VERELAN PM Drug Patent Profile

Which patents cover Verelan Pm, and when can generic versions of Verelan Pm launch?

Verelan Pm is a drug marketed by Azurity and is included in one NDA.

The generic ingredient in VERELAN PM is verapamil hydrochloride. There are seventeen drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the verapamil hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Verelan Pm

A generic version of VERELAN PM was approved as verapamil hydrochloride by EXELA PHARMA on March 30^th, 1984.

Summary for VERELAN PM

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	12
Patent Applications:	2,984
Drug Prices:	Drug price information for VERELAN PM
What excipients (inactive ingredients) are in VERELAN PM?	VERELAN PM excipients list
DailyMed Link:	VERELAN PM at DailyMed

See drug prices for VERELAN PM

Recent Clinical Trials for VERELAN PM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Assiut University	Early Phase 1
Theracos	Phase 1
City of Hope Medical Center	Phase 1

See all VERELAN PM clinical trials

Pharmacology for VERELAN PM

Drug Class	Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

Paragraph IV (Patent) Challenges for VERELAN PM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VERELAN PM	Extended-release Capsules	verapamil hydrochloride	100 mg and 200 mg	020943	1	2006-07-20
VERELAN PM	Extended-release Capsules	verapamil hydrochloride	300 mg	020943	1	2006-05-19

US Patents and Regulatory Information for VERELAN PM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	VERELAN PM	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020943-001	Nov 25, 1998		RX	Yes	No
Azurity	VERELAN PM	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020943-002	Nov 25, 1998		RX	Yes	No
Azurity	VERELAN PM	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020943-003	Nov 25, 1998		RX	Yes	Yes

Expired US Patents for VERELAN PM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	VERELAN PM	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020943-001	Nov 25, 1998
Azurity	VERELAN PM	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020943-003	Nov 25, 1998
Azurity	VERELAN PM	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020943-002	Nov 25, 1998

International Patents for VERELAN PM

See the table below for patents covering VERELAN PM around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	3776982
Philippines	23993	CONTROLLED ABSORPTION PHARMACEUTICAL COMPOSITION
European Patent Office	0250267	CONTROLLED ABSORPTION PHARMACEUTICAL COMPOSITION
Austria	72975

VERELAN PM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Verelan PM

Introduction

Verelan PM, a brand name for the extended-release formulation of verapamil hydrochloride, is a crucial medication for managing hypertension and other cardiovascular conditions. The market dynamics and financial trajectory of Verelan PM are influenced by several factors, including manufacturing, market share, pricing, and regulatory environments.

Approval and Formulation

Verelan PM was approved by the FDA on November 25, 1998, and is manufactured by AZURITY. It utilizes the proprietary CODAS™ (Chronotherapeutic Oral Drug Absorption System) technology, which delays the release of verapamil by 4-5 hours after ingestion, providing a controlled-onset delivery system[3][4].

Market Share and Manufacturers

Historically, Verelan PM has had limited competition due to its unique formulation and the absence of a therapeutically equivalent generic version in the United States. The primary manufacturers involved have been Kremers Urban Pharmaceuticals and Mylan Pharmaceuticals, although Mylan discontinued its generic version of Verapamil ER PM in 2019[1][4].

Impact of Mylan's Discontinuation

Mylan's decision to discontinue its generic Verapamil ER PM led to a significant increase in prices for Verelan PM. With Kremers holding the majority of the market share, especially for the 200 mg and 300 mg strengths, the company increased the Average Wholesale Price (AWP) and Wholesale Acquisition Cost (WAC) by 185%, aligning the prices of the authorized generic with the brand version. This resulted in substantial price hikes, with increases ranging from 271.3% to 339.1% for different strengths[1].

Pricing Dynamics

The pricing of Verelan PM has been volatile, particularly after Mylan's exit from the market. The lack of competition allowed Kremers to dominate the market, leading to significant price increases. For instance, the price of Verapamil ER PM 100 mg, 200 mg, and 300 mg capsules skyrocketed, making it one of the notable cases where a generic drug effectively reverted back to a brand drug in terms of pricing[1].

