INNOPRAN XL Drug Patent Profile

Which patents cover Innopran Xl, and what generic alternatives are available?

Innopran Xl is a drug marketed by Ani Pharms and is included in one NDA.

The generic ingredient in INNOPRAN XL is propranolol hydrochloride. There are twenty-two drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the propranolol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Innopran Xl

A generic version of INNOPRAN XL was approved as propranolol hydrochloride by INNOGENIX on October 22^nd, 1985.

Summary for INNOPRAN XL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	157
Clinical Trials:	4
Patent Applications:	3,873
Drug Prices:	Drug price information for INNOPRAN XL
What excipients (inactive ingredients) are in INNOPRAN XL?	INNOPRAN XL excipients list
DailyMed Link:	INNOPRAN XL at DailyMed

See drug prices for INNOPRAN XL

Recent Clinical Trials for INNOPRAN XL

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

Sponsor	Phase
University of Missouri-Columbia	Early Phase 1
United States Department of Defense	Early Phase 1
University of North Carolina, Chapel Hill	Phase 2

See all INNOPRAN XL clinical trials

Pharmacology for INNOPRAN XL

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

US Patents and Regulatory Information for INNOPRAN XL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	INNOPRAN XL	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021438-001	Mar 12, 2003	BX	RX	Yes	No
Ani Pharms	INNOPRAN XL	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021438-002	Mar 12, 2003	BX	RX	Yes	Yes

Expired US Patents for INNOPRAN XL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	INNOPRAN XL	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021438-001	Mar 12, 2003	6,500,454
Ani Pharms	INNOPRAN XL	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021438-002	Mar 12, 2003	6,500,454

International Patents for INNOPRAN XL

See the table below for patents covering INNOPRAN XL around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	335070
Norway	20041740
Mexico	PA04003234	FORMAS DE DOSIFICACION DE PARTICLAS MULTIPLES DE PROPANONOL DE LIBERACION SOSTENIDA, PROGRAMADA. (TIMED, SUSTAINED RELEASE MULTI-PARTICULATE DOSAGE FORMS OF PROPRANOLOL.)
Germany	60233668
Austria	442134
Japan	2005508922
South Korea	20040084890

INNOPRAN XL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for INNOPRAN XL

Introduction

INNOPRAN XL, a brand name for the extended-release formulation of propranolol hydrochloride, is a nonselective beta-adrenergic receptor-blocking agent used primarily for the treatment of hypertension, angina, and certain heart rhythm disorders. Here, we will delve into the market dynamics and financial trajectory of INNOPRAN XL.

Market Overview

Global Propranolol Market

The global propranolol market is experiencing significant growth, driven by increasing demand for cardiovascular treatments. The oral segment of the propranolol market, which includes INNOPRAN XL, accounted for a noticeable share in 2023 and is projected to continue growing[3].

Regional Analysis

The market for propranolol is segmented into major regions including North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region has its own trends and growth rates, with North America and Europe being significant markets due to high prevalence of cardiovascular diseases[3].

Product Specifics

Formulation and Dosage

INNOPRAN XL is available as 80-mg and 120-mg extended-release capsules. The dosage is typically administered once daily at bedtime, either on an empty stomach or with food. The full antihypertensive response is usually achieved within 2 to 3 weeks[1].

Manufacturer and Approval

INNOPRAN XL is manufactured by ANI Pharmaceuticals and was approved by the FDA on March 12, 2003. It is available in strengths of 80 mg and 120 mg[4].

Financial Performance

Revenue Trends

ANI Pharmaceuticals, the manufacturer of INNOPRAN XL, reported a decrease in sales of branded pharmaceutical products, including INNOPRAN XL and Inderal XL, during the second quarter of 2022. This decrease contributed to a 23% drop in sales compared to the same period in 2021[2].

Company Financials

In the second quarter of 2022, ANI Pharmaceuticals reported net revenues of $73.9 million, a 52% increase from the previous year. However, the net loss available to common shareholders was $(15.3) million, and the diluted GAAP loss per share was $(0.94). Adjusted non-GAAP diluted earnings per share were $0.13, down from $0.67 in the same period of 2021[2].

Full-Year Guidance

For 2022, ANI Pharmaceuticals guided total company net revenue between $295 million and $315 million, representing a 36% to 46% growth from 2021. Adjusted non-GAAP EBITDA was expected to be between $54 million and $60 million, and adjusted non-GAAP diluted earnings per share were projected to be between $1.34 and $1.62[2].

Market Dynamics

Competitive Landscape

Currently, there is no therapeutically equivalent generic version of INNOPRAN XL available in the United States. This lack of generic competition helps maintain the market share of the brand name product. However, fraudulent online pharmacies may attempt to sell counterfeit versions, which poses a risk to consumers[4].

Growth Drivers

The growth of the propranolol market, including INNOPRAN XL, is driven by the increasing prevalence of cardiovascular diseases and the need for effective hypertension management. The oral extended-release formulation of INNOPRAN XL offers convenience and improved patient compliance, which are key factors in its market success[1][3].

Market Restraints

Despite the growth potential, the propranolol market faces several restraints. These include adverse reactions associated with the drug, such as fatigue, dizziness, and constipation, which can affect patient adherence. Additionally, the absence of generic alternatives in some regions can limit market expansion due to higher costs associated with brand name drugs[1][3].

Clinical and Market Impact

Clinical Trials and Adverse Reactions

Clinical trials have shown that INNOPRAN XL is effective in lowering blood pressure and reducing the risk of cardiovascular events. However, adverse reactions such as fatigue, dizziness, and constipation have been reported in a significant percentage of patients. These reactions can impact patient compliance and overall market acceptance[1].

Market Penetration

The strong launch trajectory of other ANI Pharmaceuticals products, such as Cortrophin Gel, has expanded market access and increased the number of lives covered by formularies. This trend suggests potential for increased market penetration for INNOPRAN XL as well, especially if it remains a preferred treatment option for hypertension and related conditions[2].

Key Takeaways

• Market Growth: The global propranolol market, including INNOPRAN XL, is expected to grow significantly due to increasing demand for cardiovascular treatments.
• Financial Performance: ANI Pharmaceuticals reported mixed financial results, with a decrease in branded product sales but overall revenue growth.
• Competitive Advantage: The absence of a generic equivalent in the U.S. market helps maintain INNOPRAN XL's market share.
• Growth Drivers: Convenience of the extended-release formulation and the need for effective hypertension management drive market growth.
• Market Restraints: Adverse reactions and the lack of generic alternatives are key restraints.

FAQs

What is INNOPRAN XL used for?

INNOPRAN XL is used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders.

Is there a generic version of INNOPRAN XL available?

No, there is currently no therapeutically equivalent generic version of INNOPRAN XL available in the United States[4].

What are the common side effects of INNOPRAN XL?

Common side effects include fatigue, dizziness, and constipation[1].

How is INNOPRAN XL administered?

INNOPRAN XL should be administered once daily at bedtime, either on an empty stomach or with food[1].

What is the financial outlook for ANI Pharmaceuticals regarding INNOPRAN XL?

ANI Pharmaceuticals has reported a decrease in sales of INNOPRAN XL but expects overall revenue growth for 2022. The company has guided total company net revenue between $295 million and $315 million for the full year[2].

Sources

1. RxList: InnoPran XL (Propranolol Hydrochloride): Side Effects, Uses...
2. Biospace: ANI Pharmaceuticals Reports Second Quarter 2022 Financial Results
3. Cognitive Market Research: Propranolol Drug Market Report 2024 (Global Edition)
4. Drugs.com: Generic InnoPran XL Availability