Drybench Patent.
OLANZAPINE; SAMIDORPHAN L-MALATE, NDA 213378
The patents and exclusivities FDA's Orange Book lists for NDA 213378 as captured on 14 October 2026, each date named by its rule and its rows, and the rows of FDA's Paragraph IV list that give this NDA's number, as captured on 17 October 2026. Listed protection is a range of dates, never one date.
FDA capture · review pending. Each row is shown as captured from FDA's Orange Book files and Paragraph IV list. Dates are FDA's own; spreadsheet day numbers are shown as dates, and a cell that cannot be read as one date is shown as written and left out of the range. Where FDA lists a *PED row without flags, its flags are read from the base row and marked so. A Paragraph IV row is placed here only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads FDA's files has not been independently reviewed by a regulatory-affairs reviewer.
- Orange Book captured
- 14 October 2026
- Paragraph IV list captured
- 17 October 2026
- Last checked
- 30 October 2026
- Data-branch commit
- dadcab56563716abea6c5e31a5e1970080c778ef
Listed protection is a range of the dates FDA lists, not a forecast of market entry, and not legal, regulatory or investment advice.
Dates as listed in FDA's Orange Book capture of 14 October 2026. This page does not say whether a date has passed; compare it with today's date and FDA's current Orange Book. This page shows only what the capture of 14 October 2026 lists. It does not show patents or exclusivities listed before and since removed.
Listed protection
Listed dates run from 28 May 2026 to 12 Nov 2041, each by its own rule; no one date stands for this product.
- Earliest listed date
- 28 May 2026NCE exclusivityRule R3 · Products 001, 002, 003, 004 · exclusivity.txt lines 1,214–1,217
- Latest listed date
- 12 Nov 2041US 12,390,474, product patentRule R1 · Products 001, 002, 003, 004 · patent.txt lines 14,897, 14,918, 14,939, 14,960
- Latest substance patent
- 30 Aug 2031US 9,119,848, substance patentRule R1 · Products 001, 002, 003, 004 · patent.txt lines 14,900, 14,921, 14,942, 14,963
- Latest listed patent
- 12 Nov 2041US 12,390,474, product patentRule R1 · Products 001, 002, 003, 004 · patent.txt lines 14,897, 14,918, 14,939, 14,960
- Latest exclusivity
- 28 May 2026NCE exclusivityRule R3 · Products 001, 002, 003, 004 · exclusivity.txt lines 1,214–1,217
72 use-code patents, blocking the coded use only
This page shows only the dates FDA lists. The app also shows NCE-1, the one date it computes, with its qualifications. Open in the app
Products
Each product number FDA lists under NDA 213378, as listed. The sections below name products by these numbers.
Product 001 · LYBALVI
- Dosage form; route
- TABLET;ORAL
- Strength
- 5MG;EQ 10MG BASE
- Approval date as listed
- 28 May 2021
- Type as listed
- RX
- Applicant as listed
- ALKERMES INC
Product 002 · LYBALVI
- Dosage form; route
- TABLET;ORAL
- Strength
- 10MG;EQ 10MG BASE
- Approval date as listed
- 28 May 2021
- Type as listed
- RX
- Applicant as listed
- ALKERMES INC
Product 003 · LYBALVI
- Dosage form; route
- TABLET;ORAL
- Strength
- 15MG;EQ 10MG BASE
- Approval date as listed
- 28 May 2021
- Type as listed
- RX
- Applicant as listed
- ALKERMES INC
Product 004 · LYBALVI
- Dosage form; route
- TABLET;ORAL
- Strength
- 20MG;EQ 10MG BASE
- Approval date as listed
- 28 May 2021
- Type as listed
- RX
- Applicant as listed
- ALKERMES INC
Listed patents
Every patent the FDA lists for this product, as the application holder submitted it, with its flags. The FDA does not verify listings.
