1.) New Drugs Approved by CDSCO 2.) Jazz Pharmaceuticals, Inc. and Avadel CNS Pharmaceuticals, LLC.- Sodium oxybate (District Court for the District of Delaware)

Contents

New Drugs Approved by CDSCO

General information

Hearing Against Pfizer Set For 29 September In Contraceptive ‘Depo-Provera’ Multidistrict Litigation

FDA Initiates Approval Process for Leucovorin Calcium as Potential Autism Treatment

Intellectual Property

Jazz Pharmaceuticals, Inc. and Avadel CNS Pharmaceuticals, LLC.- Sodium oxybate

New Drugs Approved by CDSCO

Generally, we follow the US FDA's approvals every month. This week, we decided to check what is happening in India. Therefore, we reviewed recent approvals from the Central Drugs Standard Control Organisation (CDSCO). We examined approvals from the past three months. The list of new drugs approved in 2025 so far can be found here.

General information

Hearing Against Pfizer Set For 29 September In Contraceptive ‘Depo-Provera’ Multidistrict Litigation

1. Global pharmaceutical company Pfizer Inc. (NYSE:PFE), manufacturer of contraceptive injection Depo-Provera (DMPA), is facing a multidistrict litigation (MDL No. 3140) in the USA being brought on behalf of women who developed an intracranial meningioma, a type of brain tumour after using Pfizer’s Depo-Provera.
2. This litigation followed a study by EPI-PHARE (Roland et al.) published in March 2024 in the British Medical Journal, which found that women who had used the Pfizer contraceptive injection Depo-Provera for more than one year were 5.6 times more likely to develop an intracranial meningioma.
3. An estimated 74 million women globally receive Depo-Provera injections according to a 2019 UN study. Also, according to the UN, 247 million worldwide are on hormonal contraceptives.
4. In a recent case management order, Judge M. Casey Rodgers instructed law firms to file their claims as soon as possible.

News here

FDA Initiates Approval Process for Leucovorin Calcium as Potential Autism Treatment

The U.S. Food and Drug Administration (FDA) has announced the initiation of the approval process for leucovorin calcium, a prescription-strength form of folinic acid, as a treatment option for certain patients. The announcement has drawn attention to ongoing research suggesting that folinic acid may have potential benefits in improving communication, behavior, and developmental outcomes in children with autism spectrum disorder (ASD). News here

Intellectual Property

Jazz Pharmaceuticals, Inc. and Avadel CNS Pharmaceuticals, LLC.- Sodium oxybate

This document summarises the Memorandum Opinion from the United States District Court for the District of Delaware concerning an antitrust case between Jazz Pharmaceuticals, Inc. and Avadel CNS Pharmaceuticals, LLC. The litigation centres on the product sodium oxybate, which is utilised to mitigate cataplexy attacks and excessive daytime sleepiness (EDS) in patients with narcolepsy. Background of the Dispute The dispute originated with Jazz Pharmaceuticals filing a complaint against Avadel for patent infringement of U.S. Patent No. 8,731,963 (the '963 patent). Avadel countered with an answer and counterclaims, alleging that Jazz violated Section 2 of the Sherman Act. Avadel's antitrust claim asserted that Jazz improperly listed and subsequently refused to delist the '963 patent—characterised as a REMS (Risk Evaluation and Mitigation Strategy) patent related to a distribution system—in the Orange Book. Avadel argued that Jazz's conduct was designed to impede the launch of a competitive oxybate product. Specifically, Avadel alleged that this improper listing necessitated a Paragraph IV certification in their New Drug Application (NDA) for LUMRYZ, which in turn allowed Jazz to file a lawsuit, triggering an automatic 30-month stay on FDA approval. Prior Court Actions The Court had previously ordered Jazz to request the FDA to delete the '963 patent from the Orange Book, having determined that the patent did not claim the drug or an approved method of using the drug. Following this, Jazz filed a Motion to Dismiss Avadel's antitrust counterclaims. The Court denied a subsequent Motion for Leave to File a Supplemental Brief by Jazz, reasoning that Avadel had sufficiently pleaded facts indicating that the FDA would have granted the NDA for LUMRYZ prior to Jazz delisting the '963 patent. Avadel’s NDA for LUMRYZ was submitted and approved via the 505(b)(2) regulatory pathway. This pathway allows an applicant to rely on the FDA's findings of safety and effectiveness for a previously approved drug, or on published literature. For LUMRYZ, the application referenced Jazz Pharmaceuticals' Xyrem (sodium oxybate), which was the original FDA-approved drug. The key distinction is that LUMRYZ is a once-nightly, extended-release formulation taken as a single dose at bedtime, while Xyrem is an immediate-release formulation requiring two doses per night, necessitating the patient to wake up for the second dose. Motions for Summary Judgment (MSJ) and Decision A Motion for Summary Judgment seeks to resolve a lawsuit without a full trial when there is no genuine dispute of material fact, and the moving party is entitled to judgment as a matter of law. Jazz filed two Motions for Summary Judgment: 1. MSJ No. 1: No Antitrust Standing 2. MSJ No. 2: No Antitrust Liability In MSJ No. 1, Jazz contended that Avadel lacked antitrust standing because it could not demonstrate that the FDA would have approved LUMRYZ by a specific date (October 15, 2021) absent Jazz's actions regarding the '963 patent. The legal standard for summary judgment requires the court to grant the motion only if there is no genuine dispute as to any material fact, reviewing the record and drawing all reasonable inferences in favour of the non-moving party. The Court's decision found a genuine dispute of material fact concerning when the FDA would have approved Avadel's NDA for LUMRYZ had the '963 patent not been listed in the Orange Book. Specifically, the Court referenced Avadel’s arguments, suggesting that the FDA had concluded LUMRYZ was clinically superior to Xyrem shortly after the patent was delisted. Conclusion Consequently, the Court denied both Jazz's MSJ No. 1 and MSJ No. 2 (the latter pursuant to the court's summary judgment ranking procedures). The case will now proceed for further consideration, given the presence of disputed material facts. Decision here