FDA / ANDA Tracker
ANDA Pipeline & FDA Tracker
Company-level ANDA filing & approval pipeline across the universe, plus Rubicon's product-level filing status — from development through final approval and launch.
Reported · sourced (FY25)
What this shows
The pipeline of US generic-drug applications (ANDAs). 'Filed' = submitted to the FDA; 'approved' = cleared to sell. The gap is the pending pipeline that drives future US revenue.
How to use it
The first table ranks companies by their ANDA portfolio and approval success rate. The second shows Rubicon's products and exactly where each sits — from development through filed, under review, to launched.
Key terms
- ANDA
- — Abbreviated New Drug Application — the FDA filing to sell a generic drug.
- Tentative approval
- — FDA says the drug is approvable but can't launch yet (usually patent/exclusivity blocks).
- Pending
- — Filed but not yet approved — the future-revenue pipeline.
- Approval rate
- — Approved ÷ filed — a rough read on filing quality and FDA standing.
ANDAs filed (universe)
2,487
ANDAs approved
1,965
Pending (est.)
522
Rubicon filed / appr.
64 / 38
complex-weighted
Company ANDA Pipeline
Filed vs approved vs pending (illustrative)
| Company | Filed | Approved | Pending | Approval rate |
|---|---|---|---|---|
| Aurobindo Pharma | 830 | 600 | 230 | 72% |
| Sun Pharmaceutical Industries | 650 | 541 | 109 | 83% |
| Lupin | 441 | 340 | 101 | 77% |
| Alembic Pharmaceuticals | 250 | 220 | 30 | 88% |
| Alkem Laboratories | 179 | 154 | 25 | 86% |
| Rubicon Research | 81 | 72 | 9 | 89% |
| Caplin Point Laboratories | 48 | 38 | 10 | 79% |
| Laurus Labs | 8 | 8 | 0% |
Rubicon — Product-Level Filing Status
From development to launch
| Product | Molecule | Pathway | Status | Market size | Competitors |
|---|---|---|---|---|---|
| Dexmethylphenidate ER | Dexmethylphenidate HCl | ANDA (complex) | Launched | $720M | 4 |
| Potassium Chloride ER | Potassium Chloride | ANDA | Launched | $240M | 6 |
| Lisdexamfetamine Capsule | Lisdexamfetamine Dimesylate | ANDA (FTF) | Approved | $3.1B | 9 |
| Icosapent Ethyl Capsule | Icosapent Ethyl | ANDA (Para IV) | Under Review | $1.4B | 5 |
| Naloxone Nasal Spray | Naloxone HCl | ANDA (complex device) | Filed | $560M | 3 |
| Budesonide EC Capsule | Budesonide | ANDA (complex) | Launched | $380M | 5 |
| Tacrolimus ER Tablet | Tacrolimus | ANDA + EU | Development | $650M | 2 |
| Specialty Brand — Migraine ODT | Rizatriptan (505b2 reformulation) | 505(b)(2) | Development | $900M | 1 |