You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

Betamethasone acetate; betamethasone sodium phosphate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for betamethasone acetate; betamethasone sodium phosphate and what is the scope of patent protection?

Betamethasone acetate; betamethasone sodium phosphate is the generic ingredient in two branded drugs marketed by Am Regent, Hikma, and Organon, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

Five suppliers are listed for this compound.

Summary for betamethasone acetate; betamethasone sodium phosphate
Recent Clinical Trials for betamethasone acetate; betamethasone sodium phosphate

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

SponsorPhase
Tel-Aviv Sourasky Medical CenterN/A
University of KentuckyEarly Phase 1
Edward KasaraskisEarly Phase 1

See all betamethasone acetate; betamethasone sodium phosphate clinical trials

Pharmacology for betamethasone acetate; betamethasone sodium phosphate
Anatomical Therapeutic Chemical (ATC) Classes for betamethasone acetate; betamethasone sodium phosphate
A06AD Osmotically acting laxatives
A06A DRUGS FOR CONSTIPATION
A06 DRUGS FOR CONSTIPATION
A Alimentary tract and metabolism
A06AG Enemas
A06A DRUGS FOR CONSTIPATION
A06 DRUGS FOR CONSTIPATION
A Alimentary tract and metabolism
A07EA Corticosteroids acting locally
A07E INTESTINAL ANTIINFLAMMATORY AGENTS
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
B05XA Electrolyte solutions
B05X I.V. SOLUTION ADDITIVES
B05 BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B Blood and blood forming organs
C05AA Corticosteroids
C05A AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05 VASOPROTECTIVES
C Cardiovascular system
D07AC Corticosteroids, potent (group III)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07XC Corticosteroids, potent, other combinations
D07X CORTICOSTEROIDS, OTHER COMBINATIONS
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
R01AD Corticosteroids
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
R Respiratory system
R03BA Glucocorticoids
R03B OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03 DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R Respiratory system
S01BA Corticosteroids, plain
S01B ANTIINFLAMMATORY AGENTS
S01 OPHTHALMOLOGICALS
S Sensory organs
S01CB Corticosteroids/antiinfectives/mydriatics in combination
S01C ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01 OPHTHALMOLOGICALS
S Sensory organs
S02BA Corticosteroids
S02B CORTICOSTEROIDS
S02 OTOLOGICALS
S Sensory organs
S03BA Corticosteroids
S03B CORTICOSTEROIDS
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs
V03AG Drugs for treatment of hypercalcemia
V03A ALL OTHER THERAPEUTIC PRODUCTS
V03 ALL OTHER THERAPEUTIC PRODUCTS
V Various

US Patents and Regulatory Information for betamethasone acetate; betamethasone sodium phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Am Regent BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE betamethasone acetate; betamethasone sodium phosphate INJECTABLE;INJECTION 090747-001 Jul 31, 2009 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Organon CELESTONE SOLUSPAN betamethasone acetate; betamethasone sodium phosphate INJECTABLE;INJECTION 014602-001 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE betamethasone acetate; betamethasone sodium phosphate INJECTABLE;INJECTION 077838-001 Jan 17, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Betamethasone acetate; betamethasone sodium phosphate Market Analysis and Financial Projection Experimental

Betamethasone Sodium Phosphate and Betamethasone Acetate: Market Dynamics and Financial Trajectory

Introduction

Betamethasone sodium phosphate and betamethasone acetate are crucial corticosteroids used in the treatment of various inflammatory and allergic conditions. The market for these drugs is experiencing significant growth, driven by several key factors. Here, we delve into the market dynamics and financial trajectory of these medications.

Market Size and Growth Projections

The global betamethasone sodium phosphate market is projected to witness a Compound Annual Growth Rate (CAGR) of 6.51% from 2024 to 2031. This growth will see the market expand from USD 607.2 million in 2023 to USD 1005.67 million by 2031[1][4].

Drivers of Market Growth

Increasing Prevalence of Arthritis and Allergies

The rising cases of arthritis and allergies are major drivers of the market. For instance, the Centre for Disease Control and Prevention estimates that approximately 5.4% of adults in the United States have reported arthritis between 2019 and 2021. This increase in arthritis cases boosts the demand for betamethasone sodium phosphate, which is administered intra-articularly for conditions such as rheumatoid arthritis, osteoarthritis, and acute gouty arthritis[1].

Pharmaceutical Industry Expansion

The rapid expansion of the pharmaceutical industry, particularly in regions like North America and Europe, is another significant factor. North America, for example, accounted for 49.1% of global pharmaceutical sales in 2021, while Europe accounted for 23.4%. This expansion supports the increased demand for pharmaceutical products, including those containing betamethasone sodium phosphate[1].

Research and Development

Ongoing research studies are evaluating the efficacy of betamethasone sodium phosphate for various conditions, further propelling market growth. For example, the OrthoCarolina Research Institute is conducting a study to determine if corticosteroid injections (betamethasone) modify the course of De Quervain’s Tenosynovitis compared to toradol injections. Similar studies by institutions like Thammasat University in Thailand are also contributing to the market's growth[1].

