Assyro AI

Orange Book product · Brand (NDA)

CABENUVA KIT

CABOTEGRAVIR; RILPIVIRINE

Brand (NDA)NDA 212888RX VIIV HLTHCARE

At a glance

Jan 21, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

10

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 21, 2021

    5 yr 6 mo ago

  2. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    Jan 21, 2026

    5 mo ago

  3. Patent 10927129 expires

    Listed drug substance patent expiration.

    Apr 28, 2026

    2 mo ago

  4. Today

  5. Patent 11389447 expires

    Listed method-of-use patent (U-3405) expiration.

    Jun 30, 2027

    in 1 yr 1 mo

  6. Patent 8410103 expires

    Listed drug substance patent expiration.

    Feb 04, 2031

    in 4 yr 8 mo

  7. Patent 11224597 expires

    Listed drug product patent expiration.

    Sep 15, 2031

    in 5 yr 4 mo

  8. Patent 12138264 expires

    Listed drug product patent expiration.

    Sep 15, 2031

    in 5 yr 4 mo

  9. Patent RE50189 expires

    Listed method-of-use patent (U-3348) expiration.

    Nov 27, 2031

    in 5 yr 6 mo

  10. Patent 11389448 expires

    Listed drug product patent expiration.

    Apr 13, 2032

    in 5 yr 11 mo

  11. Patent 12178815 expires

    Listed method-of-use patent (U-3348) expiration.

    Jul 18, 2038

    in 12 yr 3 mo

  12. Patent 12636285 expires

    Listed method-of-use patent (U-3348) expiration.

    Oct 01, 2040

    in 14 yr 6 mo

  13. Patent 12636286 expires

    Listed method-of-use patent (U-3348) expiration.

    Oct 01, 2040

    in 14 yr 6 mo

Pharmaceutical detail

Active ingredient

CABOTEGRAVIR; RILPIVIRINE

Strength

400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)

Dosage form

SUSPENSION, EXTENDED RELEASE

Route

INTRAMUSCULAR

TE code

Not listed

Application

NDA 212888

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Marketing exclusivity (1)

  • NCENew chemical entity exclusivity (5 years)

    Jan 21, 2026

    5 mo ago

Listed patents (10)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10927129Apr 28, 20262 mo ago
SubstanceProduct
11389447Jun 30, 2027in 1 yr 1 mo
U-3405
8410103Feb 04, 2031in 4 yr 8 mo
SubstanceProductU-3348
11224597Sep 15, 2031in 5 yr 4 mo
ProductU-3348
12138264Sep 15, 2031in 5 yr 4 mo
ProductU-3348
RE50189Nov 27, 2031in 5 yr 6 mo
U-3348
11389448Apr 13, 2032in 5 yr 11 mo
Product
12178815Jul 18, 2038in 12 yr 3 mo
U-3348
12636285Oct 01, 2040in 14 yr 6 mo
U-3348
12636286Oct 01, 2040in 14 yr 6 mo
U-3348
Agent CTA Background

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