API & IP Brief: Dr. Reddy’s Patent Landscape, Semaglutide Revocation & Voquezna Updates

API & IP Intelligence Brief: Dr. Reddy’s Patent Strategy & Semaglutide Patent Revocation

Keywords: Dr. Reddy's patent filings, Semaglutide patent revocation, EPO Board of Appeal T 0187/25, Factor XIa inhibitors, API solid-state forms, skinny label generic, Voquezna ANDA litigation.

Dr. Reddy’s Patent Landscape: Early-Stage Generic Positioning

An analysis of 24 patent applications published between October 2024 and October 2026 highlights Dr. Reddy’s Laboratories’ (DRL) aggressive pre-loss-of-exclusivity (LOE) strategy. Small-molecule generic enablement accounts for 67% (16 filings) of the total, divided between API process/solid-state chemistry (38%, 9 filings) and differentiated dosage forms (29%, 7 filings). The remaining pipeline spans biologics (13%), nutraceuticals (8%), digital health (8%), and a single new chemical entity (NCE) pan-KRAS degrader filing from Aurigene Oncology (4%).

DRL is building alternative crystal forms, salts, amorphous solid dispersions (ASDs), and non-infringing routes years before brand LOE to anchor first-to-file and Paragraph IV positions. Key strategic focal areas include:

• Factor XIa Anticoagulants: Five dedicated filings secure API process, solid-state forms, stable liquids, ASDs, and once-daily sustained-release formulations for milvexian and asundexian.

• Metabolic & Oral Incretins: Solid dispersions for oral GLP-1 candidates orforglipron and danuglipron, plus ready-to-use glucagon liquids, reinforce DRL’s commercial push in diabetes and obesity.

• High-Value Small Molecules: Early filings target newly launched or late-phase candidates, including aficamten, acoramidis, vidofludimus calcium, and blarcamesine.

• Value-Added Differentiation: Value-added reformulations, including an abiraterone nanosuspension to mitigate food effect and ready-to-dilute lurbinectedin, create 505(b)(2)-style differentiation against plain generics.

EPO Revokes Novo Nordisk’s Semaglutide CV Patent (EP 3 448 416)

In decision T 0187/25 (October 8, 2026), the European Patent Office Technical Board of Appeal 3.3.04 revoked Novo Nordisk’s patent covering semaglutide for reducing major adverse cardiovascular events (MACE) and stroke in high-risk type 2 diabetes patients.

The Board determined that the maintained claims lacked entitlement to the priority date, invalidating them for lack of novelty over intervening prior art (document D9). During oral proceedings, Novo Nordisk withdrew all pending requests and introduced an unprompted "New Main Request". The Board refused to admit this late submission under Article 13(2) RPBA 2020 due to an absence of exceptional circumstances and prima facie clarity deficiencies under Article 84 EPC. With no valid claim text on record, the patent was revoked in its entirety across all EPC member states. Consequently, generic applicants in Europe can launch with full label parity for stroke and cardiovascular indications without relying on skinny labels.

FDA Updates: Voquezna ANDA & Fentanyl Prophylaxis

• Phathom Pharmaceuticals vs. FDA: The FDA established public docket FDA-2026-N-13038 to address legal and regulatory challenges arising from BDR Pharmaceuticals’ lawsuit over its rejected ANDA for generic Voquezna (vonoprazan tablets).

• Hepion Pharmaceuticals (GV104): The FDA issued constructive feedback supporting the 504(b)(2) development of GV104 (16 mg nalmefene buccal film), which fully prevented fentanyl-induced cardiac arrest in a 200-subject virtual simulation when administered prophylactically.

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Contents

Dr. Reddy's Laboratories, A Brief  Patent Filing Landscape (Oct 2024 – Oct 2026)

General information

Phathom Pharmaceuticals provides update on FDA litigation over BDR's ANDA for generic Voquezna

Hepion Pharmaceuticals Receives FDA Feedback Supporting a Path to Demonstrating Prophylactic Protection for GV104 Against Fentanyl-Induced Cardiac Arrest

Intellectual Property

Novo Nordisk Patent Revocation on Semaglutide CV Indication- the Board of Appeal (European Patent Office)

Dr. Reddy's Laboratories, A Brief  Patent Filing Landscape (Oct 2024 – Oct 2026)

Of 24 Dr. Reddy's (DRL) group patent applications published in the last two years, 16 (67%) protect generic-entry positions on small molecules: 9 cover API process chemistry and solid-state forms, and 7 cover dosage-form formulations. The remaining 8 are biologics (3), nutraceuticals (2), digital health (2) and one new-compound filing from Aurigene Oncology.

The defining pattern is early positioning on innovator molecules that are still in late-stage development or newly launched: milvexian (3 filings), asundexian (2), orforglipron, danuglipron, vidofludimus, blarcamesine, aficamten, acoramidis and rimegepant. DRL is building non-infringing API forms and differentiated formulations years ahead of loss of exclusivity, with a heavy tilt toward cardiovascular targets (Factor XIa anticoagulants, cardiomyopathy).

