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  • INJECTABLE;INJECTION - EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • IMPLANT;IMPLANTATION - EQ 80MG BASE/IMPLANT
  • FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE
  • FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG BASE
  • FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG BASE
  • TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • FILM;BUCCAL - EQ 0.075MG BASE
  • FILM;BUCCAL - EQ 0.15MG BASE
  • FILM;BUCCAL - EQ 0.3MG BASE
  • FILM;BUCCAL - EQ 0.45MG BASE
  • FILM;BUCCAL - EQ 0.6MG BASE
  • FILM;BUCCAL - EQ 0.75MG BASE
  • FILM;BUCCAL - EQ 0.9MG BASE
  • FILM;BUCCAL, SUBLINGUAL - EQ 12MG BASE;EQ 3MG BASE
  • FILM;BUCCAL, SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE
  • FILM;BUCCAL, SUBLINGUAL - EQ 4MG BASE;EQ 1MG BASE
  • FILM;BUCCAL, SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-november-15-2023-17266.pdf

FDA
15 Nov 2023

https://www.prnewswire.com/news-releases/wexler-boley--elgersma-llp-miller-law-llc-hilliard-shadowen-llp-motley-rice-llc-and-spector-roseman--kodroff-pc-announce-a-30-million-class-action-settlement-for-those-who-may-have-purchased-or-provided-reimbursement-for--301910202.html

PR NEWSWIRE
28 Aug 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214737

FDA
11 Aug 2023

https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=print.getPrintData&ts=11202310416

FDA
01 Feb 2023

https://www.thehindu.com/business/suboxone-settlement-boosts-dr-reddys-q1-net/article65694389.ece

THE HINDU
28 Jul 2022

https://www.temad.com/en/morphine-sulfate-10-mg-tablets%d8%8c-api-and-finished-research-and-development-teamunveiling-of-three-new%d8%8c-and-innovative-products%d8%8c-of-temad-company%d8%8c-acetaminophen-325-oxycodone-5-mg/

PRESS RELEASE
22 Jul 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212756

FDA
02 Jun 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211594

FDA
03 Aug 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214930

FDA
15 Jun 2021

https://www.pharmaceutical-technology.com/news/indivior-settles-opioid-claims/

PHARMACEUTICAL-TECHNOLOGY
28 Jul 2020

https://www.ftc.gov/news-events/press-releases/2020/07/indivior-inc-pay-10-million-consumers-settling-ftc-charges

FTC
25 Jul 2020

https://www.prnewswire.com/news-releases/camurus-announces-submission-of-request-for-final-approval-of-brixadi-for-the-treatment-of-opioid-use-disorder-in-the-us-301068822.html

PRNEWSWIRE
01 Jun 2020

https://www.fiercebiotech.com/medtech/coronavirus-crisis-opens-access-to-online-opioid-addiction-treatment

Phil Galewitz FIERCE BIOTECH
24 Apr 2020

https://www.pharmacompass.com/pdf/news/Premier-Pharmacy-Labs-Issues-Voluntary-Nationwide-Recall-of-all-Unexpired-Sterile-Drug-Product-Lots-Due-to-Lack-of-Sterility-Assurance-1560923636.pdf

FDA
18 Jun 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211594

FDA
12 Jun 2019

https://www.pharmacompass.com/pdf/news/Spectrum-Laboratory-Products-Receives-FDA-Warning-Letter-1560408618.pdf

FDA
04 Jun 2019

https://www.reuters.com/article/us-health-opioids-treatment-access/in-states-with-most-overdose-deaths-poor-patients-struggle-to-find-treatment-idUSKCN1T42QS

Lisa Rapaport REUTERS
04 Jun 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205954

FDA
24 Jan 2019

https://www.business-standard.com/article/markets/dr-reddy-s-labs-hits-52-week-high-stock-up-5-in-two-days-118113000187_1.html

BUSINESS STANDARD
30 Nov 2018

https://www.reuters.com/article/us-indivior-results/british-drugmaker-indiviors-shares-hit-by-copycat-new-drug-worries-idUSKBN1KF0KK?feedType=RSS&feedName=healthNews

Justin Varghese REUTERS
26 Jul 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207607

FDA
16 Jun 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205806

FDA
16 Jun 2018

https://insight.rpxcorp.com/litigation_documents/12865763

PATENT LITIGATION
03 Apr 2018

https://insight.rpxcorp.com/litigation_documents/12865090

PATENT LITIGATION
03 Apr 2018

https://insight.rpxcorp.com/litigation_documents/12865762

PATENT LITIGATION
03 Apr 2018

http://www.nwaonline.com/news/2018/feb/26/fda-to-boost-drug-therapy-for-addicts-2/?news-national

