Viewing data from:

SIROLIMUS

ANDA

SIROLIMUS | A201676 | ZYDUS PHARMACEUTICALS USA INC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: RAPAMUNE(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 3 NDCs

Highest NADAC/Unit

$2.64

per ea

Lowest NADAC/Unit

$0.8350

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
68382035201SIROLIMUS 2 MG TABLET	$2.64	EA	Generic	—	2026-08-19
68382052001SIROLIMUS 0.5 MG TABLET	$0.9386	EA	Generic	—	2026-08-19
68382035101SIROLIMUS 1 MG TABLET	$0.8350	EA	Generic	—	2026-08-19

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain16 active DMFs6 inactive

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

FUJIAN KERUI PHARMACEUTICAL CO LTDSIROLIMUS

DMF 168902003

LONZA AGSIROLIMUS

DMF 198132006

CURIA ITALY SRLSIROLIMUS

DMF 210372007

BIOCON LTDSIROLIMUS DRUG SUBSTANCE

DMF 215712008

CONCORD BIOTECH LTDSIROLIMUS

DMF 244682011

APOTEX INCSIROLIMUS DRUG SUBSTANCE

DMF 269042013

HANGZHOU HUADONG MEDICINE GROUP KANGRUN PHARMACEUTICAL CO LTDSIROLIMUS (INTERMEDIATE)

DMF 269832013

HISUN PHARMACEUTICAL HANGZHOU CO LTDSIROLIMUS

DMF 277252013

CHONGQING DAXIN PHARMACEUTICAL CO LTDSIROLIMUS

DMF 310522016

HEILONGJIANG WEIKAIER BIOTECHNOLOGY CO LTDSIROLIMUS

DMF 315272017

PARTNERS PHARMACEUTICALS INCSIROLIMUS (INTERMEDIATE)

DMF 350232020

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDSIROLIMUS

DMF 355272021

LUNAN NEW TIME BIO-TECH CO LTDSIROLIMUS

DMF 368582024

LUNAN NEW TIME BIO-TECH CO LTDSIROLIMUS INTERMEDIATE

DMF 368672022

YANGZHOU LIANAO BIOPHARMACEUTICAL CO LTDSIROLIMUS

DMF 370912022

ROLABO OUTSOURCING SLSIROLIMUS INTERMEDIATE

DMF 423372025

HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTDInactiveSIROLIMUS

DMF 231092009

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveSIROLIMUS

DMF 251472011

AADI BIOSCIENCES INCInactiveSIROLIMUS ALBUMIN-BOUND NANOPARTICLES FOR INJECTABLE SUSPENSION (COMPANY CODE: ABI-009)

DMF 285352015

PARTNERS PHARMACEUTICALS INCInactiveSIROLIMUS (INTERMEDIATE)

DMF 324142017

YANGZHOU LIANAO BIOPHARMACEUTICAL CO LTDInactiveSIROLIMUS (INTERMEDIATE OF DRUG SUBSTANCE)

DMF 330752018

TRIVIUMVETInactiveSIROLIMUS DELAYED-RELEASE TABLETS, 1.2 AND 2.4 MG

DMF 371032022

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

Products (3)

Sort:

#001 — 1MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 15, 2023

No patent or exclusivity listings for this strength.

#002 — 2MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 15, 2023

#003 — 0.5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 8, 2014