Evidence map›Paper›PMID 36635930›Full record

ReviewRecent patents on biotechnology2023

Patent and Marketing Exclusivities 101 for Drug Developers.

Bryan Oronsky, Scott Caroen, Franck Brinkhaus, Tony Reid, Meaghan Stirn, Raj Kumar

Open access · hybridAbstract readReview
In one paragraph

Review in Recent patents on biotechnology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.5field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Bryan OronskyEpicentRx, Torrey Pines, San Diego, California, USA.
Scott CaroenEpicentRx, Torrey Pines, San Diego, California, USA.
Franck BrinkhausEpicentRx, Torrey Pines, San Diego, California, USA.
Tony ReidEpicentRx, Torrey Pines, San Diego, California, USA.
Meaghan StirnEpicentRx, Torrey Pines, San Diego, California, USA.
Raj KumarEpicentRx, Torrey Pines, San Diego, California, USA.
Torrey Pines Institute For Molecular Studies · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Despite an ever-increasing need for newer, safer, more effective, and more affordable therapies to treat a multitude of diseases and conditions, drug development takes too long, costs too much, and is too uncertain to be undertaken without the conferment of exclusionary rights or entry barriers to motivate and sustain investment in it. These entry barriers take the form of patents that protect intellectual property and marketing exclusivity provisions that are provided by statute. This review focuses on the basic ins and outs of regulatory and patent exclusivities for which new chemical entities (NCEs), referring to never-before approved drugs with an entirely new active ingredient, are eligible and uses RRx-001, a small molecule aerospace-derived NCE in development for the treatment of cancer, radiation toxicity, and diseases of the NLR family pyrin domain containing 3 (NLRP3) inflammasome, as a "real world" example. This is intended as a '101-type' of primer; its aim is to help developers of original pharmaceuticals navigate the maze of patents, other IP regulations, and statutory exclusivities in major markets so that they can make proper use of them.

Indexed as

AzetidinesNeoplasmsDrug IndustryHumansMarketingPatents as TopicAzetidinesanticancerNLRP3 inhibitorPatentsradioprotectionregulatory exclusivitiesRRx-001

Identifiers

PMID36635930
PMCPMC10242760
OpenAlexW4315927792

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.