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FDA Orange Book · active-ingredient family

Diclofenac epolamine

Diclofenac epolamine is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:LICART · NDA 206976

2

Brand (NDA)

0

Generics (ANDA)

2

Listed patents

1

Exclusivity periods

Brand (NDA) products · system

ProductApplicantApplicationTEApproved
LICARTRLDIBSA INST BIONDA 206976—Dec 19, 2018
FLECTORRLDIBSANDA 021234—Jan 31, 2007

Marketing exclusivity (1)

  • NPPNew patient population exclusivity (3 years)

    Mar 27, 2029

    in 2 yr 10 mo

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11351133Feb 20, 2035in 8 yr 10 mo
U-3393
11344520Feb 20, 2035in 8 yr 10 mo
U-3393

Diclofenac epolamine — frequently asked questions

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

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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