21 entries from 84 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 10,716,785, use patent
patent.txt lines 14,886, 14,907, 14,928, 14,949- Expiry as listed
- 23 Aug 2031
- Rule
- R1
- Flags
- use code U-3136
- Product numbers
- 001, 002, 003, 004
US 10,716,785, use patent
patent.txt lines 14,887, 14,908, 14,929, 14,950- Expiry as listed
- 23 Aug 2031
- Rule
- R1
- Flags
- use code U-3137
- Product numbers
- 001, 002, 003, 004
US 11,185,541, use patent
patent.txt lines 14,888, 14,909, 14,930, 14,951- Expiry as listed
- 23 Aug 2031
- Rule
- R1
- Flags
- use code U-3140
- Product numbers
- 001, 002, 003, 004
US 11,241,425, use patent
patent.txt lines 14,889, 14,910, 14,931, 14,952- Expiry as listed
- 23 Aug 2031
- Rule
- R1
- Flags
- use code U-3137
- Product numbers
- 001, 002, 003, 004
US 11,351,166, use patent
patent.txt lines 14,890, 14,911, 14,932, 14,953- Expiry as listed
- 23 Aug 2031
- Rule
- R1
- Flags
- use code U-3140
- Product numbers
- 001, 002, 003, 004
US 11,351,166, use patent
patent.txt lines 14,891, 14,912, 14,933, 14,954- Expiry as listed
- 23 Aug 2031
- Rule
- R1
- Flags
- use code U-3141
- Product numbers
- 001, 002, 003, 004
US 11,793,805, use patent
patent.txt lines 14,893, 14,914, 14,935, 14,956- Expiry as listed
- 23 Aug 2031
- Rule
- R1
- Flags
- use code U-3734
- Product numbers
- 001, 002, 003, 004
US 12,194,035, use patent
patent.txt lines 14,896, 14,917, 14,938, 14,959- Expiry as listed
- 23 Aug 2031
- Rule
- R1
- Flags
- use code U-3141
- Product numbers
- 001, 002, 003, 004
US 9,126,977, product and use patent
patent.txt lines 14,901, 14,922, 14,943, 14,964- Expiry as listed
- 23 Aug 2031
- Rule
- R1
- Flags
- product · use code U-3136
- Product numbers
- 001, 002, 003, 004
US 9,126,977, product and use patent
patent.txt lines 14,902, 14,923, 14,944, 14,965- Expiry as listed
- 23 Aug 2031
- Rule
- R1
- Flags
- product · use code U-3137
- Product numbers
- 001, 002, 003, 004
US 9,517,235, use patent
patent.txt lines 14,903, 14,924, 14,945, 14,966- Expiry as listed
- 23 Aug 2031
- Rule
- R1
- Flags
- use code U-3138
- Product numbers
- 001, 002, 003, 004
US 9,517,235, use patent
patent.txt lines 14,904, 14,925, 14,946, 14,967- Expiry as listed
- 23 Aug 2031
- Rule
- R1
- Flags
- use code U-3139
- Product numbers
- 001, 002, 003, 004
US 9,119,848, substance patent
patent.txt lines 14,900, 14,921, 14,942, 14,963- Expiry as listed
- 30 Aug 2031
- Rule
- R1
- Flags
- substance
- Product numbers
- 001, 002, 003, 004
US 8,778,960, use patent
patent.txt lines 14,898, 14,919, 14,940, 14,961- Expiry as listed
- 13 Feb 2032
- Rule
- R1
- Flags
- use code U-3136
- Product numbers
- 001, 002, 003, 004
US 8,778,960, use patent
patent.txt lines 14,899, 14,920, 14,941, 14,962- Expiry as listed
- 13 Feb 2032
- Rule
- R1
- Flags
- use code U-3137
- Product numbers
- 001, 002, 003, 004
US 10,300,054, product and use patent
patent.txt lines 14,884, 14,905, 14,926, 14,947- Expiry as listed
- 31 May 2033
- Rule
- R1
- Flags
- product · use code U-3140
- Product numbers
- 001, 002, 003, 004
US 10,300,054, product and use patent
patent.txt lines 14,885, 14,906, 14,927, 14,948- Expiry as listed
- 31 May 2033
- Rule
- R1
- Flags
- product · use code U-3141
- Product numbers
- 001, 002, 003, 004
US 11,707,466, product patent
patent.txt lines 14,892, 14,913, 14,934, 14,955- Expiry as listed
- 12 Nov 2041
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003, 004
US 11,951,111, use patent
patent.txt lines 14,894, 14,915, 14,936, 14,957- Expiry as listed
- 12 Nov 2041
- Rule
- R1
- Flags
- use code U-3886
- Product numbers
- 001, 002, 003, 004
US 11,951,111, use patent
patent.txt lines 14,895, 14,916, 14,937, 14,958- Expiry as listed
- 12 Nov 2041
- Rule
- R1
- Flags
- use code U-3887
- Product numbers
- 001, 002, 003, 004
US 12,390,474, product patent
patent.txt lines 14,897, 14,918, 14,939, 14,960- Expiry as listed
- 12 Nov 2041
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003, 004
Listed exclusivities
Each exclusivity FDA lists for NDA 213378, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
NCE exclusivity
exclusivity.txt lines 1,214–1,217- Date
- 28 May 2026
- Rule
- R3
- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
Paragraph IV list rows giving NDA 213378
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 213378, each cell as listed.
FDA's Paragraph IV list names no patent number, so it does not say which of the patents on this page an applicant certified against.
The list gives the last qualifying patent's expiry without pediatric exclusivity; in the app's Patents view, the Orange Book lists any *PED period as a separate row with its own date. The two dates describe different things. A blank cell is one FDA left blank in its list. Dates are FDA's own; the last qualifying patent expiry is not recomputed from the Orange Book.
Rows whose RLD/NDA cell we could not read as exactly one NDA number are kept apart on the list page; some may concern this product.
Rows on FDA's Paragraph IV list whose RLD/NDA cell gives NDA 213378
Olanzapine and Samidorphan L-Malate · Tablets · 5 mg/10 mg 10 mg/10 mg 15 mg/10 mg 20 mg/10 mg
RLD/NDA as listed: Lybalvi 213378- First PIV submission
- 28 May 2025
- ANDAs
- 3
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 12 Nov 2041
Notes from the trace
- R6 tentative approvals: not in the Orange Book data files as captured; the Drugs@FDA join is a later ruling.
Patents vs FDA exclusivityHow to read the Orange Book data filesParagraph IV certificationWhat changed, by week