Products

Our prescription opioid medications you may have heard about in the news recently include:

DURAGESIC® (fentanyl transdermal system), CII

DURAGESIC® (fentanyl transdermal system), CII is an FDA-approved transdermal patch.1 DURAGESIC® has a child-resistant packaging and is part of an FDA-approved and required Risk Evaluation and Mitigation Strategy (REMS) program. The REMS program outlines strategies to manage known or potential risks associated with these products to ensure that the benefits of a drug outweigh its risks.2

Although we continue to make DURAGESIC® available to patients, we stopped promotion of this medicine in 2008.

For more information about DURAGESIC®, click here for full prescribing information, instructions for use, and medication guide.

Find more information about DURAGESIC® in our recent court filings.

Read the full Defendant’s Proposed Findings of Fact and Conclusions of Law document

NUCYNTA® and NUCYNTA® ER (tapentadol), CII

We manufactured two forms of NUCYNTA® (tapentadol) tablets, CII - an immediate release tablet and an extended release tablet. The extended release tablet was designed to make it harder to be split, crushed or dissolved.3 Both medicines are FDA-approved and NUCYNTA® ER was launched with an FDA-approved REMS program.

We sold the U.S. NUCYNTA® brand to another manufacturer in 2015.4

For more information about NUCYNTA®, click here for full prescribing information and medication guide.5

For more information about NUCYNTA® ER, click here for full prescribing information and medication guide.6

Find more information about NUCYNTA® in our recent court filings.

Read the full Defendant’s Proposed Findings of Fact and Conclusions of Law document

References

  1. DURAGESIC® https://www.duragesic.com/
  2. Risk Evaluation and Mitigation Strategy (REMS). Risk Evaluation and Mitigation Strategy, Opioid Analgesic REMS. https://opioidanalgesicrems.com/RpcUI/home.u
  3. Vosburg SK, Jones JD, Manubay JM, et al. A comparison among tapentadol tamper-resistant formulations (TRF) and OxyContin® (non-TRF) in prescription opioid abusers. Addiction. 2013; 108(6): 1095-1106. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3664924/
  4. Janssen, Janssen Pharmaceuticals, Inc. Completes Divestiture of U.S. License Rights to NUCYNTA® (tapentadol), NUCYNTA® ER (tapentadol) extended-release tablets and NUCYNTA® (tapentadol) Oral Solution to Depomed, Inc. Johnson and Johnson. https://www.jnj.com/media-center/press-releases/janssen-pharmaceuticals-inc-completes-divestiture-of-us-license-rights-to-nucynta-tapentadol-nucynta-er-tapentadol-extended-release-tablets-and-nucynta-tapentadol-oral-solution-to-depomed-inc
  5. NUCYNTA® Prescribing Information.https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=80938c30-9fe3-4c7d-9d9c-5476638cfb2d
  6. NUCYNTA® ER Prescribing Information.https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=80938c30-9fe3-4c7d-9d9c-5476638cfb2d
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