USFDA Generic Trends: 87 ANDA Approvals and Key Generic Launches in April 2026, Impact of Nintedanib and Dapagliflozin Approvals; Validity of EirGen Pharma’s Vitamin D Formulation Patent

Global API & IP Insights: April 2026 ANDA Approvals and Landmark Patent Rulings

Stay ahead of the curve with our comprehensive analysis of the latest developments in the pharmaceutical and intellectual property landscape. This report highlights significant USFDA approvals, high-stakes patent litigation in Europe, and major industry investments in genetic medicine.

USFDA ANDA Approvals: April 2026 Highlights

The USFDA maintained high momentum in April 2026, issuing a total of 87 Abbreviated New Drug Application (ANDA) approvals, including 9 tentative approvals. A tentative approval indicates the product meets all safety and quality standards but is withheld from the market due to existing patents or exclusivities.

Top Performing Companies

Leading global generic manufacturers secured multiple approvals this month, signaling strong pipeline growth:

CompanyTotal ANDAs Approved
Apotex7
Aurobindo Pharma7
Micro Labs6
Cipla5
MSN4
Teva Pharmaceuticals4

Key Generic Launches & Market Impact

  • Nintedanib Esylate (Generic Ofev): Cipla, along with Apotex and Sandoz, received approval for this high-value IPF treatment. With global sales of Ofev reaching $4.1 billion in 2025, the expiration of compound patent US 6762180 in April 2026 has paved the way for immediate generic entry.

  • Dapagliflozin (Generic Farxiga): Inventia Healthcare joined a competitive wave of filers for this SGLT2 inhibitor. The market for Dapagliflozin was valued at $7.71 billion in early 2026, with shared 180-day exclusivity expected for several Paragraph IV filers.

  • Emtricitabine; Tenofovir Alafenamide Fumarate (Generic Descovy): Macleods Pharms Ltd secured approval for this HIV-1 PrEP medication. While patent protection extends to 2032, recent settlements suggest generic launches could begin as early as mid-2026, targeting a market that saw $2.5 billion in 2025 sales.

Intellectual Property & Legal Updates

EPO Confirms Validity of EirGen Pharma’s Vitamin D Patent

In a significant victory for EirGen Pharma (a subsidiary of OPKO Health), the EPO Boards of Appeal upheld the validity of European Patent EP 2,968,172.

  • The Product: The patent covers Rayaldee, a stabilized formulation of calcifediol used to treat secondary hyperparathyroidism in CKD patients.

  • The Ruling: The Board rejected challenges from DSM Nutritional Products, ruling that EirGen’s use of at least 5 wt% cellulose ether was both novel and non-obvious for stabilizing the dissolution profile.

  • Status: While the patent is maintained under amended claims (Auxiliary Request 1), related litigation regarding divisional applications continues through late 2026.

Trademark Victory for Sun Pharma

The Bombay High Court granted an interim injunction in favor of Sun Pharmaceutical Industries. The ruling prevents United Biotech from using trademarks that are identical or "deceptively similar" to Sun Pharma’s 'Octride' brand.


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Contents

ANDA approvals-April 2026

General information

Sun Pharma gets relief in trademark case from High Court

Eli Lilly Opens First Dedicated Genetic Medicine Facility

Intellectual Property

EPO Boards of Appeal Confirm Validity of EirGen Pharma’s Vitamin D Formulation Patent


ANDA approvals-April 2026

We follow ANDA approvals.

In April 2026, the USFDA issued 87 ANDA approvals, of which 9 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 could seek more than two ANDA approvals (including tentative ones) in April were as follows. 


Some of our other comments about a few ANDA approvals sought by Indian companies are listed below.


General information

Sun Pharma gets relief in trademark case from High Court

Sun Pharmaceutical Industries received a significant interim judicial order this week, as the Bombay High Court granted an injunction against New Delhi-based United Biotech. The ruling bars United Biotech from using any mark identical or deceptively similar to Sun Pharma's 'Octride' brand. 

News here

Eli Lilly Opens First Dedicated Genetic Medicine Facility

Eli Lilly today opened Lilly Lebanon Advanced Therapies, its first dedicated genetic medicine manufacturing facility, located in Lebanon, Indiana. The move signals a broader industry inflection point as the cell and gene therapy (CGT) market accelerates toward a near-tripling of approved products by the end of the decade.
Alongside the facility opening, Lilly announced an additional $4.5 billion investment across two of its three Lebanon sites, bringing the company's total Indiana capital expansion commitments since 2020 to more than $21 billion and its total US commitments since 2020 to more than $50 billion.

