Viewing data from:

KAPSPARGO SPRINKLE

NDA

METOPROLOL SUCCINATE | N210428 | SUN PHARMA INDUSTRIES LTD

4 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

2029

2030

2031

2032

2033

2034

2035

Today

9504655

Jul. 9, 2035

9700530

Jul. 9, 2035

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Kapspargo Sprinkle (2023)

Total Spending

$2.2M

Total Claims

36,915

Beneficiaries

12,241

Avg Cost/Unit

$2.00

Spending Trend

$583K(2019)→$1.3M(2020)→$1.6M(2021)→$2.0M(2022)→$2.2M(2023)

YoY Change:+4.7%

5yr CAGR:+5.0%

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

API Supply Chain26 active DMFs12 inactive

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

TAPI NL BVMETOPROLOL SUCCINATE

DMF 146121999

MOEHS IBERICA SLMETOPROLOL SUCCINATE

DMF 166212003

DR REDDYS LABORATORIES LTDMETOPROLOL SUCCINATE USP

DMF 183482005

APITORIA PHARMA PRIVATE LTDMETOPROLOL SUCCINATE USP

DMF 192812006

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTDMETOPROLOL SUCCINATE USP

DMF 195682006

IPCA LABORATORIES LTDMETOPROLOL SUCCINATE USP (PROCESS-II)

DMF 196382006

ZYDUS LIFESCIENCES LTDMETOPROLOL SUCCINATE USP

DMF 197602006

ZHEJIANG HISOAR PHARMACEUTICAL CO LTDMETOPROLOL SUCCINATE

DMF 214542008

ALEMBIC PHARMACEUTICALS LTDMETOPROLOL SUCCINATE USP

DMF 215102008

CTX LIFE SCIENCES PVT LTDMETOPROLOL SUCCINATE USP

DMF 217322008

YUNG ZIP CHEMICAL IND CO LTDMETOPROLOL SUCCINATE

DMF 246572011

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDMETOPROLOL SUCCINATE USP

DMF 268042013

HEC PHARM CO LTDMETOPROLOL SUCCINATE NON-STERILE BULK DRUG SUBSTANCE

DMF 279152014

ZHEJIANG YONGTAI PHARMACEUTICAL CO LTDMETOPROLOL SUCCINATE USP

DMF 299542015

ASTRAZENECA PHARMACEUTICALS LPMETOPROLOL SUCCINATE EXTENDED RELEASE TABLETS

DMF 311402016

SUN PHARMACEUTICAL INDUSTRIES LTDMETOPROLOL SUCCINATE USP

DMF 314532017

UNICHEM LABORATORIES LTDMETOPROLOL SUCCINATE USP

DMF 325252018

YUNG ZIP CHEMICAL IND CO LTDMETOPROLOL SUCCINATE (PROCESS II)

DMF 332022018

MACLEODS PHARMACEUTICALS LTDMETOPROLOL SUCCINATE

DMF 333292019

GRANULES INDIA LTDMETOPROLOL SUCCINATE USP

DMF 335442019

HETERO DRUGS LTDMETOPROLOL SUCCINATE

DMF 336242019

MSN LIFE SCIENCES PRIVATE LTDMETOPROLOL SUCCINATE USP

DMF 347062020

INDOCO REMEDIES LTDMETOPROLOL SUCCINATE USP

DMF 348902020

KOPRAN RESEARCH LABORATORIES LTDMETOPROLOL SUCCINATE USP

DMF 351102020

GRANULES PHARMACEUTICALS INCMETOPROLOL SUCCINATE MICROSPHERES 90% W/W

DMF 359592021

ATUL BIOSCIENCE LTDMETOPROLOL SUCCINATE USP

DMF 420422025

ESTEVE QUIMICA SAInactiveMETOPROLOL SUCCINATE

DMF 105471993

ZENTIVA KSInactiveMETOPROLOL SUCCINATE

DMF 116001995

SYN-TECH CHEM AND PHARM CO LTDInactiveMETOPROLOL SUCCINATE USP

DMF 159662002

MEDICHEM SAInactiveMETOPROLOL SUCCINATE

DMF 170192003

IPCA LABORATORIES LTDInactiveMETOPROLOL SUCCINATE

DMF 170562003

AARTI DRUGS LTDInactiveMETOPROLOL SUCCINATE

DMF 194902006

ZAKLADY FARMACEUTYCZNE POLPHARMA SAInactiveMETOPROLOL SUCCINATE

DMF 197432006

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveMETOPROLOL SUCCINATE USP

DMF 206462007

AREVIPHARMA GMBHInactiveMetoprolol Succinate

DMF 211552007

POLYDRUG LABORATORIES PVT LTDInactiveMETOPROLOL SUCCINATE

DMF 218842008

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveMETOPROLOL SUCCINATE USP

DMF 219792008

ASTRAZENECA PHARMACEUTICALS LPInactiveMETOPROLOL SUCCINATE EXTENDED RELEASE/HYDROCHLOROTHIAZIDE 25/12.5,50/12.5 AND100/12.5 TABLETS

DMF 282062014

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 17, 2023	SUPPL -6	View Letter (PDF)
Jan 30, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 25MG TARTRATE

RLD

2 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jan 26, 2018

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9504655	Jul 9, 2035	—	—	Yes	—	—
9700530	Jul 9, 2035	—	—	Yes	—	—

#002 — EQ 50MG TARTRATE

RLD

2 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jan 26, 2018

#003 — EQ 100MG TARTRATE

RLD

2 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jan 26, 2018

#004 — EQ 200MG TARTRATE

RLD

2 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jan 26, 2018