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

Last Updated: December 22, 2024

CARBAGLU Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Carbaglu patents expire, and what generic alternatives are available?

Carbaglu is a drug marketed by Recordati Rare and is included in one NDA.

The generic ingredient in CARBAGLU is carglumic acid. There are two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the carglumic acid profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Carbaglu

A generic version of CARBAGLU was approved as carglumic acid by NOVITIUM PHARMA on October 13th, 2021.

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for CARBAGLU?
  • What are the global sales for CARBAGLU?
  • What is Average Wholesale Price for CARBAGLU?
Summary for CARBAGLU
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 85
Clinical Trials: 6
Patent Applications: 238
What excipients (inactive ingredients) are in CARBAGLU?CARBAGLU excipients list
DailyMed Link:CARBAGLU at DailyMed
Drug patent expirations by year for CARBAGLU
Recent Clinical Trials for CARBAGLU

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

SponsorPhase
National Taiwan University HospitalN/A
King Abdullah International Medical Research CenterPhase 3
University of Colorado, DenverPhase 2

See all CARBAGLU clinical trials

Pharmacology for CARBAGLU

US Patents and Regulatory Information for CARBAGLU

CARBAGLU is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Recordati Rare CARBAGLU carglumic acid TABLET, FOR SUSPENSION;ORAL 022562-001 Mar 18, 2010 AB RX Yes Yes ⤷  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

EU/EMA Drug Approvals for CARBAGLU

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Eurocept International BV Ucedane carglumic acid EMEA/H/C/004019
Ucedane is indicated in treatment of:hyperammonaemia due to N-acetylglutamate synthase primary deficiency;Hyperammonaemia due to isovaleric acidaemia;Hyperammonaemia due to methymalonic acidaemia;Hyperammonaemia due to propionic acidaemia.
Authorised yes no no 2017-06-23
Recordati Rare Diseases Carbaglu carglumic acid EMEA/H/C/000461
Carbaglu is indicated in treatment of:hyperammonaemia due to N-acetylglutamate-synthase primary deficiency;hyperammonaemia due to isovaleric acidaemia;hyperammonaemia due to methymalonic acidaemia;hyperammonaemia due to propionic acidaemia.
Authorised no no no 2003-01-24
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

CARBAGLU Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Carbaglu (Carglumic Acid)

Market Overview

Carbaglu, also known as carglumic acid, is a medication primarily used to treat hyperammonemia, a condition characterized by elevated levels of ammonia in the blood. This condition can arise from various metabolic disorders, including urea cycle disorders.

Market Size and Growth

The global carglumic acid market has been experiencing significant growth. As of 2023, the market generated USD 138.27 million in revenue and is projected to grow at a CAGR of 7.38% from 2024 to 2033, reaching USD 281.81 million by 2033[1][3][5].

Key Growth Drivers

Rising Prevalence of Metabolic Disorders

The increasing incidence rates of metabolic disorders such as hepatic encephalopathy, Reye's syndrome, and cirrhosis globally are major drivers of the market. Additionally, the growing prevalence of metabolic diseases like metabolic syndrome, type 2 diabetes mellitus, hypertension, and non-alcoholic fatty liver disease (NAFLD) contributes to the demand for carglumic acid[1][5].

Awareness and Diagnosis of Rare Diseases

The heightened awareness and diagnosis of rare diseases, including urea cycle disorders (UCDs), are significant factors driving the market's growth. UCDs are caused by a lack of enzymes or transporters involved in ammonia detoxification, making carglumic acid a crucial treatment option[1][4].

Technological Advancements

Integrating carglumic acid treatment with digital health solutions such as remote monitoring and telehealth enhances patient management, improves adherence, and streamlines healthcare delivery. These technological advancements offer opportunities for market growth[3].

Patient Assistance Programs

Expanding and optimizing patient assistance programs, including financial assistance, co-pay support, and educational resources, improve patient access to carglumic acid. These initiatives contribute to the market's growth potential[3].

Market Segmentation

Dosage Form

The market is segmented by dosage form, with dispersible tablets holding the largest market share. In 2023, the dispersible tablets segment accounted for 54.29% of the market revenue, amounting to USD 75.10 million. Other dosage forms include orally disintegrating tablets and others[3][5].

Distribution Channel

The market is also segmented by distribution channel, with hospital pharmacies dominating the market. In 2023, hospital pharmacies generated around USD 77 million in revenue, followed by retail pharmacies and online pharmacies[5].

