The following should be read in conjunction with our consolidated financial statements and related notes beginning on page F 1 of this Annual Report. We earn revenue on net sales of VIVITROL, ARISTADA and ARISTADA INITIO, which are proprietary products that we manufacture, market and sell in the U.S., and manufacturing and/or royalty revenues on
An Indian national who heads a pharmaceutical company in Russia has been reportedly hospitalized after falling victim to an armed attack in Moscow. Four unknown assailants beat Jyoti Loomba and his driver with bats on the southeastern outskirts of Moscow Thursday evening, a police source told the RBC news website. They then shot Loomba several time
Albany, NY 02/15/2019 Biosimilars are biological products that are similar to FDA- approved drug known as branded drug. Biosimilars are drugs licensed by the European Medicines Agency and the U.S. FDA. Infliximab is a monoclonal antibody first manufactured by Janssen Biotech, Inc. in collaboration with Merck& Co. The U.S. Food and Drug Admini
We've been taking new policy steps at the FDA to support downward pressure on drug prices by helping to clear a path for more efficient generic development. We're working to reduce barriers to generic development and to lower the cost of generic entry so that more of the generic medicines that the FDA approves are launched and reach patients.
Alkermes plc today reported financial results for the year ended Dec. 31, 2018 and provided financial expectations for 2019.. Proprietary product net sales for VIVITROL and ARISTADA i were $132.7 million for the quarter, reflecting a 28% increase compared to the same period in the prior year. Net loss according to generally accepted accounting pr
Tokyo, Japan 02/14/2019 Recent trends suggest the Biosimilars Market is poised to grow rapidly in the near future just in time for the fast approaching tenth anniversary of the Affordable Care Act's Biologics Price Competition and Innovation Act of 2009.. Top Key Players:- Pfizer- Sandoz International GmbH- Teva Pharmaceuticals Industries-
Valley Cottage, NY 02/14/2019 Differential and innovative product strategies that are adopted by various multinational pharma companies have been fuelling the growth of branded generics market at a global scale. These strategies include establishing sustained local capabilities with the strong local talents, engaging in portfolio marketing,..
Nexus Pharmaceuticals announced today it has received U.S. Food and Drug Administration approval for Dicyclomine Hydrochloride Injection, USP in 20 mg/2mL vial, the generic equivalent to Bentyl . Dicyclomine HCl, USP, is currently listed on the American Society of Health-System Pharmacists' drug shortage list. The addition of Dicyclomine Injec
Sarasota, FL 02/13/2019 Pharmacology is the study of drugs and medicines, including their uses, effects, and characteristic. Generic drugs are chemically identical to their branded counterparts. It should be manufactured under the same rules and regulation of FDA's good manufacturing practice required for branded drugs.
DUBLIN- Perrigo Company plc, a leading global provider of' Quality, Affordable Self-care Products', today announced that it has settled its Hatch-Waxman litigation relating to its first-to-file Abbreviated New Drug Application for the generic equivalent to Jublia Topical Solution 10% brought by Valeant Pharmaceuticals North America LLC, Valeant...
Pharmaceutical giant Pfizer holds a lead in the erectile dysfunction market even as competition from generics erodes sales of its once-blockbuster male libido treatment, Viagra. In its first quarter, Viagra brought a total of $400 million in revenue for Pfizer and would later produce annual sales of about $1.8 billion. U.S. sales of "the little blu
Samsung Bioepis announces licensing agreement with C-Bridge to bring third-wave biosimilars to the Chinese market. The partnership will see Samsung Bioepis license biosimilar candidates to C-Bridge Capital, including SB11 and SB12 biosimilars to Lucentis and Soliris, respectively. C-Bridge is the right partner for this mission as evidenced in its..
