06 April 2026 Pharmaceutical IP & FDA Update: New 505(b)(2) Approvals and UPC Patent Rulings
2026 Pharmaceutical IP & FDA Update: New 505(b)(2) Approvals and Patent Rulings
The pharmaceutical industry is seeing a surge in innovation through the 505(b)(2) regulatory pathway and landmark decisions in the Unified Patent Court (UPC). This 06 April 2026 update covers critical developments in drug formulations, biosimilar settlements, and intellectual property litigation that impact market access and patient care.
High-Impact 505(b)(2) FDA Approvals (March 2026) The 505(b)(2) NDA route is essential for manufacturers seeking to improve existing drugs, such as changing dosage forms or enhancing stability. The following approvals represent significant shifts in their respective therapeutic categories: 1. PYLARIFY TRUVU (Piflufolastat F-18)
- Manufacturer: Filed by Aphelion, an affiliate of Lantheus Holdings.
- Innovation: This 505(b)(2) application utilizes the original PYLARIFY as its Reference Listed Drug (RLD) but introduces a formulation allowing for 50% larger batch sizes.
- Market Impact: The extended shelf life enables prostate cancer diagnostics to reach remote areas that previously lacked access to PSMA PET imaging.
- Commercial Timeline: A transition for existing customers is expected to begin in Q4 2026.
- Indication: Treatment of ADHD in adults and pediatric patients aged 6 and older.
- Clinical Advantage: Provides an accessible format for patients with dysphagia (difficulty swallowing) or pill fatigue who cannot use traditional capsules.
- IP Challenge: While it offers non-stimulant benefits, the manufacturer (MAP77) must circumvent Eli Lilly’s US9326935 patent, which remains valid until 2034.
3. KITPROZY (Carfilzomib) – Tentative Approval
- Status: Received tentative approval but is currently blocked by a 30-month litigation stay involving U.S. Patent 7,737,112.
- Benefit: Once launched, it will serve as a critical alternative source to prevent oncology drug shortages in hospital settings.
Global IP Litigation and Biosimilar Settlements Aflibercept Biosimilar Settlement (Formycon & Regeneron) A major hurdle for Eylea biosimilars was cleared on March 19, 2026. Formycon and Klinge Biopharma reached a settlement with Regeneron and Bayer. • Launch Date: AHZANTIVE and BAIAMA are now scheduled for launch in Europe and select APAC/Latin American markets in May 2026. UPC Court of Appeal: Sinocare & Menarini Injunction The UPC Court of Appeal recently upheld a preliminary injunction regarding the GlucoMen iCan CGM system.
- Ruling: Sinocare and Menarini are prohibited from selling the system in UPC territories.
- Focus: The ongoing dispute will now shift to challenging the validity of Abbott’s patent.
Technical Patent Spotlight: Glenmark’s Ryaltris (Decision T 0492/24) The Technical Board of Appeal recently ruled on European Patent EP 3043773, involving a fixed-dose nasal spray of mometasone furoate and olopatadine hydrochloride.
- The Stability Problem: Previous formulations faced "phase separation" within hours.
- The Solution: Glenmark successfully argued that a specific concentration of sodium carboxymethyl cellulose (NaCMC) at ≥ 0.5% w/w combined with a pH of 3.5 to 3.9 provided a non-obvious stability profile.
- The Ruling: The patent was maintained, securing Glenmark’s and its partner Menarini’s position in 33 European countries.
-----------------------------------------X------------------------------------------
Contents
Recent 505 (b) (2) filings
General information
Court of Appeal upholds PI against Sinocare and Menarini
Formycon and Regeneron Settle European Aflibercept Biosimilar Litigation
Intellectual Property
Decision T 0492/24: Glenmark Speciality S.A.
Recent 505 (b) (2) filings
We follow 505 (b) (2) filings. Generally, 505(b)(2) NDAs relate to changes compared to previously approved drugs, such as indication, active ingredient, fixed-combination, dosage form, route of administration, dosing regimen, strength, and formulation (not approvable under section 505(j)). More details 505 (b) (2) FDA approvals can be found here. The details of March 2026, 505 (b) (2) filings are as follows:
General information
Court of Appeal upholds PI against Sinocare and Menarini
Sinocare and its distribution partner Menarini may no longer sell the GlucoMen iCan CGM system in UPC territory. The UPC Court of Appeal decided this yesterday, upholding a preliminary injunction from the local division The Hague. Further proceedings in the dispute will therefore likely focus primarily on the companies' challenges to the validity of Abbott's patent. News hereFormycon and Regeneron Settle European Aflibercept Biosimilar Litigation
On March 19, 2026, Formycon and its license partner Klinge Biopharma announced a settlement and license agreement with Regeneron and Bayer resolving all patent disputes relating to the EU-approved AHZANTIVE and BAIAMA aflibercept biosimilars referencing EYLEA. Nicola Mikulcik, Chief Business Officer of Formycon AG stated of the announcement, “The agreement for Europe and further territories is a significant milestone, as it secures timely market access for our commercialization partners.” Under the agreement, AHZANTIVE and BAIAMA may be launched in Europe and other Latin America and Asia-Pacific markets in May 2026. News hereIntellectual Property
Decision T 0492/24: Glenmark Speciality S.A.