Regional Analysis

North America is the largest market for carglumic acid, accounting for USD 60.4 million in revenue in 2023. The market in this region is expected to witness substantial growth due to the high prevalence of metabolic disorders and advanced healthcare infrastructure[1][5].

Financial Performance and Key Players

Revenue and Profitability

Recordati, a key player in the market, has seen significant financial performance driven by its rare disease segment, which includes Carbaglu. In 2021, Recordati's revenue reached € 1,580.1 million, with a notable contribution from the legacy metabolic portfolio and endocrine franchise. The company's EBITDA margin was 38.1%, and adjusted net income grew by 3.5% compared to the previous year[2].

Market Competitiveness

The global carglumic acid market is moderately competitive, with several major players including Recordati Rare Diseases, Apothecon Pharmaceuticals Pvt Ltd., Manus Aktteva Biopharma LLP, Civentichem LLC, and Dipharma Francis S.r.l. These companies are employing various strategies such as R&D investments, business acquisitions, and the development of generic products to strengthen their market positions[4].

Regulatory Approvals and Expansions

FDA Approvals

In 2021, the FDA approved a new indication for Carbaglu (carglumic acid) 200 mg tablets as an adjunctive therapy for the primary treatment of acute hyperammonemia caused by propionic acidemia (PA) or methylmalonic acidemia (MMA) in pediatric and adult patients. This approval marked a significant milestone, as Carbaglu is the first and only drug approved by the FDA for this specific indication[2].

Generic Versions

The market has also seen the introduction of generic versions of Carbaglu. For instance, ANI Pharmaceuticals and Eton Pharmaceuticals announced the commercial availability of a generic version of carglumic acid tablets in December 2021, which was approved by the FDA for treating acute and chronic hyperammonemia[4].

Future Outlook

Emerging Markets

The pharmaceutical markets in countries like China and India are rapidly growing, driven by increased investments in research and development. These markets present opportunities for the development and commercialization of carglumic acid, contributing to the market's expected growth[3].

Research and Development

Key players are increasing their investments in R&D to develop innovative therapies and gain a competitive edge. This focus on R&D is likely to drive market growth by introducing new treatments and improving existing ones[4].

Key Takeaways

  • The global carglumic acid market is projected to grow significantly, driven by the rising prevalence of metabolic disorders and rare diseases.
  • Technological advancements and patient assistance programs are enhancing market growth.
  • North America is the largest market for carglumic acid, with hospital pharmacies dominating the distribution channel.
  • Key players are investing heavily in R&D and expanding their product portfolios to maintain market competitiveness.
  • Emerging markets in Asia are expected to contribute to the market's future growth.

FAQs

Q: What is the primary use of Carbaglu (carglumic acid)? A: Carbaglu is primarily used to treat hyperammonemia, a condition characterized by elevated levels of ammonia in the blood, often caused by metabolic disorders such as urea cycle disorders.

Q: What is the projected market size of the global carglumic acid market by 2033? A: The global carglumic acid market is expected to reach USD 281.81 million by 2033, growing at a CAGR of 7.38% from 2024 to 2033[1][3].

Q: Which region dominates the carglumic acid market? A: North America is the largest market for carglumic acid, accounting for a significant portion of the global revenue[1][5].

Q: Who are some of the key players in the carglumic acid market? A: Key players include Recordati Rare Diseases, Apothecon Pharmaceuticals Pvt Ltd., Manus Aktteva Biopharma LLP, Civentichem LLC, and Dipharma Francis S.r.l.[4].

Q: What are some of the growth drivers for the carglumic acid market? A: Growth drivers include the rising prevalence of metabolic disorders, increased awareness and diagnosis of rare diseases, technological advancements, and expanding patient assistance programs[1][3][5].

Sources

  1. The Brainy Insights: "Carglumic Acid Market Size, Trend Analysis, Insights"[1]
  2. Recordati: "2021 Annual Report"[2]
  3. GlobeNewswire: "Carglumic Acid Market Size Worth $281.81 Million by 2033: The Brainy Insights"[3]
  4. GlobeNewswire: "Carglumic Acid Market Size to Reach US$ 314.4 million in 2033; Treatment of Hyperammonemia to Drive the Market Growth | Fact.MR's Study"[4]
  5. Global Market Insights: "Carglumic Acid Market Forecasts 2024-2032 | Statistics Report"[5]

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.