Financial Impact on Medicaid

The price increases had a substantial financial impact on Medicaid programs. However, there have been instances where other generic drugs have seen price drops, offering some relief. For example, the price drop of generic Clomipramine (Anafranil) resulted in $1.3 million in annualized savings for state Medicaid programs[1].

Financial Performance of Related Companies

Companies involved in the manufacturing and distribution of Verelan PM and its generics have reported varied financial performances.

Societal CDMO

Societal CDMO, which has a license and supply agreement with Lannett for Verapamil PM products, reported a decline in revenues from these products in the first half of 2022. However, the company executed an amendment to its agreement, which is expected to improve economics and strengthen revenues in the second half of the year. Despite this, the overall revenue from Verapamil PM products was lower compared to the prior year, contributing to a decline in total revenues[2].

Revenue and Cost Analysis

In the second quarter of 2022, Societal CDMO reported revenues of $23.2 million, a 29% increase from the prior year, but this was partially offset by declining revenues from Verapamil PM products. The cost of sales and total operating expenses increased, reflecting higher costs associated with new business agreements and expanded capabilities[2].

Regulatory Environment

The absence of a generic equivalent for Verelan PM in the U.S. market is a significant factor in its pricing dynamics. The FDA's approval process and the lack of generic competition have allowed the brand to maintain its market position without significant price pressure from generics[4].

Market Outlook

The market outlook for Verelan PM is influenced by the ongoing lack of generic competition and the financial performance of companies involved in its manufacturing and distribution.

Future Projections

Given the current market dynamics, it is likely that Verelan PM will continue to be a high-priced medication unless a generic equivalent is approved or other market forces intervene. Companies like Societal CDMO are focusing on improving their economics through amended agreements and new business ventures, but these efforts may not directly impact the pricing of Verelan PM[2][5].

Key Takeaways

• Market Dominance: Verelan PM's unique formulation and the absence of a generic equivalent have allowed it to dominate the market.
• Pricing Volatility: The discontinuation of Mylan's generic version led to significant price increases.
• Financial Impact: Price hikes have substantial financial implications for Medicaid and other healthcare programs.
• Regulatory Influence: The FDA's approval process and lack of generic competition are crucial in maintaining Verelan PM's market position.
• Company Performance: Companies involved in Verelan PM's manufacturing and distribution face varied financial performances, with efforts to improve economics through new agreements and ventures.

FAQs

What is Verelan PM used for?

Verelan PM is used for managing hypertension and other cardiovascular conditions. It is an extended-release formulation of verapamil hydrochloride designed for bedtime dosing.

Why are there no generic versions of Verelan PM available?

There is currently no therapeutically equivalent generic version of Verelan PM available in the United States, which is a key factor in its pricing dynamics[4].

How did Mylan's discontinuation affect Verelan PM prices?

Mylan's discontinuation of its generic Verapamil ER PM led to Kremers increasing the prices significantly, aligning them with the brand version's prices[1].

What is the financial impact of Verelan PM's pricing on Medicaid?

The price increases have resulted in substantial financial burdens on Medicaid programs, although other generic drug price drops have offered some relief[1].

What steps are companies taking to address declining revenues from Verelan PM products?

Companies like Societal CDMO are executing amended agreements and focusing on new business ventures to improve their economics and strengthen revenues[2].

Sources

1. 46brooklyn.com: "What's happening to generic drug prices? April 2019 NADAC Survey Update"
2. Societal CDMO: "Societal CDMO Reports Second Quarter 2022 Financial Results"
3. FDA: "Verelan® PM capsules (verapamil hydrochloride) - Label"
4. Drugs.com: "Generic Verelan PM Availability"
5. Biospace: "Societal CDMO Reports First Quarter 2023 Financial Results"