Product (compound) patents are rare: the only one is Aurigene Oncology's KRAS degrader application. Biologics filings are few and focus on rituximab (anti-CD20) formulation and antibody purification, consistent with DRL's biosimilar pipeline rather than novel biologics.

The window is applications published between October 2024 and October 2026. Most PCT and US applications are published about 18 months after first filing, so filings made after roughly April 2025 are still largely invisible; the true filing count for the period is higher than shown here.

• Applicants covered: Dr Reddy's Laboratories Ltd. and group entities, including Aurigene Oncology Ltd.
• Filing date: the international (PCT) filing date for WO publications; the US filing date for US publications. Four entries (two US, two WO) were filed before October 2024 but published within the window; they are marked with an asterisk (*).
• Trademarks, granted patents and Indian-only provisional filings are excluded unless noted.
• Applications published, Oct 2024 – Oct 2026
• Filing dates marked * fall before October 2024; the application was published within the window. 24 applications, with the newest publication first.

Mix by patent type

Process and formulation filings make up 67% of the set; Aurigene Oncology has a single product (compound) application.

By therapy area, cardiovascular and thrombosis lead with 7 filings, followed by oncology (5), metabolic disease including obesity (4), CNS and neuro-immunology (3), consumer GI and musculoskeletal (3), and immunology / renal and platform biologics (1 each).

Analysis

DRL's filing strategy reads as a generics and complex-generics company securing entry routes early, with discovery confined to Aurigene and biologics IP kept lean.

1. Early stakes in next-wave blockbusters. Nine filings target molecules that were late-stage or recently launched when filed: milvexian (BMS/J&J), asundexian (Bayer), orforglipron (Lilly), danuglipron (Pfizer), vidofludimus (Immunic), blarcamesine (Anavex), aficamten (Cytokinetics), acoramidis (BridgeBio) and rimegepant (Pfizer). Owning alternative forms and routes years ahead of LOE strengthens first-to-file and Paragraph IV positions. The risk shows in danuglipron, which Pfizer stopped developing in 2025, leaving that filing with little commercial value.
2. A concentrated Factor XIa bet. Five filings cover the FXIa anticoagulant class across API process, solid forms, liquid, SR and ASD dosage forms. 
3. Obesity and diabetes as a strategic theme. Oral GLP-1 small molecules (orforglipron, danuglipron) and a ready-to-use glucagon line up with DRL's semaglutide programme, which is already being contested in court (Novo Nordisk v. Dr. Reddy's, Delhi HC, Dec 2025).
4. Formulation patents as differentiation. The abiraterone nanosuspension (lower dose, less food effect), ready-to-dilute lurbinectedin and RTU glucagon are designed to create value-added products, not just copies, giving pricing power and some protection against plain generics.
5. Biologics IP is enabling, not inventive. Only three biologics filings appeared, all on rituximab formulation and antibody purification. That fits a biosimilar model where value comes from execution and approvals, such as the US rituximab approval in Aug 2026, not from new patents.
6. Discovery is thin and sits in Aurigene. The one compound filing is Aurigene Oncology's pan-KRAS degrader PCT, which has already entered national phase in Australia, China, Brazil and other markets. 
7. Diversification at the edges. Two nutraceutical and two digital-health filings support consumer-health products and patient-support programmes; they are small in number but show IP being used beyond prescription drugs.
8. This is not an exhaustive list; patent searches were done using Google Patents, and some filings may have been missed. 
9. This list provides an overview of research conducted by Dr Reddy’s from approximately April 2023 to April 2025. 
10. The legal status of these families is not checked; some may not be validated by Dr Reddy’s and may be abandoned. 

Some takeaway messages

1. The FXIa and obesity clusters are the filings to track; their value depends on innovator approvals, LOE timing, and Paragraph IV outcomes.
2. DRL's form and process filings on these molecules can constrain competitors' choice of polymorph, salt or ASD carrier, so they belong on any freedom-to-operate list for the same APIs.

General information

Phathom Pharmaceuticals provides update on FDA litigation over BDR's ANDA for generic Voquezna

Phathom Pharmaceuticals announced the Food and Drug Administration’s establishment of a public docket (Docket No. FDA-2026-N-13038) to solicit comment on legal and regulatory questions regarding certain issues raised by a filer of an abbreviated new drug application.

The application references Voquezna (vonoprazan) tablets, BDR Pharmaceuticals International, in litigation brought against the FDA following its rejection of the ANDA. 

