Product Spotlight for 6/1/2020: An Overview of Research Exemption Peptides

For drug discovery investigators, there is an important and crucial exemption to controlled products that was enacted in 1984, which insulates them from patent infringement, particularly to prevent delays in regulatory approval of generic and innovative new uses after original patent expiration.  This protection, often referred to as the "Safe Harbor" or "Bolar" exemption is part of the extensive Drug Price Competition and Patent Term Restoration Act of 1984 (the "Hatch-Waxman Act"), which created the Section 271(e)(1). 1   For other North American researchers, the Bolar Exemption has similar exemptions that have been enacted in Canada and Mexico along with their European Union counterparts by directive 2001/82/EC.

 

Research Exemption Products Available From NEP | PI

Since 2014, there have been a variety of items that are part of this group.  While many of these are related to diabetes research, other areas are represented as well.  Here is a partial listing grouped by applicability, along with some references and other supporting literature:

Circulation

Bivalirudin2
BIV-3767-PI
Specific, Reversible, Direct Thrombin Inhibitor; Anti-Coagulant

Eptifibatide3
EPT-3786-PI
Anti-Platelet

BNP-32 (Human) (Nesiritide)4
PBN-4212-v

Feeding Regulation

Exendin-4 (Exenatide)5
PEX-3784-PI
GLP-1 (Glucagon-Like Peptide-1) Receptor Agonist

Liraglutide6
PGL-3781-PI
Glucagon-Like-Peptide-1 (GLP-1) Receptor Agonist

Lixisenatide (Lyxumia)
LIX-3799-PI
Potent and Highly Selective Once-Daily GLP-1 Peptide Agonist

Semaglutide7
GLP-3875-PI
Glucagon-Like Peptide-1 (GLP-1) Analog Shown to Stimulate Insulin and Suppress Glucagon Secretion in a Glucose-Dependent Manner

Teduglutide8
TED-3880-PI
Glucagon-Like Peptide-2 Analog Used to Treat Short Bowel Syndrome

Pain Management

ACTH (Human,1-24) (Tetracosatide)9
PAC-4109-v
Adrenocorticotropic Hormone

ω-Conotoxin MVII-A (Ziconotide)10
PCN-4289-v

Other Applications

Enfuvirtide(Fuzeon)11
ENF-3787-PI
HIV Antiviral

Linaclotide12
LIN-3796-PI
Agonist of Gaunylate Cyclase 2c

Parathyroid Hormone (Human, 1-34) (Teriparatide)13
PTH-4068-s
Effective Anabolic Agent Used in the Treatment of Some Forms of Osteoporosis

Please Note: These are FDA-regulated products. It is the responsibility of the customer to ensure that they are complying with Federal rules. New England Peptide | Peptides International cannot be liable for infringement of rights made by the user.

NEP | PI can also custom synthesize impurity compounds related to these peptide drugs.  Contact us for more information.

Resources
Previous PepTalk blog posts:

The NEP | PI Research Exemption Peptides Brochure 

References

  1. https://www.natlawreview.com/article/bolar-exemptions-north-america
  2. https://pubmed.ncbi.nlm.nih.gov/18449412/
  3. https://link.springer.com/article/10.2165/00019053-200321120-00005
  4. https://www.annualreviews.org/doi/10.1146/annurev.bi.60.070191.001305
  5. A. Alcántara, et al., Arch Biochem Biophys., 341, 1, (1997).
  6. https://pubmed.ncbi.nlm.nih.gov/19801361/
  7. https://www.nejm.org/doi/full/10.1056/NEJMoa1607141
  8.  https://pubmed.ncbi.nlm.nih.gov/22570676/
  9. https://www.nature.com/articles/newbio235114b0
  10. https://www.natlawreview.com/article/bolar-exemptions-north-america
  11. https://www.tandfonline.com/doi/abs/10.1310/hct0906-375
  12. https://pubmed.ncbi.nlm.nih.gov/22986437/
  13. https://onlinelibrary.wiley.com/doi/abs/10.1002/bip.1981.360200907

 

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