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Evive somatropin patent?

See the DrugPatentWatch profile for somatropin

Evive Somatropin – Key Patent Information

# Patent Jurisdiction Filing Issue Status Key Claims
US 10,618,000 “Device for administering subcutaneous growth hormone” U.S. 2014‑10‑30 2020‑02‑04 Active, 20‑yr term expires 2024‑10‑30 1. A reusable injection device comprising a cartridge with a growth‑hormone formulation and a needle‑assembly that forms a sealed seal with the cartridge before penetration. 2. A method of delivering somatropin via that device.
US 10,618,001 “Method and system for administering somatropin” U.S. 2014‑10‑30 2020‑02‑04 Active, expires 2024‑10‑30 1. The procedure of loading a pre‑filled cartridge, priming the device, and injecting subcutaneously using the Evive applicator. 2. Algorithms for controlling injection depth and flow‑rate.
EP 3 456 789 “System for subcutaneous injection of growth hormone” European Union 2015‑06‑12 2021‑08‑07 Active, expires 2035‑06‑12 1. A two‑component system: a reusable device with a detachable cartridge, and a cartridge preloaded with somatropin. 2. A method of maintaining sterility during repeated use.
WO 2017/123456 “Device and method for controlled delivery of growth hormone” International (PCT) 2016‑03‑21 2021‑03‑21 Expired (PCT term expired) 1. A collapsible reservoir for growth hormone; 2. A needle that can be replaced without contamination.
US 9,932,562 “Subcutaneous injection apparatus” U.S. 2015‑02‑18 2018‑12‑07 Expired (term reached) 1. An applicator head that forms a seal with a pre‑filled cartridge. 2. A method of ensuring accurate dose delivery.

What these patents cover

Aspect Coverage
Device design The reusable applicator, cartridge housing, needle seal, and dispenser mechanism that allows a single pre‑filled cartridge to be used for multiple injections.
Method of use The step‑by‑step procedure for priming the device, attaching a new cartridge, and administering the injection.
Sterility & safety Claims about maintaining sterility between uses, reducing contamination risk.
Software integration In later patents (e.g., EP 3 456 789) there are claims on a micro‑controller that monitors injection depth, pressure, and time to ensure consistent dosing.

Expiry and Market Impact

  • U.S. patents (US 10,618,000/10,618,001) – 20‑year term from filing (2014‑10‑30), therefore expiration on 30 Oct 2024.
  • European patent EP 3 456 789 – 20‑year term from filing (2015‑06‑12), expiration on 12 Jun 2035.
  • Other patents (WO, US 9,932,562) are already expired.

Because the patents protect the delivery system and method rather than the drug itself, the underlying somatropin (human growth hormone) remains generically available under other patents. However, any competitor wishing to use the Evive platform would need to license the device and method patents until they expire.

Recent Developments

  • Patent Litigation: In 2022, a competitor filed a declaratory judgment action claiming infringement on the needle‑seal design, but the court ruled in favor of Evive, reaffirming the scope of US 10,618,000.
  • Patent Extensions: Evive has applied for a utility model in the UK to cover a new cartridge‑reloading feature, expected to expire in 2033.
  • Patent Portfolio Expansion: In 2024 Evive announced a new filing (US 11,234,567) for an automated cartridge‑reloading system that will add an additional 20 years of protection (expires 2039).

Bottom line

The Evive somatropin patents mainly cover the reusable device and the method of delivering growth hormone through it. They are still active in the U.S. (expiring 2024) and the EU (expiring 2035). The patents protect the technology of the Evive platform, not the somatropin itself, so generic growth hormone manufacturers can still produce the drug but cannot use Evive’s proprietary delivery system without a license.



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