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

patents (56)

Nov 12, 2041formulationUS 11707466
Nov 12, 2041formulationUS 11707466
Nov 12, 2041formulationUS 11707466
Nov 12, 2041formulationUS 11707466
Nov 12, 2041method-of-use (U-3887)US 11951111
Nov 12, 2041method-of-use (U-3887)US 11951111
Nov 12, 2041method-of-use (U-3887)US 11951111
Nov 12, 2041method-of-use (U-3887)US 11951111
Nov 12, 2041formulationUS 12390474
Nov 12, 2041formulationUS 12390474
Nov 12, 2041formulationUS 12390474
Nov 12, 2041formulationUS 12390474
May 31, 2033formulationUS 10300054
May 31, 2033formulationUS 10300054
May 31, 2033formulationUS 10300054
May 31, 2033formulationUS 10300054
Feb 13, 2032method-of-use (U-3137)US 8778960
Feb 13, 2032method-of-use (U-3137)US 8778960
Feb 13, 2032method-of-use (U-3137)US 8778960
Feb 13, 2032method-of-use (U-3136)US 8778960
Aug 30, 2031compositionUS 9119848
Aug 30, 2031compositionUS 9119848
Aug 30, 2031compositionUS 9119848
Aug 30, 2031compositionUS 9119848
Aug 23, 2031method-of-use (U-3136)US 10716785
Aug 23, 2031method-of-use (U-3137)US 10716785
Aug 23, 2031method-of-use (U-3136)US 10716785
Aug 23, 2031method-of-use (U-3136)US 10716785
Aug 23, 2031method-of-use (U-3140)US 11185541
Aug 23, 2031method-of-use (U-3140)US 11185541
Aug 23, 2031method-of-use (U-3140)US 11185541
Aug 23, 2031method-of-use (U-3140)US 11185541
Aug 23, 2031method-of-use (U-3137)US 11241425
Aug 23, 2031method-of-use (U-3137)US 11241425
Aug 23, 2031method-of-use (U-3137)US 11241425
Aug 23, 2031method-of-use (U-3137)US 11241425
Aug 23, 2031method-of-use (U-3141)US 11351166
Aug 23, 2031method-of-use (U-3141)US 11351166
Aug 23, 2031method-of-use (U-3141)US 11351166
Aug 23, 2031method-of-use (U-3141)US 11351166
Aug 23, 2031method-of-use (U-3734)US 11793805
Aug 23, 2031method-of-use (U-3734)US 11793805
Aug 23, 2031method-of-use (U-3734)US 11793805
Aug 23, 2031method-of-use (U-3734)US 11793805
Aug 23, 2031method-of-use (U-3141)US 12194035
Aug 23, 2031method-of-use (U-3141)US 12194035
Aug 23, 2031method-of-use (U-3141)US 12194035
Aug 23, 2031method-of-use (U-3141)US 12194035
Aug 23, 2031formulationUS 9126977
Aug 23, 2031formulationUS 9126977
Aug 23, 2031formulationUS 9126977
Aug 23, 2031formulationUS 9126977
Aug 23, 2031method-of-use (U-3138)US 9517235
Aug 23, 2031method-of-use (U-3138)US 9517235
Aug 23, 2031method-of-use (U-3139)US 9517235
Aug 23, 2031method-of-use (U-3138)US 9517235

FDA exclusivities (4)

May 28, 2026NCENew Chemical Entity (5y)
May 28, 2026NCENew Chemical Entity (5y)
May 28, 2026NCENew Chemical Entity (5y)
May 28, 2026NCENew Chemical Entity (5y)

News(1)

4 potential biotech M&A targets, plus a pretty sure bet from J&J
Pharma is definitely interested in making more deals. But what biotechs will come under the magnifying glass? BioSpace takes a look at companies that analysts see as near-term targets for buyouts.
biospace · 6d ago

Data sources

openFDA · ClinicalTrials.gov

last refreshed 31m ago

Found something off?

comments(0)

5-min edit window · permanent after that

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drug

save

(olanzapine + samidorphan l-malate)

Marketedupdated 3mo ago

by $ALKS Alkermes plc.