On 16 January 2026, the Technical Board of Appeal issued a decision regarding European Patent EP 3043773, which concerns a stable fixed-dose aqueous pharmaceutical composition for nasal administration comprising mometasone furoate and olopatadine hydrochloride. The Board ultimately set aside the opposition division's previous decision and ordered the patent to be maintained based on Auxiliary Request 3.
Procedural Background and Amendments
The patent was originally opposed on grounds of lack of inventive step, insufficient disclosure, and added subject-matter. The Board found that both the Main Request and Auxiliary Request 1 failed the gold standard test for amendments under Article 123(2) EPC. Specifically, the requests introduced a concentration of sodium carboxymethyl cellulose (NaCMC) of at least 0.5% w/w, which the Board ruled was an unallowable artificial range created by selecting an upper limit from one original embodiment and setting it as the lower limit of a new range.
However, Auxiliary Request 3 was found acceptable. It defined the NaCMC concentration as at least 0.5% w/w specifically in conjunction with a pH range of 3.5 to 3.9. The Board ruled this combination was directly derivable from the original application, which explicitly linked that specific concentration to that pH range.
The Inventive Step Analysis (Article 56 EPC)
The core of the dispute centred on whether the stabilised composition in Auxiliary Request 3 was non-obvious in view of the prior art.
1. Closest Prior Art and Distinguishing Features
The parties agreed that D4 (WO 2014/092346) was the closest prior art. Examples 3 and 4 of D4 disclosed a similar combination of mometasone and olopatadine using Avicel RC-591 (a blend of microcrystalline cellulose and NaCMC).
The Board identified two key distinguishing features between the claimed invention and D4:
- Olopatadine Concentration: The claim specifies 0.6% to 0.7% w/w, whereas D4 explicitly lists 6.65% w/v.
- NaCMC Concentration: The claim requires at least 0.5% w/w of NaCMC as such, whereas D4’s compositions contained only approximately 0.17–0.28% w/v of NaCMC (derived from the Avicel blend).
3. Assessment of Obviousness
The Board concluded the solution was not obvious for several reasons:
- Lack of Motivation: D4 contained no mention of stability issues or phase separation. Without an identified problem in the prior art, the skilled person would have no motivation to modify the suspension to improve stability.
- Teaching Away: While reducing the olopatadine concentration to 0.665% (matching commercial products like Patanase) might have been obvious, the patent’s comparative examples proved that a lower active concentration did not inherently solve the stability problem.
- Uncommon Concentrations: The Board noted that the claimed amount of NaCMC (≥ 0.5% w/w) was actually higher than the maximum limits suggested by the FDA inactive ingredient guidance for nasal sprays (0.15% w/w) cited in D22. D22 thus taught away from the claimed solution.
- Alternative Options: While general documents (D9, D10, D34) mentioned NaCMC as a possible stabiliser, they listed it as one of many options (alongside xanthan gum or HPMC) without providing a specific concentration needed to achieve the required stability for this specific combination of actives.
Conclusion
The Board found that the specific use of at least 0.5% w/w NaCMC to stabilise the mometasone/olopatadine suspension at a specific pH was a non-obvious solution to a previously unrecognised stability problem. The patent was remitted to the opposition division to be maintained under Auxiliary Request 3.
Details here
Marketing status.
- Glenmark markets a nasal formulation containing mometasone furoate and olopatadine hydrochloride (Ryaltris) directly through its subsidiaries in some European countries, including the United Kingdom, Poland, the Czech Republic, and Slovakia.
- For the majority of the European market, Glenmark has an exclusive licensing agreement with the Menarini Group. Menarini is responsible for the commercialisation and scientific information for the product in 33 European countries, including France, Italy, Spain, and the Balkan region.
- Regulatory Status: The product received marketing approval in Europe in 2021. It is indicated for the symptomatic treatment of seasonal and perennial allergic rhinitis in adults and adolescents aged 12 years and older. Details here.
