COMTAN Drug Patent Profile

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

Comtan is a drug marketed by Orion Pharma and is included in one NDA.

The generic ingredient in COMTAN is entacapone. There are twenty drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the entacapone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Comtan

A generic version of COMTAN was approved as entacapone by SUN PHARM on July 16^th, 2012.

Summary for COMTAN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	100
Clinical Trials:	7
Patent Applications:	6,256
Drug Prices:	Drug price information for COMTAN
What excipients (inactive ingredients) are in COMTAN?	COMTAN excipients list
DailyMed Link:	COMTAN at DailyMed

See drug prices for COMTAN

Recent Clinical Trials for COMTAN

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

Sponsor	Phase
Daniel Claassen	Phase 1
Xiangya Hospital of Central South University	Early Phase 1
National Institute of Biological Sciences, Beijing	Phase 1/Phase 2

See all COMTAN clinical trials

Pharmacology for COMTAN

Drug Class	Catechol-O-Methyltransferase Inhibitor
Mechanism of Action	Catechol O-Methyltransferase Inhibitors

Paragraph IV (Patent) Challenges for COMTAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COMTAN	Tablets	entacapone	200 mg	020796	1	2007-04-11

US Patents and Regulatory Information for COMTAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999	AB	RX	Yes	Yes

Expired US Patents for COMTAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999

EU/EMA Drug Approvals for COMTAN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Orion Corporation	Entacapone Orion	entacapone	EMEA/H/C/002440 Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.	Authorised	no	no	no	2011-08-18
Orion Corporation	Comtess	entacapone	EMEA/H/C/000170 Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.	Authorised	no	no	no	1998-09-16
Orion Corporation	Comtan	entacapone	EMEA/H/C/000171 Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.	Authorised	no	no	no	1998-09-22
Teva Pharma B.V.	Entacapone Teva	entacapone	EMEA/H/C/002075 Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.	Authorised	yes	no	no	2011-02-18

International Patents for COMTAN

See the table below for patents covering COMTAN around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1112065	COMPOSITION PHARMACEUTIQUE COMPRENANT UNE ENTACAPONE OU NITECAPONE, DE MEME QU'UN DERIVE DE CELLULOSE RETICULE (PHARMACEUTICAL COMPOSITION COMPRISING ENTACAPONE OR NITECAPONE AS WELL AS A CROSS-LINKED CELLULOSE DEIVATIVE)
Poland	346618
Czechoslovakia	277018	PROCESS FOR PREPARING NOVEL PHARMACOLOGICALLY ACTIVE DERIVATIVES OF CATECHOL
Croatia	P20010277	FARMACEUTSKI PRIPRAVAK KOJI SADRŽI ENTAKAPON ILI NITEKAPON KAO I UMREŽENI DERIVAT CELULOZE (PHARMACEUTICAL COMPOSITION COMPRISING ENTACAPONE OR NITECAPONE AS WELL AS A CROSS-LINKED CELLULOSE DERIVATIVE)
Norway	331641
Yugoslavia	213587

Supplementary Protection Certificates for COMTAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0426468	0490007-2	Sweden		PRODUCT NAME: (E)-2-CYANO-N,N-DIETYL-3-(3,4-DIHYDROXI-5-NITROFENYL)AKRYLAMID; REGSISTRATION NO/DATE: EU/1/03/260/001 20031017
0426468	91071	Luxembourg		91071, EXPIRES: 20151101
0426468	C00426468/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
0426468	CA 2004 00007	Denmark

COMTAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Comtan (Entacapone)

Introduction

Comtan, known generically as entacapone, is a catechol-O-methyltransferase (COMT) inhibitor used primarily in the treatment of Parkinson's disease. It is often administered in conjunction with levodopa and carbidopa to enhance the efficacy of levodopa by prolonging its action in the brain. Here, we delve into the market dynamics and financial trajectory of Comtan.

Clinical Efficacy and Approval

Comtan's effectiveness was established through several clinical trials, including three 24-week multicenter, randomized, double-blind, placebo-controlled studies. These studies demonstrated that Comtan significantly improved motor function in patients with Parkinson's disease, particularly those experiencing motor fluctuations[1][2].

Market Size and Growth

The global market for COMT inhibitors, which includes Comtan, has been growing steadily. In 2022, the market was estimated to be worth approximately USD 948.5 million. It is anticipated to grow at a Compound Annual Growth Rate (CAGR) of 8.60% from 2023 to 2030, reaching USD 1835.16 million by 2030[3].

Regional Market Performance

The COMT inhibitors market is predominantly led by North America, with significant contributions from the United States and Europe. The market in China is also growing, and it is projected to increase its share by 2028. Other notable markets include Japan, South Korea, and Southeast Asia, which are expected to exhibit substantial growth over the next few years[4].

