250 mg/0.025 mg). Lupin's Tri-Lo-Marzia™ Tablets (Norgestimate and Ethinyl Estradiol Tablets USP, 0.180 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.250 mg/0.025 mg) are the AB rated generic equivalent of Janssen Ortho Tri-Cyclen® Lo Tablets, (Norgestimate and Ethinyl Estradiol Tablets USP, 0.180 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.250 mg/0.025 mg). It is indicated for use by women to prevent pregnancy. Ortho Tri-Cyclen® Lo Tablets had US sales of USD 488.4 million (IMS MAT September 2015). The product represents Lupin's 16th oral contraceptive launch in the US. The company has filed 37 oral contraceptive products with the FDA till date.

Vanda Pharmaceuticals Inc. Files Patent Infringement Lawsuit against Lupin Limited and Lupin Pharmaceuticals, Inc

On November 19, 2015, Vanda Pharmaceuticals Inc. filed a patent infringement lawsuit in the United States District Court for the District of Delaware against Lupin Limited and Lupin Pharmaceuticals, Inc. The lawsuit seeks an adjudication that Lupin has infringed one or more claims of the company's U.S. Patent No. 9,138,432 (the 432 Patent) and U.S. Patent No. 8,586,610 (the 610 Patent) by submitting to the U.S. Food and Drug Administration an Abbreviated New Drug Application for a generic version of Fanapt prior to the expiration of the 432 Patent in September 2025 and the 610 Patent in November 2027. The relief requested by the Company in the lawsuit includes a request for a permanent injunction preventing Lupin from infringing the asserted claims of the 432 Patent and the 610 Patent by engaging in the manufacture, use, offer to sell, sale, importation or distribution of generic versions of Fanapt before their respective expiration dates.

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