INDERAL LA Drug Patent Profile

Which patents cover Inderal La, and what generic alternatives are available?

Inderal La is a drug marketed by Ani Pharms and is included in one NDA.

The generic ingredient in INDERAL LA 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 Inderal La

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

Summary for INDERAL LA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	157
Clinical Trials:	76
Patent Applications:	4,079
Drug Prices:	Drug price information for INDERAL LA
DailyMed Link:	INDERAL LA at DailyMed

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See drug sales revenues for INDERAL LA

Recent Clinical Trials for INDERAL LA

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

Sponsor	Phase
Rigshospitalet, Denmark	Phase 2
Zealand University Hospital	Phase 2
Innovent Biologics (Suzhou) Co. Ltd.	Phase 1

See all INDERAL LA clinical trials

Pharmacology for INDERAL LA

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

US Patents and Regulatory Information for INDERAL LA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-004	Mar 18, 1987	AB	RX	Yes	No
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-001	Apr 19, 1983	AB	RX	Yes	Yes
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-002	Apr 19, 1983	AB	RX	Yes	No

Expired US Patents for INDERAL LA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-004	Mar 18, 1987	4,138,475
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-001	Apr 19, 1983	4,138,475
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-003	Apr 19, 1983	4,138,475

International Patents for INDERAL LA

See the table below for patents covering INDERAL LA around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	153773
Norway	773293
Hong Kong	10381	SUSTAINED RELEASE PHARMACEUTICAL COMPOSTION

INDERAL LA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Inderal LA

Introduction

Inderal LA, a long-acting formulation of the beta-blocker propranolol hydrochloride, has been a significant player in the pharmaceutical market, particularly in the treatment of hypertension, angina pectoris, migraine, and hypertrophic subaortic stenosis. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Indications and Usage

Inderal LA is indicated for the management of hypertension, angina pectoris due to coronary atherosclerosis, and the prevention of migraine headaches. It is also used to treat hypertrophic subaortic stenosis, a condition characterized by obstruction of blood flow from the heart[5].

Market Position and Competition

Inderal LA holds a niche position in the market as a long-acting beta-blocker, offering a convenient once-daily dosing regimen. This formulation simplifies patient treatment plans and enhances compliance compared to conventional propranolol, which requires multiple daily doses[3].

The market for beta-blockers is competitive, with various generic and branded options available. However, Inderal LA's unique sustained-release formulation and its specific indications help it maintain a distinct market presence.

Financial Performance

In 2015, Inderal LA and its authorized generic generated combined sales of $30 million, according to IMS Health. This figure highlights the drug's significant revenue contribution to its manufacturers and distributors[1][4].

Acquisition and Ownership

In 2016, ANI Pharmaceuticals, Inc. acquired the portfolio of Inderal LA assets from Cranford Pharmaceuticals, LLC. This acquisition included the New Drug Application (NDA) and trademark for Inderal LA, as well as finished goods inventory. The transaction was expected to be material to ANI's revenue and EBITDA in 2016[1][4].

Revenue Impact

The acquisition by ANI Pharmaceuticals was part of the company's strategy to pursue limited competition generic products and mature brands. The inclusion of Inderal LA in ANI's commercial portfolio was anticipated to enhance the company's financial performance, with updated financial guidance provided upon the closing of the transaction[1][4].

Market Trends and Growth

The demand for beta-blockers, including Inderal LA, is influenced by several market trends:

Increasing Prevalence of Cardiovascular Diseases

The rising prevalence of hypertension, angina pectoris, and other cardiovascular conditions drives the demand for effective treatments like Inderal LA. As the global population ages and lifestyle factors contribute to increased cardiovascular risk, the market for these medications is expected to grow[5].

Patient Compliance and Convenience

The once-daily dosing regimen of Inderal LA enhances patient compliance, which is a critical factor in the management of chronic conditions. This convenience can lead to better health outcomes and increased market demand for the drug[3].

Regulatory Environment

Regulatory approvals and compliance play a crucial role in the pharmaceutical industry. Inderal LA's NDA and ongoing regulatory oversight ensure its continued presence in the market, although changes in regulatory environments can impact its financial trajectory[2].

Challenges and Risks

Despite its market position, Inderal LA faces several challenges and risks:

Competition from Generics

The availability of generic propranolol ER capsules can impact the sales of branded Inderal LA. However, the unique formulation and brand recognition of Inderal LA help it maintain a competitive edge[1][4].

Side Effects and Safety Concerns

Like all medications, Inderal LA has potential side effects, including tiredness, dizziness, and constipation. Severe side effects such as heart failure and certain abnormal heart rhythms can also occur. These safety concerns must be managed through proper medical supervision and patient education[5].

Economic and Market Factors

General business and economic conditions, market trends, and increased competition can affect the financial performance of Inderal LA. Delays or failures in obtaining regulatory approvals and importing raw materials are additional risks[1][4].

Clinical Efficacy and Patient Outcomes

Inderal LA has been shown to be as effective as conventional propranolol in treating angina pectoris, hypertension, and preventing migraine headaches. Clinical trials have demonstrated its efficacy in reducing angina frequency, increasing exercise tolerance, and managing blood pressure[2][3].

Pharmacokinetics

The sustained-release formulation of Inderal LA ensures a consistent plasma concentration of propranolol over 24 hours, which is beneficial for maintaining therapeutic effects without the variability seen with multiple daily doses of conventional propranolol[2][3].

Key Takeaways

• Market Indications: Inderal LA is used for hypertension, angina pectoris, migraine prevention, and hypertrophic subaortic stenosis.
• Financial Performance: Generated $30 million in combined sales in 2015 and is expected to contribute significantly to ANI Pharmaceuticals' revenue and EBITDA.
• Market Trends: Driven by increasing prevalence of cardiovascular diseases and the need for convenient, once-daily dosing regimens.
• Challenges: Faces competition from generics, potential side effects, and regulatory and economic risks.
• Clinical Efficacy: Demonstrated effectiveness in clinical trials for its indicated uses.

FAQs

Q: What are the primary indications for Inderal LA?

A: Inderal LA is indicated for the management of hypertension, angina pectoris due to coronary atherosclerosis, prevention of migraine headaches, and treatment of hypertrophic subaortic stenosis[5].

Q: Who acquired the assets for Inderal LA in 2016?

A: ANI Pharmaceuticals, Inc. acquired the portfolio of Inderal LA assets from Cranford Pharmaceuticals, LLC in 2016[1][4].

Q: What is the dosing regimen for Inderal LA?

A: Inderal LA is administered once daily, providing a sustained release of propranolol hydrochloride over 24 hours[2][3].

Q: What are the common side effects of Inderal LA?

A: Common side effects include tiredness, dizziness, and constipation. Severe side effects can include heart failure and certain abnormal heart rhythms[5].

Q: How does Inderal LA compare to conventional propranolol in terms of efficacy?

A: Inderal LA is as effective as conventional propranolol in treating its indicated conditions, with the added benefit of a once-daily dosing regimen[2][3].

Sources

1. ANI Pharma Agrees To Acquire Inderal LA Assets From Cranford Pharmaceuticals. Biospace.
2. Inderal® LA (propranolol hydrochloride) Long-Acting Capsules. FDA.
3. Long-acting propranolol (Inderal LA): pharmacokinetics and clinical efficacy. PubMed.
4. ANI Pharmaceuticals Agrees to Acquire Inderal® LA Assets from Cranford Pharmaceuticals. PR Newswire.
5. Inderal® LA. Inderal LA Official Website.