PITOLISANT (pitolisant) by Lupin Pharmaceuticals, Inc.: new human prescription drug listing
PITOLISANT: new human prescription drug listing. Dated 19 days ago, it is in the active follow-up window. Score 65/100. As of 2026-11-03, from U.S. FDA National Drug Code (NDC) Directory via openFDA.
Data as of · Compiled by Zalwin from U.S. FDA National Drug Code (NDC) Directory via openFDA
Free preview: all 12 published fields of this record are shown below. Locked: 499 related FdaNdcDirectoryPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Product | PITOLISANT |
| Generic name | pitolisant |
| NDC | 70748-387 |
| Labeler | Lupin Pharmaceuticals, Inc. |
| Product type | HUMAN PRESCRIPTION DRUG |
| Approval pathway | ANDA |
| Application number | ANDA218846 |
| Dosage form | TABLET, FILM COATED |
| Route | ORAL |
| Active ingredients | PITOLISANT HYDROCHLORIDE 17.8 mg/1 |
| Marketing start | 2026-10-16 |
| Package configurations | 1 |
| Peer records CSV (500 records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch PITOLISANT
Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.
Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.
Free first: a 10-record sample of records
See the real columns before you buy. One confirmation email, nothing else unless you opt in.
Unlock PITOLISANT + 500 peer records (CSV)
Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
CSV columns: Product · Labeler · Pathway · Form · Listed · official source URL
- Source agency: U.S. FDA National Drug Code (NDC) Directory via openFDA
- Record date: 2026-10-16
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FdaNdcDirectoryPulse records (HUMAN PRESCRIPTION DRUG first): Norepinephrine Bitartrate by Northstar Rx LLC · Magnesium Sulfate (Magnesium Sulfate Heptahydrate) by SQUARE · Isosorbide Mononitrate by AiPing Pharmaceutical, Inc. · Isosorbide Mononitrate by AiPing Pharmaceutical, Inc. · Isosorbide Mononitrate by AiPing Pharmaceutical, Inc. · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA National Drug Code (NDC) Directory via openFDA · Last refreshed: Tue, 03 Nov 2026 18:09:00 GMT
Is this your business? Add a "Listed on Zalwin" badge to your site
Paste this snippet into your website. It links to this public record; nothing is tracked on your site.
Peer benchmark and outreach value: PITOLISANT and 1,241 HUMAN PRESCRIPTION DRUG peers
- HUMAN PRESCRIPTION DRUG FdaNdcDirectoryPulse records like this one: 1,241
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every HUMAN PRESCRIPTION DRUG peer: $248,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
65 / 100 Launch Signal Score
- Prescription or biologic product.
- New generic entry: wholesalers and GPOs re-bid contracts.
What is the FdaNdcDirectoryPulse record for PITOLISANT?
PITOLISANT by Lupin Pharmaceuticals, Inc.: new human prescription drug listing (ANDA) starting 2026-10-16.
How does PITOLISANT compare to other FdaNdcDirectoryPulse records?
It is 19 days old, still within a typical 45-day follow-up window.
PITOLISANT vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| PITOLISANT | HUMAN PRESCRIPTION DRUG | 2026-10-16 |
| ENZEEVU | HUMAN PRESCRIPTION DRUG | 2026-10-26 |
| Daptomycin | HUMAN PRESCRIPTION DRUG | 2026-10-22 |
| TechneLite | HUMAN PRESCRIPTION DRUG | 2026-10-21 |
Related records
FdaNdcDirectoryPulse: Prescription (Rx) FdaNdcDirectoryPulse: Generic (ANDA)
How to monitor PITOLISANT and peer generic (anda) records
Get new FdaNdcDirectoryPulse records like PITOLISANT by email (free, weekly)
We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.
Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.
Get new listings in your categories
FdaNdcDirectoryPulse emails new drug listings matching your pathway and product type.
✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days
Listing data comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn. Informational only; not medical advice.