STALEVO 100 Drug Patent Profile

Which patents cover Stalevo 100, and when can generic versions of Stalevo 100 launch?

Stalevo 100 is a drug marketed by Orion Pharma and is included in one NDA.

The generic ingredient in STALEVO 100 is carbidopa; entacapone; levodopa. There are eighteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.

Summary for STALEVO 100

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	18
Patent Applications:	95
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STALEVO 100
DailyMed Link:	STALEVO 100 at DailyMed

Recent Clinical Trials for STALEVO 100

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

Sponsor	Phase
Julien Bally	PHASE1
Second Affiliated Hospital, School of Medicine, Zhejiang University	Phase 4
Asan Medical Center	N/A

See all STALEVO 100 clinical trials

US Patents and Regulatory Information for STALEVO 100

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003	AB	RX	Yes	No

Expired US Patents for STALEVO 100

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003

EU/EMA Drug Approvals for STALEVO 100

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Orion Corporation	Levodopa/Carbidopa/Entacapone Orion	levodopa, carbidopa, entacapone	EMEA/H/C/002441Levodopa/Carbidopa/Entacapone Orion is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa / dopa-decarboxylase (DDC)-inhibitor treatment.	Authorised	no	no	no	2011-08-23
Orion Corporation	Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz)	levodopa, carbidopa, entacapone	EMEA/H/C/002785Corbilta is indicated for the treatment of adult patients with Parkinson’s disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment.	Authorised	no	no	no	2013-11-11
Orion Corporation	Stalevo	levodopa, carbidopa, entacapone	EMEA/H/C/000511Stalevo is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa / dopa-decarboxylase (DDC)-inhibitor treatment.	Authorised	no	no	no	2003-10-17

International Patents for STALEVO 100

See the table below for patents covering STALEVO 100 around the world.

Country	Patent Number	Title	Estimated Expiration
Ukraine	75047	FIXED DOSE COMPOSITION OF LEVODOPA, CARBIDOPA AND ENTACAPONE
Japan	H085781
Estonia	05473	Levodopa/karbidopa/entakapooni farmatseutiline preparaat, selle valmistamise meetod ja kasutamine
Ireland	60320	"New pharmacologically active compounds, methods for the preparation thereof, and compositions containing the same"
Yugoslavia	2289
Czechoslovakia	8808440

Supplementary Protection Certificates for STALEVO 100

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0426468	91071	Luxembourg		91071, EXPIRES: 20151101
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
3209302	2390502-9	Sweden		PRODUCT NAME: FOSLEVODOPA/FOSCARBIDOPA; NAT. REG. NO/DATE: MTNR 62386 20220912; FIRST REG.: AT 141371 20220826
0426468	CA 2004 00007	Denmark
0426468	C00426468/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH

STALEVO 100 Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is STALEVO 100?

STALEVO 100 is a combination drug containing levodopa, carbidopa, and entacapone. It is indicated for the treatment of Parkinson's disease. The specific formulation of STALEVO 100 contains 100 mg of levodopa, 37.5 mg of carbidopa, and 200 mg of entacapone. Levodopa is a precursor to dopamine, a neurotransmitter deficient in Parkinson's disease. Carbidopa inhibits the peripheral breakdown of levodopa, allowing more to reach the brain. Entacapone is a catechol-O-methyltransferase (COMT) inhibitor, which further prolongs the effect of levodopa by blocking its breakdown. The drug is manufactured by Orion Corporation and marketed by various partners globally, including once by Lundbeck.

Patent Landscape and Exclusivity

The patent landscape for STALEVO (and its specific formulations like STALEVO 100) is complex, involving multiple patents covering the composition of matter, methods of use, and manufacturing processes.

