Oxytocin - Generic Drug Details

What are the generic sources for oxytocin and what is the scope of patent protection?

Oxytocin is the generic ingredient in six branded drugs marketed by Dr Reddys, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Sagent Pharms Inc, Abbott, Endo Operations, Novartis, and Rtrx, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for oxytocin. Six suppliers are listed for this compound.

Summary for oxytocin

US Patents:	0
Tradenames:	6
Applicants:	9
NDAs:	9
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	762
Patent Applications:	5,972
Drug Prices:	Drug price trends for oxytocin
What excipients (inactive ingredients) are in oxytocin?	oxytocin excipients list
DailyMed Link:	oxytocin at DailyMed

See drug prices for oxytocin

Recent Clinical Trials for oxytocin

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

Sponsor	Phase
University Hospital, Gentofte, Copenhagen	N/A
University of Colorado, Denver	Phase 2
Karolinska Institutet	Phase 2

See all oxytocin clinical trials

Pharmacology for oxytocin

Drug Class	Oxytocic
Physiological Effect	Increased Uterine Smooth Muscle Contraction or Tone

Medical Subject Heading (MeSH) Categories for oxytocin

Oxytocics

Anatomical Therapeutic Chemical (ATC) Classes for oxytocin

H01BB	Oxytocin and analogues
H01B	POSTERIOR PITUITARY LOBE HORMONES
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for oxytocin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	PITOCIN	oxytocin	INJECTABLE;INJECTION	018261-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Abbott	OXYTOCIN 5 USP UNITS IN DEXTROSE 5%	oxytocin	INJECTABLE;INJECTION	019185-001	Mar 29, 1985		DISCN	Yes	No
Fresenius Kabi Usa	OXYTOCIN	oxytocin	INJECTABLE;INJECTION	018248-002	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Abbott	OXYTOCIN 20 USP UNITS IN DEXTROSE 5%	oxytocin	INJECTABLE;INJECTION	019185-002	Mar 29, 1985		DISCN	Yes	No
Novartis	SYNTOCINON	oxytocin	INJECTABLE;INJECTION	018245-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Oxytocin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Oxytocin

Market Overview

The oxytocin market is poised for significant growth over the next several years, driven by various factors including advancements in maternity care, increasing healthcare expenditures, and the essential role of oxytocin in obstetrics and gynecology.

Global Market Size and Growth

• The global oxytocin market was valued at approximately USD 83.0 million in 2022 and is expected to reach USD 164.9 million by 2030, growing at a CAGR of 9.0% during the forecast period[1].
• Another projection indicates that the market size could reach USD 193.02 million by 2032, with a CAGR of 9.3% from 2024 to 2032[3].
• A slightly different estimate suggests the market will grow to USD 178.99 million by 2031, with a CAGR of 8.9% from 2024 to 2031[5].

Key Drivers of Growth

Increasing Healthcare Expenditure and Maternal Care

• The rise in healthcare expenditure and per capita income, particularly in emerging markets such as Africa, China, and India, offers significant opportunities for oxytocin manufacturers[1].
• Improvements in maternity care, including the use of oxytocin to prevent and treat postpartum hemorrhage, are key drivers of market growth[1][3].

Technological and Scientific Advancements

• Emerging scientific and technological advancements are expanding the indications for oxytocin beyond traditional uses, such as labor induction and postpartum hemorrhage prevention, to include potential treatments for pregnancy complications, autism, and social anxiety[1].
• Innovations in drug delivery systems and formulations, such as high stability formulations and convenient dosage forms, are expected to further boost market growth[1][3].

Government Initiatives and Regulations

• Government programs aimed at improving maternal health and reducing maternal mortality rates are supporting the growth of the oxytocin market. For instance, WHO prequalification and other regulatory approvals are crucial for market expansion[1][3].

Regional Market Dynamics

North America

• North America, particularly the United States, dominates the global oxytocin market due to high healthcare spending, significant research investments, and the presence of major pharmaceutical companies[3][4].
• The region is expected to continue its dominance, driven by factors such as rising pre-term birth rates and increased fertility rates[3].

Europe

• Europe, with Germany as a key market, is expected to register a CAGR of around 9.2% over the next several years. Germany's advanced maternity care and the presence of large industry players like Novartis contribute to this growth[1][2].