Valley Cottage, NY 02/13/2019 Specialty Generics are the generic versions of specialty pharmaceutical products. They are cost-effective when compared with specialty pharmaceuticals. For instance, in October 2016, Intellipharmaceutics entered into an exclusive license and supply agreement with Mallinckrodt to market, distribute, and sell its e
Alembic Pharmaceuticals Limited today announced that its wholly owned step down subsidiary Orit Laboratories LLC has received approval from the US Food& Drug Administration for its Abbreviated New Drug Application Fenofibrate Tablets USP, 54 mg and 160 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product Tricor..
Global pharmaceutical company, Alvogen, today announced the launch of the first generic equivalent of Revlimid? in a range of its operating CEE markets including Romania, Croatia, Bulgaria and the Baltic states. By the time of Alvogen launch, Revlimid? is perceived as the single biggest-selling oncology drug with approximately $9.8 billion sale
New York, NY 02/12/2019 The latest report on the Biosimilars market closely surveys, examines and offers vital statistics on the Biosimilars market for the forecast period 2018- 2026. This market intelligence assessment report weighs up on the potential region that reserves greater opportunities for this industry. The major players covered in
Boca Raton- Breckenridge Pharmaceutical, Inc. announced today the immediate launch of Tetracycline Capsules. The U.S. Food and Drug Administration had granted final approval for this Abbreviated New Drug Application on November 7, 2018. Breckenridge Pharmaceutical, Inc. is a privately-held own-label distributor that performs pharmaceutical...
Hyderabad- Dr. Reddy's Laboratories Ltd. today announced the launch of Tadalafil Tablets USP, a therapeutic equivalent generic version of Adcirca Tablets in the United States market, approved by the U.S. Food and Drug Administration. Dr. Reddy's Laboratories Ltd. is an integrated pharmaceutical company, committed to providing affordable and innovat
WASHINGTON As Maine people struggle with ever-increasing healthcare costs, Congressman Jared Golden introduced a bill today to help address unfair price hikes for prescription drugs. Representatives Sean Casten, Elissa Slotkin, Gil Cisneros, Max Rose, and Chellie Pingree cosponsored Golden's bill, the Forcing Limits on Abusive and Tumultuous Pric
The "Global Generic Pharmaceutical Partnering Terms and Agreements 2012-2018: Deal trends, players and financials" report has been added to ResearchAndMarkets.com' s offering. Global Generic Pharmaceutical Partnering Terms and Agreements 2012 to 2018 report provides a detailed understanding and analysis of how and why companies enter Generic...
Mumbai- Pharma major Lupin announced the launch of Tadalafil Tablets USP 20 mg, having received an approval from the United States Food and Drug Administration earlier. For the financial year ended 31st March, 2018, Lupin's Consolidated sales and Net profits before exceptional items were at Rs. 155,598 million and Rs. 13,934 million respectively.
Mumbai- Pharma major Lupin announced that it has received approval for its Fluoxetine Tablets USP, 60 mg, from the United States Food and Drug Administration to market a generic version of Alvogen's Fluoxetine Tablets, 60 mg. Lupin's Fluoxetine Tablets USP, 60 mg, is the generic version of Alvogen's Fluoxetine Tablets, 60 mg. It is indicated in the
HERTFORDSHIRE- Mylan N.V. today announced the launch of the first FDA- approved therapeutically equivalent, substitutable generic of ADVAIR DISKUS, Wixela Inhub, approved by the U.S. Food and Drug Administration through the Abbreviated New Drug Application pathway. The wholesale acquisition costs of Wixela Inhub 100 mcg/50 mcg, 250 mcg/50 mcg and 5
Perrigo Company plc, a leading global provider of "Quality, Affordable Self-care Products?", today announced that it has settled its Hatch-Waxman litigation relating to its first-to-file Abbreviated New Drug Application for the generic equivalent to Jublia Topical Solution 10% brought by Valeant Pharmaceuticals North America LLC, Valeant...
According to Market Research Future, the Global Pharmaceutical Excipients Market to provide readers with a clear view of the market's likely growth trajectory over the coming years. The report utilizes historical trends of the Global Pharmaceutical Excipients Market and present statistics to derive. Global Pharmaceutical Excipients Market will...