Patent Expiration Dates

A drug's patent is of extreme importance to the company that has developed the drug, and competitors looking for acquisition.  This is a running patent list, as new drugs become of interest.  The typical drug patent extends for 20 years from the priority date, once the patent is approved.  After 20 years, and any additional patent extensions, generic companies are able to replicate, and sell the drug at a very high discount to the expired patented drug.

AVP-923 US 2026                                                          

AVP-923 EU 2023

AVP-786 US 2030
AVP-786 EU 2028
AXS-05  US 2040
AXS-07 US 2036
D-Baricitinib US (August 2032)
D-Baricitinib EU xxxx
Baricitinib US 2028
CTP-543 US 2037
CTP-543 EU xxxx
Ruxolitinib US (Dec 2027)
CTP- 656 US (May 2031)
CTP- 656 EU xxxx
Kalydeco US 2027
Kalydeco EU 2025
CTP-692 2038
CTP- 730 US 2030
CTP- 730 EU 2030
Otezla US 2024 (pending through 2028)
Otezla EU 2028
GLPG0634  US (June 2029)
GLPG 1837  US 2034
ITI- 007 US 2028
JZP-386 US, EU, JP (2030-2032)
Xyrem  2019-2024
MIN-101 GR US 2035
D-Momelotinib US (Jan 2033)
D-Momelotinib EU  xxxx
Momelotinib US (March 2027)
Nuplazid US 2028
Nuplazid EU 2025
Rexulti US (February 2027)

Rexulti EU (December 2026)
SAGE-217 US  April 2034
SAGE-217 EU April 2034
SAGE-547 US  to 2033 - 2037
SAGE-718 US  Sep 2032 or Oct 2037
                                  
 

Rexulti & AVP-923 Safety Profile Comparison

There is not an FDA approved drug for the treatment of agitation in patients with dementia of the Alzheimer's type.  Otsuka Pharmaceuticals has a total of five phase 3 clinical trials that have been in progress, or about to start.  The two drugs that are addressing this indication are Rexulti (Brexpiprazole), and AVP-923 (AVP-786). Rexulti is a joint 50% ownership between Lundbeck and Otsuka.  AVP-923 (AVP-786) is 100% owned by Otsuka, with a milestone and royalty licensing agreement with Concert Pharmaceuticals.  The side effect comparison between Rexulti and AVP-923 is below.

Rexulti (Brexpiprazole)
In clinical trials here phase 3 Schizophrenia, the 2 mg group of Rexulti exhibited the following side effect profile.
Insomnia 13.4%
Headache 9.3%
Agitation 8.6%
In clinical trials here phase 3 Adjunctive Major Depression, the 2 mg group of Rexulti exhibited the following side effect profile.
Weight Increase 8.0%
Akathisia 7.4%

AVP-923 (AVP-786)
In a phase 2 clinical trial for patients with agitation of the Alzheimer's type, the following side effect profile was exhibited.
Falls 8.6%
Diarrhea 5.9%
Urinary Tract Infection 5.3%

Falls had a baseline skew, that had more patients in the treatment group (17.2% to 12.6%) and 25% more patient-day exposure to AVP-923 than placebo, noted here JAMA DM/Q Phase 2 Alz. Agitation.  In addition from that phase 2 clinical trial, there were no new cardiovascular safety signals and no clinically significant changes in QTc observed in the study.  These results above are consistent with several other clinical trials that Avanir has run with AVP-923, for traumatic brain injury, or stroke here Prism II, with diarrhea being the most commonly reported adverse event.

Bottom Line:  Otsuka has advanced the deutered version of AVP-923, (known as AVP-786) into three phase 3 clinical trials for the treatment of agitation in patients with dementia of the Alzheimer's type, to begin soon.  The company also has two ongoing clinical trials in progress with Rexulti for the same patients, that started in 2013. The patent for Rexulti runs until 2027 US and until 2025 EU, the patent for AVP-786 runs until 2030 in the US, and 2028 in the EU. Thank you for reading.
              

Concert Pharmaceuticals - ($14.73)

Concert Pharmaceuticals (CNCE), is an interesting company, with a well established and cohesive management team.  The company description below is directly from the most recent 10-K. "We are a clinical stage biopharmaceutical company applying our extensive knowledge of deuterium chemistry to discover and develop novel small molecule drugs. Our approach starts with approved drugs, advanced clinical candidates or previously studied compounds that we believe can be improved with deuterium substitution to provide better pharmacokinetic or metabolic properties, thereby enhancing clinical safety, tolerability or efficacy. We believe our approach may enable drug discovery and clinical development that is more efficient and less expensive than conventional small molecule drug research and development".

The company is taking existing drugs, and potentially improving them with selective deuterium.  They plan on developing drugs in-house and through partnership with other companies.  Some quick facts below.

Quick Facts:
22 million shares outstanding
330 million market cap
75 million in cash

Intellectual Property:
AVP-786 (Otsuka) (2030 US), (2028 EU) 
AVP-923 (Otsuka) (2026 US), (2023 EU)
Rexulti (Otsuka) (2027 US), (2025 EU)
CTP-499 (2029 - 2030) U.S. EU, Japan
CTP-730 (2029 - 2034) U.S. EU, Japan
JZP-386 (2030 - 2032) U.S. EU, Japan
CTP-656 (2032) U.S.
Kalydeco (Vertex) (2027 US), (2025 EU)

As you can see above, the company has done a fine job of protecting their intellectual property with extended patent dates, which gives them enough time to get through clinical trials to commercialization, either in house or through partnership. A $280 million market cap puts CNCE in microcap territory (less than $300 million). Hard to find a microcap stock with this much future potential, with an established and cohesive management team in place. We'll have more to say about Concert Pharmaceuticals. Thank you for reading.