Viewing data from:

FAMCICLOVIR

ANDA

FAMCICLOVIR | A077487 | TEVA PHARMACEUTICALS USA

3 strengths0 unique patents0 unique exclusivities

Medicare Part D Spending

CMS annual spending data for Famciclovir (2023)

Total Spending

$7.1M

Total Claims

124,054

Beneficiaries

60,825

Avg Cost/Unit

$1.29

Spending Trend

$7.4M(2019)→$8.4M(2020)→$7.9M(2021)→$8.2M(2022)→$7.1M(2023)

YoY Change:-12.6%

5yr CAGR:-1.6%

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

API Supply Chain9 active DMFs1 inactive

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

TAPI NL BVFAMCICLOVIR

DMF 179082004

CIPLA LTDFAMCICLOVIR USP

DMF 191812006

CHONGQING SHENGHUAXI PHARMACEUTICAL CO LTDFAMCICLOVIR

DMF 196922006

APITORIA PHARMA PRIVATE LTDFAMCICLOVIR USP

DMF 222042008

MACLEODS PHARMACEUTICALS LTDFAMCICLOVIR

DMF 223912009

SIGNA SA DE CVFAMCICLOVIR USP

DMF 227132009

HETERO DRUGS LTDFAMCICLOVIR

DMF 238222010

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTDFAMCICLOVIR

DMF 340982019

SHANGHAI PHARMA GROUP CHANGZHOU KONY PHARMACEUTICAL CO LTDFAMCICLOVIR

DMF 350502020

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveFAMCICLOVIR (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 186902005

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Aug 27, 2007	ORIG -1	View Letter (PDF)
Jul 5, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 125MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 24, 2007

No patent or exclusivity listings for this strength.

#002 — 250MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 24, 2007

#003 — 500MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 24, 2007