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FDA Orange Book · active-ingredient family

Heparin sodium; taurolidine

Heparin sodium; taurolidine is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:DEFENCATH · NDA 214520

1

Brand (NDA)

0

Generics (ANDA)

2

Listed patents

4

Exclusivity periods

Brand (NDA) products · solution

ProductApplicantApplicationTEApproved
DEFENCATHRLD×2CORMEDIXNDA 214520—Nov 15, 2023

Marketing exclusivity (4)

  • NCENew chemical entity exclusivity (5 years)

    Nov 15, 2028

    in 2 yr 5 mo

  • GAINQualified infectious disease product exclusivity (adds 5 years)

    Nov 15, 2033

    in 7 yr 6 mo

  • NCENew chemical entity exclusivity (5 years)

    Nov 15, 2028

    in 2 yr 5 mo

  • GAINQualified infectious disease product exclusivity (adds 5 years)

    Nov 15, 2033

    in 7 yr 6 mo

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7696182May 16, 20261 mo ago
SubstanceProductU-3774
11738120Apr 15, 2042in 16 yr 1 mo
SubstanceProduct

Heparin sodium; taurolidine — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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