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Pharma Regulatory & IP Digest: 2026 CGT Trends, GLP-1 Breakthroughs, and EPO Patent Rulings
This comprehensive digest analyses the critical updates impacting generic manufacturers, drug compounders, and IP strategists today.
1. The Competitive Generic Therapy (CGT) Market Race
The traditional generic drug market is frequently characterised as a "race to the bottom," with heavy multi-competitor volume often triggering severe price erosions of 80% to 95%. To promote generic development in areas with historically inadequate competition, the FDA utilises the Competitive Generic Therapy (CGT) pathway under the FDA Reauthorisation Act (FDARA).
Securing a CGT designation offers a highly lucrative incentive: 180 days of market exclusivity. However, recent data highlights a stark commercial reality: securing a designation does not guarantee market exclusivity, and capturing the prize requires flawless operational timing.
Exclusivity Granted vs. Denied
To qualify for the coveted 180-day exclusivity window, a generic developer must be a "first approved applicant". Crucially, at the time the Abbreviated New Drug Application (ANDA) is originally submitted, the brand-name Reference Listed Drug (RLD) must have no unexpired patents or regulatory exclusivities listed in the FDA's Orange Book.
Why Some Win: Successful companies target niche, off-patent blockbusters or complex, difficult-to-copy formulations that currently have only one generic alternative. Getting approved on day one secures a highly profitable temporary duopoly with the brand innovator.
Why Some Lose: Many developers secure a CGT designation to accelerate development or FDA review meetings but fail to achieve final exclusivity. This occurs if a competitor wins approval first, or if hidden, unexpired patents disqualify the drug at the time of submission.
The 75-Day Forfeiture Trap
Unlike standard Hatch-Waxman exclusivity, which can be legally "parked" or delayed via settlement agreements, CGT exclusivity is bound by a strict, non-negotiable 75-day commercial marketing rule. An eligible company must introduce its drug into interstate commerce within 75 days of final FDA approval. Failing to clear this operational hurdle results in total forfeiture of exclusivity, opening the market to all other generic entries.
2026 CGT Approval Snapshot & Corporate Leaderboard
A review of recent approvals shows that fewer than half of CGT approvals ultimately transition into real market exclusivity. Major generic leaders like Natco, Lupin, and Dr. Reddy's secured recent CGT approvals but were completely ineligible for exclusivity at the time of approval. Conversely, Novitium Pharma executed perfectly, dodging forfeiture and launching its Pimozide generic just 8 days after approval to secure its 180-day duopoly.
The most cautionary operational tale is DifGen Pharma, which was granted CGT eligibility for its Mesalamine ER capsules but forfeited it entirely by failing to commercially market the product within the required 75-day window.
Recent CGT Exclusivity Tracker (2026)
Total CGT Approvals by Company (2026 YTD)
Zydus: 5
Glenmark: 3
Novitium Pharma LLC: 3
Amneal: 2
Apotex Inc.: 2
DifGen Pharmaceuticals LLC: 2
Lupin: 2
Umedica Laboratories: 2
Thirteen companies hold 1 approval each (including Cipla, Dr. Reddy's, Natco, Sandoz, and Teva).
2. Global Biopharma & GLP-1 Market Dynamics
Novo Nordisk Litigates South African Semaglutide Compounder
Driven by a massive global surge in demand for metabolic and weight-loss therapies, Novo Nordisk has entered a legal standoff with South African drug compounder iDexis. Novo Nordisk is seeking a formal court order to halt iDexis from selling unregistered, compounded semaglutide products. While iDexis has rejected the allegations and demanded structural evidence, international regulators have cited the compounder for rule violations, raising ongoing safety and quality concerns.
AstraZeneca’s Oral GLP-1 Success in Phase 2
AstraZeneca has released mid-stage clinical data for its investigational oral GLP-1 pill, elecoglipron, positioning it as a strong competitor against Eli Lilly's Foundayo and Novo Nordisk's oral Ozempic.
In an obesity Phase 2 trial, elecoglipron achieved an 11.2% weight loss over 36 weeks.
