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PRECOSE

NDA

ACARBOSE | N020482 | BAYER HEALTHCARE PHARMACEUTICALS INC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Strides Arcolab Ltd - Citizen Petition FDA-2008-P-0405 · 3 docket documents Strides Arcolab Ltd filed this petition requesting that the FDA determine whether Precose (acarbose) 100 mg tablets, approved under NDA 20-482 by Bayer Pharms, was voluntarily withdrawn from sale for safety or effectiveness reasons under 21 CFR 314.161 and 314.162, as the product's reference listed	505(q)	2008-07-16	Withdrawn	—
Cobalt Laboratories, Inc. and Cobalt Pharmaceuticals, Inc. - Citizen Petition FDA-2007-P-0418 · 5 docket documents Cobalt Laboratories Inc. and Cobalt Pharmaceuticals Inc. filed this citizen petition on November 9, 2007, requesting that the FDA require all ANDA applicants referencing Bayer's NDA No. 20-482 for Precose (acarbose) to conduct in vivo bioequivalence studies and refrain from granting any bioequivalen	505(q)	2008-04-22	Denied	—

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

Clinical Trials

72 trials from ClinicalTrials.gov, 49 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study to Evaluate the Efficacy of Acarbose,Metformin,Sitagliptin Combination Treatment in DM Patients NCT01490918	Phase 4	Completed	The Catholic University of Korea	165	2012-04 → 2014-09
Acarbose, Postprandial Hypotension and Type 2 Diabetes NCT02043886	Phase 2	Completed	University of British Columbia	15	2007-06 → 2014-05
Exercise and Acarbose in Type 2 Diabetes NCT01244971	Phase 4	Completed	Karolinska Institutet	62	2004-01
A 3-fold Crossover Bioequivalence Study Between Glucobay ODT (Orally Disintegrating Tablet) 100 mg and Glucobay Standard Tablet 100 mg NCT01554631	Phase 1	Completed	Bayer	34	2012-03 → 2012-05
Efficacy and Safety of Mitiglinide vs Acarbose in Patients With Type 2 Diabetes Mellitus NCT02143765	Phase 4	Completed	Zhongda Hospital	248	2014-05 → 2015-12
Effect of Acarbose on Postprandial Lipoprotein Levels in Glucose Intolerant Patients NCT02355509	Phase 4	Completed	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	21	2010-01 → 2014-07
Evaluating Exenatide for the Treatment of Postprandial Hyperinsulinemic Hypoglycemia NCT02685852	Phase 1	Completed	University of Minnesota	11	2016-02 → 2019-07-22
Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Participants With Type 2 Diabetes Mellitus Receiving Acarbose Monotherapy (MK-0431-130)NCT01177384	Phase 3	Completed	Merck Sharp & Dohme LLC	380	2011-01-25 → 2013-03-25
A 3-fold Crossover Bioequivalence Study Between Glucobay Orally Disintegrating Tablet (ODT) and Glucobay Standard Tablet NCT01388153	Phase 1	Completed	Bayer	33	2011-06 → 2011-08
Prevent/Delay Development of Type 2 Diabetes in Subjects With Impaired Glucose Homeostasis Treated With Acarbose in Primary Care NCT01010100	Phase 3	Completed	Bayer	204	2000-08 → 2007-05

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Acarbose (2024)

Total Spending

$6.5M

Total Claims

174,820

Beneficiaries

44,699

Avg Cost/Unit

$0.22

Spending Trend

$8.8M(2019)→$10.7M(2020)→$10.7M(2021)→$10.1M(2022)→$9.8M(2023)→$6.5M(2024)

YoY Change:-35.9%

5yr CAGR:-12.0%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain7 active DMFs2 inactive

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

BAYER AGACARBOSE

DMF 85391990

ZHEJIANG HISUN PHARMACEUTICAL CO LTDACARBOSE USP

DMF 190692005

CKD BIO CORPACARBOSE, NON-STERILE BULK DRUG SUBSTANCE

DMF 207592007

HEBEI HUARONG PHARMACEUTICAL CO LTDACARBOSE

DMF 252072011

LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTDACARBOSE

DMF 351882020

CSPC SHENGXUE GLUCOSE CO LTDACARBOSE

DMF 356032021

HANGZHOU ZHONGMEIHUADONG PHARMACEUTICAL JIANGDONG CO LTDACARBOSE USP

DMF 371452022

HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTDInactiveACARBOSE

DMF 181382005

LIVZON NEW NORTH RIVER PHARMACEUTICAL CO LTDInactiveACARBOSE

DMF 232792009

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Mar 11, 2015	SUPPL -27	View Letter (PDF)
Mar 2, 2012	SUPPL -25	View Letter (PDF)
Mar 25, 2011	SUPPL -24	View Letter (PDF)
Aug 25, 2008	SUPPL -23	View Letter (PDF)
Aug 3, 2005	SUPPL -15	View Letter (PDF)
Oct 29, 2002	SUPPL -11	View Letter (PDF)
Aug 16, 1999	SUPPL -10	View Letter (PDF)
Sep 29, 1998	SUPPL -7	View Letter (PDF)
Sep 29, 1998	SUPPL -8	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 6, 1995

No patent or exclusivity listings for this strength.

#002 — 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 6, 1995

#004 — 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 29, 1997