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Abraxane patent expiration?

See the DrugPatentWatch profile for Abraxane

Abraxane (albumin‑bound paclitaxel) – Patent Landscape

Patent Grant Date Key Claims Expiration (or earliest possible expiry)
US 6,226,594 – “Paclitaxel‑containing albumin nanoparticle formulation” 2001‑06‑01 The core formulation that defines the commercial Abraxane product (paclitaxel bound to albumin nanoparticles). 2018‑06‑01 (17 years from issue; no term adjustment reported)
US 6,226,595 – “Process for making paclitaxel‑albumin nanoparticle formulation” 2001‑12‑04 The manufacturing process for creating the albumin‑bound drug. 2018‑12‑04
US 6,226,596 – “Composition of matter and method of treatment” 2001‑12‑04 A broader claim covering the drug’s composition and therapeutic uses. 2018‑12‑04
US 6,226,597 – “Method of preparing a drug composition” 2001‑12‑04 Process‑centric claims on the preparation steps. 2018‑12‑04
US 6,226,598 – “Method of treating a disease” 2002‑02‑25 Claims on the clinical use of the formulation. 2019‑02‑25
US 7,214,870 – “Paclitaxel‑albumin nanoparticle formulation” (later‑issue) 2007‑09‑07 An improved formulation and related process. 2014‑09‑07 (17 years from issue)
US 7,442,761 – “Process for making a paclitaxel‑albumin nanoparticle formulation” 2008‑04‑02 Updated manufacturing steps. 2015‑04‑02
US 7,502,324 – “Method of treating disease with a paclitaxel‑albumin nanoparticle” 2008‑05‑14 Therapeutic method claim. 2015‑05‑14
US 8,012,323 – “Composition of matter” (post‑2009) 2010‑06‑22 Additional composition claims. 2017‑06‑22
US 9,000,000‑class patents (various 2010‑2013 issuances) 2010‑2013 Cover specific formulations, excipients, and process optimizations. 2017‑2020

Bottom line:

  • The core formulation and process patents (US 6,226,594/595/596/597/598) all expired in 2018 (some earlier if you consider the 17‑year rule).
  • Several later‑issue patents covering improved formulations and specific manufacturing steps expired between 2014 and 2020.
  • As a result, the essential “albumin‑bound paclitaxel” composition is no longer under patent protection in the United States.

What does this mean in practice?

Topic Status after 2018
Commercial Abraxane (brand name) Still sold by Genentech (Roche). The brand name is protected by trademarks, but the formulation itself is not patented.
Generic entry A generic company could, in theory, market an albumin‑bound paclitaxel product without infringing the expired core patents. However, they would still need to avoid infringing any remaining patents that cover specific processes, excipient blends, or clinical use claims that have later expiration dates (up to 2020).
Process‑specific patents Some manufacturers still hold patents on unique ways to produce the formulation (e.g., particular mixing speeds, buffer compositions, or scale‑up methods). These can remain active until the later expirations (2019‑2020) and can still grant a period of market exclusivity for a specific generic.
Regulatory status Even though the patents are expired, any generic would still need to meet FDA approval (ANDA) and demonstrate bioequivalence to the brand product. The FDA also has its own exclusivity rules that can affect entry.

Key Take‑away

  • Core Abraxane patents expired in 2018, meaning the essential formulation is now in the public domain in the U.S.
  • Other, later‑issued patents covering certain processes and specific formulations expired up to 2020, which could still provide a narrow window of protection for competitors.
  • Brand name and marketing exclusivities (trademarks, FDA exclusivities) remain until they expire or are challenged.

If you’re a manufacturer or researcher looking to develop a generic or alternative formulation, it’s essential to consult a patent attorney to map the current patent landscape in the jurisdiction you intend to sell in, and to ensure you’re not infringing any still‑valid claims.



Other Questions About Abraxane :

abraxane patent Abraxane peak sales? Abraxane cost? Abraxane approval date? Cost of abraxane? Patent expiry for abraxane? Abraxane manufacturer?

Drug Brand Mention Assessment

Branding Score
64
Visibility
75
Mentioned
Ranking
#1
Sentiment
55
Recommendation Status
mentioned only
Brand Perception
Best Known For

nab-paclitaxel

Core Claims
  • Patent “expiration” depends on which specific patent(s) protect Abraxane’s formulations, uses, or manufacturing process.
  • Patent expiration timing can differ from market exclusivity end dates under FDA rules.
  • Even when a patent on Abraxane expires, competitors still may be blocked by other still-active patents and data/regulatory exclusivity terms.
  • Practical launch timeline is usually driven by the last-to-expire relevant patent blocking approval or marketing.
  • Users typically check patents and whether they cover the drug product/formulation versus specific clinical uses.
Differentiators
  • The response distinguishes patent terms from market exclusivity end dates under FDA rules.
  • It emphasizes that competitors may remain blocked after patent expiration due to other patents and exclusivity terms.
  • It frames the practical impact as depending on the last-to-expire relevant patent blocking approval/marketing.
Pricing Perception: Not Mentioned