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RYTARY Drug Patent Profile

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

Rytary is a drug marketed by Impax and is included in one NDA. There are eight patents protecting this drug and two Paragraph IV challenges.

This drug has twenty-five patent family members in twelve countries.

The generic ingredient in RYTARY is carbidopa; levodopa. There are eighteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Rytary

A generic version of RYTARY was approved as carbidopa; levodopa by DR REDDYS LABS SA on August 28^th, 1992.

Summary for RYTARY

International Patents:	25
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	7
Clinical Trials:	1
Patent Applications:	464
Drug Prices:	Drug price information for RYTARY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RYTARY
What excipients (inactive ingredients) are in RYTARY?	RYTARY excipients list
DailyMed Link:	RYTARY at DailyMed

See drug prices for RYTARY

See drug sales revenues for RYTARY

Recent Clinical Trials for RYTARY

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

Sponsor	Phase
National Institutes of Health (NIH)	Phase 2
Northwestern University	Phase 2
Northwestern Medical Group	Phase 2

See all RYTARY clinical trials

Pharmacology for RYTARY

Drug Class

Aromatic Amino Acid

Paragraph IV (Patent) Challenges for RYTARY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RYTARY	Extended-release Capsules	carbidopa; levodopa	23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg	203312	1	2015-06-24
RYTARY	Extended-release Capsules	carbidopa; levodopa	61.25 mg/245 mg	203312	1	2015-06-10

US Patents and Regulatory Information for RYTARY

RYTARY is protected by fifteen US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-003	Jan 7, 2015		RX	Yes	No	9,901,640		Y
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-004	Jan 7, 2015		RX	Yes	Yes	9,089,608		Y
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-003	Jan 7, 2015		RX	Yes	No	9,089,608		Y
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-004	Jan 7, 2015		RX	Yes	Yes	9,089,607		Y

Expired US Patents for RYTARY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-004	Jan 7, 2015	7,094,427
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-001	Jan 7, 2015	7,094,427
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-003	Jan 7, 2015	7,094,427
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-002	Jan 7, 2015	7,094,427

EU/EMA Drug Approvals for RYTARY

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Amneal Pharma Europe Ltd	Numient	levodopa, carbidopa	EMEA/H/C/002611 Symptomatic treatment of adult patients with Parkinson’s disease	Withdrawn	no	no	no	2015-11-19

International Patents for RYTARY

When does loss-of-exclusivity occur for RYTARY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

China

European Patent Office

Israel

Japan

Mexico

New Zealand

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering RYTARY around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2921170	Combinaison à libération immédiate de lévodopa à libération contrôlée/formes posologiques de carbidopa (Combination immediate release controlled release levodopa/carbidopa dosage forms)
South Korea	101451564
New Zealand	586870	Controlled release formulations of levodopa, carbidopa andd a caboxylic acid
Taiwan	200633730	Oral disintegrating dosage forms

RYTARY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for RYTARY

Introduction to RYTARY

RYTARY, a formulation of carbidopa and levodopa, is a significant drug in the treatment of Parkinson’s disease. Developed by Impax Pharmaceuticals, now part of Amneal Pharmaceuticals, RYTARY has been making waves in the pharmaceutical industry since its FDA approval in 2015.

FDA Approval and Clinical Impact

The FDA approval of RYTARY marked a significant milestone in the treatment of Parkinson’s disease. This oral capsule combines carbidopa and levodopa, reducing the time needed for treatment and eliminating the need for invasive methods. The clinical results have been promising, contributing positively to the global Parkinson’s disease drugs market[1].

Market Growth and Projections

The global Parkinson’s disease drugs market, driven in part by the success of RYTARY, is projected to grow substantially. In 2018, the market was valued at $4,500 million and is expected to reach $8,383.2 million by 2026, exhibiting a CAGR of 8.1%[1].

By 2032, the market is forecasted to expand further, reaching $13,580 million, with a CAGR of 8.2% during the forecast period (2018-2032). Decarboxylase inhibitors, which include carbidopa and levodopa formulations like RYTARY, are expected to dominate this growth due to their high efficacy and preference among patients[4].

