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NATEGLINIDE

ANDA

NATEGLINIDE | A077461 | DR REDDYS LABORATORIES LTD

2 strengths0 unique patents0 unique exclusivities

Medicare Part D Spending

CMS annual spending data for Nateglinide (2023)

Total Spending

$14.1M

Total Claims

151,348

Beneficiaries

38,358

Avg Cost/Unit

$0.57

Spending Trend

$22.6M(2019)→$18.2M(2020)→$15.2M(2021)→$14.1M(2022)→$14.1M(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 Chain8 active DMFs2 inactive

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

DR REDDYS LABORATORIES LTDNATEGLINIDE (PREMIX)

DMF 178472004

TAPI NL BVNATEGLINIDE

DMF 179102004

SYNTHIMED LABS PRIVATE LTDNATEGLINIDE USP

DMF 202312007

UNICHEM LABORATORIES LTDNATEGLINIDE

DMF 214842008

CADILA PHARMACEUTICALS LTDNATEGLINIDE FORM H USP

DMF 265182013

USV PRIVATE LTDNATEGLINIDE USP [MICRONISED]

DMF 268822013

UNICHEM LABORATORIES LTDNATEGLINIDE (FORM-H) USP

DMF 289342015

ZYDUS LIFESCIENCES LTDNATEGLINIDE USP

DMF 375012022

CIPLA LTDInactiveNATEGLINIDE USP

DMF 179062004

CADILA PHARMACEUTICALS LTDInactiveNATEGLINIDE FORM B

DMF 219622008

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 16, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 60MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 9, 2009

No patent or exclusivity listings for this strength.

#002 — 120MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 9, 2009