Full Press Release Details
| Dr. Reddy's Laboratories Ltd. | |
| 8-2-337, Road No. 3, Banjara Hills, | |
| Hyderabad - 500 034, Telangana, | |
| India. | |
| CIN : L85195TG1984PLC004507 | |
| Tel : +91 40 4900 2900 | |
| Fax : +91 40 4900 2999 | |
| Email : mail@drreddys.com | |
| www.drreddys.com |
| Corporate Relationship Department | National Stock Exchange of India Ltd. | ||
| BSE Limited | "Exchange Plaza" | ||
| Dalal Street, Fort | Bandra-Kurla Complex, Bandra (East), | ||
| Mumbai - 400 001 | Mumbai - 400 051 | ||
| Fax Nos.: | 022-22723121 / 22723719 / | Fax Nos.: | 022-26598120/ 26598237/ |
| 22722037 / 22722039 | 26598238 | ||
| Scrip Code: 500124 | Scrip Code: DRREDDY-EQ |
Please find enclosed a Press Release
on "Dr. Reddy's Laboratories announces the re-launch of its Buprenorphine and Naloxone Sublingual Film after
favorable ruling in patent litigation"
This is for your information and record.
| With regards, | |
| /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. | AMIT AGARWAL amita@drreddys.com (Ph: +91-40-49002135) | MITALI SARKAR mitali.sarkar@drreddys.com (Ph: +91-40- 49002121) |
Dr. Reddy's Laboratories announces the re-launch
Buprenorphine and Naloxone Sublingual Film
after favorable ruling in patent litigation
Hyderabad, India and Princeton, NJ, USA. February 20,
2019 - Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred
to as "Dr. Reddy's") announced today the re-launch of its Buprenorphine and Naloxone Sublingual Film, 2 mg/0.5
mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg, a therapeutic equivalent generic version of Suboxone (buprenorphine and naloxone)
sublingual film, in the United States market.
The re-launch comes on the heels of a favorable decision
issued by the United States Court of Appeals for the Federal Circuit concluding that Indivior had not shown that it is likely to
succeed on its claim that Dr. Reddy's product infringes U.S. Patent No. 9,931,305. The Federal Circuit's 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. The Federal Circuit's decision went into effective yesterday. As a result of
the Federal Circuit's ruling, Dr. Reddy's has resumed shipping of the product.
"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 continuing to market
this important drug to the public," explains Marc Kikuchi, Chief Executive Officer, North America Generics. "Dr. Reddy's
is committed to providing affordable treatment options for opioid use disorder and addiction. We look forward to helping patients
and our communities in the United States who are impacted by the opioid epidemic."
In June 2018, 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
activities halted as a result of a court-imposed temporary restraining order (TRO) and preliminary injunction against Dr. Reddy's.
The TRO and preliminary injunction did not prohibit commercial manufacturing of the product.
Please click below for full Prescribing Information including
Suboxone is a registered trademark of Indivior UK
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 contained