SHEILA KAPLAN The New York Times NWA ONLINE
26 Feb 2018

https://www.pharmacompass.com/pdf/news/suboxone-buprenorphine-hcl-naloxone-hcl-indivior-v-actavis-laboratories-1518418406.pdf

PATENT LITIGATION
07 Feb 2018

https://www.pharmacompass.com/pdf/news/suboxone-buprenorphine-hcl-naloxone-hclindivior-v-dr-reddys-laboratories-1518418478.pdf

PATENT LITIGATION
07 Feb 2018

https://www.pharmacompass.com/pdf/news/suboxone-buprenorphine-hcl-naloxone-hcindivior-v-par-pharmaceutical-1518418555.pdf

PATENT LITIGATION
07 Feb 2018

https://www.pharmacompass.com/pdf/news/suboxone-buprenorphine-hcl-naloxone-hclindivior-v-teva-pharmaceuticals-1518418609.pdf

PATENT LITIGATION
07 Feb 2018

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004407/human_med_002193.jsp&mid=WC0b01ac058001d124

EMA
13 Jan 2018

http://www.pharmafile.com/news/515208/indivior-reaches-settlement-mylan-over-patent-dispute

PHARMAFILE
26 Sep 2017

https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-challenge-of-bunavail-buprenorphine-and-naloxone-buccal-film-1498628104.pdf

FDA
27 Jun 2017

https://www.pharmacompass.com/pdf/news/FDA-Confirms-Paragraph-IV-Patent-Challenge-of-Zubsolv-Buprenorphine-Hydrochloride-Naloxone-Hydrochloride-Dihydrate-Sublingual-Tablets-1498628514.pdf

PRESS RELEASE
27 Jun 2017

http://www.pharmabiz.com/NewsDetails.aspx?aid=101191&sid=2

PHARMABIZ
03 Apr 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207276

FDA
27 Mar 2017

https://www.pharmacompass.com/pdf/news/orexo-us-inc-zubsolv-buprenorphine-hydrochloride-naloxone-hydrochloride-recieves-supplemental-approval-in-us-1475925853.pdf

07 Oct 2016

https://www.pharmacompass.com/pdf/news/kremers-urban-pharms-generic-buprenorphine-hydrochloride-approved-in-us-1474551233.pdf

FDA
19 Sep 2016

https://www.pharmacompass.com/pdf/news/sun-pharm-anda-buprenorphine-hydrochloride-naloxone-hydrochloride-1471603765.pdf

FDA
05 Aug 2016

https://www.pharmacompass.com/pdf/news/titans-generic-buprenorphine-hydrochloride-approved-in-us-for-opioid-addiction-1464601291.pdf

FDA
27 May 2016

http://twofourinsight.com/analyzing-data-earliest-market-entry-subsequent-anda-filers/

TWOFOUR INSIGHT
12 Feb 2016

https://www.pharmacompass.com/pdf/news/sun-pharmas-generic-buprenorphine-hcl-approved-in-us-as-opioid-analgesic-1454409827.pdf

FDA
29 Jan 2016

http://www.mmm-online.com/agency/former-greyhealth-and-cdm-executives-launch-minds-assembly/article/464691/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+MMMHome+%28MMM+Home%29

MMM
12 Jan 2016

http://www.prnewswire.com/news-releases/endo-pharmaceuticals-and-biodelivery-sciences-present-new-data-on-investigational-product-buprenorphine-hcl-buccal-film-for-chronic-pain-management-300139366.html

PR NEWS WIRE
09 Sep 2015

http://www.prnewswire.com/news-releases/biodelivery-sciences-secures-exclusive-preferred-formulary-status-for-bunavail-with-tennessee-medicaid-tenncare-300138771.html

PR NEWS WIRE
08 Sep 2015

http://www.biospace.com/News/orexo-ab-wins-fda-approval-for-zubsolv/387640/source=TopBreaking?intcid=homepage-seekernewssection-tabtopbreakingnews

BIOSPACE
11 Aug 2015

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/06/in-case-you-missed-it-we-did-prometheus-takes-action-against-fda-over-generic-lotronex-approval-and-.html

Kurt R. Karst FDA LAW BLOG
25 Jun 2015

http://fox8.com/2015/06/19/suboxone-what-is-the-drug-linked-to-charleston-shooting-suspect/

CNN Wire FOX 8
20 Jun 2015

https://www.pharmacompass.com/pdf/news/sandoz-generic-buprenorphine-hcl.pdf

FDA
10 Jun 2015
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