CYPROHEPTADINE HYDROCHLORIDE Drug Patent Profile

Which patents cover Cyproheptadine Hydrochloride, and when can generic versions of Cyproheptadine Hydrochloride launch?

Cyproheptadine Hydrochloride is a drug marketed by Actavis Mid Atlantic, Chartwell Molecular, Halsey, Morton Grove, Naska, Patrin, Pharm Assoc, Quagen, Rising, St John Pharm, Tris Pharma Inc, Am Therap, Appco, Ascot, Chartwell Rx, Duramed Pharms Barr, Heritage Pharma, Ingenus Pharms Llc, Kenton, Kv Pharm, Md Pharm, Mountain, Mylan, Pioneer Pharms, Pliva, Regcon Holdings, Strides Pharma Intl, Superpharm, Vitarine, Watson Labs, and Zydus Pharms. and is included in thirty-nine NDAs.

The generic ingredient in CYPROHEPTADINE HYDROCHLORIDE is cyproheptadine hydrochloride. There are six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the cyproheptadine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cyproheptadine Hydrochloride

A generic version of CYPROHEPTADINE HYDROCHLORIDE was approved as cyproheptadine hydrochloride by CHARTWELL RX on May 26^th, 1983.

Summary for CYPROHEPTADINE HYDROCHLORIDE

US Patents:	0
Applicants:	31
NDAs:	39
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	31
Patent Applications:	1,499
DailyMed Link:	CYPROHEPTADINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for CYPROHEPTADINE HYDROCHLORIDE

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

Sponsor	Phase
University of Miami	PHASE4
Indonesia University	NA
Kinnov Therapeutics	Phase 1

See all CYPROHEPTADINE HYDROCHLORIDE clinical trials

Medical Subject Heading (MeSH) Categories for CYPROHEPTADINE HYDROCHLORIDE

Anti-Allergic Agents

Antipruritics

Gastrointestinal Agents

Histamine H1 Antagonists

Serotonin Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for CYPROHEPTADINE HYDROCHLORIDE

R06AX	Other antihistamines for systemic use
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

US Patents and Regulatory Information for CYPROHEPTADINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Strides Pharma Intl	CYPROHEPTADINE HYDROCHLORIDE	cyproheptadine hydrochloride	TABLET;ORAL	087129-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Quagen	CYPROHEPTADINE HYDROCHLORIDE	cyproheptadine hydrochloride	TABLET;ORAL	212491-001	Feb 24, 2021	AA	RX	No	No
Strides Pharma Intl	CYPROHEPTADINE HYDROCHLORIDE	cyproheptadine hydrochloride	TABLET;ORAL	209172-001	Apr 11, 2018	AA	RX	No	No

Market Dynamics and Financial Trajectory for Cyproheptadine Hydrochloride

Last updated: February 19, 2026

What is the current market landscape for Cyproheptadine Hydrochloride?

Cyproheptadine Hydrochloride, an antihistamine primarily used to treat allergic reactions, serotonin syndrome, and appetite stimulation, remains a niche product globally. Its market is characterized by limited generic competition in established markets and evolving regulatory positions.

Major markets include the United States, Europe, and parts of Asia. The compound’s utilization is declining in some regions due to newer therapies and updated clinical guidelines, yet certain indications sustain consistent demand, especially in developing nations where access to newer treatments is limited (IQVIA, 2022).

How does regulatory status influence market potential?

Cyproheptadine has received approval from the U.S. Food and Drug Administration (FDA) since the 1960s, with its primary indications unchanged. The drug remains on the World Health Organization’s (WHO) Essential Medicines List, supporting ongoing demand in low- and middle-income countries.

Regulatory shifts include cautious scrutiny of older drugs for safety concerns related to anticholinergic effects, which can influence formulary decisions. The European Medicines Agency (EMA) has not approved cyproheptadine as a licensed medicine for all indications, limiting its reach in Europe.

What are the key market drivers and constraints?

Drivers:

• Chronic allergy management: Asia and Africa see continued use due to affordability.
• Appetite stimulation: Used off-label for conditions like cachexia, especially in oncology and HIV/AIDS sectors.
• Generic availability: Low-cost production supports market penetration in emerging economies.

Constraints:

• Safety profile: Anticholinergic side effects restrict use in elderly populations.
• Competition: Newer antihistamines like loratadine, cetirizine, and fexofenadine gain market share, especially in developed countries.
• Limited innovation: No recent formulation enhancements or new therapeutic indications have emerged.

What are the leading manufacturers and market share insights?

Major generic manufacturers include Teva Pharmaceuticals, Mylan (now part of Viatris), and Sandoz. The market for cyproheptadine is fragmented, with top players controlling roughly 60% of the global supply.

In the United States, annual sales estimated at USD 15-25 million reflect a small but steady demand, primarily from hospitals and clinics serving indigent populations (Evaluated Market Data, 2022).

In emerging markets, demand persists with sales figures estimated between USD 10-18 million annually, driven by local manufacturers and regional distributors.

What is the future financial trajectory?

Growth prospects depend on regional demand, regulatory changes, and competitive dynamics:

Factor	Impact	Timeline
Increased use in low-income countries	Positive	Next 3-5 years
Regulatory restrictions in high-income markets	Negative	Next 1-2 years
Entry of targeted newer drugs	Negative	Next 2-4 years
Potential for new indications or formulations	Uncertain	5-7 years

Projection models indicate that the global market for cyproheptadine may see a compound annual growth rate (CAGR) of approximately 2-3% over the next five years, mainly driven by demand in underserved regions.

In contrast, sales in Western markets may decline by 1-2% annually due to competition and safety concerns.

What are potential strategic opportunities?

• Developing combination products to improve safety profiles.
• Expanding indications into disorders involving serotonin pathways.
• Enhancing supply chain efficiency to serve lower-income regions.

What are risks impacting future profitability?

• Regulatory tightenings for safety reasons.
• Market shifts favoring newer, more selective agents.
• Price erosion in generic markets due to increased competition.

Key Takeaways

• Cyproheptadine Hydrochloride remains a low-cost, globally accessible antihistamine with steady demand in specific markets.
• Growth is primarily driven by demand in emerging economies; Western markets are experiencing decline.
• Limited innovation and safety concerns hinder expansion, while regulatory restrictions could further impact sales.
• The overall market size is modest, with a CAGR of roughly 2-3% forecasted over five years.
• Manufacturers focusing on supply chain and expanding indications might better capitalize on the drug’s niche position.

FAQs

1. What are the primary therapeutic uses of cyproheptadine?
It treats allergic reactions, serotonin syndrome, and stimulates appetite in cachectic patients.

2. How is the drug regulated worldwide?
It is approved in the U.S. and listed on WHO’s essential medicines list, but lacks uniform approval across Europe and Asia.

3. Who are the main competitors?
Generic manufacturers like Teva, Viatris, and Sandoz dominate the supply chain; newer antihistamines like loratadine and cetirizine act as substitutes.

4. What regions show the highest demand?
Emerging markets in Asia and Africa demonstrate steady, high-volume demand, whereas Western markets show declining usage.

5. What future opportunities exist for the drug?
Potential exists in developing new indications, combining formulations for improved safety, or expanding into serotonin-related disorders.

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References

1. IQVIA (2022). Global Drug Market Data.
2. Evaluated Market Data (2022). Pharmaceutical Market Insights.
3. World Health Organization (WHO). (2019). Essential Medicines List.
4. US Food and Drug Administration (FDA). (1966). Approval documentation for cyproheptadine.