Asia-Pacific

• The Asia-Pacific region, particularly China and India, is expected to grow at the fastest rate due to increasing awareness of maternal health, escalating childbirth rates, and advancements in healthcare infrastructure[3][4].
• China holds a significant share in the East Asia market and is projected to increase at a CAGR of 6.2% during the forecast period[1].

Market Segmentation

By Indication

• The postpartum segment holds a substantial share of the market, with over 88.8% in 2021, due to the critical role of oxytocin in preventing and treating postpartum hemorrhage[1].
• Antepartum and other indications are also significant, with potential growth in areas such as pregnancy complications and social anxiety[1][3].

By Distribution Channel

• Hospitals are the primary distribution channel, accounting for the majority of the market share due to their accessibility and the convenience of treatment[3].
• Retail pharmacies, drug stores, and online pharmacies also play important roles in the distribution of oxytocin products[5].

Competitive Landscape

• The oxytocin market is highly competitive and fragmented, with both regional and global players. Key companies include Pfizer, Novartis, Ferring, Fresenius Kabi, and Hikma Pharmaceuticals[3][4].
• Market participants are engaged in new product development, mergers and acquisitions, and strategic alliances to gain market share and expand their presence[3][4].

Financial Trajectory

Revenue Projections

• The oxytocin market is expected to more than double in size over the next eight years, from approximately USD 83.0 million in 2022 to USD 164.9 million by 2030[1].
• Another projection indicates that the market will grow from USD 94.97 million in 2024 to USD 193.02 million by 2032[3].

CAGR and Growth Rate

• The market is anticipated to grow at a CAGR of 9.0% to 9.3% during the forecast period, depending on the source[1][3][5].

Key Markets and Regions

• North America, Europe, and the Asia-Pacific region are expected to drive the demand for oxytocin products, with the U.S., India, and Canada being key producers[1][3][4].

Challenges and Opportunities

Challenges

• Stringent regulations, limited access in developing regions, and patent expirations pose challenges to the market growth[3].
• The COVID-19 pandemic caused disruptions in supply chains and manufacturing, although demand for oxytocin remained steady due to its essential role in obstetrics and gynecology[3].

Opportunities

• Emerging applications such as pregnancy complications, autism, and social anxiety offer potential growth opportunities for the oxytocin market[1].
• Collaborative approaches and partnerships are expected to provide high market penetration and growth opportunities, especially in developing regions[1].

"Highly fragmented market, increased licensing activities and WHO prequalification are some of the key trends being witnessed in this marketplace."[1]

Key Takeaways

• The oxytocin market is expected to experience significant growth driven by improvements in maternity care, increasing healthcare expenditure, and technological advancements.
• North America and Europe are key markets, while the Asia-Pacific region is expected to grow at the fastest rate.
• The market is highly competitive, with major players focusing on new product development and strategic alliances.
• Emerging applications and innovations in drug delivery systems are expected to further boost market growth.

FAQs

Q: What is the projected CAGR for the oxytocin market from 2022 to 2030?

A: The oxytocin market is expected to grow at a CAGR of 9.0% from 2022 to 2030[1].

Q: Which region is expected to grow at the fastest rate in the oxytocin market?

A: The Asia-Pacific region is expected to grow at the fastest rate due to increasing awareness of maternal health and advancements in healthcare infrastructure[3][4].

Q: What are the key drivers of growth in the oxytocin market?

A: Key drivers include improvements in maternity care, increasing healthcare expenditure, and technological advancements expanding the indications for oxytocin[1][3][4].

Q: Who are the major players in the global oxytocin market?

A: Major players include Pfizer, Novartis, Ferring, Fresenius Kabi, and Hikma Pharmaceuticals[3][4].

Q: How has the COVID-19 pandemic impacted the oxytocin market?

A: Despite disruptions in supply chains and manufacturing, demand for oxytocin remained steady due to its essential role in obstetrics and gynecology[3].

Sources

1. Future Market Insights, "Oxytocin Market | Global Sales Analysis Report - 2030".
2. Future Market Insights, "Oxytocic Pharmaceuticals Market Share & Forecast 2033 | FMI".
3. Polaris Market Research, "Oxytocin Market Opportunities, Growth Analysis Report, 2024-2032".
4. Grand View Research, "Oxytocin Market Size, Share & Growth Analysis Report, 2030".
5. SNS Insider, "Oxytocin Market Size & Share, Global Growth Report 2024-2032".