1.) Recent ANDA filings with P-IV certificate 2.) Calcifediol Soft Capsules by FAES FARMA — An EPO decision
Contents
Recent P-IV filings.
General information
How to realise therapeutic potential with the right excipients
ARS Pharmaceuticals Sues AptarGroup Over Alleged Monopoly in Epinephrine Device Supply
Intellectual Property
Calcifediol Soft Capsules by FAES FARMA — An EPO decision
Recent P-IV filings.
We monitor ANDAs with P-IV certification filings on the USFDA website. The Significance of P-IV Filing: The first applicant (or multiple applicants on the first day) to submit an ANDA with a P-IV certification and successfully challenge the brand's patent is generally eligible for 180 days of generic market exclusivity. The USFDA updated the list on 01 September 2025, and there was one P-IV filing.
Reference Listed Drug (RLD): The brand name drug for Finerenone is Kerendia, manufactured by Bayer.
Date of First P-IV Submission: A substantially complete ANDA with a Paragraph IV certification for Finerenone Tablets (10 mg and 20 mg) was first submitted on 09 July 2025. It was an NCE-1 date.
Finerenone is approved to treat adults with chronic kidney disease (CKD) associated with type 2 diabetes
Number of ANDAs: Based on the available data, nine ANDAs containing a Paragraph IV certification for Finerenone were submitted on the NCE-1 date.
Bayer expects Kerendia (finerenone) to reach peak annual sales of over €3 billion (about $3.3 billion)
A specific compound is claimed in the WO2008104306A2 patent family, and its equivalent is US 8436180.
In the US, it is valid till April 2029, and generic launches before April 2029 are unlikely.
There are nine generic ANDA filings with P-IV certificates, and it is highly likely that many of them have filed P-IV certificates for US RE49826 and had non-infringing arguments for the process and polymorph 1.
There are 15 DMF filers, and some of them may have filed ANDAs on the NCE-1 date. DRL and Zydus have imported innovator samples and might be among the ANDA filers.
General information
How to realise therapeutic potential with the right excipients
With the increasing prevalence of poorly soluble drugs in the pharmaceutical pipeline, Matt Finkelhor, commercial manager, Global Novel Polymers at Lubrizol, explores how to realise therapeutic potential with the right excipients. News hereARS Pharmaceuticals Sues AptarGroup Over Alleged Monopoly in Epinephrine Device Supply
San Diego-based ARS Pharmaceuticals, the biotech company behind the FDA-approved epinephrine nasal spray neffy, has filed an antitrust lawsuit against packaging giant AptarGroup Inc., alleging the company has unlawfully monopolized the supply of critical device components. The case, filed in the U.S. District Court for the Southern District of California, could have sweeping implications for both the pharmaceutical device supply chain and the accessibility of needle-free emergency treatments for patients at risk of anaphylaxis. News hereIntellectual Property
Calcifediol Soft Capsules by FAES FARMA — An EPO decision
Background The case concerns an appeal against the interlocutory decision of the Opposition Division of the European Patent Office regarding European Patent No. 3204047, related to "Calcifediol Soft Capsules". Three oppositions were initially filed against the patent, alleging a lack of novelty and inventive step, insufficient disclosure, and extension beyond the content of the application as filed. The Opposition Division found that the patent met the requirements of the European Patent Convention (EPC) based on the main request with claims filed on March 6, 2023. Parties Involved- Appellant: Opponent 2, represented by IP2 Patentanwalts GmbH.
- Respondent: FAES FARMA, S.A., the patent proprietor, represented by ABG Intellectual Property Law, S.L.
- Parties as of right: Opponent 1 (Helbig, Christian, Dr., represented by Meissner Bolte Partnerschaft mbB) and Opponent 3 (DSM Nutritional Products AG, represented by Kraus & Lederer PartGmbB).
The drug is popular in Spain and is increasingly gaining popularity in other EU countries. Although the exact sales of Soft Capsules are not publicly available, FAES FARMA's total income from Calcifediol was €45 million in 2022. FAES FARMA’s revenue is approximately €300 million, with Calcifediol Soft Capsules being a significant contributor.
Claim 1 of the Main Request
The core of the patent lies in Claim 1, which describes an immediate-release soft capsule comprising:
A soft capsule shell made of:
- 40 to 80 wt% gelatin
- 10 to 30 wt% glycerol
- 5 to 15 wt% sorbitol
- Admittance of Third-Party Observations: The appellant requested that observations filed by a third party on May 14, 2025, including a technical report comparing the bioavailability of calcifediol from soft and hard gelatin capsules, be admitted into the appeal proceedings.
- Admittance of New Documents and Arguments: The appellant sought to introduce new evidence (D114-D120, D122) and arguments related to the reliability of experimental data, the absence of a technical effect, and shortcomings in the respondent's in vivo assays.
- Article 123(2) EPC Infringement: The appellant argued that Claim 1 combines features from different parts of the application as filed (page 9) in a way that is not unambiguously disclosed, infringing Article 123(2) EPC (added subject matter).
- Lack of Clarity: The appellant contended that the absence of a limitation on water content in Claim 1 renders it unclear, violating Article 84 EPC.
- Lack of Inventive Step: The appellant argued that the closest prior art is Formulation 9 of D11 (an immediate-release formulation in a hard gelatin capsule) and that the claimed invention (soft gelatin capsule) does not involve an inventive step.
- Inadmissibility of Third-Party Observations: The respondent argued that the third-party observations were filed late and should not be admitted.
- Inadmissibility of New Documents and Arguments: The respondent argued that the new documents (D114-D120, D122) and arguments represent an amendment to the appellant's case, were not submitted in direct response to a newly raised argument, and should have been submitted in the first instance proceedings.
- Compliance with Article 123(2) EPC: The respondent asserted that the combination of features in Claim 1 is disclosed in the application as filed in a convergent and narrower manner.
- Clarity of Claim 1: The respondent argued that the amendments made to Claim 1 did not generate a lack of clarity, as the original claims also did not specify water content.
- Inventive Step: The respondent maintained that the claimed invention involves an inventive step because the soft gelatin capsule provides improved bioavailability of calcifediol compared to the hard gelatin capsule of the closest prior art (D11)
- Third-Party Observations: The Board decided to disregard the third-party observations because neither the third party nor the appellant justified the late filing by any exceptional circumstances.
- Admittance of D114-D120 and D122: The Board decided not to admit any of D114-D120 and D122, considering they should have been filed in the first-instance proceedings.
- Article 123(2) EPC: The Board found that Claim 1 of the main request combines features disclosed in the application as filed, and the claimed combination of features does not extend beyond the content of the application as filed.
- Clarity (Article 84 EPC): The Board rejected the appellant's claim that the absence of a water content specification in Claim 1 caused a lack of clarity. They noted that the granted claims also did not include this specification; therefore, the amendment did not introduce any new lack of clarity. The Board stated that no violation of the requirements of Article 84 EPC has occurred. Essentially, the Board found that limiting the claim to a specific soft gelatin capsule shell did not make it any less clear than the original granted claims.
- Inventive Step: The Board found that the closest prior art is D11, D5 (Annexe III and Annexe IV) and D83 (Annexe V), evidence of a technical effect on bioavailability associated with the differentiating feature. The Board concluded that the objective technical problem is to provide soft capsules with improved bioavailability of calcifediol.
