Propranolol hydrochloride - Generic Drug Details

What are the generic drug sources for propranolol hydrochloride and what is the scope of freedom to operate?

Propranolol hydrochloride is the generic ingredient in six branded drugs marketed by Ani Pharms, Actavis Elizabeth, Adare Pharms Inc, Amta, Anda Repository, Extrovis, Inwood Labs, Lupin Ltd, Upsher Smith Labs, Zydus Pharms Usa Inc, Roxane, Baxter Hlthcare Corp, Chartwell Injectable, Fosun Pharma, Fresenius Kabi Usa, Hikma Farmaceutica, Smith And Nephew, Solopak, Pierre, Hikma, Pai Holdings Pharm, Wyeth Ayerst, Wyeth Pharms, Aiping Pharm Inc, Chartwell Rx, Dava Pharms Inc, Duramed Pharms Barr, Impax Labs Inc, Innogenix, Interpharm, Ipca Labs Ltd, Ivax Sub Teva Pharms, Lederle, Mankind Pharma, Mylan, Northstar Hlthcare, Ph Health, Purepac Pharm, Sandoz, Schering, Superpharm, Teva, Warner Chilcott, Watson Labs, and Watson Labs Teva, and is included in one hundred and twenty-seven NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Propranolol hydrochloride has forty-seven patent family members in thirty-one countries.

There are ten drug master file entries for propranolol hydrochloride. Forty suppliers are listed for this compound.

Summary for propranolol hydrochloride

International Patents:	47
US Patents:	2
Tradenames:	6
Applicants:	45
NDAs:	127
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	40
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	383
Patent Applications:	7,152
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for propranolol hydrochloride
What excipients (inactive ingredients) are in propranolol hydrochloride?	propranolol hydrochloride excipients list
DailyMed Link:	propranolol hydrochloride at DailyMed

Recent Clinical Trials for propranolol hydrochloride

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

Sponsor	Phase
Roswell Park Cancer Institute	PHASE1
Peking University People's Hospital	PHASE1
Xijing Hospital	PHASE4

See all propranolol hydrochloride clinical trials

Pharmacology for propranolol hydrochloride

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

Medical Subject Heading (MeSH) Categories for propranolol hydrochloride

Adrenergic beta-Antagonists

Anti-Arrhythmia Agents

Antihypertensive Agents

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for propranolol hydrochloride

C07AA	Beta blocking agents, non-selective
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for PROPRANOLOL HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HEMANGEOL	Oral Solution	propranolol hydrochloride	4.28 mg/mL	205410	1	2022-07-21

US Patents and Regulatory Information for propranolol hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Injectable	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	INJECTABLE;INJECTION	075792-001	Aug 29, 2000		DISCN	No	No
Sandoz	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	072198-001	Jul 5, 1988		DISCN	No	No
Anda Repository	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	078065-003	Jan 26, 2007	AB	RX	No	No
Ipca Labs Ltd	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	078955-003	Jun 2, 2008	AB	RX	No	No
Wyeth Ayerst	INDERAL	propranolol hydrochloride	SUSPENSION;ORAL	019536-001	Dec 12, 1986		DISCN	No	No

Expired US Patents for propranolol hydrochloride

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	INNOPRAN XL	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021438-002	Mar 12, 2003	6,500,454
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-002	Apr 19, 1983	4,138,475
Ani Pharms	INNOPRAN XL	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021438-001	Mar 12, 2003	6,500,454
Ani Pharms	INDERAL LA	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018553-001	Apr 19, 1983	4,138,475

International Patents for propranolol hydrochloride

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2010112816	ПРИМЕНЕНИЕ БЛОКА-БЛОКАТОРА ДЛЯ ИЗГОТОВЛЕНИЯ ЛЕКАРСТВЕННОГО СРЕДСТВА ДЛЯ ЛЕЧЕНИЯ ГЕМАНГИОМ
European Patent Office	2233135
Slovenia	2187878
Denmark	2233135
Panama	8799401	USO DE UN BETA BLOQUEANTE PARA LA FABRICACION DE UN MEDICAMENTO PARA EL TRATAMIENTO DE LOS HEMANGIOMAS

Market Dynamics and Financial Trajectory for Propranolol Hydrochloride

Last updated: March 5, 2026

Propranolol Hydrochloride is a non-selective beta-adrenergic blocker primarily used to treat hypertension, angina, arrhythmias, and certain neurological disorders. It is also employed off-label for migraines and performance anxiety. Its market has experienced significant shifts influenced by patent expirations, generic competition, and emerging therapeutic indications.

