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 91198484.9y
Aug 30, 2031compositionUS 91198484.9y
Aug 30, 2031compositionUS 91198484.9y
Aug 30, 2031compositionUS 91198484.9y
Aug 23, 2031method-of-use (U-3136)US 107167854.9y
Aug 23, 2031method-of-use (U-3137)US 107167854.9y
Aug 23, 2031method-of-use (U-3136)US 107167854.9y
Aug 23, 2031method-of-use (U-3136)US 107167854.9y
Aug 23, 2031method-of-use (U-3140)US 111855414.9y
Aug 23, 2031method-of-use (U-3140)US 111855414.9y
Aug 23, 2031method-of-use (U-3140)US 111855414.9y
Aug 23, 2031method-of-use (U-3140)US 111855414.9y
Aug 23, 2031method-of-use (U-3137)US 112414254.9y
Aug 23, 2031method-of-use (U-3137)US 112414254.9y
Aug 23, 2031method-of-use (U-3137)US 112414254.9y
Aug 23, 2031method-of-use (U-3137)US 112414254.9y
Aug 23, 2031method-of-use (U-3141)US 113511664.9y
Aug 23, 2031method-of-use (U-3141)US 113511664.9y
Aug 23, 2031method-of-use (U-3141)US 113511664.9y
Aug 23, 2031method-of-use (U-3141)US 113511664.9y
Aug 23, 2031method-of-use (U-3734)US 117938054.9y
Aug 23, 2031method-of-use (U-3734)US 117938054.9y
Aug 23, 2031method-of-use (U-3734)US 117938054.9y
Aug 23, 2031method-of-use (U-3734)US 117938054.9y
Aug 23, 2031method-of-use (U-3141)US 121940354.9y
Aug 23, 2031method-of-use (U-3141)US 121940354.9y
Aug 23, 2031method-of-use (U-3141)US 121940354.9y
Aug 23, 2031method-of-use (U-3141)US 121940354.9y
Aug 23, 2031formulationUS 91269774.9y
Aug 23, 2031formulationUS 91269774.9y
Aug 23, 2031formulationUS 91269774.9y
Aug 23, 2031formulationUS 91269774.9y
Aug 23, 2031method-of-use (U-3138)US 95172354.9y
Aug 23, 2031method-of-use (U-3138)US 95172354.9y
Aug 23, 2031method-of-use (U-3139)US 95172354.9y
Aug 23, 2031method-of-use (U-3138)US 95172354.9y

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 · 2mo ago

Data sources

openFDA · ClinicalTrials.gov

last refreshed 2h ago

Found something off?

comments(0)

5-min edit window · permanent after that

no comments yet — first sniff?

drug

save

(olanzapine + samidorphan l-malate)

Marketedupdated 5mo 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

~4.9 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 91198484.9y
Aug 30, 2031compositionUS 91198484.9y
Aug 30, 2031compositionUS 91198484.9y
Aug 30, 2031compositionUS 91198484.9y
Aug 23, 2031method-of-use (U-3136)US 107167854.9y
Aug 23, 2031method-of-use (U-3137)US 107167854.9y
Aug 23, 2031method-of-use (U-3136)US 107167854.9y
Aug 23, 2031method-of-use (U-3136)US 107167854.9y
Aug 23, 2031method-of-use (U-3140)US 111855414.9y
Aug 23, 2031method-of-use (U-3140)US 111855414.9y
Aug 23, 2031method-of-use (U-3140)US 111855414.9y
Aug 23, 2031method-of-use (U-3140)US 111855414.9y
Aug 23, 2031method-of-use (U-3137)US 112414254.9y
Aug 23, 2031method-of-use (U-3137)US 112414254.9y
Aug 23, 2031method-of-use (U-3137)US 112414254.9y
Aug 23, 2031method-of-use (U-3137)US 112414254.9y
Aug 23, 2031method-of-use (U-3141)US 113511664.9y
Aug 23, 2031method-of-use (U-3141)US 113511664.9y
Aug 23, 2031method-of-use (U-3141)US 113511664.9y
Aug 23, 2031method-of-use (U-3141)US 113511664.9y
Aug 23, 2031method-of-use (U-3734)US 117938054.9y
Aug 23, 2031method-of-use (U-3734)US 117938054.9y
Aug 23, 2031method-of-use (U-3734)US 117938054.9y
Aug 23, 2031method-of-use (U-3734)US 117938054.9y
Aug 23, 2031method-of-use (U-3141)US 121940354.9y
Aug 23, 2031method-of-use (U-3141)US 121940354.9y
Aug 23, 2031method-of-use (U-3141)US 121940354.9y
Aug 23, 2031method-of-use (U-3141)US 121940354.9y
Aug 23, 2031formulationUS 91269774.9y
Aug 23, 2031formulationUS 91269774.9y
Aug 23, 2031formulationUS 91269774.9y
Aug 23, 2031formulationUS 91269774.9y
Aug 23, 2031method-of-use (U-3138)US 95172354.9y
Aug 23, 2031method-of-use (U-3138)US 95172354.9y
Aug 23, 2031method-of-use (U-3139)US 95172354.9y
Aug 23, 2031method-of-use (U-3138)US 95172354.9y

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 · 2mo ago

Data sources

openFDA · ClinicalTrials.gov

last refreshed 2h 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)