Viewing data from:

CYCLOSET

NDA

BROMOCRIPTINE MESYLATE | N020866 | VEROSCIENCE LLC

1 strength13 unique patents0 unique exclusivities

Patent Timeline

13 unique patents by expiration date

Active (13)Today

2027

2028

2029

2030

2031

2032

Today

Apr. 30, 2032

Apr. 30, 2032

Jun. 7, 2030

Apr. 30, 2032

Jun. 7, 2030

Apr. 30, 2032

Apr. 30, 2032

Jun. 7, 2030

Apr. 30, 2032

Apr. 30, 2032

Jun. 7, 2030

Apr. 30, 2032

Apr. 30, 2032

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 Cycloset (2023)

Total Spending

$3.2M

Total Claims

3,358

Beneficiaries

777

Avg Cost/Unit

$5.74

Spending Trend

$3.9M(2019)→$3.9M(2020)→$4.0M(2021)→$3.6M(2022)→$3.2M(2023)

YoY Change:+8.2%

5yr CAGR:+8.5%

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

API Supply Chain3 active DMFs5 inactive

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

LEK PHARMACEUTICALS DDBROMOCRIPTINE MESYLATE USP

DMF 68271987

CURIA ITALY SRLBROMOCRIPTINE MESYLATE

DMF 69551987

TAPI NL BVBROMOCRIPTINE MESYLATE

DMF 147682000

GEDEON RICHTER LTDInactiveBROMOCRIPTINE MESYLATE USP

DMF 67371986

CHEMAPOL LTDInactiveBROMOCRIPTINE MESYLATE

DMF 69841987

LABOCHIMInactiveBROMOCRIPTINE MESYLATE

DMF 70881987

CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTDInactiveBROMOCRIPTINE MESYLATE

DMF 106791993

GALENA ASInactiveBROMOCRIPTINE MESYLATE

DMF 119731996

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Aug 18, 2020	SUPPL -12	View Letter (PDF)
Apr 6, 2020	SUPPL -13	View Letter (PDF)
Feb 7, 2017	SUPPL -6	View Letter (PDF)
Feb 7, 2017	SUPPL -7	View Letter (PDF)
Feb 4, 2016	SUPPL -9	View Letter (PDF)
Oct 21, 2015	SUPPL -8	View Letter (PDF)
Mar 28, 2011	SUPPL -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.8MG BASE

RLD

13 patents0 exclusivities▴

TABLET;ORAL | Approved: May 5, 2009

Patents (13)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
8431155	Apr 30, 2032	—	—	Yes	—
8613947	Apr 30, 2032	—	—	Yes	—
8877708	Jun 7, 2030	—	—	Yes	—
9192576	Apr 30, 2032	—	—	Yes	—
9352025	Jun 7, 2030	—	—	—	—
9522117	Apr 30, 2032	—	—	Yes	—
9700555	Apr 30, 2032	—	—	Yes	—
9895422	Jun 7, 2030	—	—	—	—
9993474	Apr 30, 2032	—	—	—	—
10688094	Apr 30, 2032	—	—	—	—
10688155	Jun 7, 2030	—	—	—	—
11000522	Apr 30, 2032	—	—	—	—
11666567	Apr 30, 2032	—	—	—	—