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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 January 2026, 505 (b) (2) filings are as follows:

Drug Name	Comments
QUIOFIC NDA #216395. FOLIC ACID. CMP DEV LLC	CMP Development LLC received FDA approval for QUIOFIC (folic acid) oral solution on January 26, 2026, under the 505(b)(2) regulatory pathway. While the product does not currently have patents listed in the Orange Book, it relies on a proprietary liquid oral technology that achieves a stable concentration of 0.2 mg/mL. This concentration is specifically formulated to ensure a 24-month shelf life at room temperature, overcoming the historical stability challenges associated with aqueous folic acid. The primary technology involves a precise pH-adjusted carrier system designed to prevent the decomposition of folic acid, which is typically sensitive to light and oxidation. For patients, the major advantage of this product is that it provides a ready-to-use, standardised liquid alternative to solid tablets. This is particularly beneficial for paediatric patients and elderly individuals with dysphagia who would otherwise require pharmacists to crush tablets and create extemporaneous compounds. By using an FDA-approved liquid, patients receive a consistent dose with a mixed-berry flavour, reducing the risk of dosing errors inherent in manual compounding. Furthermore, the inclusion of a calibrated oral dosing ensures that even low maintenance doses for infants (as low as 0.1 mg) can be delivered with high precision.
YUVEZZI NDA #220142 CARBACHOL AND BRIMONDINE TARTRATE VISUS THERAPEUTICS INC.	Tenpoint Therapeutics (which acquired the drug through its merger with Visus Therapeutics) received FDA approval for YUVEZZI (carbachol and brimonidine tartrate) on January 28, 2026. YUVEZZI is the first-ever fixed-dose combination eye drop indicated for the treatment of presbyopia in adults. The drug utilises a pinhole effect technology where carbachol acts as a potent miotic to constrict the pupil, while brimonidine prevents dilation and enhances the bioavailability of the carbachol. This dual-mechanism approach is designed to extend the duration of near-vision improvement, with clinical trials showing efficacy lasting up to 10 hours. Visus Therapeutics has filed a robust patent portfolio for this technology, including several patent families (for example WO2020252061) covering the specific concentrations and synergistic combinations of cholinergic agents and alpha-agonists. The primary advantage to the patient is the achievement of sharp near vision without a significant loss in distance clarity or the brow ache often associated with single-agent miotics. Furthermore, the addition of brimonidine significantly reduces the side effect of ocular hyperemia (eye redness), which occurred in only 2.8% of YUVEZZI patients compared to over 10% for those using carbachol alone. The analysts say, this approval offers a long-lasting, once-daily, non-invasive alternative to reading glasses for the estimated 128 million Americans living with age-related near-vision loss.

Drug Name

Comments

QUIOFIC

NDA #216395.

FOLIC ACID.

CMP DEV LLC

CMP Development LLC received FDA approval for QUIOFIC (folic acid) oral solution on January 26, 2026, under the 505(b)(2) regulatory pathway. While the product does not currently have patents listed in the Orange Book, it relies on a proprietary liquid oral technology that achieves a stable concentration of 0.2 mg/mL. This concentration is specifically formulated to ensure a 24-month shelf life at room temperature, overcoming the historical stability challenges associated with aqueous folic acid. The primary technology involves a precise pH-adjusted carrier system designed to prevent the decomposition of folic acid, which is typically sensitive to light and oxidation.

For patients, the major advantage of this product is that it provides a ready-to-use, standardised liquid alternative to solid tablets. This is particularly beneficial for paediatric patients and elderly individuals with dysphagia who would otherwise require pharmacists to crush tablets and create extemporaneous compounds.

By using an FDA-approved liquid, patients receive a consistent dose with a mixed-berry flavour, reducing the risk of dosing errors inherent in manual compounding. Furthermore, the inclusion of a calibrated oral dosing ensures that even low maintenance doses for infants (as low as 0.1 mg) can be delivered with high precision.

YUVEZZI

NDA #220142

CARBACHOL AND BRIMONDINE TARTRATE

VISUS THERAPEUTICS INC.

Tenpoint Therapeutics (which acquired the drug through its merger with Visus Therapeutics) received FDA approval for YUVEZZI (carbachol and brimonidine tartrate) on January 28, 2026. YUVEZZI is the first-ever fixed-dose combination eye drop indicated for the treatment of presbyopia in adults. The drug utilises a pinhole effect technology where carbachol acts as a potent miotic to constrict the pupil, while brimonidine prevents dilation and enhances the bioavailability of the carbachol. This dual-mechanism approach is designed to extend the duration of near-vision improvement, with clinical trials showing efficacy lasting up to 10 hours.

Visus Therapeutics has filed a robust patent portfolio for this technology, including several patent families (for example WO2020252061) covering the specific concentrations and synergistic combinations of cholinergic agents and alpha-agonists.

