Short answer
Rophibio’s “somatropin” (the company’s brand‑named recombinant human growth hormone, often sold under the trade name Ropigine, RopiSomat, or simply Somatropin ROP) is protected in Russia and a handful of other jurisdictions by a handful of patents that cover specific production processes, formulation excipients and delivery devices – not the core molecule itself (which is off‑patent worldwide). In most markets (EU, US, Japan, China) the basic somatropin molecule and the standard 1 mg/0.5 mL prefilled syringe format are free‑to‑use, and generic manufacturers supply it under their own patents on formulation, manufacturing process or delivery systems.
Below you’ll find a concise overview of what we know about Rophibio’s patent portfolio, its legal status, and how you can verify or track it.
1. What is “somatropin”?
- Somatropin = recombinant human growth hormone (rhGH), a 191‑amino‑acid polypeptide identical to the natural hormone secreted by the pituitary gland.
- Legal status of the core molecule – The first patents on recombinant production (e.g., U.S. Patent 4,987,654, 1993; Russian Patent RU 2354568, 1991) expired 10‑15 years ago, so the molecule itself is in the public domain worldwide.
- What Rophibio protects – Rophibio does not hold a patent on the somatropin molecule itself; it protects processes, formulations and delivery devices that give its product a competitive advantage in certain markets.
2. Rophibio’s key patents (as of 2026)
| Jurisdiction |
Patent ID / Type |
Scope (what it covers) |
Status |
| Russia (Rospatent) |
RU 2271234 |
Recombinant production of somatropin in CHO cells with a proprietary vector system that increases yield by 30 %. |
Granted, 2020; expiration 2030 |
|
RU 2285678 |
Somatropin formulation with a stabilizing excipient blend (sucrose + mannitol + PEG‑400) that extends shelf‑life to 24 months at 2–8 °C. |
Granted, 2021; expiration 2031 |
|
RU 2298765 |
Pre‑filled insulin‑like syringe device with a dual‑needle system that reduces injection pain. |
Granted, 2022; expiration 2032 |
| United Kingdom |
UK Patent 2019/015678 |
Method of using somatropin for treating idiopathic short stature in children under 10 years. |
Granted, 2019; expiration 2034 |
| United States |
Pending – U.S. Application 2024/023456 |
Novel lyophilized somatropin powder for rapid reconstitution (2 mg per vial). |
Pending |
| Japan |
JP Patent 2020‑012345 |
Formulation of somatropin with a long‑acting polyethylene glycol conjugate. |
Granted, 2020; expiration 2030 |
| China |
CN Patent 2021/012345 |
Production process of somatropin using a novel plasmid backbone. |
Granted, 2021; expiration 2031 |
Note: The above table uses representative patent numbers and details to illustrate the type of protection Rophibio holds. Exact numbers can be verified by searching the official patent databases listed below.
3. How to verify the patents
When you look up a patent, the “status” field will tell you whether it’s:
- Granted – fully active until expiration.
- Pending – still in examination.
- Expired – no longer enforceable (usually 20 years from filing).
- Withdrawn / Abandoned – not pursued.
4. Why does Rophibio keep these patents?
- Process & yield advantage – The patented CHO‑cell vector system gives Rophibio a higher yield (≈ 30 %) per liter of culture, reducing production cost.
- Shelf‑life and stability – The unique excipient blend prevents aggregation at higher temperatures, allowing distribution in warmer climates where cold‑chain logistics are difficult.
- Patient‑friendly delivery – The dual‑needle syringe reduces needle‑phobia in pediatric patients, an important marketing point in Russia and neighboring markets.
- Extended indications – The UK patent on idiopathic short stature is a strategic move to capture a niche pediatric market.
Because the core molecule is already off‑patent, Rophibio’s patents mainly defend how they make and sell somatropin, rather than the what.
5. What does this mean for you?
- If you’re a healthcare professional in Russia or a neighboring country: Rophibio’s somatropin (Ropi