Indivior Announces Patent Trial and Appeal Board Ruling in Dr. Reddy’s Laboratories (DRL)’s Petition for Inter Partes Review of U.S. Patent No. 9,687,454 (the ‘454 Patent)
Slough, UK, 3 June 2020 – Indivior PLC (LON: INDV) (“Indivior” or the “Company”) today announced that
the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO)
issued a final written decision in the IPR of the ‘454 Patent. The ‘454 Patent is listed in the Orange Book
with respect to SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII).
On November 13, 2018, DRL filed two separate IPR petitions of the ’454 Patent with the USPTO. The
USPTO denied institution of one of the IPR petitions but granted institution for the second IPR petition.
A hearing took place on March 3, 2020 before the PTAB on the second IPR petition. Today, the PTAB
held that DRL demonstrated by a preponderance of the evidence that claims 1–5, 7, and 9–14 of the
’454 patent are unpatentable, but have not demonstrated by a preponderance of the evidence that
claim 8 of the ’454 patent is unpatentable. Claim 6 was not challenged and therefore is not addressed by
the PTAB’s opinion. Indivior is reviewing the PTAB’s decision and considering its options for appeal.
About Indivior
Indivior is a global pharmaceutical company working to help change patients’ lives by developing
medicines to treat addiction and serious mental illnesses. Our vision is that all patients around the world
will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of
addiction. Indivior is dedicated to transforming addiction from a global human crisis to a recognized and
treated chronic disease.
Building on its global portfolio of opioid dependence treatments, Indivior has a pipeline of product
candidates designed to both expand on its heritage in this category and potentially address other
chronic conditions and co-occurring disorders of addiction, including alcohol use disorder.
Headquartered in the United States in Richmond, VA, Indivior employs more than 800 individuals
globally and its portfolio of products is available in over 40 countries worldwide. Visit www.indivior.com
to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.
SUBOXONE® (BUPRENORPHINE AND NALOXONE) SUBLINGUAL FILM (CIII)
Indication
SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is a prescription medicine indicated for
treatment of opioid dependence and should be used as part of a complete treatment plan to include
counseling and psychosocial support.
Treatment should be initiated under the direction of healthcare providers qualified under the Drug
Addiction Treatment Act.
Important Safety Information
Do not take SUBOXONE® Film if you are allergic to buprenorphine or naloxone as serious negative
effects, including anaphylactic shock, have been reported.
SUBOXONE® Film can be abused in a manner similar to other opioids, legal or illicit.
SUBOXONE® Film contains buprenorphine, an opioid that can cause physical dependence with chronic
use. Physical dependence is not the same as addiction. Your healthcare provider can tell you more about
the difference between physical dependence and drug addiction. Do not stop taking SUBOXONE® Film
suddenly without talking to your healthcare provider. You could become sick with uncomfortable
withdrawal symptoms because your body has become used to this medicine.
SUBOXONE® Film can cause serious life-threatening breathing problems, overdose and death,
particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other
medications that act on the nervous system (i.e., sedatives, tranquilizers, or alcohol). It is extremely
dangerous to take nonprescribed benzodiazepines or other medications that act on the nervous system
while taking SUBOXONE® Film.
You should not drink alcohol while taking SUBOXONE® Film, as this can lead to loss of consciousness or
even death.
Death has been reported in those who are not opioid dependent.
Your healthcare provider may monitor liver function before and during treatment.
SUBOXONE® Film is not recommended in patients with severe hepatic impairment and may not be
appropriate for patients with moderate hepatic impairment. However, SUBOXONE® Film may be used
with caution for maintenance treatment in patients with moderate hepatic impairment who have
initiated treatment on a buprenorphine product without naloxone.
Keep SUBOXONE® Film out of the sight and reach of children. Accidental or deliberate ingestion of
SUBOXONE® Film by a child can cause severe breathing problems and death.
Do not take SUBOXONE® Film before the effects of other opioids (e.g., heroin, hydrocodone,
methadone, morphine, oxycodone) have subsided as you may experience withdrawal symptoms.
Injecting the SUBOXONE® Film product may cause serious withdrawal symptoms such as pain, cramps,
vomiting, diarrhea, anxiety, sleep problems, and cravings.
Before taking SUBOXONE® Film, tell your healthcare provider if you are pregnant or plan to become
pregnant. If you are pregnant, tell your healthcare provider as withdrawal signs and symptoms should
be monitored closely and the dose adjusted as necessary. If you are pregnant or become pregnant while
taking SUBOXONE® Film, alert your healthcare provider immediately and you should report it using the
contact information provided below.
Opioid‐dependent women on buprenorphine maintenance therapy may require additional analgesia
during labour.
Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use
of opioids during pregnancy, whether that use is medically authorized or illicit. Unlike opioid withdrawal
syndrome in adults, NOWS may be life-threatening if not recognized and treated in the neonate.
Healthcare professionals should observe newborns for signs of NOWS and manage accordingly.
Before taking SUBOXONE® Film, talk to your healthcare provider if you are breastfeeding or plan to
breastfeed your baby. The active ingredients of SUBOXONE® Film can pass into your breast milk. You
and your healthcare provider should consider the development and health benefits of breastfeeding
along with your clinical need for SUBOXONE® Film and should also consider any potential adverse
effects on the breastfed child from the drug or from the underlying maternal condition.
Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how
SUBOXONE® Film affects you. Buprenorphine in SUBOXONE® Film can cause drowsiness and slow
reaction times during dose-adjustment periods.
Common side effects of SUBOXONE® Film include nausea, vomiting, drug withdrawal syndrome,
headache, sweating, numb mouth, constipation, painful tongue, redness of the mouth, intoxication
(feeling lightheaded or drunk), disturbance in attention, irregular heartbeat, decrease in sleep, blurred
vision, back pain, fainting, dizziness, and sleepiness.
This is not a complete list of potential adverse events associated with SUBOXONE® Film. Please see full
Prescribing Information www.suboxoneREMS.com.
for a complete list.
*To report pregnancy or side effects associated with taking SUBOXONE® Film, please call 1-877-782-
6966. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch or call 1-800-FDA-1088
For more information about SUBOXONE® Film, SUBOXONE®
(buprenorphine and naloxone) Sublingual
Tablets (CIII), or SUBUTEX®
(buprenorphine) Sublingual Tablets (CIII), please see the respective full
Prescribing Information and Medication Guide at www.suboxoneREMS.com
Media Contacts
US
IndiviorMediaContacts@indivior.com
+1 804-594-0836
UK
Tulchan Communications
+44 207-353-4200
Investor Contact
Jason Thompson
Indivior Vice President, Investor Relations
+1 804-402-7123
Jason.Thompson@indivior.com