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FDA Orange Book · active-ingredient family

Rucaparib camsylate

Rucaparib camsylate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:RUBRACA · NDA 209115

1

Brand (NDA)

0

Generics (ANDA)

9

Listed patents

3

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
RUBRACARLD×3PHARMAANDNDA 209115—Dec 19, 2016

Marketing exclusivity (3)

  • I-982New indication exclusivity (3 years)

    Dec 17, 2028

    in 2 yr 6 mo

  • I-982New indication exclusivity (3 years)

    Dec 17, 2028

    in 2 yr 6 mo

  • I-982New indication exclusivity (3 years)

    Dec 17, 2028

    in 2 yr 6 mo

Listed patents (9)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8143241Aug 12, 2027in 1 yr 2 mo
U-2012
8071579Aug 12, 2027in 1 yr 2 mo
U-2273
9861638Feb 10, 2031in 4 yr 9 mo
U-2012
8754072Feb 10, 2031in 4 yr 9 mo
SubstanceProduct
10278974Feb 10, 2031in 4 yr 9 mo
Product
9045487Feb 10, 2031in 4 yr 9 mo
SubstanceProduct
8859562Aug 04, 2031in 5 yr 2 mo
U-2012
10130636Aug 17, 2035in 9 yr 4 mo
U-2273
9987285Aug 17, 2035in 9 yr 4 mo
Product

Rucaparib camsylate — 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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