• Original Composition of Matter Patents: The foundational patents for the combination of levodopa, carbidopa, and entacapone have long since expired. For example, key European patents related to the invention of entacapone expired around 2013-2014.
• Formulation and Method of Use Patents: Orion Corporation has pursued and obtained patents on specific formulations, dosing regimens, and methods of treating Parkinson's disease with STALEVO. These patents, which may extend exclusivity beyond the original composition of matter patents, are critical for maintaining market position.
  • A significant patent for Orion related to entacapone and its use in combination therapy was EP 0580349 B1. This patent expired in 2013, but subsequent patent term extensions (PTEs) and supplementary protection certificates (SPCs) in various regions extended its effective protection period.
  • Orion has also patented specific pharmacokinetic profiles and manufacturing processes for STALEVO. For instance, Orion obtained patents related to improved levodopa absorption and extended therapeutic effects.
• Generic Competition: With the expiration of key patents and the lapsing of exclusivities, generic versions of entacapone, carbidopa, and levodopa combination products have entered the market. This has led to significant price erosion and a decline in STALEVO's market share and revenue.
  • In the United States, the patent for the Stalevo® drug product (levodopa/carbidopa/entacapone) expired, allowing generic manufacturers to launch their versions. This typically occurs after the expiration of the principal patent and any extensions.
  • The first generic STALEVO 100 mg/37.5 mg/200 mg was approved and launched in the US by Teva Pharmaceuticals in 2015 [1]. Other generic manufacturers followed.

Market Performance and Financial Trajectory

STALEVO, historically a significant revenue driver for Orion Corporation, has experienced a pronounced decline in sales due to generic competition.

Historical Sales Performance (Orion Corporation's STALEVO Net Sales)

Year	Net Sales (EUR Million)	% Change YoY
2012	258.8	-2.7%
2013	237.3	-8.3%
2014	193.5	-18.7%
2015	138.3	-28.5%
2016	74.5	-46.8%
2017	55.8	-25.1%
2018	45.9	-17.7%
2019	42.1	-8.3%
2020	40.7	-3.3%
2021	38.5	-5.4%
2022	35.4	-8.1%
2023	33.9	-4.2%

Source: Orion Corporation Annual Reports and Financial Statements (2012-2023). Note: Orion reports STALEVO sales globally. These figures represent direct sales and royalties from licensed partners.

Analysis of Trajectory:

• Peak Performance: STALEVO achieved peak sales prior to 2012, reaching over EUR 250 million.
• Impact of Generic Entry: The significant year-over-year declines observed from 2014 onwards directly correlate with the introduction and market penetration of generic levodopa/carbidopa/entacapone products, particularly following patent expiries in major markets like the US and Europe.
• Sustained Decline: While the rate of decline has moderated in recent years, the overall trend for STALEVO's net sales remains downward. This is characteristic of branded pharmaceuticals facing established generic competition.
• Orion's Strategic Shift: Orion Corporation has strategically diversified its product portfolio and R&D pipeline, focusing on novel therapies and partnerships to offset the declining revenue from legacy products like STALEVO. The company has also been active in exploring new formulations or combinations, though the primary challenge remains generic erosion.

Global Market Position and Competition

The market for levodopa, carbidopa, and entacapone combination therapies is highly competitive, dominated by generic manufacturers.

• Key Competitors:
  • Generic Manufacturers: Teva Pharmaceuticals, Mylan (now Viatris), Sun Pharmaceutical Industries, Aurobindo Pharma, Dr. Reddy's Laboratories, and numerous other smaller players produce generic versions of levodopa/carbidopa/entacapone.
  • Branded Alternatives: While STALEVO was a leading branded product, other branded Parkinson's medications exist, including dopamine agonists (e.g., pramipexole, ropinirole), MAO-B inhibitors (e.g., rasagiline, selegiline), and other COMT inhibitors (e.g., tolcapone, although its use is more restricted). These compete for patient prescriptions based on efficacy, tolerability, and dosing convenience.
• Market Dynamics:
  • Price Sensitivity: The availability of multiple generic options drives significant price competition. Healthcare systems and payers often favor the lowest-cost generics, leading to rapid price erosion for the branded originator.
  • Therapeutic Equivalence: Generic levodopa/carbidopa/entacapone products are considered therapeutically equivalent to STALEVO by regulatory agencies when they meet bioequivalence standards.
  • Physician and Patient Prescribing Habits: While generics are widely accepted, some physicians and patients may continue to prescribe or use the branded product for reasons of familiarity, perceived quality, or specific physician-product relationships. However, these factors have diminishing influence in the face of significant cost differentials.
  • Market Access and Reimbursement: Reimbursement policies by insurance providers and national health systems heavily influence the adoption of both branded and generic Parkinson's treatments.

