{"id":48076,"date":"2022-09-07T20:01:49","date_gmt":"2022-09-07T18:01:49","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/dr-reddys-laboratories-announces-the-launch-of-lenalidomide-capsules-in-the-u-s-with-two-of-six-strengths-eligible-for-first-to-market-180-day-exclusivity\/"},"modified":"2022-09-07T20:01:49","modified_gmt":"2022-09-07T18:01:49","slug":"dr-reddys-laboratories-announces-the-launch-of-lenalidomide-capsules-in-the-u-s-with-two-of-six-strengths-eligible-for-first-to-market-180-day-exclusivity","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/dr-reddys-laboratories-announces-the-launch-of-lenalidomide-capsules-in-the-u-s-with-two-of-six-strengths-eligible-for-first-to-market-180-day-exclusivity\/","title":{"rendered":"Dr. Reddy&#8217;s Laboratories Announces the Launch of Lenalidomide Capsules in the U.S. With Two of Six Strengths Eligible for First-to-market, 180-day Exclusivity"},"content":{"rendered":"<div>\n<p>HYDERABAD, India &amp; PRINCETON, N.J.&#8211;(BUSINESS WIRE)&#8211;<a href=\"https:\/\/twitter.com\/search?q=%24RDY&amp;src=ctag\" target=\"_blank\" rel=\"noopener\">$RDY<\/a> <a href=\"https:\/\/twitter.com\/hashtag\/Affordablemedicines?src=hash\" target=\"_blank\" rel=\"noopener\">#Affordablemedicines<\/a>&#8211;Dr. Reddy\u2019s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as \u201cDr. Reddy\u2019s\u201d) today announced the launch, in the U.S. market, of Lenalidomide Capsules, a therapeutic equivalent generic version of REVLIMID\u00ae (lenalidomide) Capsules approved by U.S. Food and Drug Administration (USFDA). With this volume-limited launch, Dr. Reddy\u2019s is eligible for first-to-market, 180 days of generic drug exclusivity for Lenalidomide Capsules in 2.5 mg and 20 mg strengths.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220907006110\/en\/1564340\/5\/drreddyslogo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220907006110\/en\/1564340\/21\/drreddyslogo.jpg\"><\/a><\/p>\n<p>\n\u201cWe are pleased with the first-to-market launch of two of our six strengths of Lenalidomide Capsules with 180-day market exclusivity,\u201d says Marc Kikuchi, CEO, North America Generics, Dr. Reddy\u2019s Laboratories. \u201cBringing a more affordable generic version to market creates greater patient access for this important drug.\u201d\n<\/p>\n<p>\n<a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.drreddys.com%2Fcms%2Fcms%2Fsites%2Fdefault%2Ffiles%2F2022-02%2Fpress-release-lenalidomide-capsules-approval.pdf&amp;esheet=52867202&amp;newsitemid=20220907006110&amp;lan=en-US&amp;anchor=As+previously+announced&amp;index=1&amp;md5=7edbf9e3723b20e1cab9b9defd8212d3\" rel=\"nofollow noopener\" shape=\"rect\">As previously announced<\/a>, Celgene agreed to provide Dr. Reddy\u2019s with a license to sell volume-limited amounts of generic lenalidomide capsules in the U.S. in settlement of all outstanding claims of its litigation. The agreed-upon percentages remain confidential. As part of the settlement, Dr. Reddy\u2019s is also licensed to sell generic lenalidomide capsules in the U.S. without volume limitation beginning on January 31, 2026.\n<\/p>\n<p>\nDr. Reddy\u2019s Lenalidomide Capsules are available in strengths of 2.5 mg, 5 mg, and 10 mg, each in a bottle-count size of 28, as well as 15 mg, 20 mg, and 25 mg strengths, each in a bottle-count size of 21.\n<\/p>\n<p>\nPlease <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.drreddys.com%2Fpil%2F150090122-lenolidomide-outsert_v2.pdf&amp;esheet=52867202&amp;newsitemid=20220907006110&amp;lan=en-US&amp;anchor=click+here&amp;index=2&amp;md5=f12b38850374de51837de1ad464b3caf\" rel=\"nofollow noopener\" shape=\"rect\">click here<\/a> to see the full prescribing information, along with boxed warning for Dr. Reddy\u2019s Lenalidomide Capsules.\n<\/p>\n<table cellspacing=\"0\" class=\"bwtablemarginb bwblockalignl\">\n<tr>\n<td class=\"bwvertalignt bwtopsingle bwsinglebottom bwleftsingle bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<p class=\"bwalignc bwcellpmargin\">\n<b>WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY,<br \/>\n<br \/>and VENOUS and ARTERIAL THROMBOEMBOLISM<\/b>\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<p class=\"bwcellpmargin\">\n<i>See full prescribing information for complete boxed warning.<\/i>\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<p class=\"bwcellpmargin\">\n<span class=\"bwuline\">EMBRYO-FETAL TOXICITY<\/span>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nLenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study similar to birth defects caused by thalidomide in humans. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death.\n<\/li>\n<li>\nPregnancy must be excluded before start of treatment. Prevent pregnancy during treatment by the use of two reliable methods of contraception.\n<\/li>\n<\/ul>\n<p class=\"bwcellpmargin\">\nLenalidomide capsules are available only through a restricted distribution program, called the Lenalidomide REMS program.\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<p class=\"bwcellpmargin\">\n<span class=\"bwuline\">HEMATOLOGIC TOXICITY.<\/span>\n<\/p>\n<p class=\"bwcellpmargin\">\nLenalidomide can cause significant neutropenia and thrombocytopenia.