April 22, 2018 6:27 PM ET

Pharmaceuticals

Company Overview of Lupin Pharmaceuticals, Inc.

Company Overview

Lupin Pharmaceuticals, Inc. develops and manufactures branded and generic pharmaceutical products for healthcare professionals and patients in India and the United States. It offers generic pharmaceutical products in the areas of oral and injectable cephalosporins; cardiovascular; controlled release ANDA's; and paragraph IV's. It also offers fermentation products; Suprax, an anti-infective product available in tablets and suspension formulations in pediatric and other physician practices for children; cephalosporin API’s; ACE-inhibitors and cholesterol reducing agents; and Amabelz (Estradiol and Norethindrone Acetate tablets) for treatment of moderate to severe vasomotor symptoms due to meno...

111 South Calvert Street

Harborplace Tower

21st Floor

Baltimore, MD 21202

United States

Founded in 2003

Phone:

866-587-4617

Fax:

866-587-4627

Key Executives for Lupin Pharmaceuticals, Inc.

Chief Executive Officer and Managing Director
Age: 49
Compensation as of Fiscal Year 2017.

Lupin Pharmaceuticals, Inc. Key Developments

Horizon Pharma plc Announces District Court Decision to Uphold VIMOVO® (Naproxen/Esomeprazole Magnesium) Patents

Horizon Pharma plc announced that the United States District Court for the District of New Jersey upheld the validity of two Horizon Pharma patents covering VIMOVO® (naproxen/esomeprazole magnesium), and that Dr. Reddy’s Laboratories Inc. and Dr. Reddy’s Laboratories Ltd., Mylan Pharmaceuticals Inc., Mylan Laboratories Ltd., and Mylan Inc., and Lupin Ltd. and Lupin Pharmaceuticals Inc. would infringe at least one of the two patents with their proposed generic naproxen/esomeprazole magnesium products. On April 21, 2011, July 25, 2011, and June 28, 2013, Horizon filed patent infringement lawsuits in District Court against Dr. Reddy’s, Lupin, and Mylan, respectively, related to Abbreviated New Drug Applications filed with the U.S. Food and Drug Administration to market generic versions of VIMOVO. The lawsuits claim infringement of Horizon's U.S. Patent Nos. 8,557,285 (‘285 patent) and 6,926,907 (‘907 patent) titled “Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs,” which cover VIMOVO. The District Court’s decision was made based on the validity of Horizon Pharma’s ‘285 and ‘907 patents for VIMOVO and the Court’s judgment will prevent Dr. Reddy’s, Mylan, and Lupin from launching generic versions of VIMOVO in the United States.

Lupin Pharmaceuticals Inc. Announces Nationwide Recall of MibelasTM 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1Mg/0.02Mg Chewable Tablets and Ferrous Fumarate 75Mg) Tablets

Lupin Pharmaceuticals Inc. announced that it has voluntarily recalled lot L600518, Exp 05/18 of Mibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg) Tablets at the consumer level. A confirmed market complaint indicated a packaging error, where the blister was rotated 180 degrees within the wallet, reversing the weekly tablet orientation and making the lot number and expiration date no longer visible. The first four days of therapy would have had four non-hormonal placebo tablets as opposed to the active tablets. As a result of this packaging error, oral contraceptive tablets that are taken out of sequence may place the user at risk for contraceptive failure and unintended pregnancy. The reversing the order may not be apparent to either new users or previous users of the product, increasing the likelihood of taking the tablets out of order. For patients in whom a pregnancy is contraindicated or in whom concomitant medication(s) may have teratogenic effects, an unintended pregnancy may cause significant adverse maternal or fetal health consequences, including death. To date there have been no reports of such adverse events. This product is an oral contraceptive indicated for the prevention of pregnancy in women who elect to use oral contraceptives. These products are packaged in blister packs containing 28 tablets: 24 white/off-white tablets of active ingredients debossed with 'LU' on one side and 'N81' on the other; and 4 tablets of inert ingredients debossed with 'LU' on one side and 'M22' on the other side. This product was distributed Nationwide in the U.S.A. to wholesalers, clinics and retail pharmacies.

Medicis Pharmaceutical Corp., Valeant Pharmaceuticals International, Inc., Impax Laboratories, Inc., Lupin Limited, Lupin Pharmaceuticals Inc., and Sandoz Inc. Partially Settle Class Action Lawsuit Involving the Antibiotic Drug Solodyn

Partial settlements have been reached in a class action lawsuit involving the antibiotic drug Solodyn. The lawsuit claims that Medicis Pharmaceutical Corp., Valeant Pharmaceuticals International, Inc., Impax Laboratories, Inc., Lupin Limited, Lupin Pharmaceuticals Inc., and Sandoz Inc. (Defendants) violated state competition (antitrust and consumer protection) and unjust enrichment laws by agreeing not to compete with each other and keeping lower-cost generic versions of Solodyn off the market. The Defendants deny this. No one is claiming that Solodyn is unsafe or ineffective. To settle the lawsuit, Lupin Pharmaceuticals Inc. and Lupin Limited (Lupin Defendants) and Sandoz Inc. have each agreed: that they would be willing to provide certain witnesses that Plaintiffs could call and a declaration that the Plaintiffs could use during the Solodyn case involving the overall End-Payor Class, other Plaintiffs, and the Non-Settling Defendants; and to deposit $625,000 and $1.75 million, respectively, into Settlement Funds. If the Settlements are approved by the Court and become final, the Settlement Funds, inclusive of interest, will be used to: pay for costs and expenses incurred or to be incurred by Counsel in continuing the lawsuit against Medicis Pharmaceutical Corp., Valeant Pharmaceuticals International, Inc., and Impax Laboratories, Inc. (Non-Settling Defendants); cover taxable costs and taxes payable on the Settlement Funds; pay for notice and other expenses; and pay for service awards not to exceed $10,000 to the class representatives in recognition of their efforts to date on behalf of the Classes. Any remainder in the Settlement Funds, after the payment of the above expenses, shall be distributed to the End-Payor Class for the Lupin Settlement and the End-Payor Class for the Sandoz Settlement in a manner approved by the court at the conclusion of the litigation. These settlements involve only the Lupin Defendants and Sandoz. The case will continue against the non-settling defendants.

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