Approved

community read0 votes

🐶 often sniffed alongside

top 6

Small molecule drug with a maximum clinical stage of Approval (across all indications), with 7 approved and 27 investigational indications.

indications

investigational

Schizophrenia

all catalysts(7)

approval · 7

LYBALVI (OLANZAPINE) — FDA approval

(olanzapine + samidorphan l-malate)

LYBALVI (OLANZAPINE) — FDA approval

(olanzapine + samidorphan l-malate)

LYBALVI (OLANZAPINE) — FDA approval

(olanzapine + samidorphan l-malate)

LYBALVI (OLANZAPINE) — FDA approval

(olanzapine + samidorphan l-malate)

LYBALVI (OLANZAPINE) — FDA approval

(olanzapine + samidorphan l-malate)

LYBALVI (OLANZAPINE) — FDA approval

(olanzapine + samidorphan l-malate)

LYBALVI (OLANZAPINE) — FDA approval

(olanzapine + samidorphan l-malate)

→

Patent cliff

source: FDA Orange Book

first barrier falls

Aug 23, 2031

~5.0 years out

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

patents (56)

Nov 12, 2041formulationUS 11707466
Nov 12, 2041formulationUS 11707466
Nov 12, 2041formulationUS 11707466
Nov 12, 2041formulationUS 11707466
Nov 12, 2041method-of-use (U-3887)US 11951111
Nov 12, 2041method-of-use (U-3887)US 11951111
Nov 12, 2041method-of-use (U-3887)US 11951111
Nov 12, 2041method-of-use (U-3887)US 11951111
Nov 12, 2041formulationUS 12390474
Nov 12, 2041formulationUS 12390474
Nov 12, 2041formulationUS 12390474
Nov 12, 2041formulationUS 12390474
May 31, 2033formulationUS 10300054
May 31, 2033formulationUS 10300054
May 31, 2033formulationUS 10300054
May 31, 2033formulationUS 10300054
Feb 13, 2032method-of-use (U-3137)US 8778960
Feb 13, 2032method-of-use (U-3137)US 8778960
Feb 13, 2032method-of-use (U-3137)US 8778960
Feb 13, 2032method-of-use (U-3136)US 8778960
Aug 30, 2031compositionUS 9119848
Aug 30, 2031compositionUS 9119848
Aug 30, 2031compositionUS 9119848
Aug 30, 2031compositionUS 9119848
Aug 23, 2031method-of-use (U-3136)US 10716785
Aug 23, 2031method-of-use (U-3137)US 10716785
Aug 23, 2031method-of-use (U-3136)US 10716785
Aug 23, 2031method-of-use (U-3136)US 10716785
Aug 23, 2031method-of-use (U-3140)US 11185541
Aug 23, 2031method-of-use (U-3140)US 11185541
Aug 23, 2031method-of-use (U-3140)US 11185541
Aug 23, 2031method-of-use (U-3140)US 11185541
Aug 23, 2031method-of-use (U-3137)US 11241425
Aug 23, 2031method-of-use (U-3137)US 11241425
Aug 23, 2031method-of-use (U-3137)US 11241425
Aug 23, 2031method-of-use (U-3137)US 11241425
Aug 23, 2031method-of-use (U-3141)US 11351166
Aug 23, 2031method-of-use (U-3141)US 11351166
Aug 23, 2031method-of-use (U-3141)US 11351166
Aug 23, 2031method-of-use (U-3141)US 11351166
Aug 23, 2031method-of-use (U-3734)US 11793805
Aug 23, 2031method-of-use (U-3734)US 11793805
Aug 23, 2031method-of-use (U-3734)US 11793805
Aug 23, 2031method-of-use (U-3734)US 11793805
Aug 23, 2031method-of-use (U-3141)US 12194035
Aug 23, 2031method-of-use (U-3141)US 12194035
Aug 23, 2031method-of-use (U-3141)US 12194035
Aug 23, 2031method-of-use (U-3141)US 12194035
Aug 23, 2031formulationUS 9126977
Aug 23, 2031formulationUS 9126977
Aug 23, 2031formulationUS 9126977
Aug 23, 2031formulationUS 9126977
Aug 23, 2031method-of-use (U-3138)US 9517235
Aug 23, 2031method-of-use (U-3138)US 9517235
Aug 23, 2031method-of-use (U-3139)US 9517235
Aug 23, 2031method-of-use (U-3138)US 9517235

FDA exclusivities (4)

May 28, 2026NCENew Chemical Entity (5y)
May 28, 2026NCENew Chemical Entity (5y)
May 28, 2026NCENew Chemical Entity (5y)
May 28, 2026NCENew Chemical Entity (5y)

News(1)

4 potential biotech M&A targets, plus a pretty sure bet from J&J
Pharma is definitely interested in making more deals. But what biotechs will come under the magnifying glass? BioSpace takes a look at companies that analysts see as near-term targets for buyouts.
biospace · 6d ago

Data sources

openFDA · ClinicalTrials.gov

last refreshed 31m ago

Found something off?

comments(0)

5-min edit window · permanent after that

no comments yet — first sniff?

(olanzapine + samidorphan l-malate)

🐶 often sniffed alongside

indications

all catalysts(7)

Patent cliff

patents (56)

FDA exclusivities (4)

News(1)

Report a data issue

comments(0)

(olanzapine + samidorphan l-malate)

🐶 often sniffed alongside

indications

all catalysts(7)

Patent cliff

patents (56)

FDA exclusivities (4)

News(1)

Report a data issue

comments(0)