In a separate type 2 diabetes trial, the pill demonstrated greater reductions in blood sugar and weight loss than a control group taking oral Ozempic.
3. Intellectual Property Case Law Spotlight
3D Systems v. ARKEMA FRANCE (EPO Case T 0770/24)
The Technical Board of Appeal of the European Patent Office (EPO) issued a pivotal ruling overturning the revocation of European patent No. 3426737, held by 3D Systems, Incorporated. The patent covers advanced, non-isocyanate polyurethane ink formulations optimised for industrial 3-D printing systems (such as stereolithography and MultiJet Printing).
The Sufficiency of Disclosure (Article 83 EPC) Dispute
The patent was originally revoked by the Opposition Division after the respondent, Arkema France, filed a post-published experimental report D19. Arkema's data showed that mixtures replicating Claim 1 exhibited rapid, premature curing and gelled within as little as 2 hours, allegedly breaching the patent specification's 6-month thermal stability goals. Arkema argued the patent lacked a "sufficiency of disclosure" because a POSA could not reliably achieve a stable, printable composition.
The Board of Appeal soundly rejected Arkema's arguments, establishing key boundaries for Article 83 EPC:
Optional Embodiments: The six-month stability parameters were strictly limited to "some embodiments" in the description and could not be retroactively read into Claim 1 as a functional requirement.
Alternative Mixing Modes: Arkema's data assumed the ink had to be stored long-term as a single-pack product. The Board noted that the patent explicitly teaches alternative systems (such as multi-jet modelling) in which reactive components are isolated in separate channels and blended immediately prior to or during deposition.
No Performance Mandates: The Board ruled that because Claim 1 defines a chemical composition and carries no explicit structural performance mandates for the final printed item, the absence of detailed printing examples or finalised physical data did not constitute a deficiency of disclosure. The case was officially remitted to the Opposition Division for further prosecution.
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Contents
CGT approvals in CY 2026
General information
Novo Nordisk faces off in court with South African weight-loss drug compounder
AstraZeneca’s GLP-1 pill succeeds in mid-stage trials
Intellectual Property
3D Systems Vs ARKEMA FRANCE
CGT approvals in CY 2026
High-Stakes Race of Competitive Generic Therapy (CGT) Approvals
The vanilla generic drug market is often described as a "race to the bottom," where a high volume of competitors can trigger price drops of 80% to 95%. To combat this and incentivise development in spaces with inadequate competition, the FDA created the Competitive Generic Therapy (CGT) pathway under the FDA Reauthorisation Act (FDARA).
For generic manufacturers, securing a CGT designation represents a potential goldmine: 180 days of market exclusivity. However, a review of recent data highlights a stark reality: obtaining a CGT designation does not guarantee exclusivity, and winning the prize requires flawless operational timing.
1. The Tale of Two Realities: Exclusivity Granted vs. Denied
To be eligible for CGT exclusivity, a generic drug must be a "first approved applicant". Crucially, at the time the application is originally submitted, the brand-name drug must have no unexpired patents or regulatory exclusivities listed in the FDA's Orange Book.
- Why Some Win: Companies take advantage of the CGT pathway by targeting niche, off-patent blockbusters or complex, difficult-to-copy formulations that currently have only one generic alternative on the market. If they are the first to get their ANDA approved on day one, they capture a massive commercial advantage through a temporary, highly profitable duopoly with the brand company.
- Why Some Lose: Many companies successfully secure a CGT designation to speed up their development or review meetings with the FDA, but they fail to win exclusivity. This typically happens if another generic manufacturer files or gets approved first, or if there are hidden, unexpired patents/exclusivities that disqualify the drug from market exclusivity at submission.
2. The Crucial 75-Day Forfeiture Trap
Unlike standard Hatch-Waxman exclusivity, which can be legally "parked" or delayed, CGT exclusivity is subject to a strict, non-negotiable 75-day commercial marketing rule.
The Rule: An eligible company must introduce its drug into interstate commerce within 75 days of final FDA approval. Failing to clear this hurdle means the company completely forfeits its 180-day exclusivity, opening the floodgates for alternative generic entries.
