ANDA approvals in May 2025 and FDA Decision on Voquezna Exclusivity

Contents

ANDA approvals in May 2025

General information

FDA Action Update, May 2025: Approval, Clearance, and Authorisation

Court of Appeal implements CJEU ruling in Janssen’s dispute with INPI

Intellectual Property

FDA Decision on Voquezna Exclusivity:

ANDA approvals in May 2025

We follow ANDA approvals every month. There were about 98 approvals in May, 27 of which were tentative approvals. The companies whose two or more ANDAs were approved in May 2025 are listed below.

The comments regarding the few ANDA approvals of Indian companies are as follows.

General information

FDA Action Update, May 2025: Approval, Clearance, and Authorisation

• ZEISS Medical’s INTRABEAM 700 received FDA clearance for intraoperative radiation therapy, enhancing precision and workflow efficiency in neuro-oncology and breast cancer treatments.
• Efgartigimod's pre-filled syringe approval offers patients with generalized myasthenia gravis and CIDP greater convenience and flexibility for in-home administration.
• CT-132, the first digital therapeutic for migraine prevention, was approved, providing a new adjunctive treatment option for episodic migraine in adults.
• Diazepam nasal spray's indication was expanded to treat seizure clusters in children aged 2 to 5, broadening access to this rescue therapy.
• The FDA authorised Epiminder’s Minder, the first implantable continuous EEG monitor for epilepsy, enhancing diagnostic accuracy and therapeutic monitoring.

News here

Court of Appeal implements CJEU ruling in Janssen’s dispute with INPI

The French Court of Appeal has implemented the CJEU's decision on supplementary protection certificates for the first time. As a result, the French Patent Office (INPI) must now grant SPC applications for HIV treatment filed by Janssen Pharmaceutica.

News here

Intellectual Property

FDA Decision on Voquezna Exclusivity:

A Summary This write-up outlines the USFDA’s decision regarding a citizen petition submitted by Phathom Pharmaceuticals, Inc., concerning the exclusivity period for their drug Voquezna (vonoprazan fumarate). The orange book lists patents and exclusivities for vonoprazan fumarate. They are as follows.

The core question is whether Voquezna should benefit from the extended New Chemical Entity (NCE) exclusivity granted to Voquezna Triple Pak and Voquezna Dual Pak, which are related co-packaged products containing the same active ingredient. The FDA's decision grants the petition, confirming Voquezna's eligibility for the extended exclusivity. Context: The Players and the Drugs Phathom Pharmaceuticals: The company that developed Voquezna and submitted the citizen petition seeking clarity on its market exclusivity. Voquezna (vonoprazan fumarate): A single-ingredient drug containing vonoprazan, a new type of acid-reducing agent. It's used to treat conditions like erosive esophagitis and gastroesophageal reflux disease (GERD). Voquezna Triple Pak & Voquezna Dual Pak: These are combination products that include vonoprazan along with antibiotics (amoxicillin and clarithromycin). They're used to treat Helicobacter pylori (H. pylori) infections. The details of the Triple Pak and Suel Pak are as follows: Voquezna Triple Pak Amoxicillin; Clarithromycin; Vonoprazan Fumarate (Voquezna Triple Pak) Capsule, Tablet, Tablet 500mg;500mg;Eq 20mg Base Patent Data

Voquezna Duel Pak Amoxicillin; Vonoprazan Fumarate (Voquezna Dual Pak) Capsule, Tablet 500mg;Eq 20mg Base

Phathom's Argument: Leveraging NCE*GAIN Exclusivity 

Phathom's petition rested on two main arguments: 

1. The NCE*GAIN Connection: The Voquezna Paks were granted extended exclusivity under the GAIN (Generating Antibiotic Incentives Now) Act because they were designated as Qualified Infectious Disease Products (QIDPs). This extended exclusivity (NCE*GAIN) provides 10 years of protection from generic competition. Phathom argued that since Voquezna contains the same active ingredient (vonoprazan) as the Voquezna Paks, it should also benefit from this extended exclusivity. 
2. The "Umbrella Policy": The FDA's "umbrella policy" states that if a new chemical entity (NCE) is first approved in one drug product, and then that same NCE is included in a different drug product that is later approved, the later drug product is also protected by the NCE exclusivity, provided it's approved during the exclusivity period of the first drug. Phathom argued that Voquezna falls under this umbrella, even though it wasn't itself designated as a QIDP. 