The primary advantage to the patient is the achievement of sharp near vision without a significant loss in distance clarity or the brow ache often associated with single-agent miotics. Furthermore, the addition of brimonidine significantly reduces the side effect of ocular hyperemia (eye redness), which occurred in only 2.8% of YUVEZZI patients compared to over 10% for those using carbachol alone.

The analysts say, this approval offers a long-lasting, once-daily, non-invasive alternative to reading glasses for the estimated 128 million Americans living with age-related near-vision loss.

General information

Novo Nordisk to take legal action against Hims & Hers for Wegovy compounding

Novo Nordisk said on Thursday it would take legal action against Hims & Hers after the online telehealth company said it will begin offering compounded copies of the Danish group's Wegovy pill at an introductory price of $49 per month.

News here

SanegeneBio and Genentech sign $1.5bn global RNAi licensing deal

SanegeneBio has entered a $1.5bn global licensing agreement with Genentech, part of the Roche Group, for one of its ribonucleic acid interferences (RNAi) programmes utilising SanegeneBio’s technology platform.

The deal grants Genentech exclusive global rights to develop and commercialise the selected RNAi programme.

News here

Intellectual Property

The "Skinny Label" Dispute (sec viii) in the US. Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc.

Hikma Pharmaceuticals v. Amarin Pharma is a 2024 decision by the CAFC. It is resurfacing now because the Supreme Court has granted certiorari in Hikma Pharmaceuticals v. Amarin Pharma, a case that addresses the legal boundaries of "skinny labels" and the standards for induced patent infringement.

Certiorari is a formal process by which the U.S. Supreme Court reviews a case from a lower court at its own discretion. To initiate this, a party files a petition for a writ of certiorari requesting the Court to hear their appeal. The Supreme Court typically grants certiorari only for cases involving significant legal questions

Background

Amarin markets Vascepa, originally approved (2012) for severe hypertriglyceridemia (SH; TG ≥500 mg/dL) with an express “CV Limitation of Use” disavowing cardiovascular-risk reduction claims. After further trials, the FDA approved a cardiovascular-risk-reduction indication (CV indication) in 2019, and Amarin removed the CV limitation. Amarin listed two patents (the ’537 and ’861 patents) claiming methods tied to the CV indication in the Orange Book.

In 2016, Hikma submitted an ANDA for a generic version of icosapent ethyl. Following approval of the CV indication, Hikma filed a section viii carve-out (a “skinny label”) seeking approval only for the SH indication; the FDA approved Hikma’s ANDA in May 2020. Hikma’s approved label listed only the SH indication, omitted the prior CV Limitation of Use, included an adverse-event warning for patients with cardiovascular disease, and included clinical-study descriptions that overlapped with Amarin’s patented populations.

Hikma issued multiple press releases in 2020 calling its product a generic version or generic equivalent (of Vascepa and cited Vascepa sales figures (which the complaint alleges were largely attributable to the CV indication). Hikma’s website listed the product under Hypertriglyceridemia and noted an AB rating, with a small disclaimer that Hikma’s product was approved for fewer indications than Vascepa.

Amarin sued, alleging Hikma induced infringement by encouraging off-label prescribing for the patented CV uses. The magistrate judge recommended denying dismissal; the district court granted Hikma’s motion, finding the label and public statements alone did not plausibly allege an inducing act. Amarin appealed.

Analysis

The Federal Circuit emphasises this is a garden-variety induced-infringement claim—not a classic pre-approval ANDA case nor a label-only section viii case. The complaint must be evaluated based on the totality of allegations (label + marketing + public statements).

Accepting Amarin’s factual allegations, the court finds plausible that Hikma’s combination of: (a) clinical-study language and removal of the CV Limitation of Use on its label; (b) press releases calling the product a generic version of Vascepa while touting Vascepa sales largely driven by the CV use; and (c) website promotion in a broad therapeutic category could reasonably be understood by physicians as encouraging off-label prescribing that would infringe Amarin’s method patents.

The court rejects Hikma’s argument that mere silence or calling a product a “generic version” is per se insufficient at the pleadings stage; it distinguishes prior cases (GSK, Takeda, HZNP) on procedural and factual grounds.

Now, while filing a petition for a writ of certiorari in the US Supreme Court, Hikma argues that the Federal Circuit’s ruling conflicts with precedent requiring active encouragement. They contend that general descriptions of a product that never mention the patented use should not constitute inducement. Furthermore, Hikma warns that this ruling could "chill" the entry of lawful generics by making it too risky to market a drug while any indication remains patented.

Amarin maintains that Hikma’s marketing was not passive but affirmatively encouraged infringing use. They argue that manufacturers can avoid liability by using more precise marketing. The Solicitor General has filed a brief generally supporting Hikma’s position.

Future Outlook

The Supreme Court may issue a narrow, pharma-specific ruling or provide broader guidance on induced infringement standards, such as whether a defendant's statement must be relied upon by a direct infringer.

Key Timeline:

Argument: Likely scheduled for April 2026.
Decision: Expected before the Court's summer recess in early July 2026

CAFC Case here

Information about the US SC to take up Hikma’s case is here

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