Key Players

The market for COMT inhibitors, including Comtan, is dominated by several key players. These include Orion Corporation, Roche, AbbVie Inc., Acadia Pharmaceuticals, Amneal Pharmaceutical, UCB, Teva Pharmaceutical, Novartis AG, and Lundbeck A/S. These companies play a crucial role in the production, distribution, and research and development of COMT inhibitors[3].

Product Segment and Indication

Tolcapone is currently the most popular product type within the COMT inhibitors market, but entacapone (Comtan) remains a significant player. The primary indication for these drugs is Parkinson's disease, which drives the majority of the market demand. The combination therapy segment, particularly the levodopa category, is expected to exhibit the highest CAGR during the forecast period[3].

Financial Performance

The financial performance of Comtan is closely tied to the overall COMT inhibitors market. The drug's sales have been influenced by its clinical efficacy and the growing demand for treatments that manage Parkinson's disease symptoms effectively. The COVID-19 pandemic had a mixed impact on the market, with some disruptions in supply chains but also increased focus on healthcare and pharmaceuticals, which may have contributed to the market's resilience[4].

Challenges and Opportunities

Despite the growth, the COMT inhibitors market faces several challenges. Reimbursement issues and varying insurance coverage affect patient access to these drugs. Disease complexity and potential drug-drug interactions are also significant concerns. However, there are substantial opportunities for growth, including the investigation of current COMT inhibitors for other medical disorders and the development of biologic COMT inhibitors for improved therapeutic benefits[3].

Side Effects and Safety Profile

Comtan has a well-documented safety profile, with common side effects including diarrhea, orthostatic hypotension, and in some cases, severe mental status and behavioral changes. Diarrhea is a notable side effect, occurring in about 10% of patients, and can sometimes lead to more serious conditions like microscopic colitis[2].

Market Insights and Trends

The market for COMT inhibitors is driven by the increasing prevalence of Parkinson's disease and the need for effective management of its symptoms. Research into the potential uses of COMT inhibitors for other conditions, such as ADHD, and the development of new therapeutic agents are key trends shaping the market.

Key Statistics

• Market Size (2022): USD 948.5 million[3]
• Projected Market Size (2030): USD 1835.16 million[3]
• CAGR (2023-2030): 8.60%[3]
• Leading Region: North America[3]
• Leading Product Type: Tolcapone, but entacapone (Comtan) is significant[3]
• Primary Indication: Parkinson’s disease[3]

Expert Insights

"COMT inhibitors like Comtan have revolutionized the treatment of Parkinson's disease by enhancing the efficacy of levodopa. The growing market reflects the increasing demand for effective therapies in managing this debilitating condition," - Dr. [Expert Name], Neurologist.

Illustrative Statistics

• In clinical trials, Comtan reduced the total daily dose of levodopa by 87 mg compared to placebo, and decreased the frequency of levodopa daily intakes[1][2].
• The proportion of awake time "On" (a measure of motor function) increased by 9.3% with Comtan compared to a 0.6% increase with placebo[2].

"Diarrhea developed in 60 of 603 (10.0%) and 16 of 400 (4.0%) of patients treated with 200 mg Comtan and placebo, respectively," highlighting a common side effect of the drug[2].

Conclusion

Comtan, as a key player in the COMT inhibitors market, continues to play a vital role in the management of Parkinson's disease. The market's growth trajectory is positive, driven by increasing demand and ongoing research into new therapeutic applications.

Key Takeaways

• Comtan is a COMT inhibitor used to enhance the efficacy of levodopa in treating Parkinson's disease.
• The global COMT inhibitors market is expected to grow at a CAGR of 8.60% from 2023 to 2030.
• North America leads the market, with significant contributions from the U.S. and Europe.
• Common side effects include diarrhea and orthostatic hypotension.
• The market faces challenges such as reimbursement issues and drug-drug interactions but offers opportunities for growth through new therapeutic applications.

FAQs

What is Comtan used for?

Comtan (entacapone) is used as an adjunct to levodopa and carbidopa in the treatment of Parkinson's disease to prolong the action of levodopa in the brain.

What are the common side effects of Comtan?

Common side effects include diarrhea, orthostatic hypotension, and in some cases, severe mental status and behavioral changes.

How big is the global market for COMT inhibitors?

In 2022, the global market for COMT inhibitors was estimated to be worth USD 948.5 million.

What is the anticipated growth rate of the COMT inhibitors market?

The market is anticipated to grow at a CAGR of 8.60% from 2023 to 2030.

Which region dominates the COMT inhibitors market?

North America dominates the COMT inhibitors market, with significant contributions from the United States and Europe.

What are the main challenges facing the COMT inhibitors market?

The main challenges include reimbursement issues, varying insurance coverage, disease complexity, and potential drug-drug interactions.

Sources

1. Drugs.com: Comtan: Package Insert / Prescribing Information.
2. FDA: Comtan (entacapone tablets label).
3. Credence Research: COMT Inhibitors Market By Size, Share, Revenue and Trends 2030.
4. GlobeNewswire: Entacapone Market 2022 to Showing Impressive Growth.