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ORLADEYO

NDA

BEROTRALSTAT DIHYDROCHLORIDE | N219776 | BIOCRYST PHARMACEUTICALS INC

4 strengths16 unique patents3 unique exclusivities

Patent Timeline

16 unique patents, 1 exclusivity by expiration date

Active (16)TodayPED (+6 mo)Exclusivity

2026

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2041

Today

Oct. 7, 2035

Sep. 9, 2035

May. 1, 2040

Sep. 9, 2035

May. 1, 2040

Sep. 9, 2035

May. 1, 2040

Sep. 9, 2035

Sep. 9, 2035

May. 1, 2040

May. 1, 2040

May. 1, 2040

May. 1, 2040

May. 1, 2040

May. 1, 2040

May. 1, 2040

Jun. 11, 2029

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

HETERO LABS LTDBEROTRALSTAT DIHYDROCHLORIDE

DMF 404112024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 15, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 72MG BASE/PACKET

RLD

16 patents3 exclusivities▴

PELLETS;ORAL | Approved: Dec 11, 2025

Patents (16) · 8 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10125102	Apr 7, 2035PED: Oct 7, 2035	PED	Yes	—		—
10329260	Mar 9, 2035PED: Sep 9, 2035	PED	Yes	—	—	—
10662160	Nov 1, 2039PED: May 1, 2040	PED	Yes	—		—
10689346	Mar 9, 2035PED: Sep 9, 2035	PED	—	—		—
11117867	Nov 1, 2039PED: May 1, 2040	PED	—	Yes		—
11230530	Mar 9, 2035PED: Sep 9, 2035	PED	—	—		—
11618733	Nov 1, 2039PED: May 1, 2040	PED	—	—		—
11708333	Mar 9, 2035PED: Sep 9, 2035	PED	—	—		—
12116346	Mar 9, 2035PED: Sep 9, 2035	PED	Yes	—	—	—
12344585	Nov 1, 2039PED: May 1, 2040	PED	—	—		—
12545645	Nov 1, 2039PED: May 1, 2040	PED	Yes	Yes	—	—
12545646	Nov 1, 2039PED: May 1, 2040	PED	Yes	Yes	—	—
12545647	Nov 1, 2039PED: May 1, 2040	PED	Yes	Yes	—	—
12552750	Nov 1, 2039PED: May 1, 2040	PED	Yes	Yes	—	—
12590068	Nov 1, 2039PED: May 1, 2040	PED	Yes	Yes	—	—
12590069	Nov 1, 2039PED: May 1, 2040	PED	Yes	Yes	—	—

Exclusivities (3)

Code	Date	Status
NP	Dec 11, 2028	Active
PED	Jun 11, 2029	Active
NP*PEDNewly listed — daily FDA feed, not yet in monthly Orange Book edition	Jun 11, 2029	Active

#002 — EQ 96MG BASE/PACKET

RLD

16 patents3 exclusivities▾

PELLETS;ORAL | Approved: Dec 11, 2025

#003 — EQ 108MG BASE/PACKET

RLD

16 patents3 exclusivities▾

PELLETS;ORAL | Approved: Dec 11, 2025

#004 — EQ 132MG BASE/PACKET

RLD

16 patents3 exclusivities▾

PELLETS;ORAL | Approved: Dec 11, 2025