Full Press Release Details
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| Scrip Code: 500124 | Scrip Code: DRREDDY-EQ |
Please find enclosed a Press Release on "Dr. Reddy's
Laboratories announces favorable outcome in Buprenorphine and Naloxone Sublingual Film patent litigation".
This is for your information and record.
| /s/ Vikas Sabharwal | |
| Vikas Sabharwal |
Assistant Company Secretary
CC:- New York Stock Exchange Inc.(Stock Code :RDY)
| CONTACT | ||
| DR. REDDY'S LABORATORIES LTD. | Investor relationS | Media relationS |
| 8-2-337, Road No. 3, Banjara Hills, Hyderabad - 500034. Telangana, India. | Saunak SAVLA saunaks@drreddys.com (Ph: +91-40-49002135) | Calvin Printer calvinprinter@drreddys.com (Ph: +91-40- 49002121) |
Dr. Reddy's Laboratories announces favorable
Buprenorphine and Naloxone Sublingual Film patent litigation
India, November 20, 2018
Hyderabad, India and Princeton, NJ, USA. November 20, 2018
- Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred
to as "Dr. Reddy's") announced today that the United States Court of Appeals for the Federal Circuit issued a
decision in favor of Dr. Reddy's Laboratories Inc., concluding that Indivior had not shown that it is likely to succeed on
the merits of its infringement case on U.S. Patent No. 9,931,305. This decision vacates the District Court's preliminary
injunction that had prohibited Dr. Reddy's from selling its generic version of Suboxone (buprenorphine and
naloxone) sublingual film. As a result of today's ruling, Dr. Reddy's will resume its launch activities as soon as
A company spokesperson stated, "We are pleased with the
decision of the appellate court in Dr. Reddy's favor, vacating the preliminary injunction that had prevented Dr. Reddy's
from bringing this important drug to the public. We are committed to providing affordable and innovative medicines that address
the unmet and under-met needs of patients around the world and in particular look forward to taking the lead in helping to fight
Opioid Use Disorder."
In June, the U.S. Food and Drug Administration (USFDA) approved
Dr. Reddy's Buprenorphine and Naloxone Sublingual Film, in four strengths including 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and
12 mg/3 mg, for sale in the U.S. market. The product was launched immediately after approval, with sales and commercialization
activites halted as a result of a court-imposted temporary restraining order (TRO) against Dr. Reddy's. The TRO did not include
a prohibition on commercial manufacturing of the product.
Please click below for full Prescribing Information including
Suboxone is a registered trademark of Indivior UK Ltd.
About Dr. Reddy's: Dr. Reddy's Laboratories
Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) is an integrated pharmaceutical company, committed to providing affordable and innovative
medicines for healthier lives. Through its three businesses - Pharmaceutical Services & Active Ingredients, Global Generics
and Proprietary Products - Dr. Reddy's 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's operates in markets across the globe. Our major markets
include - USA, India, Russia & CIS countries, and Europe. For more information, log on to: www.drreddys.com
Disclaimer: This press release may include statements
of future expectations and other forward-looking statements that are based on the management's 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 "may", "will", "should", "expects", "plans", "intends", "anticipates",
"believes", "estimates", "predicts", "potential", or "continue" 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
The company assumes no obligation to update any information