The short version
4 companies supply this market — a reasonable cushion if one runs into trouble.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Qsymia
phentermine and topiramate · PHENTERMINE HYDROCHLORIDE 3.75 mg/1; TOPIRAMATE 23 mg/1 · Capsule, Extended Release · Oral · Vivus LLC
NDC 62541-0201-14 · 14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE · NDA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
90-day shortage risk (model v2)
0.1%chance of a new FDA shortage posting for phentermine and topiramate (oral solid) in the next 90 days
sole-source market
For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.
Backtested statistical model over the whole market, not this package alone. Model details →
Where it's made
- Catalent Pharma Solutions, LLCUnited Statesanalysis · manufacture
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Is this a "specialty" drug?
There's no legal definition — it meets 1 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program · Qsymia
Regulatory
- Application
- NDA022580
- TE code
- AB
- Approval date
- Jul 17, 2012
- Patents / exclusivity
- 24 patents, 4 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | M-308 | Sep 13, 2027 |
| exclusivity | M-308 | Sep 13, 2027 |
| exclusivity | M-308 | Sep 13, 2027 |
| exclusivity | M-308 | Sep 13, 2027 |
| patent | 8580299 | Jun 14, 2029 |
| patent | 8580299 | Jun 14, 2029 |
| patent | 8580299 | Jun 14, 2029 |
| patent | 8580299 | Jun 14, 2029 |
| patent | 8580298 | May 15, 2029 |
| patent | 8580298 | May 15, 2029 |
| patent | 8580298 | May 15, 2029 |
| patent | 8580298 | May 15, 2029 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of phentermine and topiramate (Capsule, Extended Release)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Catalent Pharma Solutions, LLC | PHENTERMINE HYDROCHLORIDE 18.66 mg/1; TOPIRAMATE 92 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Teva Pharmaceuticals, Inc. | PHENTERMINE HYDROCHLORIDE 15 mg/1; TOPIRAMATE 92 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Teva Pharmaceuticals, Inc. | PHENTERMINE HYDROCHLORIDE 11.25 mg/1; TOPIRAMATE 69 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Teva Pharmaceuticals, Inc. | PHENTERMINE HYDROCHLORIDE 3.75 mg/1; TOPIRAMATE 23 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Teva Pharmaceuticals, Inc. | PHENTERMINE HYDROCHLORIDE 7.5 mg/1; TOPIRAMATE 46 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Prasco Laboratories | PHENTERMINE HYDROCHLORIDE 11.25 mg/1; TOPIRAMATE 69 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Prasco Laboratories | PHENTERMINE HYDROCHLORIDE 15 mg/1; TOPIRAMATE 92 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Prasco Laboratories | PHENTERMINE HYDROCHLORIDE 3.75 mg/1; TOPIRAMATE 23 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Prasco Laboratories | PHENTERMINE HYDROCHLORIDE 7.5 mg/1; TOPIRAMATE 46 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Vivus LLC | PHENTERMINE HYDROCHLORIDE 11.25 mg/1; TOPIRAMATE 69 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Vivus LLC | PHENTERMINE HYDROCHLORIDE 3.75 mg/1; TOPIRAMATE 23 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Vivus LLC | PHENTERMINE HYDROCHLORIDE 7.5 mg/1; TOPIRAMATE 46 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Vivus LLC | PHENTERMINE HYDROCHLORIDE 15 mg/1; TOPIRAMATE 92 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Catalent Pharma Solutions, LLC | PHENTERMINE HYDROCHLORIDE 9.33 mg/1; TOPIRAMATE 46 mg/1 | Jul 15, 2026 | Aug 31, 2026 |
| Catalent Pharma Solutions, LLC | PHENTERMINE HYDROCHLORIDE 14 mg/1; TOPIRAMATE 69 mg/1 | Jul 15, 2026 | Aug 31, 2026 |
| Catalent Pharma Solutions, LLC | PHENTERMINE HYDROCHLORIDE 4.67 mg/1; TOPIRAMATE 23 mg/1 | Jul 15, 2026 | Aug 28, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Qsymia — NDC 62541-0201-14," retrieved September 3, 2026, https://drugdashboards.com/drug/62541020114.
Free to cite with attribution — see how the data is put together.