Viewing data from:

SAPROPTERIN DIHYDROCHLORIDE

ANDA

SAPROPTERIN DIHYDROCHLORIDE | A207200 | PH HEALTH LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: KUVAN(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
BIOMARIN PHARMACEUTICAL INC. et al v. PAR PHARMACEUTICAL, INC. 3:2015cv01706 8 patentsANDA 207200sapropterin dihydrochloride	D.N.J.	2015-03-06	Terminated 2017-04-18	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Medicare Part D Spending

CMS annual spending data for Sapropterin Dihydrochloride (2023)

Total Spending

$14.7M

Total Claims

1,667

Beneficiaries

137

Avg Cost/Unit

$84.62

Spending Trend

$1.3M(2020)→$9.3M(2021)→$14.9M(2022)→$14.7M(2023)

YoY Change:-16.0%

5yr CAGR:-6.9%

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

API Supply Chain9 active DMFs

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

DIPHARMA SASAPROPTERIN DIHYDROCHLORIDE

DMF 266822012

ASYMCHEM LABORATORIES TIANJIN CO LTDSAPROPTERIN

DMF 284162014

INNOPHARMAX INCSAPROPTERIN DIHYDROCHLORIDE

DMF 335532019

HONOUR LAB LTDSAPROPTERIN DIHYDROCHLORIDE

DMF 339282019

SOLARA ACTIVE PHARMA SCIENCES LTDSAPROPTERIN DIHYDROCHLORIDE

DMF 341852019

DIPHARMA SASAPROPTERIN DIHYDROCHLORIDE (NEW PROCESS)

DMF 349262020

BIOPHORE INDIA PHARMACEUTICALS PVT LTDSAPROPTERIN DIHYDROCHLORIDE

DMF 361472021

MAITHRI DRUGS PRIVATE LTDSAPROPTERIN DIHYDROCHLORIDE

DMF 410772024

CHONGQING MIDECO PHARMACEUTICAL CO LTDSAPROPTERIN DIHYDROCHLORIDE

DMF 421462025

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 17, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 10, 2019

No patent or exclusivity listings for this strength.