News here

Hepion Pharmaceuticals Receives FDA Feedback Supporting a Path to Demonstrating Prophylactic Protection for GV104 Against Fentanyl-Induced Cardiac Arrest

- In a simulation of 200 virtual subjects, a single dose of GV104 (16 mg nalmefene buccal film) taken at least 15 minutes before exposure prevented every potential fentanyl-induced cardiac arrest, at intravenous fentanyl doses known to be lethal in humans -

- FDA re-affirmed the overall approach and provided comments that will improve the Company's ability to "demonstrate long-term prophylactic protection" -

- The FDA comments are an important step in the path leading to an NDA. The Company intends to submit its response promptly -

News here

Intellectual Property 

Novo Nordisk Patent Revocation on Semaglutide CV Indication- the Board of Appeal (European Patent Office)

Case Number: T 0187/25 (Technical Board of Appeal 3.3.04)

Decision Date: 8 October 2026

Patent in Suit: EP 3 448 416 (Application No. 17721109.1)

Title: Semaglutide in cardiovascular conditions

Patent Proprietor: Novo Nordisk A/S

Opponents: STADA Arzneimittel AG, Teva Pharmaceutical Industries Ltd., Elkington and Fife LLP, Sandoz AG, Adalvo Ltd., Appleyard Lees IP LLP, Generics (U.K.) Limited, and Dr. Schön, Neymeyr & Partner Patentanwälte mbB

Procedural Background

The appeals arose from an interlocutory decision of the EPO Opposition Division posted on 21 January 2025, maintaining EP 3 448 416 in amended form under Auxiliary Request 13. Oppositions were lodged under Article 100(a) EPC (novelty and inventive step), Article 100(b) EPC (sufficiency), and Article 100(c) EPC (added matter). Both the proprietor and eight opponents appealed. Novo Nordisk sought rejection of the oppositions, while the opponents requested complete patent revocation.

The Subject Matter in Dispute

The patent covers secondary medical uses of semaglutide in cardiovascular indications. Claim 1 of the request maintained by the Opposition Division (former Auxiliary Request 13) was directed to:

"A pharmaceutical composition for use in a method for reducing the risk of a major adverse cardiovascular event (MACE) in subjects with type 2 diabetes mellitus and high cardiovascular risk, wherein said MACE is non-fatal stroke; and said pharmaceutical composition consists of semaglutide and one or more pharmaceutically acceptable excipients."

Subsequent requests (notably Auxiliary Request 14) attempted to narrow the claim by specifying that the use was "in treating type 2 diabetes, wherein the use is in a method for reducing the risk of a major adverse cardiovascular event (MACE)..." while adding criteria defining "high cardiovascular risk".

Procedural Turn at Oral Proceedings

During oral proceedings on 8 October 2026, the Board communicated that neither the main request (former Auxiliary Request 13) nor Auxiliary Request 1 (former Auxiliary Request 14) was entitled to the claimed priority date. Consequently, the claimed subject matter lacked novelty over intervening prior art (document D9).

Facing this adverse finding, Novo Nordisk withdrew its main request and all pending auxiliary requests (Auxiliary Requests 1 through 16) and submitted an unprompted "New Main Request" during the hearing. The newly drafted claim altered the wording to: "for use in treating type 2 diabetes, wherein said method reduces the risk of a major adverse cardiovascular event (MACE)...".

The Dispute on Admittance (Article 13(2) RPBA 2020)

The decisive contest turned on whether Novo Nordisk’s eleventh-hour request could be admitted under Article 13(2) RPBA 2020, which prohibits late amendments absent exceptional circumstances justified by cogent reasons.

• Novo Nordisk's Position: The patentee argued that exceptional circumstances existed because the Board departed from its preliminary opinion under Article 15(1) RPBA. It claimed the opponents' written priority objections regarding Auxiliary Request 14 were inadequately substantiated and were only fully developed during the hearing, depriving it of an earlier chance to amend.
• Opponents' Position: The opponents maintained that priority defects had been prominently raised throughout, including in written grounds of appeal filed by Opponents 1, 2, 5, 7, and 8. Opponents 1 and 7 explicitly argued that the priority application failed to disclose semaglutide for treating type 2 diabetes where MACE risk reduction was uncoupled from antidiabetic glycemic control.

Ruling of the Board of Appeal

The Technical Board of Appeal refused to admit the New Main Request and revoked the patent:

1. No Exceptional Circumstances (Art. 13(2) RPBA): A departure from a preliminary view does not constitute exceptional circumstances unless prompted by new facts or evidence. The hearing arguments merely elaborated on positions already detailed in the written pleadings of Opponents 1 and 7. Novo Nordisk had chosen not to file responsive claims during the written phase.
2. Prima Facie Clarity Deficiencies (Art. 13(1) RPBA): The amendment generated fresh clarity objections under Article 84 EPC, as the phrase "said method" lacked an antecedent following "for use".
3. Patent Revocation (Art. 113(2) EPC): Because Novo Nordisk withdrew all prior requests and the New Main Request was not admitted, no approved claim text remained. Under established case law (T 73/84), the patent was revoked in its entirety without substantive patentability review.

With the Board of Appeal revoking this patent in its entirety across all EPC contracting states, generic competitors will not be compelled to file a "skinny label" that carves out this crucial cardiovascular indication when applying for generic marketing authorisations (MAAs) via the EMA or national health authorities. In short, this decision directly clears the path for generic manufacturers to include major cardiovascular and stroke risk-reduction claims on their European product labels at launch.

Decision here

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