3. Data Snapshot: Recent CGT Approvals & Exclusivity Status
The table below lists recent approvals (CY 2026) from the official FDA CGT database, indicating which companies obtained exclusivity and which did not or forfeited it.
4. List of companies that sought CGT approvals in CY 2026 since January 2026
Short Analysis
A review of this trend shows that fewer than half of CGT approvals ultimately achieve real market exclusivity. For example, major generic leaders like Natco, Lupin, and Dr. Reddy's secured recent CGT approvals but were completely ineligible for exclusivity at the time of approval. Conversely, companies like Novitium Pharma executed perfectly, dodging forfeiture and launching their Pimozide generic just 8 days after approval to secure their 180-day duopoly.
The most cautionary tale from the data is DifGen Pharma. Though they were granted coveted CGT eligibility for their Mesalamine ER capsules, they forfeited it entirely because they failed to commercially market the product within the required 75-day window.
The Bottom Line: In the modern generic playbook, winning a CGT approval is only half the battle. The new benchmark for success requires end-to-end alignment, ensuring supply chains, manufacturing, and commercial distribution networks are fully armed and ready to ship the moment the FDA gives the green light.
More details are here.
General information
Novo Nordisk faces off in court with South African weight-loss drug compounder
• Novo Nordisk seeks court order to halt iDexis selling unregistered semaglutide products
• iDexis rejects Novo Nordisk's claims, demands evidence
• Regulators found iDexis violated rules, citing safety and quality concerns
• Demand for GLP-1 drugs surged on launches of Mounjaro, Wegovy
News here
AstraZeneca’s GLP-1 pill succeeds in mid-stage trials
Data released yesterday on AstraZeneca’s investigational GLP-1 pill suggest it may be competitive against other pills like Lilly’s Foundayo and Novo’s oral Ozempic.
In one Phase 2 trial, the drug, called elecoglipron, led patients with obesity to lose 11.2% of their weight after 36 weeks. (Eli Lilly’s pill Foundayo led to the same rate of weight loss in a Phase 3 study that lasted twice as long, but it’s hard to compare across trials in different phases.)
In a separate Phase 2 trial in people with diabetes, the drug helped patients lower their blood sugar and lose weight, by a greater magnitude than a comparator group taking oral Ozempic.
News here and here
Intellectual Property
3D Systems Vs ARKEMA FRANCE
Summary
In case T 0770/24, the Technical Board of Appeal of the European Patent Office (EPO) reviewed an appeal by patent proprietor 3D Systems, Incorporated (appellant) against the Opposition Division's decision to revoke European patent No. 3426737. The patent concerns non-isocyanate polyurethane inks designed for three-dimensional (3-D) printing. The Board of Appeal set aside the decision under appeal, ruling that the invention met the requirements for sufficiency of disclosure under Article 83 EPC, and remitted the case back to the Opposition Division for further prosecution.
Technical Background and Claim Structure
The patented invention relates to an ink formulation intended for a 3-D printing system. In the industrial 3D printing space, "inks" refer to the advanced liquid photopolymer resins and bioprinting inks used in high-precision manufacturing.
Photopolymer resins (inks): Used in 3D Systems, Incorporated’s high-performance stereolithography (SLA) and MultiJet Printing (MJP) systems. This includes the patentee’s Figure 4 platform, which relies on advanced non-isocyanate and acrylate chemistries optimised for industrial-grade printing. Claim 1 of the main request defines the ink as comprising:
• A cyclic carbonate monomer in an amount of 10 to 70 wt.%;
• An amine monomer in an amount of 10 to 70 wt.%; and
• A further ethylenically unsaturated monomer (excluding the cyclic carbonate and amine monomers) in an amount of up to 80 wt.%, based on the total weight of the ink.
Crucially, both parties agreed during the oral proceedings that the functional definition "for use in a three-dimensional printing system" represents a limiting technical feature of the claim.
