1.) Recent ANDA approvals 2.) Pharma updates 3.) Case: Nexus Pharmaceuticals Vs Exela Pharma Sciences
Recent ANDA approvals
General information
Brazil: Regulatory Changes on Drug Pricing Control can Trigger Innovation
The Jan Vishwas (Amendment of Provisions) Bill, 2025, and the Amendments to the Drugs and Cosmetics Act, 1940
Intellectual Property
Nexus Pharmaceuticals Vs Exela Pharma Sciences
Recent ANDA approvals
We follow ANDA approvals. In July, a total of 79 ANDA approvals were issued, of which 12 were tentative. A tentative approval is a formal notification from the USFDA indicating that a generic drug application has met all scientific and regulatory requirements for safety, efficacy, and quality, but cannot be granted final marketing approval due to unexpired patents or market exclusivities held by the original brand-name drug. The companies that sought more than 2 ANDA approvals (including tentative) were as follows.
Some of our other comments about a few ANDA approvals are listed below.
General information
Brazil: Regulatory Changes on Drug Pricing Control can Trigger Innovation
2025 has been a remarkable year for discussions on drug pricing regulation. On June, the Chamber for Drug Market Regulation (CMED), through its Council of Ministers, approved Rule #2/2025 which formalized the proceeding for pricing medicines under the “omissive cases” category and recognized the right to request pre-submission meetings and technical hearings during the review of pricing dossiers. Furthermore, The Council of Ministers is expected to also approve the new drug pricing framework - already submitted to Public Consultation #1/2025, which received more than 1400 contributions to the regulated sector- and to release to public consultation a draft rule on the pricing of Advanced Therapy Products (ATMPs). News hereThe Jan Vishwas (Amendment of Provisions) Bill, 2025, and the Amendments to the Drugs and Cosmetics Act, 1940
The bill explicitly mentions amending Section 33-I, sub-section (2), of the Drugs and Cosmetics Act, 1940. Here's a breakdown:- Original Provision (Prior to Amendment): Section 33-I (2) previously stipulated that an offence under that section would be punishable with imprisonment for a term that could extend to six months AND with a fine, the lower limit was ten thousand rupees.
- Amended Provision (Under Jan Vishwas Bill 2025): The amendment removes the possibility of imprisonment. The amended text states that the offence will be punishable only with a fine, and that the amount "shall not be less than thirty thousand rupees".
Intellectual Property
Nexus Pharmaceuticals Vs Exela Pharma Sciences
Generally, we cover inventive step discussions in our IP write-ups simply because they are more scientific and allow readers to understand how the Court considers the scientific aspect. This week, let us examine some procedural aspects of court cases and how parties argue about the inclusion and deletion of an expert’s testimony. In September 2022, Nexus Pharmaceuticals filed a Paragraph IV patent infringement lawsuit against Exela Pharma Sciences regarding its ready-to-use ephedrine sulfate injection, sold under the brand name EMERPHED. Nexus claims that Exela's generic version infringes patents related to Nexus's formulation. Background Nexus's EMERPHED: Nexus received FDA approval for EMERPHED (ephedrine sulfate) in April 2020. It was the first FDA-approved, premixed, "ready-to-use" ephedrine formulation at a concentration of 5 mg/mL. Nexus's Patents: Nexus holds several patents protecting its stable, ready-to-use ephedrine sulfate composition, including U.S. Patent Nos. 11,426,369 ('369), 11,464,752 ('752), and 11,571,398 ('398). The OB listed patents are as follows.
Exela's Generic:
Exela submitted an Abbreviated New Drug Application (ANDA) to market a generic version of ephedrine sulfate. As part of this application, Exela filed a Paragraph IV certification, stating its generic would not infringe Nexus's patents.
The lawsuit:
In response to Exela's certification, Nexus filed a lawsuit against Exela for patent infringement in the U.S. District Court for the District of Delaware. The lawsuit alleges that Exela's product and manufacturing process infringe on Nexus's patented formulation and methodology.
Key issues
- Scope of patent claims: The litigation revolves around whether Exela's generic product infringes on Nexus's patented methods for creating a shelf-stable, ready-to-use ephedrine sulfate solution. Nexus asserts that Exela's product, marketed as AKOVAZ PFS, infringes on claims in the '369 patent related to the manufacturing process.
- Patent invalidity: Exela has argued that Nexus's patents are invalid based on anticipation by prior art. The court has stated that a jury, not the court, would resolve the factual disputes related to Exela's invalidity claims.
- Patent Trial and Appeal Board (PTAB): In a related proceeding, Nexus filed a petition against Exela with the PTAB in February 2024 to challenge one of Exela's patents. However, the PTAB denied Nexus's petition in August 2024.
- Comparison to Prior Art: The Court finds that Dr. Emamifar does provide specific and descriptive opinions that show non-obviousness and no anticipation. Dr. Emamifar opines on the stability and sterility of the compounded product.
- Rebuttal Report: The Court notes that Exela's expert (Dr. Myers) failed to conduct any analysis on a product-by-product basis, which is the burden of the party demonstrating invalidity
- Expert Testimony: The Court states that experts in patent cases routinely give legal conclusions that a claim is not invalid because they can be helpful to the jury.
- Dr. Fix's Opinions: The Court finds that Dr. Emamifar does more than merely restate that Dr. Fix will opine on validity.