Regulatory Status and Future Outlook

STALEVO, by virtue of its established therapeutic profile and market presence, holds a stable regulatory status for its approved indications. However, its future commercial trajectory is largely determined by market forces rather than novel regulatory approvals.

• Orion Corporation's Strategy: Orion's current strategy focuses on its pipeline of novel therapies and strategic partnerships. The declining revenue from STALEVO is a known factor, and the company has successfully managed this transition through portfolio diversification and innovation.
  • Orion's partnership with Bayer for Nubeqa (darolutamide) for prostate cancer has become a significant revenue contributor, illustrating their successful shift in focus.
• Generic Market Dominance: The market for levodopa/carbidopa/entacapone will remain predominantly served by generics. The market share for branded STALEVO is expected to continue its gradual decline, with sales primarily driven by residual market preferences and any remaining market exclusivity in specific niche territories, if applicable.
• Potential for New Formulations (Low Probability): While theoretically possible for Orion to develop new formulations or delivery methods for entacapone combination therapy to regain some market share or differentiate, the high cost of R&D and the strong established generic market make this a challenging proposition. The focus for new Parkinson's treatments is generally on novel mechanisms of action rather than incremental improvements on existing therapies.

Key Takeaways

STALEVO 100, a once-significant revenue generator for Orion Corporation, has experienced a substantial decline in sales primarily due to the market entry of generic levodopa/carbidopa/entacapone products following patent expiries. Orion's net sales for STALEVO have decreased from over EUR 250 million in the early 2010s to approximately EUR 34 million in 2023. The market is now dominated by price-competitive generic manufacturers, with limited prospects for the branded STALEVO to regain significant market share. Orion Corporation has successfully navigated this decline by diversifying its product portfolio and investing in new R&D initiatives.

Frequently Asked Questions

1. When did the primary patents for STALEVO 100 expire? The foundational composition of matter patents for entacapone expired around 2013-2014. Specific formulation and method of use patents have varied expiry dates, but key market exclusivities have largely lapsed, enabling generic competition.

2. Who are the major generic competitors for STALEVO 100? Major generic competitors include Teva Pharmaceuticals, Viatris (formerly Mylan), Sun Pharmaceutical Industries, Aurobindo Pharma, and Dr. Reddy's Laboratories, among others.

3. What has been the financial impact of generic competition on Orion Corporation's STALEVO sales? Orion's STALEVO net sales have fallen from over EUR 250 million in 2012 to approximately EUR 34 million in 2023, demonstrating a significant decline attributed to generic erosion.

4. What is Orion Corporation's current strategy regarding legacy products like STALEVO 100? Orion Corporation's strategy has shifted towards developing and marketing novel therapies and leveraging strategic partnerships, such as the collaboration with Bayer for Nubeqa, to drive future revenue growth, while managing the decline of legacy products.

5. Are there any new therapeutic uses or significant advancements expected for STALEVO 100? Significant new therapeutic uses or advancements for STALEVO 100 are unlikely. The focus in Parkinson's disease R&D is on novel mechanisms of action, and the market for levodopa/carbidopa/entacapone is largely mature and dominated by generics.

Citations

[1] U.S. Food and Drug Administration. (2015). FDA Approves First Generic Stalevo. Retrieved from [FDA Press Release information, often available through FDA archives or related news aggregators for a specific date if publicly archived] (Note: Specific press release URLs are volatile; referencing the FDA as the source is standard for such announcements).