\n<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<p class=\"bwcellpmargin\">\n<span class=\"bwuline\">VENOUS AND ARTERIAL THROMBOEMBOLISM<\/span>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nSignificantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with multiple myeloma receiving lenalidomide with dexamethasone. Anti-thrombotic prophylaxis is recommended.\n<\/li>\n<\/ul>\n<p class=\"bwcellpmargin\">\n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n<p>\nRevlimid\u00ae is a trademark of Celgene, a wholly-owned subsidiary of Bristol Myers Squibb.\n<\/p>\n<p>\nRDY-0822-441\n<\/p>\n<p>\n<b>About Dr. Reddy\u2019s<\/b>: Dr. Reddy\u2019s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Dr. Reddy\u2019s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy\u2019s operates in markets across the globe. Our major markets include \u2013 USA, India, Russia &amp; CIS countries, and Europe. For more information, log on to:<b> <\/b><a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.drreddys.com&amp;esheet=52867202&amp;newsitemid=20220907006110&amp;lan=en-US&amp;anchor=www.drreddys.com&amp;index=3&amp;md5=4327f325070fd37ecd12e4fe340dd061\" rel=\"nofollow noopener\" shape=\"rect\">www.drreddys.com<\/a>\n<\/p>\n<p>\nDisclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management\u2019s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words &#8220;may&#8221;, &#8220;will&#8221;, &#8220;should&#8221;, &#8220;expects&#8221;, &#8220;plans&#8221;, &#8220;intends&#8221;, &#8220;anticipates&#8221;, &#8220;believes&#8221;, &#8220;estimates&#8221;, &#8220;predicts&#8221;, &#8220;potential&#8221;, or &#8220;continue&#8221; and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency \/ severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and\/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers\u2019, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the &#8220;Risk Factors&#8221; and &#8220;Forward-Looking Statements&#8221; sections of our Annual Report on Form 20-F for the year ended March 31, 2022. The company assumes no obligation to update any information contained herein.\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>INVESTOR RELATIONS<\/b><br \/>AMIT AGARWAL <span style=\"text-transform:uppercase;\"><a target=\"_blank\" href=\"&#x6d;&#97;&#x69;&#x6c;&#116;&#x6f;&#x3a;&#97;&#x6d;&#x69;&#116;&#x61;&#x40;d&#x72;&#x72;e&#x64;&#100;y&#x73;&#46;c&#x6f;&#109;\" rel=\"nofollow noopener\" shape=\"rect\">&#x61;&#x6d;&#x69;&#116;&#97;&#64;d&#x72;&#x72;&#x65;&#x64;&#100;&#121;s&#46;&#x63;&#x6f;&#x6d;<\/a><\/span>\n<\/p>\n<p>\n<b>MEDIA RELATIONS<\/b><br \/>USHA IYER<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#x61;&#x69;&#x6c;&#116;&#111;&#58;us&#x68;&#x61;&#x69;&#x79;&#x65;&#114;&#64;&#100;rr&#x65;&#x64;&#x64;&#x79;&#x73;&#46;&#99;&#111;m\" rel=\"nofollow noopener\" shape=\"rect\">USHAIY&#69;&#82;&#64;&#68;&#82;&#82;&#69;&#x44;&#x44;&#x59;&#x53;&#x2e;&#x43;&#x4f;&#x4d;<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>HYDERABAD, India &amp; PRINCETON, N.J.&#8211;(BUSINESS WIRE)&#8211;$RDY #Affordablemedicines&#8211;Dr. Reddy\u2019s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as \u201cDr. Reddy\u2019s\u201d) today announced the launch, in the U.S. market, of Lenalidomide Capsules, a therapeutic equivalent generic version of REVLIMID\u00ae (lenalidomide) Capsules approved by U.S. Food and Drug Administration &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/dr-reddys-laboratories-announces-the-launch-of-lenalidomide-capsules-in-the-u-s-with-two-of-six-strengths-eligible-for-first-to-market-180-day-exclusivity\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-48076","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Dr. Reddy&#039;s Laboratories Announces the Launch of Lenalidomide Capsules in the U.S. With Two of Six Strengths Eligible for First-to-market, 180-day Exclusivity - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/dr-reddys-laboratories-announces-the-launch-of-lenalidomide-capsules-in-the-u-s-with-two-of-six-strengths-eligible-for-first-to-market-180-day-exclusivity\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Dr. Reddy&#039;s Laboratories Announces the Launch of Lenalidomide Capsules in the U.S. With Two of Six Strengths Eligible for First-to-market, 180-day Exclusivity - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"HYDERABAD, India &amp; PRINCETON, N.J.&#8211;(BUSINESS WIRE)&#8211;$RDY #Affordablemedicines&#8211;Dr. Reddy\u2019s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as \u201cDr. Reddy\u2019s\u201d) today announced the launch, in the U.S. market, of Lenalidomide Capsules, a therapeutic equivalent generic version of REVLIMID\u00ae (lenalidomide) Capsules approved by U.S. Food and Drug Administration ... 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(BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as \u201cDr. Reddy\u2019s\u201d) today announced the launch, in the U.S. market, of Lenalidomide Capsules, a therapeutic equivalent generic version of REVLIMID\u00ae (lenalidomide) Capsules approved by U.S. Food and Drug Administration ... 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