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VIGABATRIN

ANDA

VIGABATRIN | A208218 | PH HEALTH LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: SABRIL(TE code: AA)

Citizen Petitions

3 petitions (3 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 3_ vigabatrin-proposed-product-pi-clean re: Suitability Petition f... FDA-2023-P-5209 Upadhye Tang LLP filed a suitability petition regarding vigabatrin, seeking FDA determination of whether the drug is suitable for development as an abbreviated new drug application (ANDA). The petition requests that FDA confirm vigabatrin's eligibility for generic development under the ANDA pathway.	Suitability	2023-11-27	Open	Upadhye Tang LLP
Attachment 4_ vigabatrin-proposed-product-pi-tracked re: Suitability Petition... FDA-2023-P-5209 Upadhye Tang LLP filed a suitability petition regarding vigabatrin, seeking FDA confirmation that the proposed product information and formulation are suitable for commercial development and approval as a new drug application (NDA) or abbreviated new drug application (ANDA).	Suitability	2023-11-27	Open	Upadhye Tang LLP
Attachment 2 - SABRIL- vigabatrin powder, for solution Lundbeck Pharmaceutica... FDA-2022-P-0214 Upadhye Tang LLP filed a suitability petition on behalf of Lundbeck Pharmaceuticals LLC regarding SABRIL (vigabatrin powder for solution), requesting FDA evaluation of the suitability of the proposed manufacturing process, formulation, or other pharmaceutical development aspects to support regulator	Suitability	2022-02-23	Open	Upadhye Tang

Source: Regulations.gov. FDA citizen petitions matched by application number.

Medicare Part D Spending

CMS annual spending data for Vigabatrin (2023)

Total Spending

$15.9M

Total Claims

1,198

Beneficiaries

124

Avg Cost/Unit

$84.47

Spending Trend

$18.3M(2019)→$21.6M(2020)→$18.8M(2021)→$16.0M(2022)→$15.9M(2023)

YoY Change:-7.5%

5yr CAGR:-6.3%

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

API Supply Chain7 active DMFs1 inactive

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

MSN LABORATORIES PRIVATE LTDVIGABATRIN USP [ROUTE CODE - "VB"]

DMF 272402013

DIVIS LABORATORIES LTDVIGABATRIN USP

DMF 319532017

SIONC PHARMACEUTICALS PVT LTDVIGABATRIN

DMF 331542018

HETERO DRUGS LTDVIGABATRIN

DMF 332252018

APITORIA PHARMA PRIVATE LTDVIGABATRIN USP

DMF 337692019

METROCHEM API PRIVATE LTDVIGABATRIN USP

DMF 380892023

MSN LIFE SCIENCES PRIVATE LTDVIGABATRIN USP

DMF 405172024

DIVIS LABORATORIES LTDInactiveVIGABATRIN

DMF 215792008

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 2, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 500MG/PACKET

0 patents0 exclusivities▴

FOR SOLUTION;ORAL | Approved: Apr 27, 2017

No patent or exclusivity listings for this strength.