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Last Updated: September 24, 2021

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Regulatory Exclusivity: MISCELLANEOUS


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Drugs with Miscellaneous Regulatory Exclusivity

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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Exclusivity Expiration Patented / Exclusive Use
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-002 Sep 28, 2016 RX Yes No ⤷  Free Forever Trial ADDITIONAL INFORMATION ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING REGARDING A NEW CLINICAL TRIAL IN PATIENTS AGED 6 THROUGH 11 YEARS (TRIAL 4)
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes ⤷  Free Forever Trial ADDITIONAL INFORMATION ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING REGARDING A NEW CLINICAL TRIAL IN PATIENTS AGED 6 THROUGH 11 YEARS (TRIAL 4)
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011 RX Yes Yes ⤷  Free Forever Trial INFORMATION ADDED TO SECTION 8.1 OF THE LABELING REGARDING PREGNANT PATIENTS WHO ARE ALREADY ON A STABLE RILPIVIRINE REGIMEN PRIOR TO PREGNANCY AND WHO ARE VIROLOGICALLY SUPPRESSED (HIV-1 RNA LESS THAN 50 COPIES/ML)
Pf Prism Cv PRISTIQ desvenlafaxine succinate TABLET, EXTENDED RELEASE;ORAL 021992-003 Aug 20, 2014 AB RX Yes No ⤷  Free Forever Trial ADDITION OF DATA BASED ON THE ASSESSMENT OF SAFETY AND EFFICACY IN PEDIATRIC PATIENTS WITH MAJOR DEPRESSIVE DISORDER TO FULFILL POSTMARKETING STUDY REQUIREMENT 1229-1
Pf Prism Cv PRISTIQ desvenlafaxine succinate TABLET, EXTENDED RELEASE;ORAL 021992-001 Feb 29, 2008 AB RX Yes No ⤷  Free Forever Trial ADDITION OF DATA BASED ON THE ASSESSMENT OF SAFETY AND EFFICACY IN PEDIATRIC PATIENTS WITH MAJOR DEPRESSIVE DISORDER TO FULFILL POSTMARKETING STUDY REQUIREMENT 1229-1
Pf Prism Cv PRISTIQ desvenlafaxine succinate TABLET, EXTENDED RELEASE;ORAL 021992-002 Feb 29, 2008 AB RX Yes Yes ⤷  Free Forever Trial ADDITION OF DATA BASED ON THE ASSESSMENT OF SAFETY AND EFFICACY IN PEDIATRIC PATIENTS WITH MAJOR DEPRESSIVE DISORDER TO FULFILL POSTMARKETING STUDY REQUIREMENT 1229-1
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Exclusivity Expiration >Patented / Exclusive Use

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Serving leading biopharmaceutical companies globally:

Merck
Baxter
Colorcon
Express Scripts
AstraZeneca
Johnson and Johnson

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