News here

Intellectual Property 

EPO Boards of Appeal Confirm Validity of EirGen Pharma’s Vitamin D Formulation Patent

The Technical Board of Appeal of the European Patent Office (EPO) issued a significant decision on February 26, 2026, in case T 0433/24, confirming the validity of European Patent EP 2,968,172. The patent, held by EirGen Pharma Ltd. (a subsidiary of OPKO Health), protects a stabilised, modified-release formulation of vitamin D compounds specifically 25-hydroxyvitamin D2 and/or D3. This formulation is the basis for the drug Rayaldee, which is used to treat secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease (CKD). 

In short, the patent safeguards formulations of the active ingredient calcifediol. It is significant because it covers Rayaldee, a medicinal product approved in the US, Canada, and ten European countries for treating secondary hyperparathyroidism.

Procedural Background and Context
The legal battle was initiated by DSM Nutritional Products AG, a subsidiary of DSM-Firmenich. Unlike typical patent disputes between originators and generic manufacturers, this case involves a clash between a pharmaceutical company and a novel food manufacturer. While EirGen uses the active ingredient calcifediol for medical treatment, DSM received EU approval in 2024 for its "ampli-D" calcifediol monohydrate as a novel food to improve vitamin D levels. 

The case reached the Boards of Appeal after both parties appealed an interlocutory decision by the EPO Opposition Division, which had previously found the patent maintainable in a more limited form (Auxiliary Request 3). During the appeal, the Board addressed several procedural matters: 
  • Admissibility of Evidence: The Board denied EirGen's attempt to exclude document D79 and certain opposition grounds, ruling that they remained part of the appeal because they had been admitted during the first-instance proceedings. 
  • Witness Testimony: The Board refused the Proprietor's request to summon Charles W. Bishop and Colm Nulty as witnesses, noting that they had already served as technical experts and that no new factual details required their testimony. 

The Main Request and Added Subject-Matter
  • The Board first scrutinised the Main Request (the patent as originally granted) regarding Article 100(c) EPC. The core issue was Claim 16, which described the treatment of patients with CKD. The Opponent argued that this claim improperly omitted the phrase secondary hyperparathyroidism, which was present in the original application. 
  • The Board agreed with the Opponent, finding that the original filing did not provide a basis for treating CKD patients generally without the specific context of secondary hyperparathyroidism or a verified need for vitamin D supplementation. Because this omission created added subject-matter, the Main Request was rejected for infringing Article 123(2) EPC. 

Auxiliary Request 1: Establishing Novelty
EirGen's Auxiliary Request 1 successfully overcame the previous hurdle by reinstating the limitation that the disease being treated must be secondary hyperparathyroidism. The Board then evaluated this request for novelty under Article 54 EPC. 

DSM challenged the novelty by citing several documents (D26, D7, D8, D9, D24, D27, and D28). Their strategy relied on combining specific examples from these texts with general lists of alternative excipients found elsewhere in the same documents. The Board rejected this pick and choose methodology, reiterating that novelty requires a direct and unambiguous disclosure of all claimed features in combination. Since no single document explicitly disclosed the combination of 25-hydroxyvitamin D2/D3 with at least 5 wt% of a cellulose ether, the formulation was deemed novel. 

Inventive Step Analysis
The Board's analysis of Article 56 EPC (Inventive Step) turned on whether the use of at least 5 wt% cellulose ether was an obvious solution to a technical problem. 
  • Closest Prior Art: Both parties agreed that document D3 (WO 2008/134512), which describes a controlled-release vitamin D formulation using a waxy carrier, was the correct starting point. 
  • The Technical Problem: The Board identified the objective technical problem as providing a formulation with an improved dissolution release profile stability during storage. This was noted as distinct from the mere chemical stabilisation of the active ingredient itself. 
  • Assessment of Obviousness: After reviewing common general knowledge and various technical documents, the Board concluded that the prior art did not suggest that cellulose ethers (like HPMC) would specifically stabilise the dissolution profile of 25-hydroxyvitamin D formulations. It noted that release profiles are often drug-dependent, and that the existing literature has focused on chemical degradation rather than on the storage stability of the release mechanism. Consequently, the Board found the invention to be non-obvious. 

Final Order and Ongoing Litigation
The Board concluded that Auxiliary Request 1 met all European Patent Convention (EPC) requirements. It set aside the previous decision and remitted the case to the opposition division, ordering that the patent be maintained based on these amended claims. 

While this is a victory for EirGen Pharma and ensures the basic patent for Rayaldee remains valid, the broader dispute continues. The same Technical Board is scheduled to decide on DSM’s opposition to a divisional application (EP 773). Another divisional patent (EP 016) is currently back at the first-instance level for a new hearing scheduled for October 20, 2026, following a successful appeal by EirGen in early 2026.

Decision here




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Location: Mumbai, Maharashtra, India

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