Market Segmentation

The betamethasone sodium phosphate market is segmented based on type and application.

Type

The market includes segments such as injection, powder injection, and drops. The solid form of betamethasone sodium phosphate is particularly preferred due to its ease of handling, cost efficiency in transportation and distribution, and its use in formulating injections and tablets[1][4].

Application

The applications include intramuscular injection, intravenous injection, and intra-articular injection. The intra-articular application is significant, given the drug's use in treating various forms of arthritis and other inflammatory conditions[1][4].

Geographical Distribution

North America

North America dominates the global betamethasone sodium phosphate market due to the strong presence of leading market players, increasing prevalence of health conditions like arthritis and allergic disorders, and significant investments in research activities. The region's robust pharmaceutical industry, accounting for 49.1% of global pharmaceutical sales in 2021, further supports this dominance[1].

Europe and Other Regions

Europe also plays a crucial role, with 23.4% of global pharmaceutical sales in 2021. Other regions, including Asia-Pacific, South America, and the Middle East and Africa, are also experiencing growth due to increasing healthcare needs and investments in pharmaceutical research[1][4].

Challenges and Restraints

Side Effects and Complications

Corticosteroid-associated infections can be mild but can also be severe and sometimes fatal. The risk of infections increases with higher corticosteroid dosages. Additionally, the use of betamethasone sodium phosphate and betamethasone acetate in patients with latent tuberculosis or tuberculin reactivity can lead to reactivation of the disease[2][5].

Pediatric and Geriatric Considerations

In pediatric patients, long-term use of these medications can lead to slower growth and bone problems. In geriatric patients, while there are no specific age-related problems, elderly patients are more sensitive to the effects of these medicines[5].

Financial Trajectory

The financial trajectory of the betamethasone sodium phosphate market is characterized by sustained growth. Here are some key financial highlights:

  • Market Size: The market is expected to grow from USD 607.2 million in 2023 to USD 1005.67 million by 2031[1].
  • CAGR: A projected CAGR of 6.51% from 2024 to 2031 indicates robust growth[1].
  • Revenue Projections: The market is subjected to a thorough assessment, with revenue projections indicating a persistent upward trend in market dynamics[4].

Key Takeaways

  • The betamethasone sodium phosphate market is driven by the increasing prevalence of arthritis and allergies.
  • The pharmaceutical industry's expansion, particularly in North America and Europe, supports market growth.
  • Ongoing research studies are evaluating the efficacy of betamethasone sodium phosphate, further boosting demand.
  • The market is segmented by type and application, with solid forms and intra-articular applications being significant.
  • North America dominates the market due to strong industry presence and research investments.
  • Despite growth, the market faces challenges related to side effects and complications.

FAQs

What is the projected CAGR for the betamethasone sodium phosphate market from 2024 to 2031?

The projected CAGR for the betamethasone sodium phosphate market from 2024 to 2031 is 6.51%[1].

What are the primary drivers of the betamethasone sodium phosphate market?

The primary drivers include the increasing prevalence of arthritis and allergies, the expansion of the pharmaceutical industry, and ongoing research studies evaluating the drug's efficacy[1].

Which region dominates the global betamethasone sodium phosphate market?

North America dominates the global betamethasone sodium phosphate market due to the strong presence of leading market players and significant investments in research activities[1].

What are the potential side effects of betamethasone sodium phosphate and betamethasone acetate?

Potential side effects include corticosteroid-associated infections, reactivation of latent tuberculosis, and slower growth and bone problems in pediatric patients. Elderly patients are also more sensitive to the effects of these medicines[2][5].

How is the betamethasone sodium phosphate market segmented?

The market is segmented based on type (injection, powder injection, drops) and application (intramuscular injection, intravenous injection, intra-articular injection)[1][4].

Sources

  1. Markets and Data, Betamethasone Sodium Phosphate Market Size, Growth, Report 2031, https://www.marketsanddata.com/industry-reports/betamethasone-sodium-phosphate-market
  2. DailyMed, Betamethasone Sodium Phosphate and Betamethasone Acetate, https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=a363b861-4873-465e-8009-0e9690666224
  3. PubChem, Betamethasone Acetate; Betamethasone Sodium Phosphate, https://pubchem.ncbi.nlm.nih.gov/compound/Betamethasone%20Acetate;%20Betamethasone%20Sodium%20Phosphate
  4. Market Research Intellect, Global Betamethasone Sodium Phosphate Market Size, Scope And Forecast 2023-2031, https://www.marketresearchintellect.com/product/global-betamethasone-sodium-phosphate-market/
  5. Mayo Clinic, Betamethasone sodium phosphate and betamethasone acetate injection, https://www.mayoclinic.org/drugs-supplements/betamethasone-sodium-phosphate-and-betamethasone-acetate-injection-route/description/drg-20425905

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.