Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (100)

May 1, 2040patentUS 10662160*PED
May 1, 2040patentUS 10662160*PED
May 1, 2040patentUS 11117867*PED
May 1, 2040patentUS 11117867*PED
May 1, 2040patentUS 11618733*PED
May 1, 2040patentUS 11618733*PED
May 1, 2040patentUS 12344585*PED
May 1, 2040patentUS 12344585*PED
May 1, 2040patentUS 12545645*PED
May 1, 2040patentUS 12545645*PED
May 1, 2040patentUS 12545645*PED
May 1, 2040patentUS 12545645*PED
May 1, 2040patentUS 12545645*PED
May 1, 2040patentUS 12545645*PED
May 1, 2040patentUS 12545646*PED
May 1, 2040patentUS 12545646*PED
May 1, 2040patentUS 12545646*PED
May 1, 2040patentUS 12545646*PED
May 1, 2040patentUS 12545646*PED
May 1, 2040patentUS 12545646*PED
May 1, 2040patentUS 12545647*PED
May 1, 2040patentUS 12545647*PED
May 1, 2040patentUS 12545647*PED
May 1, 2040patentUS 12545647*PED
May 1, 2040patentUS 12545647*PED
May 1, 2040patentUS 12545647*PED
May 1, 2040patentUS 12552750*PED
May 1, 2040patentUS 12552750*PED
May 1, 2040patentUS 12552750*PED
May 1, 2040patentUS 12552750*PED
May 1, 2040patentUS 12552750*PED
May 1, 2040patentUS 12552750*PED
Nov 1, 2039compositionUS 10662160
Nov 1, 2039compositionUS 10662160
Nov 1, 2039formulationUS 11117867
Nov 1, 2039formulationUS 11117867
Nov 1, 2039method-of-use (U-3300)US 11618733
Nov 1, 2039method-of-use (U-3300)US 11618733
Nov 1, 2039method-of-use (U-3010)US 12344585
Nov 1, 2039method-of-use (U-3010)US 12344585
Nov 1, 2039compositionUS 12545645
Nov 1, 2039compositionUS 12545645
Nov 1, 2039compositionUS 12545645
Nov 1, 2039compositionUS 12545645
Nov 1, 2039compositionUS 12545645
Nov 1, 2039compositionUS 12545645
Nov 1, 2039compositionUS 12545646
Nov 1, 2039compositionUS 12545646
Nov 1, 2039compositionUS 12545646
Nov 1, 2039compositionUS 12545646
Nov 1, 2039compositionUS 12545646
Nov 1, 2039compositionUS 12545646
Nov 1, 2039compositionUS 12545647
Nov 1, 2039compositionUS 12545647
Nov 1, 2039compositionUS 12545647
Nov 1, 2039compositionUS 12545647
Nov 1, 2039compositionUS 12545647
Nov 1, 2039compositionUS 12545647
Nov 1, 2039compositionUS 12552750
Nov 1, 2039compositionUS 12552750
Nov 1, 2039compositionUS 12552750
Nov 1, 2039compositionUS 12552750
Nov 1, 2039compositionUS 12552750
Nov 1, 2039compositionUS 12552750
Nov 1, 2039compositionUS 12590068
Nov 1, 2039compositionUS 12590068
Nov 1, 2039compositionUS 12590068
Nov 1, 2039compositionUS 12590068
Nov 1, 2039compositionUS 12590068
Nov 1, 2039compositionUS 12590068
Nov 1, 2039compositionUS 12590069
Nov 1, 2039compositionUS 12590069
Nov 1, 2039compositionUS 12590069
Nov 1, 2039compositionUS 12590069
Nov 1, 2039compositionUS 12590069
Nov 1, 2039compositionUS 12590069
Oct 7, 2035patentUS 10125102*PED
Oct 7, 2035patentUS 10125102*PED
Sep 9, 2035patentUS 10329260*PED
Sep 9, 2035patentUS 10329260*PED
Sep 9, 2035patentUS 10689346*PED
Sep 9, 2035patentUS 10689346*PED
Sep 9, 2035patentUS 11230530*PED
Sep 9, 2035patentUS 11230530*PED
Sep 9, 2035patentUS 11708333*PED
Sep 9, 2035patentUS 11708333*PED
Sep 9, 2035patentUS 12116346*PED
Sep 9, 2035patentUS 12116346*PED
Apr 7, 2035compositionUS 10125102
Apr 7, 2035compositionUS 10125102
Mar 9, 2035compositionUS 10329260
Mar 9, 2035compositionUS 10329260
Mar 9, 2035method-of-use (U-3010)US 10689346
Mar 9, 2035method-of-use (U-3010)US 10689346
Mar 9, 2035method-of-use (U-3300)US 11230530
Mar 9, 2035method-of-use (U-3300)US 11230530
Mar 9, 2035method-of-use (U-3300)US 11708333
Mar 9, 2035method-of-use (U-3300)US 11708333
Mar 9, 2035compositionUS 12116346
Mar 9, 2035compositionUS 12116346

