List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic and Case Agilent Technologies, Inc. Vs Axion Biosystems, Inc.

Contents

List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic

General information

AbbVie to cut drug prices, pledges $100 billion for research

Bionpharma Inc. Receives USFDA Approval for Etravirine Tablets Developed in Collaboration with STEERLife

Intellectual Property

Agilent Technologies, Inc. Vs Axion Biosystems, Inc.: United States District Court for the District of Delaware.

List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic

The FDA maintains a list of approved new drug applications (NDA) that are no longer protected by patents or exclusivities, and for which the FDA has not approved an abbreviated new drug application (ANDA) referencing that NDA product. The FDA updates this list every six months (in June and December) to improve transparency and encourage the development and submission of ANDAs in markets with little competition. December 2025 lists of off-patent, off-exclusivity drugs without an approved generic are published here. Some of the tablets, capsules, and Injectable dosage forms that are no longer protected by patents or exclusivities, and for which the FDA has not approved an ANDA, are as follows.

General information

AbbVie to cut drug prices, pledges $100 billion for research

AbbVie on Monday that it has struck a three-year deal with U.S. President Donald Trump's administration to reduce drug prices, and has pledged $100 billion over the next decade for research and development in the country. The drugmaker said the investment will include manufacturing and will expand direct-to-patient offerings through TrumpRx for widely used medicines such as Alphagan, Combigan, Humira and Synthroid. News here

Bionpharma Inc. Receives USFDA Approval for Etravirine Tablets Developed in Collaboration with STEERLife

Marking a significant milestone in the global effort to expand access to advanced HIV therapies, STEERLife (the life sciences division of STEER World), and Bionpharma Inc. today announced that Bionpharma has received Abbreviated New Drug Application (ANDA) approval from the United States Food and Drug Administration (USFDA) for its generic Etravirine tablets. Developed using STEERLife's proprietary FragMelt™ continuous processing platform, this approval represents a breakthrough in pharmaceutical manufacturing. The platform enables a sustainable, solvent-free manufacturing route while maintaining strict bioequivalence to the reference product, INTELENCE®. News here

Intellectual Property

Agilent Technologies, Inc. Vs Axion Biosystems, Inc.: United States District Court for the District of Delaware.

In patent litigation, claim construction serves as the critical foundation for the case, as it defines the precise legal scope and boundaries of the patented invention, thereby determining exactly what is protected by law. This process—often established during a "Markman hearing"—is essential because the specific meaning of technical terms can determine whether a competitor's product is found to infringe or whether the patent itself is held invalid. In this particular case involving Agilent Technologies and Axion Biosystems, the Court deferred ruling on the "cell index" terms following the initial Markman hearing because indefiniteness (the question of whether a term is too vague to be understood by a person skilled in the art) is a complex legal issue often better suited for resolution at the summary judgment stage. Consequently, this Memorandum Opinion provides the final determination on these terms, confirming their validity and defining them for the upcoming jury trial. It is interesting to notice how parties debate to arrive at the meanings of the words in the patent litigation. Background Agilent filed this action on February 23, 2023, alleging infringement of United States Patent Nos. 7,192,752 (the "'752 patent"), 7,468,255 (the "'255 patent"), and 8,026,080 (the "'080 patent," collectively, the "asserted patents"), along with a false advertising claim. The motions at hand, filed on July 10, 2025, involve:

1. Agilent's motion for entry of claim construction for "cell index" terms and summary judgment of no indefiniteness for asserted claims.
2. Axion's motion for summary judgment that claims using "calculating cell index values" and "cell index" are invalid due to indefiniteness.