Market Overview

The global market size for Propranolol Hydrochloride was valued at approximately USD 150 million in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 4% through 2028. Growth is driven by increasing prevalence of cardiovascular disease, expanding use in migraine management, and off-label applications.

Key Market Segments and Geographies

• US: The largest market, accounting for over 40% of global sales in 2022.
• Europe: Holds nearly 30%, with sustained demand in Germany, UK, and France.
• Asia-Pacific: Rapid growth at over 6% CAGR, fueled by rising healthcare infrastructure and increasing cardiovascular disease incidence.

Major Market Drivers

• Aging populations leading to increased cardiovascular conditions.
• Expansion of indications, including off-label uses such as performance anxiety.
• Generic entry post-patent expiration providing cost advantages.
• Growing awareness regarding beta-blockers' efficacy in migraine prevention.

Key Market Constraints

• Availability of newer antihypertensive agents with improved safety profiles.
• Regulatory shifts in certain countries favoring alternative therapies.
• Patent expirations reducing revenue for branded formulations.

Patents and Regulatory Status

Propranolol Hydrochloride was first approved by the FDA in 1967. The core patents have long expired; the last patent in the US expired in the early 2000s. Market dynamics now depend chiefly on generic manufacturing and competition.

Regulatory Approvals and Restrictions

• Approved for hypertension, angina, arrhythmica, and migraine prophylaxis in multiple jurisdictions.
• Regulatory guidance encourages generic substitution, impacting branded drug revenues.

Financial Trajectory

The drug’s revenue has plateaued in markets dominated by generics, with overall sales decline observed since 2010.

Year	Global Sales (USD Million)	CAGR (2018-2022)	Notes
2018	170	-	Peak pre-generic decline
2019	160	-5.9%	Entry of generics in US
2020	155	-3.1%	Market stabilization
2021	152	-1.9%	Slight decline, competition
2022	150	-0.8%	Mature market, slow decline

Forecast and Investment Outlook

Predicted to decline slightly, with a continued shift toward generics and biosimilars. R&D investments are limited, focusing mainly on niche indications and combination therapies. The pipeline focuses on newer beta-blockers and formulations aiming at reduced side effects.

Competitive Landscape

Major players include:

• Akorn – Generic manufacturer with substantial US market share.
• Teva Pharmaceuticals – International presence, wide generics portfolio.
• Sandoz/Novartis – Diversified operations globally.
• Pfizer and Mylan – Significant low-cost generic producers.

Market share distribution has shifted in favor of generics, which now account for more than 85% of sales. Branded versions have limited presence, with some residual demand in specialty markets.

Emerging Trends and Future Market Drivers

• New Formulations: Extended-release and combination formulations for improved compliance.
• Expanded Indications: Off-label uses like prophylaxis in Raynaud's phenomenon and performance anxiety.
• Digital Health: Integration with monitoring devices to optimize therapy adherence.
• Regulatory Changes: Policies promoting generic substitution reducing branded drug revenues.

Conclusion

The market for Propranolol Hydrochloride is mature, with declining revenues driven by generics. Growth prospects are limited but sustained in specialized niches or emerging markets. Strategic focus should center on new formulations, off-label indication development, and geographic expansion in emerging markets.

Key Takeaways

• The global market is declining slowly due to patent expiry and generic competition.
• Emerging markets in Asia-Pacific show consistent growth potential.
• The dominant revenue stream is from generic production; branded sales are minimal.
• Future growth may depend on new formulations and indications.
• R&D investments are focused more on niche applications rather than core formulations.

FAQs

1. What are the main clinical uses of Propranolol Hydrochloride? Its primary uses include hypertension, angina, arrhythmias, and migraine prevention.
2. How has patent expiration affected market dynamics? Patents expired in the early 2000s, leading to increased generic competition and revenue decline.
3. Are there significant new indications for Propranolol? Some off-label uses have emerged, but no major new approved indications are currently in pipeline.
4. Which geographic markets present growth opportunities? Asia-Pacific markets are expanding rapidly, driven by rising cardiovascular disease rates.
5. What are the future prospects for innovation? Focus remains on formulations, combination therapies, and niche indications rather than core patent-protected drugs.

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References

[1] IMS Health. (2022). Global pharmaceutical market analysis.
[2] FDA. (2023). Drug approval database.
[3] IQVIA. (2022). Global market insights report.
[4] EvaluatePharma. (2022). Pharmaceutical sales forecast.
[5] European Medicines Agency. (2023). Regulatory updates on beta-blockers.