FDA exclusivities (12)

Jun 11, 2029PEDPediatric (6mo bonus)2.8y
Jun 11, 2029PEDPediatric (6mo bonus)2.8y
Jun 11, 2029PEDPediatric (6mo bonus)2.8y
Jun 11, 2029PEDPediatric (6mo bonus)2.8y
Dec 11, 2028NPNP2.3y
Dec 11, 2028NPNP2.3y
Dec 11, 2028NPNP2.3y
Dec 11, 2028NPNP2.3y
Jun 3, 2028PEDPediatric (6mo bonus)1.8y
Jun 3, 2028PEDPediatric (6mo bonus)1.8y
Dec 3, 2027ODE-333Orphan Drug (7y)1.3y
Dec 3, 2027ODE-333Orphan Drug (7y)1.3y

News(1)

‘We’re not afraid of competition’: BioCryst CEO sets out strategy after scrapping internal discovery
BioCryst CEO Charlie Gayer told Fierce the company is “not getting away from science and R&D” despite shutting down its internal discovery efforts.
fiercebiotech · 1d ago

brand

Orladeyo

generic

berotralstat hydrochloride

MOA

12.1 Mechanism of Action Berotralstat is a plasma kallikrein inhibitor that binds to plasma kallikrein and inhibits its proteolytic activity. Plasma kallikrein is a protease that cleaves high-molecular-weight kininogen (HMWK) to generate cleaved HMWK (cHMWK) and bradykinin, a potent vasodilator that increases vascular permeability resulting in swelling and pain associated with HAE. In patients with HAE due to C1-inhibitor (C1-INH) deficiency or dysfunction, normal regulation of plasma kallikrein activity is not present, which leads to uncontrolled increases in plasma kallikrein activity and results in angioedema attacks. Berotralstat decreases plasma kallikrein activity to control excess bradykinin generation in patients with HAE.

indication

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency)

phase

marketed

Data sources

openFDA · ClinicalTrials.gov

last refreshed 21m ago

Found something off?

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drug

save

berotralstat hydrochloride

Marketedupdated 3mo ago

by $BCRX BIOCRYST PHARMACEUTICALS INC

Approved

community read0 votes

🐶 often sniffed alongside

top 3

Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for 4 indications.

all catalysts(5)

approval · 5

ORLADEYO (BEROTRALSTAT DIHYDROCHLORIDE) — FDA approval

berotralstat hydrochloride

ORLADEYO (BEROTRALSTAT DIHYDROCHLORIDE) — FDA approval

berotralstat hydrochloride

ORLADEYO (BEROTRALSTAT DIHYDROCHLORIDE) — FDA approval

berotralstat hydrochloride

ORLADEYO (BEROTRALSTAT DIHYDROCHLORIDE) — FDA approval

berotralstat hydrochloride

ORLADEYO (BEROTRALSTAT DIHYDROCHLORIDE) — FDA approval

berotralstat hydrochloride

→

Patent cliff

source: FDA Orange Book

first barrier falls

Dec 3, 2027

~1.3 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (100)

