Viewing data from:

NYMALIZE

NDA

NIMODIPINE | N203340 | AZURITY PHARMACEUTICALS INC

2 strengths6 unique patents0 unique exclusivities

Patent Timeline

6 unique patents by expiration date

Active (6)Today

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

Today

Apr. 16, 2038

Apr. 16, 2038

Apr. 16, 2038

Apr. 16, 2038

Apr. 16, 2038

Apr. 16, 2038

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizens Petition from Annora Pharma Private Limited FDA-2020-P-1511 Annora Pharma Private Limited filed this citizen petition requesting that the FDA Commissioner determine whether Arbor Pharmaceuticals LLC voluntarily withdrew NYMALIZE (nimodipine) oral solution 3 mg/mL (NDA 203340) for reasons other than safety or effectiveness, citing that the company replaced it	505(q)	2020-06-08	Withdrawn	Annora Pharma Private Limited

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Nymalize (2023)

Total Spending

$66K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$9.62

Spending Trend

$67K(2021)→$65K(2022)→$66K(2023)

YoY Change:+9.5%

5yr CAGR:+4.7%

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

API Supply Chain4 active DMFs5 inactive

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

LUSOCHIMICA SPANIMODIPINE

DMF 149792000

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)NIMODIPINE (MICRONIZED)

DMF 169512003

DASAMI LAB PRIVATE LTDNIMODIPINE

DMF 329712018

BIOPHORE INDIA PHARMACEUTICALS PVT LTDNIMODIPINE

DMF 342032019

BAYER HEALTHCARE AGInactiveNIMODIPINE

DMF 46641982

BAYER CORPInactiveNIMODIPINE CAPS 10MG (bay e 9736)

DMF 48161982

CATALENT PHARMA SOLUTIONS LLCInactiveNIMODIPINE 30MG SOFTGEL CAPSULES

DMF 155982001

USV LTDInactiveNIMODIPINE USP

DMF 178492004

CATALENT PHARMA SOLUTIONS LLCInactiveNIMODIPINE 30MG SOFTGELS

DMF 183732005

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Oct 15, 2024	SUPPL -19	View Letter (PDF)
Dec 23, 2020	SUPPL -13	View Letter (PDF)
May 14, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: May 10, 2013

No patent or exclusivity listings for this strength.

#002 — 6MG/ML

RLDAB

6 patents0 exclusivities▾

SOLUTION;ORAL | Approved: Apr 8, 2020