XACIATO

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Dec 07, 2021

   4 yr 7 mo ago

2. Exclusivity ends · NP

   New product exclusivity (3 years)

   Dec 07, 2024

   1 yr 7 mo ago

3. Today

4. Exclusivity ends · GAIN

   Qualified infectious disease product exclusivity (adds 5 years)

   Dec 07, 2029

   in 3 yr 6 mo

5. Patent 11129896 expires

   Listed method-of-use patent (U-3293) expiration.

   Sep 22, 2036

   in 10 yr 5 mo

6. Patent 12303563 expires

   Listed drug product patent expiration.

   Sep 22, 2036

   in 10 yr 5 mo

Pharmaceutical detail

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

• CLINDESSEBrand (NDA)

  NDA 050793 · PADAGIS US

  2004
• EVOCLINBrand (NDA)

  NDA 050801 · NORVIUM BIOSCIENCE

  2004
• CLINDAGELBrand (NDA)

  NDA 050782 · BAUSCH

  2000
• CLEOCINBrand (NDA)

  NDA 050680 · PFIZER

  1992
• CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINERBrand (NDA)

  NDA 050639 · PFIZER

  1989
• CLEOCIN TBrand (NDA)

  NDA 050615 · PFIZER

  1987
• CLEOCIN PHOSPHATEBrand (NDA)

  NDA 050441 · PFIZER

  —
• CLINDAMYCIN PHOSPHATEGeneric (ANDA)

  ANDA 218942 · AUROBINDO PHARMA LTD

  2026
• CLINDAMYCIN PHOSPHATEGeneric (ANDA)

  ANDA 212466 · ALEMBIC

  2024
• CLINDAMYCIN PHOSPHATEGeneric (ANDA)

  ANDA 216587 · ZYDUS LIFESCIENCES

  2023
• CLINDAMYCIN PHOSPHATEGeneric (ANDA)

  ANDA 215219 · AMNEAL

  2022
• CLINDAMYCIN PHOSPHATEGeneric (ANDA)

  ANDA 214668 · AMNEAL

  2022

Marketing exclusivity (2)

• NPNew product exclusivity (3 years)

  Dec 07, 2024

  1 yr 7 mo ago

• GAINQualified infectious disease product exclusivity (adds 5 years)

  Dec 07, 2029

  in 3 yr 6 mo

Listed patents (2)