First Generic Drug Approvals by USFDA and Otsuka Pharmaceutical Co Ltd v Sun Pharma ANZ Pty Ltd -(Australia)

Contents

First Generic Drug Approvals

General information

Aspire Biopharma Files Provisional Patent Application for Industry-First Sublingual Powder Formulation of Clopidogrel (Generic Plavix(R)) to Address Gastric Bleeding Risks

Big Pharma Tight-Lipped on Details of API Stockpile Deals

Intellectual Property

Otsuka Pharmaceutical Co Ltd v Sun Pharma ANZ Pty Ltd -(Australia)

First Generic Drug Approvals

The FDA’s 2025 First-Time Generic Drug Approvals list represents the very first generic alternatives to previously exclusive brand-name medications. This list is specific because it only includes first generics, which are the first versions of a drug that can be sold in the U.S. after patent protections and exclusivities on the brand-name version expire. Being the "first" generic approved carries significant strategic and financial advantages for a pharmaceutical company:

1. 180-Day Market Exclusivity: The most significant advantage is that the first generic applicant (only under specific Paragraph IV filings) may be eligible for 180 days of generic market exclusivity. During this six-month window, the FDA cannot approve other generic versions of the same drug, allowing the company to capture most of the market.
2. Premium Pricing Power: While generics are cheaper than brand names, the first generic is usually more expensive than subsequent generics. During the exclusivity period, the company can charge a first-to-market premium before other competitors drive the price down further.
3. Market Dominance: Being first allows a company to establish contracts with insurers, pharmacy benefit managers (PBMs), and hospital chains, making it much harder for later competitors to unseat them.
4. Reputation and Credibility: Successfully navigating the complex regulatory and legal hurdles to be the first generic demonstrates a company’s strong R&D and legal capabilities. The “first” generic approvals for the last quarter are as follows.

General information

Aspire Biopharma Files Provisional Patent Application for Industry-First Sublingual Powder Formulation of Clopidogrel (Generic Plavix(R)) to Address Gastric Bleeding Risks

Aspire Biopharma Holdings, Inc. (Nasdaq:ASBP) ("Aspire" or the "Company"), a biopharmaceutical company developing multi-faceted patent-pending drug delivery technology, today announced the filing of a new provisional patent application with the United States Patent and Trademark Office (USPTO). The application, titled "A Sublingual Powder Formulation of Clopidogrel and Methods of Use Thereof," covers the first-ever sublingual formulation of clopidogrel, the active pharmaceutical ingredient (API) in the widely prescribed blood thinner Plavix News here

Big Pharma Tight-Lipped on Details of API Stockpile Deals

Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private. Bristol Myers Squibb, GSK and Merck delivered a show of support for the Trump administration’s supply chain resilience push late last year, committing materials to a stockpile to mitigate the risk of shortages. Weeks later, many details of the agreements remain private. News here

Intellectual Property

Otsuka Pharmaceutical Co Ltd v Sun Pharma ANZ Pty Ltd -(Australia)

In a judgment delivered on 1 December 2025, the Full Court of the Federal Court of Australia dismissed an appeal by Otsuka Pharmaceutical Co., Ltd regarding the validity of a patent term extension (PTE). While the Court reversed the primary judge's findings on the clarity and validity of the patent claims themselves, it ultimately held that the patent extension was invalid because the claimed formulations do not constitute "pharmaceutical substances per se" under the Patents Act 1990. Background and the Patent Otsuka holds Australian Patent No. 2004285448, which relates to controlled-release sterile injectable aripiprazole formulations used to treat schizophrenia and bipolar I disorder. The active pharmaceutical ingredient (API) is aripiprazole, a substance known prior to the patent’s priority date and first listed on the Australian Register of Therapeutic Goods (ARTG) in May 2003 as immediate-release tablets. Otsuka sought and was initially granted a five-year extension of the patent term (from October 2024 to July 2029) based on its long-acting injectable product, ABILIFY MAINTENA. Sun Pharma challenged this extension, arguing that the patent was invalid for lack of clarity and that the formulations did not qualify for an extension under the statutory regime. The Appeal: Patent Validity (Clarity and Definition) The primary judge had originally found that the PTE Claims (Claims 1 and 16) were invalid under ss 40(2)(b) and 40(3) of the Act. The controversy centred on the Relevant Feature of the claims: the requirement that the formulation, upon injection, "releases aripiprazole over a period of at least one week" (or two weeks for Claim 16). 1. Limitation by Result The Full Court agreed with the primary judge that the Relevant Feature was a limitation by result. Because variables like dosage, volume, and injection site affect the release duration, a person skilled in the art must adjust these factors to achieve the specified minimum release period. 2. Clarity and Definition (Grounds 1, 2, and 3) Contrary to the primary judge, the Full Court found the claims were not invalid for lack of clarity. The primary judge had ruled that release was not practicable to measure at the injection site, and that blood plasma concentration was an unreliable surrogate for determining whether the claim boundaries were met. The Full Court held that this set an unduly high bar for scientific proof. It concluded: The patent effectively teaches that blood plasma concentration is the proxy for measuring release. Clarity does not require that every hypothetical embodiment at the edge of a claim be easily distinguishable; it requires a workable standard. Experts on both sides agreed that real-world examples (such as ABILIFY MAINTENA) clearly met the at least one-week threshold. Consequently, had the patent term not already expired, the claims would have been considered valid. The Notice of Contention: Validity of the Extension (Ground 3) The core of the judgment rested on Sun Pharma’s Notice of Contention, which argued that the formulations were ineligible for a term extension. Under s 70(2)(a), an extension is only available for a "pharmaceutical substance per se". 1. Statutory Construction of "Pharmaceutical Substance" The Court conducted an extensive review of the legislative history. It was determined that: The definition of a pharmaceutical substance focuses on the active ingredient that has a chemical or physico-chemical interaction with a human physiological system. Excipients are therapeutically inert; they do not interact with the physiological system in the manner required by the Act. The term pharmaceutical substance is intended to cover active substances (such as APIs, monoclonal antibodies, or recombinant DNA products) but does not include formulations (mixtures of APIs and excipients). 2. Policy Objectives The Court emphasised that the PTE regime’s purpose is to compensate for the significant regulatory delays associated with developing new chemical entities. Extending the term for improved or modified dosage forms (like a controlled-release version of a known drug) would be inconsistent with the legislative balance between rewarding innovation and allowing generic competition. 3. "Per Se" and Method of Delivery The Court found that the claims were for a new method of delivery (controlled-release injection) of a known substance (aripiprazole). Following the Boehringer and Prejay precedents, the Court held that a claim is not for a substance per se if it includes additional integers such as delivery mechanisms or specific dissolution results. Additional Findings Reconstitution (Ground 1): The Court noted that freeze-dried formulations require reconstitution before administration, at which point the claimed "solid" formulation ceases to exist. This further disqualifies them as substances that interact with a human system. Australian Register of Therapeutic Goods (ARTG) Consistency (Ground 2): Even if formulations were eligible, the Court found that the liquid injectable formulation (Claim 1) was not actually "contained" in the ARTG-listed goods, which are sold as kits (powder and solvent) rather than the final liquid. Disposition The Full Court concluded that because the formulations are not "pharmaceutical substances" under s 70, the Patent Extension was invalid. The patent therefore expired on 18 October 2024. The appeal was dismissed, and Otsuka was ordered to pay Sun Pharma's costs. Implications: In Australia, Brand companies will no longer be able to extend the term of pharmaceutical formulation patents. Their existing patent term extensions for such patents will now be vulnerable to challenge. Decision here