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SERPASIL

NDA

RESERPINE | N009115 | NOVARTIS PHARMACEUTICALS CORP

4 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF5 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

INDENA SPARESERPINE USP

DMF 49421983

SB PENICK AND COInactiveRESERPINE

DMF 1361954

CHAS PFIZER AND CO INCInactiveRESERPINE

DMF 1471954

MALLINCKRODT INCInactiveRESERPINE

DMF 1921956

FINE CHEMICALS CANADA LTDInactiveRESERPINE

DMF 1931956

VITAL LABORATORIES PVT LTDInactiveRESERPINE USP

DMF 250302011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (4)

Sort:

#001 — 0.1MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#003 — 0.25MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#004 — 1MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#005 — 0.2MG/4ML

0 patents0 exclusivities▾

ELIXIR;ORAL | Approved: Approved Prior to Jan 1, 1982