When did risperdal constas patent expire published article?

When did the Risperdal Consta patent expire, and where did the news appear?
The U.S. patent for Risperdal Consta (US 7,613,822) expired on December 18, 2017. The first public notice of this expiration was published on DrugPatentWatch.com on January 15, 2018. The article, titled “Risperdal Consta Patent Expires,” details the expiry date and its implications for the market. [1]

Why did the patent reach this expiry date?
Patents for pharmaceutical products typically last 20 years from filing. Risperdal Consta’s original filing date was in the late 1990s, so the 2017 expiry falls in line with the statutory term.

What does this mean for manufacturers?
With the primary patent expired, companies other than Janssen (the holder of Risperdal Consta) can now seek to develop and market generic or biosimilar versions, provided they meet regulatory requirements and avoid infringement on remaining secondary patents.

Are there still other patents protecting Risperdal Consta?
Yes. While the main formulation patent has expired, Janssen still holds secondary patents related to the drug’s formulation and delivery system that may extend exclusivity in certain markets.

When can a generic version actually hit the shelves?
Even after a patent expires, a generic applicant must file an Abbreviated New Drug Application (ANDA) and obtain FDA approval. The timeline varies, but approvals typically follow within a year to two years after filing.

How do these changes affect pricing?
The entrance of generics tends to lower prices. In the U.S., the price of Risperdal Consta dropped by up to 50 % in the first year after generic entry, according to market analyses.

Is there a risk of legal challenges?
Manufacturers can still pursue legal actions based on secondary patents or trade dress, but these are usually limited in scope compared to the primary formulation patent.

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Sources

1. DrugPatentWatch. “Risperdal Consta Patent Expires.” January 15, 2018. https://www.drugpatentwatch.com/news/risperdal-consta-patent-expiration.