1.) ANDA approvals-January 2026 2.)Tapentadol: Grunenthal GmbH Vs MSN Laboratories Private Limited
Contents
ANDA approvals-January 2026
General information
Aspire Biopharma Files Provisional Patent Application for a Fast-Acting Sublingual Powder Formulation of Ondansetron (Generic Zofran(R))
Technology Platforms Spanning the Full Biopharmaceutical Development Lifecycle
Intellectual Property
Tapentadol: Grunenthal GmbH Vs MSN Laboratories Private Limited
ANDA approvals-January 2026
We follow ANDA approvals.
In January 2026, the USFDA issued 83 ANDA approvals, of which 19 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 November were as follows.
Some of our other comments about a few ANDA approvals sought by Indian companies are listed below.
General information
Aspire Biopharma Files Provisional Patent Application for a Fast-Acting Sublingual Powder Formulation of Ondansetron (Generic Zofran(R))
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 provisional patent application with the United States Patent and Trademark Office (USPTO). The application, titled "A Sublingual Powder Formulation of Ondansetron and Methods of Use Thereof," marks the first-ever sublingual powder delivery system for ondansetron-the active ingredient in Zofran®. Aspire's formulation is designed to provide rapid relief for patients suffering from nausea and vomiting induced by chemotherapy, radiation, or surgery.
News here
Technology Platforms Spanning the Full Biopharmaceutical Development Lifecycle
AsymBio, a subsidiary of Asymchem Group (stock code: 002821.SZ / 6821.HK), announced that it has established integrated technology platforms spanning the full biopharmaceutical development lifecycle. Through its end-to-end service capabilities, the company provides streamlined, integrated workflows for client programs from early development to commercial manufacturing.
AsymBio is a technology-driven biopharmaceutical CDMO focused on accelerating innovation and providing integrated development and manufacturing services for clients.
News here
Intellectual Property
Tapentadol: Grunenthal GmbH Vs MSN Laboratories Private Limited
This decision (T 1919/23) of Technical Board of Appeal 3.3.02, dated 16 December 2025, concerns an appeal by the patent proprietor Grunenthal GmbH against the Opposition Division’s decision to revoke European patent No. EP 3656765. The patent at issue claims salts or co-crystals of tapentadol (specifically (1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol) with L-(+)-tartaric acid for use as a medicament in treating pain. Multiple opponents had filed oppositions; most withdrew before opposition oral proceedings, but one remaining opponent (Opponent 4, MSN Laboratories Private Limited, the respondent) continued to contest the patent.
Background
- The Opposition Division revoked the patent on 5 October 2023, finding a lack of inventive step for the main request but acknowledging novelty over a cited document (D1) for the main claim as originally assessed. The proprietor appealed, seeking maintenance as granted; the respondent requested dismissal of the appeal.
- Oral proceedings before the Board were held by videoconference on 16 December 2025. The only claim request on file was the patent as granted (the appellant’s main request).
Key issues
- The appeal turned on the novelty (Article 54 EPC, in combination with Article 100(a) EPC) of claim 1 over prior art document D1 (WO 2006/002886 A1).
- The technical point in dispute was whether D1’s generic reference to “tartaric acid” (Weinsäure) implicitly and inevitably disclosed the specific stereoisomer L-(+)-tartaric acid such that claim 1 (which explicitly specifies L-(+)-tartaric acid) lacked novelty.
Documents and evidence
- Prior art and common general knowledge documents relied on include D1 (WO 2006/002886 A1) and reference works D2 (Handbook of Pharmaceutical Excipients, 6th ed.), D3 (European Pharmacopoeia, 7th ed.), and D4 (Handbook of Pharmaceutical Salts). The appellant additionally cited several patent documents (D28, D29, D32, D33, D34, D37, D38) to argue that “tartaric acid” is not inevitably the L-(+)-form in pharmaceutical patents.
Board’s factual and legal findings
- D1 discloses pharmaceutically acceptable salts of tapentadol and explicitly lists tartaric acid as a possible salt former, but D1 does not specify stereochemistry (i.e., L-(+), D-(–), racemic or meso).
- The Board placed weight on common general knowledge in the pharmaceutical field (from D2–D4). D2’s entry for “tartaric acid” lists synonyms that are stereochemically defined as the L-(+)-form; D3 (European Pharmacopoeia extract) defines “tartaric acid” as the (2R,3R) form (i.e., L-(+)-tartaric acid); D4 explicitly states that (+)-L-tartaric acid is “the acid of choice” in pharmaceuticals and that the other stereoisomers are not used pharmaceutically.
- Having regard to these standard references, the Board found it clear that, in the pharmaceutical context and absent any explicit indication to the contrary, the term “tartaric acid” would be understood by the skilled person to mean L-(+)-tartaric acid. This conclusion reflected the principle that an alleged implicit disclosure must be immediately apparent and inevitable to the skilled person.
- The appellant’s reliance on several patent documents showing use of different tartrate stereoisomers in particular inventions (D28, D29, D32, D33, D34, D37, D38) did not undermine the Board’s conclusion: such patent documents show that deviations from the default convention are explicitly indicated where intended, but they do not alter the baseline understanding that “tartaric acid” denotes the L-(+)-form in pharmaceutical practice in the absence of any explicit qualifier.
Assessment of novelty and related argument on the added subject matter
- The Board concluded that D1’s mention of “tartaric acid,” read in the light of common general knowledge (D2–D4), inevitably discloses L-(+)-tartaric acid. Therefore, claim 1 (L-(+)-tartaric acid salt or co-crystal with tapentadol) is directly and unambiguously disclosed in D1 and lacks novelty under Article 54 EPC
- The appellant further argued that explicitly amending D1’s claim to specify L-(+)-tartaric acid would violate Article 123(2) EPC (added subject-matter), and therefore D1 could not be held to implicitly disclose the L-(+)-form. The Board rejected this: applying the “gold standard” for added subject-matter, the Board found that, in light of common general knowledge, a skilled person would directly and unambiguously derive that the tartaric acid in D1 is L-(+)-tartaric acid. Hence, specifying L-(+)-tartaric acid would not add subject matter relative to D1.
Decision and order
- Because the sole request on file (maintain patent as granted) concerned the claim found not novel over D1, the Board dismissed the appeal.
- Order: The appeal is dismissed (the Opposition Division’s revocation of the patent is upheld).
On the commercial front, Tapentadol is marketed as the HCl salt, and approval in Europe was in 2010. There are many generics on the market, and this alternative salt strategy might not be particularly value-adding for the business in 2026.
Decision here