The parties had previously consented to the Court's jurisdiction, and a jury trial is scheduled for January 26, 2026. Marketed product The marketed device by Axion Biosystems, Inc., accused of infringement, is an impedance-based cell analysis system that measures electrical impedance to monitor cell behaviour and derives quantitative "cell index" values or similar parameters. Such devices are commonly used in biological research to track cell growth, viability, morphology, and attachment in real time without the need for labels. Factual Background Relevant to Motions: Agilent asserts infringement of specific claims across all three patents. The '752 and '080 patents share a common specification, while the '255 patent is related and includes all disclosures from the '752 and '080 patents, plus additional ones. The patents were issued between 2007 and 2011. Critically, various asserted claims use terms such as "calculating a cell index," "calculating cell index values," and "cell index," which are collectively referred to as "cell index terms." These terms were coined by the inventors of the asserted patents. Legal Standards The Court incorporated by reference its standard of review for summary judgment motions and legal standards for claim construction, as set forth in previous opinions. Regarding indefiniteness, 35 U.S.C. § 112(b) requires patent claims to "particularly point out and distinctly claim" the invention. A patent claim is indefinite if, when read in light of the specification and prosecution history, it fails to inform a "person of ordinary skill in the art" ("POSITA") with reasonable certainty about the scope of the invention. Absolute precision is not required. Indefiniteness is a question of law, and the challenger must prove it by clear and convincing evidence. Discussion The Court noted that the "cell index terms" were briefed during claim construction, where Agilent proposed constructions and Axion argued indefiniteness. The Court previously deferred ruling, allowing Axion to re-raise its indefiniteness challenge at the summary judgment stage. Axion argued that the intrinsic evidence (the patent specifications and prosecution history) fails to provide objective boundaries for the "cell index terms," thus making them indefinite. Agilent, conversely, moved for summary judgment that the terms are not indefinite and proposed the following constructions:

• "calculating cell index values" means "calculating parameters derived from measured impedance values that reflect a change in impedance values"
• "calculating a cell index" means "calculating a parameter derived from measured impedance values that reflects a change in impedance values"
• "cell index" means "a parameter derived from measured impedance values that reflects a change in impedance values"

The Court agreed with Agilent, finding its proposed constructions appropriate and that Axion failed to meet its burden of demonstrating indefiniteness by clear and convincing evidence. The Court's reasoning addressed Axion's objections:

1. Relevance of the '255 Patent Definition: Axion argued that a POSITA (Person of Skilled in Art) would not look to the '255 patent's specification to understand the "cell index terms" in the '752 and '080 patents because the '255 patent was filed later. The Court rejected this, emphasising that all asserted patents are closely related members of the same patent family, involve the same inventors, and concern the same technology. Thus, the '255 patent's usage illuminates the meaning of the terms across all three patents. The '255 patent explicitly defines "cell index" as "a parameter that can be derived from measured impedance values, and that can be used to reflect the change in impedance values." This definition is consistent with disclosures across all patents that describe a cell index as a parameter derived from measured impedance values.
2. "Can" and "Can Be" Language: Axion contended that the "can" and "can be" language in the '255 patent's definition ("is a parameter that can be derived...") created ambiguity and implied that "cell index" could be defined in other ways. The Court found that, in this context, the language conveys that it is possible to derive this specific, singular "cell index" (coined by the inventors) from raw impedance values to reflect a change. Agilent's removal of "can be" in its proposed construction was deemed an appropriate grammatical simplification that captures the inventors' intended meaning without ambiguity.
3. Lack of Calculation Method: Axion asserted that the definition was indefinite because it did not specify how to derive or calculate cell index values. The Court noted that the patent specifications disclose seven examples of how to do so. Agilent's expert testified that a POSITA would either use one of these examples or leverage their expertise to craft a formula, which the Court found provided reasonable certainty. The Court distinguished this case from Dow Chem. Co., where multiple methods yielded different results regarding infringement, whereas here the claims simply require "calculating cell index values" or "determining a cell index," not a particular value or measurement outcome. The definition provides two clear requirements: (1) it is a parameter derived from measured impedance values (not raw values), and (2) it reflects a change in impedance values. These objective criteria are sufficient to determine infringement.

The Court reiterated that while Agilent's proposed construction is broad, "breadth is not a sin" for definiteness. Disagreements among experts about whether certain concepts (e.g., "normalised resistance" or "per cent cytolysis") meet the "cell index" definition constitute infringement, not indefiniteness. Conclusion For the reasons stated, the Court found that Axion failed to prove by clear and convincing evidence that the "cell index terms" are indefinite. The Court granted Agilent's motion for summary judgment of no indefiniteness and adopted Agilent's proposed claim constructions. Therefore, it was ORDERED that Axion's motion for summary judgment of invalidity due to indefiniteness is DENIED, and Agilent's motion for claim construction and summary judgment of no indefiniteness is GRANTED. The "cell index terms" are construed as:

1. "calculating cell index values": "calculating parameters derived from measured impedance values that reflect a change in impedance values"
2. "calculating a cell index": "calculating a parameter derived from measured impedance values that reflects a change in impedance values"
3. "cell index": "a parameter derived from measured impedance values that reflects a change in impedance values" Decision here