Complex molecules. Limited competition. Proven approval track record.
Differentiated complex generics across CNS, immunology, oncology, fertility, neurology, and NTI categories — high-barrier dossiers built for niche segments where IP, BE rigor, and regulatory track record protect long-term value.
| Asset | Therapeutic Category | Dosage / Complexity | Status |
|---|---|---|---|
| Mycophenolic Acid DR Tablets 180 / 360 mg | Immunosuppressant · Transplant / Nephrology | Modified-release immunosuppressant, highly variable molecule, BE challenge. | ANDA Approved |
| Sertraline Capsules | CNS · Antidepressant (SSRI) | High-dose CNS. | Under FDA Review |
| Clomiphene Citrate | Fertility · Gynecology | Oral tablet, fertility, long half-life, BE challenge. | ANDA Approved |
| Mycophenolate Mofetil Powder for Suspension | Immunosuppressant · Transplant | Liquid immunosuppressant. | ANDA Approved |
| Glycopyrrolate Oral Solution | Gastrointestinal · Anticholinergic (also pediatric use) | Liquid, pediatric-friendly. | ANDA Approved |
| Guanfacine Tablets | CNS · ADHD / Antihypertensive | CNS, low-dose. | ANDA Approved |
| Nimodipine Oral Solution Pre-Filled Syringe | Cardiovascular / Neurology · Cerebral vasospasm | Neuro, hospital-based. | Para IV Filing |
| Nelarabine Injection | Oncology · Hematologic malignancies | Oncology, injectable. | ANDA Approved |
| Valganciclovir Oral Solution | Antiviral · Infectious Disease / Transplant | Antiviral, pediatric liquid. | Para IV Filing |
| Molecule | Therapeutic Category | Dosage Form / Strength / Notes | Stage |
|---|---|---|---|
| Solifenacin Succinate Tablets | Urology · Overactive bladder | Oral tablet | Development Completed |
| Vancomycin Hydrochloride Capsules | Anti-infective · Antibiotic (GI infections) | Oral capsule | Development Completed |
| Acyclovir Ointment | Antiviral · Dermatology | Topical semi-solid | Development Completed |
| Aminocaproic Acid Tablets | Hematology · Antifibrinolytic | Oral tablet | Development Completed |
| Nimodipine Oral Solution (PFS) | Cardiovascular / Neurology | Pre-filled syringe · neuro / hospital | Development Completed |
| Mycophenolic Acid DR Tablets | Immunosuppressant | 180 mg / 360 mg · modified-release | Development Completed |
| Glycopyrrolate Oral Solution | Gastrointestinal · Anticholinergic | 1 mg/5 mL (0.2 mg/mL) · pediatric | Development Completed |
| Norepinephrine Bitartrate Injection | Critical Care / Cardiovascular · Vasopressor | 4 mg/4 mL (1 mg/mL) | Development Completed |
| Nelarabine Injection | Oncology | 250 mg/50 mL (5 mg/mL) | Development Completed |
| Oseltamivir Phosphate | Antiviral · Influenza | Oral suspension | Development Completed |
| Sertraline HCl Capsules | CNS · Antidepressant | 150 mg & 200 mg | Development Completed |
| Mesalamine DR Tablets | Gastrointestinal · IBD (Ulcerative colitis) | 1200 mg · modified-release · pivotal BE indicative | Development Completed |
| Mesalamine DR Tablets | Gastrointestinal · IBD (Ulcerative colitis) | 800 mg · modified-release · pilot BE indicative | Development Completed |
| Cariprazine Capsules | CNS · Antipsychotic | 1.5–6 mg · multi-strength | Development Completed |
| Dalfampridine ER Tablets | CNS · Multiple sclerosis | 10 mg · extended-release | Development Completed |
| Fosfomycin Tromethamine Granules | Anti-infective · Antibiotic (UTI) | 3 g · oral granules | Development Completed |
| Itraconazole Oral Solution | Antifungal · Infectious Disease | 10 mg/mL · oral solution | Development Completed |
| Lamotrigine ODT | CNS · Antiepileptic / Mood stabilizer | 25–200 mg · orally disintegrating tablet | Development Completed |
| Loperamide HCl Capsules | Gastrointestinal · Antidiarrheal | 2 mg · oral capsule | Development Completed |
| Doxylamine + Pyridoxine DR Tablets | Gynecology · Pregnancy nausea / vomiting | 10 mg / 10 mg · delayed-release combination | Development Completed |
Beyond the existing portfolio, Airis is actively originating complex, value-added generics — purpose-built for dossier developers and B2B platforms pursuing first-to-market positioning, franchise lifecycle extension, and differentiated technology across regulated and ROW markets.
Day-1 oncology & immunology orals
First-wave generic launches engineered for Day-1 dossier filing at LOE.
- Strategic IP sequencing & Para IV positioning
- Parallel API-formulation development
- TKIs · CDK4/6 · PARP · MEK · ARAi inhibitors
Narrow Therapeutic Index & high-BE-risk programs
Assets where BE confidence and analytical robustness are the entry barrier.
- NCE-1, Para IV, non-infringing route strategies
- Cariprazine · Tacrolimus · Cladribine · Lisdexamfetamine class
- IP positioning + formulation precision define the entry window
Modified-release & VAM platforms
API behavior, polymer matrix, and dissolution profiling — inseparable by design.
- Intentional strength extensions (IR → ER → DR → MR)
- Lifecycle reformulations off anchor molecules
- EU-first-and-only positioning
Pediatric, oral liquid & PFOS franchise extensions
VAMs layered onto anchor-molecule tablet/capsule franchises — underserved across EU and ROW.
- Oral solutions, suspensions, powder-for-oral-suspension
- Twelve ANDA-approved oral liquid assets across antiviral, immunology, neurology, pediatric specialty
- Structural pricing resilience · prescriber stickiness
Complex topicals & 505(b)(2) dermatology
Creams, ointments, and gels where IVRT and topical BE define the competitive set.
- Complex 505(b)(2) reformulation work
- Difficult-to-develop generic topicals
- Tacrolimus · Adapalene/BPO · Ivermectin-class
Niche specialty & hospital injectables
Sterile and non-sterile injectables — high-margin, low-competition hospital channel.
- Pediatric oncology (Nelarabine, Clofarabine-class)
- Hospital specialty (Aminocaproic acid, Norepinephrine-class)
- Oncology · anti-infective · critical care
API-gated & supply-diversification programs
Tier-1 API integration and second-source DMF strategy as the market-entry lever.
- Parallel API-formulation development
- Strategic supply partnerships (Maithri, Divi, Laurus, equivalent)
- Built for partners managing API concentration risk
FDC & anchor-molecule franchise design
Fixed-dose combinations engineered from inception around anchor molecules.
- Shared analytical platforms across the franchise
- Unified regulatory positioning
- Built for "anchor-to-franchise" portfolio strategies
From anchor molecules to franchises.
The true value of a pharmaceutical franchise lies in systematic expansion. Airis takes ownership of second- and third-wave dossiers — fixed-dose combinations, dosage-form variants, and strength extensions — delivering analytical efficiency, BE confidence, and predictable economics.