Procedural History and Evidentiary Issues
The Opposition Division originally revoked the patent because it concluded that none of the available claim requests complied with Article 83 EPC regarding sufficiency of disclosure. During those initial proceedings, the opponent, ARKEMA FRANCE ("respondent"), filed two post-published experimental/analytical documents, D19 and D20, which were admitted by the Opposition Division.
On appeal, the appellant contested the revocation and requested that the case be remitted, or, in the alternative, that the patent be maintained on the basis of a main request or one of several auxiliary requests. The appellant also filed additional documentation (A21, A22, A24, and A25). The respondent sought a dismissal of the appeal and submitted its own supplementary document (A23). The Board chose to admit all the new documents (A21 to A25) as well as the initial documents D19 and D20, though they were ultimately not decisive in the final decision.
Key Legal Analyses
1. Sufficiency of Disclosure (Article 83 EPC)
According to Article 83 of the EPC, a patent application must disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art. This legal requirement, known as sufficiency of disclosure, ensures that the public receives a workable technical teaching in exchange for the exclusive patent rights granted to the inventor.
To satisfy this standard, the description must provide enough guidance and detail so that the skilled person can reproduce the invention across its entire claimed scope without facing an undue burden or requiring inventive skill. If an opponent can prove with verifiable facts that serious doubts exist regarding whether the invention can actually be implemented as described, the patent can be revoked for non-compliance with this article.
The primary legal dispute centred on whether a person skilled in the art could prepare inks within the claimed compositional boundaries that are suitable for 3-D printing without facing an undue burden.
The respondent pointed to data in document D19 that replicated three compositions (A, B, and C) that fall within the text of Claim 1. The data showed that these mixtures experienced rapid increases in viscosity over time, with one composition gelling after just two hours. The respondent argued this behaviour directly contradicted paragraph [0078] of the patent specification, which stated that stable non-cured inks should maintain thermal stability (defined as less than a 35% change in viscosity) for at least six months at room temperature. Consequently, the respondent asserted that the patent failed to provide sufficient guidance to prevent premature curing, rendering it impossible for the skilled person to reliably achieve a printable composition.
The Board rejected the respondent's arguments on multiple grounds:
- Optional Embodiments: The Board noted that Claim 1 lacks any explicit limitations regarding storage stability or maximum viscosity. The thresholds outlined in paragraph [0078] are strictly described as belonging to "some embodiments" and are therefore optional features that cannot be structurally read as a requirement into Claim 1.
- Alternative Mixing Modes: The respondent's objection presumed the composition had to be stored long-term as a single-pack product. However, the patent specification explicitly details alternative implementation strategies, such as multi-jet modelling (MJM) or dual-ink systems. In these scenarios, reactive components are isolated in separate channels and only blended immediately prior to or during deposition. Because Claim 1 covers only the final mixture and imposes no time constraints on when components must be blended, storage-induced viscosity degradation is not a universal barrier to printability.
- Common General Knowledge: The Board found that a skilled artisan encountering premature curing could easily apply standard general knowledge to print the ink shortly after mixing. Furthermore, selecting specific monomer variations to regulate high reactivity or adjusting environmental temperatures falls within ordinary trial-and-error procedures.
Ultimately, the Board concluded that the respondent did not present verifiable facts that raised serious doubts about the broad scope of the invention being successfully carried out.
2. Absence of Printing Examples
The respondent also argued that the patent lacked explicit examples of printing or data on the physical properties of the final 3-D-printed items. The Board ruled that because Claim 1 defines a chemical composition and does not specify performance requirements for the final product, the absence of explicit experimental data or item characteristics does not constitute a deficiency of disclosure under Article 83 EPC.
Conclusion and Remittal
Finding that the main request fulfilled the requirements of Article 83 EPC, the Board set aside the original revocation. Because the Opposition Division had originally adjudicated the case solely on the issue of sufficiency of disclosure, remaining grounds for opposition (such as Article 100(a), Article 84, and Article 123(2) EPC) had not yet been assessed. Acting in accordance with the parties' common request, the Board officially remitted the case to the Opposition Division for further prosecution.
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