Financial Performance of Amneal Pharmaceuticals

Amneal Pharmaceuticals, the parent company of Impax Laboratories, has seen significant financial gains driven by the success of RYTARY. In the fourth quarter of 2022, Amneal reported a net revenue of $610 million, a 14% increase from the same period in 2021. The full-year 2022 net revenue was $2.21 billion, up 6% from 2021, with RYTARY being one of the key products contributing to this growth[2].

Revenue Contribution

RYTARY has been a strong performer in Amneal’s product portfolio. The revenue growth in 2021 and 2022 was partly driven by the strong performance of RYTARY, along with other key products like Unithroid and the expansion of the AvKARE business segment[2][5].

Competitive Landscape

The approval and success of RYTARY have encouraged other pharmaceutical companies to invest in Parkinson’s disease treatments. Companies like AbbVie, with its orphan drug Duopa, and other players like Acadia Pharmaceuticals Inc., F. Hoffmann-La Roche Ltd, and UCB S.A, are also making significant contributions to the market. However, RYTARY remains a key player due to its unique formulation and clinical efficacy[1][4].

Generic Competition

While RYTARY enjoys a strong market position, it is not immune to generic competition. Amneal has settled patent litigation with Actavis, allowing Actavis to sell a generic version of RYTARY starting July 31, 2025, or earlier under certain conditions. This agreement, while potentially reducing RYTARY’s market share, reflects the ongoing competitive dynamics in the pharmaceutical industry[3].

Geographical Market Presence

The global Parkinson’s disease drugs market, including RYTARY, has a strong presence in various regions. Europe led the market in 2018, but North America is expected to gain significant market share by 2026 due to improved R&D spending and the launch of new products like INBRIJA by Acorda Therapeutics. The Asia Pacific region is also anticipated to show high growth due to increasing healthcare spending and improved distribution networks[4].

Route of Administration and Distribution

RYTARY, being an oral formulation, benefits from the preference for oral drugs over injections. The oral segment accounted for the maximum share in the Parkinson’s disease drugs market in 2018, supported by active government recommendations. Distribution channels such as hospital pharmacies, retail pharmacies, and online stores further facilitate the reach of RYTARY to patients[4].

Key Takeaways

• Market Growth: RYTARY has significantly contributed to the growth of the global Parkinson’s disease drugs market.
• Financial Performance: Amneal Pharmaceuticals has seen increased revenue driven by RYTARY’s success.
• Competitive Landscape: RYTARY faces competition but remains a dominant player due to its clinical efficacy.
• Generic Competition: The entry of generic versions is expected to impact RYTARY’s market share.
• Geographical Presence: RYTARY has a strong presence in Europe and is expected to grow in North America and the Asia Pacific.

FAQs

Q: What is RYTARY and how is it used in treating Parkinson’s disease? A: RYTARY is an oral capsule formulation of carbidopa and levodopa, used to treat Parkinson’s disease by reducing the time needed for treatment and eliminating the need for invasive methods.

Q: When was RYTARY approved by the FDA? A: RYTARY was approved by the FDA in 2015.

Q: How is the financial performance of Amneal Pharmaceuticals influenced by RYTARY? A: RYTARY has been a key contributor to Amneal’s revenue growth, with significant increases in net revenue in recent years.

Q: What is the projected market size for Parkinson’s disease drugs by 2032? A: The global Parkinson’s disease drugs market is projected to reach $13,580 million by 2032.

Q: How does generic competition affect RYTARY’s market position? A: Amneal has settled patent litigation allowing Actavis to sell a generic version of RYTARY starting in 2025, which may reduce RYTARY’s market share.

Cited Sources

1. Fortune Business Insights - "Parkinson’s Disease Drugs Market to Reach US$ 8,383.2 Mn by 2026"[1]
2. Amneal Pharmaceuticals - "Amneal Reports Fourth Quarter and Full Year 2022 Financial Results"[2]
3. BioSpace - "Amneal Announces Patent Litigation Settlement Agreement with Actavis Concerning RYTARY"[3]
4. Fortune Business Insights - "Parkinson's Disease Drugs Market Report by Fortune Business Insights"[4]
5. Amneal Pharmaceuticals - "Amneal Reports Fourth Quarter and Full Year 2021 Financial Results"[5]