FDA's Regulatory Framework: Defining Exclusivity 

To understand the FDA's decision, it's crucial to grasp the regulatory framework surrounding drug exclusivity: 

• Hatch-Waxman Amendments: These amendments provide incentives for pharmaceutical innovation by granting periods of market exclusivity to new drugs. 
• 5-Year NCE Exclusivity: A standard period of exclusivity granted to drugs containing a new chemical entity (NCE) that hasn't been previously approved. This prevents generic drug manufacturers from submitting Abbreviated New Drug Applications (ANDAs) or certain 505(b)(2) applications to market generic versions up to five years. 
• "Umbrella Policy" (Expanded): As mentioned, this FDA policy extends NCE exclusivity to protect all drug products containing that novel active ingredient during the initial exclusivity period, even if those later products are different formulations, dosages, or combinations. 
• GAIN Act & QIDP Designation: The GAIN Act was designed to encourage the development of new antibiotics and antifungals. It provides a 5-year extension to the standard exclusivity periods for drugs designated as Qualified Infectious Disease Products (QIDPs). 

The FDA's Analysis: Applying the Law and Policy 

The FDA agreed with Phathom's arguments, basing its decision on the following key points: 

1. GAIN Act Mandate: The FDA stated that the GAIN Act mandates the extension of the NCE exclusivity period by five years when a drug is designated as a QIDP. 
2. Umbrella Policy Scope: The agency reaffirmed that the umbrella policy extends the reach of NCE exclusivity to any subsequent drug product containing the same new active ingredient. The GAIN Act doesn't change this. Therefore, if the active ingredient is protected by extended NCE*GAIN exclusivity, any other drug containing that active ingredient also benefits from it. 
3. Consistency with GAIN's Intent: The FDA argued that its decision aligns with the purpose of the GAIN Act. While the GAIN Act was focused on incentivizing new antibiotics, Congress didn't explicitly prohibit the umbrella policy from applying in this situation. 
4. No Conflicting Limitations: The agency noted that none of the limitations outlined in Section 505E(c) of the FD&C Act (which could restrict the GAIN extension) applied in this case.  

The FDA's Decision: Voquezna Gets Extended Exclusivity 

Based on its analysis, the FDA granted Phathom's petition. The agency concluded that Voquezna does benefit from the NCEGAIN exclusivity initially awarded to the Voquezna Paks. As a result, the Orange Book will be updated to reflect the extended exclusivity period for Voquezna, providing it with market protection until May 3, 2032 (the expiration date of the Voquezna Paks' NCEGAIN exclusivity). 

Significance of the Decision 

This decision has several important implications:

• Commercial Benefit for Phathom: The extended exclusivity provides Phathom Pharmaceuticals with a significant commercial advantage. It delays the entry of generic versions of Voquezna into the market, allowing Phathom to maximize its revenue and return on investment.
• Reinforcement of Regulatory Policy: The FDA's decision reinforces the "umbrella policy" and clarifies how it interacts with the GAIN Act. This provides greater certainty for pharmaceutical companies regarding market exclusivity when developing new drugs that contain previously approved new chemical entities.
• Incentives for Innovation (Continued): This ruling reinforces the incentives for drug companies to invest in developing new drugs, even if they contain components of existing drugs, particularly in the areas of infectious diseases, which the GAIN Act specifically targets.
• Clarification of QIDP Benefits: While Voquezna itself was not designated as a QIDP, the decision clarifies that it can still benefit from the NCE*GAIN exclusivity conferred upon related QIDP-designated products containing the same active moiety through the umbrella policy.

In Summary 

1. The FDA's decision regarding Voquezna’s exclusivity is a complex issue involving the interpretation of various regulations and policies. By granting Phathom's petition, the agency has clarified the scope of NCE*GAIN exclusivity and reinforced the importance of the umbrella policy in protecting pharmaceutical innovation. This decision has both commercial and regulatory significance, providing Phathom with a valuable period of market protection and offering greater clarity for other pharmaceutical companies navigating the intricacies of drug exclusivity. It also highlights the FDA's commitment to incentivising the development of new drugs, particularly in areas like infectious diseases, where there's a critical need for new treatments. 
2. VOQUEZNA’s 2024 sales hit $55.3 million. If prescriptions keep rising at 30% annually, sales could reach $200–$250 million by 2026—a “blockbuster” target. This USFDA decision will immensely benefit Phathom Pharmaceuticals. 

Decision here