PARAPLATIN Drug Patent Profile

Which patents cover Paraplatin, and what generic alternatives are available?

Paraplatin is a drug marketed by Corden Pharma and Cordenpharma and is included in two NDAs.

The generic ingredient in PARAPLATIN is carboplatin. There are eighteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the carboplatin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Paraplatin

A generic version of PARAPLATIN was approved as carboplatin by HOSPIRA on October 14^th, 2004.

Summary for PARAPLATIN

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	623
DailyMed Link:	PARAPLATIN at DailyMed

Recent Clinical Trials for PARAPLATIN

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

Sponsor	Phase
Regeneron Pharmaceuticals	Phase 2
Shantou Central Hospital	Phase 2
Guangdong Provincial People's Hospital	Phase 2

See all PARAPLATIN clinical trials

US Patents and Regulatory Information for PARAPLATIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Corden Pharma	PARAPLATIN	carboplatin	INJECTABLE;INJECTION	019880-001	Mar 3, 1989		DISCN	Yes	No
Cordenpharma	PARAPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	020452-004	Jan 15, 2004		DISCN	Yes	No
Cordenpharma	PARAPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	020452-001	Jul 14, 2003		DISCN	Yes	No
Corden Pharma	PARAPLATIN	carboplatin	INJECTABLE;INJECTION	019880-002	Mar 3, 1989		DISCN	Yes	No
Corden Pharma	PARAPLATIN	carboplatin	INJECTABLE;INJECTION	019880-003	Mar 3, 1989		DISCN	Yes	No
Cordenpharma	PARAPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	020452-003	Jul 14, 2003		DISCN	Yes	No
Cordenpharma	PARAPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	020452-002	Jul 14, 2003		DISCN	Yes	No

Expired US Patents for PARAPLATIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cordenpharma	PARAPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	020452-002	Jul 14, 2003	4,657,927*PED
Corden Pharma	PARAPLATIN	carboplatin	INJECTABLE;INJECTION	019880-001	Mar 3, 1989	4,657,927*PED
Cordenpharma	PARAPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	020452-004	Jan 15, 2004	4,657,927*PED
Cordenpharma	PARAPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	020452-003	Jul 14, 2003	4,657,927*PED
Cordenpharma	PARAPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	020452-001	Jul 14, 2003	4,657,927*PED
Corden Pharma	PARAPLATIN	carboplatin	INJECTABLE;INJECTION	019880-003	Mar 3, 1989	4,657,927*PED
Corden Pharma	PARAPLATIN	carboplatin	INJECTABLE;INJECTION	019880-002	Mar 3, 1989	4,657,927*PED

PARAPLATIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Paraplatin

Introduction to Paraplatin

Paraplatin, also known as carboplatin, is a chemotherapy drug used primarily in the treatment of various types of cancer, including ovarian, lung, and head and neck cancers. It is a platinum-based drug that has been off-patent for several years, allowing for the production of numerous generic versions.

Generic Drug Market and Paraplatin

Brand vs. Generic Drug Profitability

Paraplatin, like many other branded oncology drugs, has long been off-patent. This has led to the emergence of multiple generic versions of carboplatin. In the U.S., generic drugs, including those for carboplatin, account for about 90% of prescription volume but only 17.5% of prescription drug spending and less than 2% of total healthcare spending[1].

Price Erosion and Supply Shortages

The generic market for carboplatin is characterized by intense price competition. Generic versions of carboplatin launch with significant discounts, typically around 80-85% compared to their branded counterparts. This price erosion has led to supply shortages, as manufacturers find it increasingly challenging to maintain profitability at such low prices. The high cost of producing platinum-based therapies, combined with the low market prices, has reduced the number of companies willing to manufacture these drugs[1].

Manufacturing and Supply Chain Challenges

Global Sourcing and Production

The production of carboplatin involves a complex global supply chain. Platinum ore is sourced from countries like South Africa and Russia, refined, and then converted into the active pharmaceutical ingredient in facilities based in Germany and India. The final product is packaged and labeled in several countries before being distributed globally. This intricate process adds to the costs and challenges of manufacturing[1].

