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STADOL PRESERVATIVE FREE

NDA

BUTORPHANOL TARTRATE | N017857 | APOTHECON INC DIV BRISTOL MYERS SQUIBB

3 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

Medicare Part D Spending

CMS annual spending data for Butorphanol Tartrate* (2023)

Total Spending

$2.5M

Total Claims

24,538

Beneficiaries

2,753

Avg Cost/Unit

$18.00

Spending Trend

$1.7M(2019)→$2.7M(2020)→$3.3M(2021)→$3.0M(2022)→$2.5M(2023)

YoY Change:-8.1%

5yr CAGR:+2.7%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain4 active DMFs3 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

ABBVIE INCBUTORPHANOL TARTRATE

DMF 89041990

TAPI NL BVBUTORPHANOL TARTRATE

DMF 103851993

SRI KRISHNA PHARMACEUTICALS LTDBUTORPHANOL TARTRATE USP

DMF 256702012

HIKAL LTDBUTORPHANOL TARTRATE USP

DMF 318752017

NV ORGANONInactiveBUTORPHANOL TARTRATE

DMF 91271991

TASMANIAN ALKALOIDS PTY LTDInactiveBUTORPHANOL TARTRATE

DMF 121191996

ABBOTT LABORATORIES LTDInactiveBUTORPHANOL TARTRATE USP

DMF 129211998

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

Products (3)

Sort:

#004 — 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#001 — 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982