May 1, 2040patentUS 10662160*PED
May 1, 2040patentUS 10662160*PED
May 1, 2040patentUS 11117867*PED
May 1, 2040patentUS 11117867*PED
May 1, 2040patentUS 11618733*PED
May 1, 2040patentUS 11618733*PED
May 1, 2040patentUS 12344585*PED
May 1, 2040patentUS 12344585*PED
May 1, 2040patentUS 12545645*PED
May 1, 2040patentUS 12545645*PED
May 1, 2040patentUS 12545645*PED
May 1, 2040patentUS 12545645*PED
May 1, 2040patentUS 12545645*PED
May 1, 2040patentUS 12545645*PED
May 1, 2040patentUS 12545646*PED
May 1, 2040patentUS 12545646*PED
May 1, 2040patentUS 12545646*PED
May 1, 2040patentUS 12545646*PED
May 1, 2040patentUS 12545646*PED
May 1, 2040patentUS 12545646*PED
May 1, 2040patentUS 12545647*PED
May 1, 2040patentUS 12545647*PED
May 1, 2040patentUS 12545647*PED
May 1, 2040patentUS 12545647*PED
May 1, 2040patentUS 12545647*PED
May 1, 2040patentUS 12545647*PED
May 1, 2040patentUS 12552750*PED
May 1, 2040patentUS 12552750*PED
May 1, 2040patentUS 12552750*PED
May 1, 2040patentUS 12552750*PED
May 1, 2040patentUS 12552750*PED
May 1, 2040patentUS 12552750*PED
Nov 1, 2039compositionUS 10662160
Nov 1, 2039compositionUS 10662160
Nov 1, 2039formulationUS 11117867
Nov 1, 2039formulationUS 11117867
Nov 1, 2039method-of-use (U-3300)US 11618733
Nov 1, 2039method-of-use (U-3300)US 11618733
Nov 1, 2039method-of-use (U-3010)US 12344585
Nov 1, 2039method-of-use (U-3010)US 12344585
Nov 1, 2039compositionUS 12545645
Nov 1, 2039compositionUS 12545645
Nov 1, 2039compositionUS 12545645
Nov 1, 2039compositionUS 12545645
Nov 1, 2039compositionUS 12545645
Nov 1, 2039compositionUS 12545645
Nov 1, 2039compositionUS 12545646
Nov 1, 2039compositionUS 12545646
Nov 1, 2039compositionUS 12545646
Nov 1, 2039compositionUS 12545646
Nov 1, 2039compositionUS 12545646
Nov 1, 2039compositionUS 12545646
Nov 1, 2039compositionUS 12545647
Nov 1, 2039compositionUS 12545647
Nov 1, 2039compositionUS 12545647
Nov 1, 2039compositionUS 12545647
Nov 1, 2039compositionUS 12545647
Nov 1, 2039compositionUS 12545647
Nov 1, 2039compositionUS 12552750
Nov 1, 2039compositionUS 12552750
Nov 1, 2039compositionUS 12552750
Nov 1, 2039compositionUS 12552750
Nov 1, 2039compositionUS 12552750
Nov 1, 2039compositionUS 12552750
Nov 1, 2039compositionUS 12590068
Nov 1, 2039compositionUS 12590068
Nov 1, 2039compositionUS 12590068
Nov 1, 2039compositionUS 12590068
Nov 1, 2039compositionUS 12590068
Nov 1, 2039compositionUS 12590068
Nov 1, 2039compositionUS 12590069
Nov 1, 2039compositionUS 12590069
Nov 1, 2039compositionUS 12590069
Nov 1, 2039compositionUS 12590069
Nov 1, 2039compositionUS 12590069
Nov 1, 2039compositionUS 12590069
Oct 7, 2035patentUS 10125102*PED
Oct 7, 2035patentUS 10125102*PED
Sep 9, 2035patentUS 10329260*PED
Sep 9, 2035patentUS 10329260*PED
Sep 9, 2035patentUS 10689346*PED
Sep 9, 2035patentUS 10689346*PED
Sep 9, 2035patentUS 11230530*PED
Sep 9, 2035patentUS 11230530*PED
Sep 9, 2035patentUS 11708333*PED
Sep 9, 2035patentUS 11708333*PED
Sep 9, 2035patentUS 12116346*PED
Sep 9, 2035patentUS 12116346*PED
Apr 7, 2035compositionUS 10125102
Apr 7, 2035compositionUS 10125102
Mar 9, 2035compositionUS 10329260
Mar 9, 2035compositionUS 10329260
Mar 9, 2035method-of-use (U-3010)US 10689346
Mar 9, 2035method-of-use (U-3010)US 10689346
Mar 9, 2035method-of-use (U-3300)US 11230530
Mar 9, 2035method-of-use (U-3300)US 11230530
Mar 9, 2035method-of-use (U-3300)US 11708333
Mar 9, 2035method-of-use (U-3300)US 11708333
Mar 9, 2035compositionUS 12116346
Mar 9, 2035compositionUS 12116346

FDA exclusivities (12)

Jun 11, 2029PEDPediatric (6mo bonus)2.8y
Jun 11, 2029PEDPediatric (6mo bonus)2.8y
Jun 11, 2029PEDPediatric (6mo bonus)2.8y
Jun 11, 2029PEDPediatric (6mo bonus)2.8y
Dec 11, 2028NPNP2.3y
Dec 11, 2028NPNP2.3y
Dec 11, 2028NPNP2.3y
Dec 11, 2028NPNP2.3y
Jun 3, 2028PEDPediatric (6mo bonus)1.8y
Jun 3, 2028PEDPediatric (6mo bonus)1.8y
Dec 3, 2027ODE-333Orphan Drug (7y)1.3y
Dec 3, 2027ODE-333Orphan Drug (7y)1.3y

News(1)

‘We’re not afraid of competition’: BioCryst CEO sets out strategy after scrapping internal discovery
BioCryst CEO Charlie Gayer told Fierce the company is “not getting away from science and R&D” despite shutting down its internal discovery efforts.
fiercebiotech · 1d ago

brand

Orladeyo

generic

berotralstat hydrochloride

MOA

indication

Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency)

phase

marketed

Data sources

openFDA · ClinicalTrials.gov

last refreshed 21m ago

Found something off?

comments(0)

5-min edit window · permanent after that

no comments yet — first sniff?

berotralstat hydrochloride

🐶 often sniffed alongside

all catalysts(5)

Patent cliff

patents (100)

FDA exclusivities (12)

News(1)

Report a data issue

comments(0)

berotralstat hydrochloride

🐶 often sniffed alongside

all catalysts(5)

Patent cliff

patents (100)

FDA exclusivities (12)

News(1)

Report a data issue

comments(0)