Quality Issues and Regulatory Interventions

Recent shortages of cisplatin, a related platinum-based drug, have highlighted the fragility of the supply chain. An inspection identifying quality issues at a manufacturing facility led to a shutdown, resulting in a shortage of cisplatin and an increased demand for carboplatin. The FDA has been working to restore supply by assisting manufacturers and exploring temporary importation options[4].

Financial Trajectory

Revenue and Market Share

Despite the high volume of prescriptions, the revenue generated from generic carboplatin is significantly lower than that from branded drugs. U.S. generic drug sales have declined by $6.4 billion over the last five years, despite increased patient utilization. This discrepancy is largely due to the deep discounts associated with generic launches[1].

Impact of Legislative Changes

The Inflation Reduction Act (IRA) in the U.S. has introduced mandatory discounts for top-selling branded drugs without generic or biosimilar competition. While generics and biosimilars are excluded from these discount negotiations, the act is expected to expedite price erosion for branded therapies before they become eligible for generic competition. This could further disincentivize private investment in these therapies, affecting the long-term supply and profitability of drugs like carboplatin[1].

Market Segmentation and Growth

Lung Cancer Market

Carboplatin is often used in the treatment of lung cancer, a market that is expected to grow significantly. The global lung cancer drugs market is projected to reach $12.84 billion by 2025, growing at a CAGR of 10.3%. This growth is driven by the rising prevalence of lung cancer and the need for efficient treatments[2].

Anticancer Drugs Market

The broader anticancer drugs market, which includes carboplatin, is valued at $140.2 billion in 2022 and is expected to grow at a CAGR of 9.1% to reach $303.1 billion by 2031. High efficacy of treatments like monoclonal antibodies and increased demand for organic treatments are key drivers of this market[3].

Competitive Landscape

Major Players

The market for anticancer drugs, including carboplatin, is highly competitive with major players such as Bristol-Myers Squibb Company, Merck & Co., F. Hoffmann-La Roche Ltd, Novartis AG, and Pfizer Inc. These companies are investing heavily in R&D to expand their product portfolios and market shares[2][3].

Future Evolution

Globalization and Regulatory Frameworks

The biopharma industry, including the market for carboplatin, is increasingly globalized. This globalization, while driving some aspects of competition, also introduces fragility due to cross-continent sourcing, multi-national clinical trials, and global distribution. Regulatory frameworks supporting R&D and the increasing healthcare expenditure in emerging countries are expected to shape the future of the anticancer drugs market[1][3].

Key Takeaways

• Price Erosion: Generic versions of carboplatin face significant price erosion, leading to supply shortages.
• Supply Chain Complexity: The global supply chain for platinum-based drugs is complex and costly.
• Regulatory Impact: Legislative changes like the Inflation Reduction Act can further impact the profitability and supply of these drugs.
• Market Growth: The lung cancer and broader anticancer drugs markets are expected to grow significantly.
• Competitive Landscape: Major pharmaceutical companies are key players in this highly competitive market.

FAQs

What is the current market situation for generic carboplatin?

The market for generic carboplatin is characterized by intense price competition, leading to significant price erosion and supply shortages.

How does the global supply chain affect the production of carboplatin?

The global supply chain for carboplatin involves sourcing platinum ore from a few countries, refining it, and manufacturing the drug in various facilities, adding to the costs and complexity.

What is the impact of the Inflation Reduction Act on the market for carboplatin?

The Inflation Reduction Act is expected to expedite price erosion for branded therapies before they become eligible for generic competition, potentially disincentivizing private investment in these therapies.

Which companies are major players in the anticancer drugs market?

Major players include Bristol-Myers Squibb Company, Merck & Co., F. Hoffmann-La Roche Ltd, Novartis AG, and Pfizer Inc.

What are the growth projections for the lung cancer drugs market?

The global lung cancer drugs market is expected to reach $12.84 billion by 2025, growing at a CAGR of 10.3%.

Sources

1. Trinity Life Sciences: "Priced Out: Generic Therapy Price Competition and Drug Shortages"
2. GlobeNewswire: "Global Lung Cancer Drugs Market (2021 to 2030) - Featuring Bristol-Myers Squibb, Merck & Co., and F. Hoffmann-La Roche Among Others"
3. Transparency Market Research: "Anticancer Drugs Market Size, Share, Statistics - 2031"
4. Cancer Letter: "Richard Pazdur discusses root causes of cisplatin and carboplatin shortages"