Viewing data from:

CEQUA

NDA

CYCLOSPORINE | N210913 | SUN PHARMACEUTICAL INDUSTRIES LTD

1 strength5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Active (5)Today

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

Today

Aug. 23, 2033

Aug. 23, 2033

Aug. 23, 2033

Feb. 28, 2037

Feb. 28, 2037

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 Cequa (2023)

Total Spending

$65.7M

Total Claims

72,958

Beneficiaries

28,834

Avg Cost/Unit

$9.64

Spending Trend

$967K(2019)→$18.0M(2020)→$49.3M(2021)→$59.5M(2022)→$65.7M(2023)

YoY Change:+14.5%

5yr CAGR:+3.5%

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

API Supply Chain14 active DMFs5 inactive

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

TAPI NL BVCYCLOSPORINE

DMF 129321998

CURIA ITALY SRLCYCLOSPORINE

DMF 129491998

FUJIAN KERUI PHARMACEUTICAL CO LTDCYCLOSPORINE

DMF 137891998

TAPI NL BVCYCLOSPORINE

DMF 137991998

ABBVIE INCCYCLOSPORINE USP

DMF 138001998

APOTEX INCCYCLOSPORINE USP (BULK)

DMF 139291999

HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTDCYCLOSPORINE (NON-STERILE BULK FORM)

DMF 189322005

CONCORD BIOTECH LTDCYCLOSPORINE USP

DMF 239622010

ZHEJIANG RUIBANG LABORATORIESCYCLOSPORINE

DMF 285122014

TAPI NL BVCYCLOSPORINE ID: 741710

DMF 295572015

NORTH CHINA PHARMACEUTICAL HUASHENG CO LTDCYCLOSPORINE USP, NON-STERILE BULK DRUG SUBSTANCE

DMF 339462019

TAPI NL BVCYCLOSPORINE ID: 741310

DMF 346422020

CURIA ITALY SRLCYCLOSPORINE 350507

DMF 363852021

FISHFA BIOGENICS (A DIV OF FISHFA RUBBERS LTD)CYCLOSPORINE USP

DMF 429662025

SANDOZ PHARMA LTDInactiveCYCLOSPORINE MANFACTURED IN BASLE, SWITZERLAND.

DMF 116181995

GALENA ASInactiveCYCLOSPORINE

DMF 119711996

ZHEJIANG RUIBANG LABORATORIES INCInactiveCYCLOSPORINE

DMF 138581998

WATSON LABORATORIES INCInactiveCYCLOSPORINE

DMF 153282001

ZHEJIANG RUIBANG LABORATORIESInactiveCYCLOSPORINE CRUDE

DMF 314652018

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Sep 23, 2019	SUPPL -2	View Letter (PDF)
Aug 20, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.09%

RLD

5 patents0 exclusivities▴

SOLUTION;OPHTHALMIC | Approved: Aug 14, 2018

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8980839	Aug 23, 2033	—	—	Yes		—
9937225	Aug 23, 2033	—	—	Yes		—
10441630	Aug 23, 2033	—	—	Yes	—	—
10918694	Feb 28, 2037	—	—	Yes	—	—
11951153	Feb 28, 2037	—	—	—		—