Generic Ohtuvayre Availability
Last updated on Apr 10, 2025.
Ohtuvayre is a brand name of ensifentrine, approved by the FDA in the following formulation(s):
OHTUVAYRE (ensifentrine - suspension;inhalation)
-
Manufacturer: VERONA PHARMA
Approval date: June 26, 2024
Strength(s): 3MG/2.5ML [RLD]
Is there a generic version of Ohtuvayre available?
No. There is currently no therapeutically equivalent version of Ohtuvayre available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Ohtuvayre. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
-
Liquid inhalation formulation comprising RPL554
Patent 10,945,950
Issued: March 16, 2021
Inventor(s): Spargo Peter Lionel & French Edward James & Haywood Phillip A.
Assignee(s): VERONA PHARMA PLCThe present invention relates to a liquid pharmaceutical composition suitable for administration by inhalation which comprises a diluent and a suspension of particles of 9,10-dimethoxy-2-(2,4,6-trimethylphenylimino)-3-(N-carbamoyl-2-aminoethyl)-3,4,6,7-tetrahydro-2H-pyrimido[6,1-a]isoquinolin-4-one (RPL554) or a pharmaceutically acceptable salt thereof. Also described is a liquid pharmaceutical composition according to the invention for use in the treatment of the human or animal body.
Patent expiration dates:
- September 15, 2035✓
- September 15, 2035
-
Particulate composition
Patent 12,251,384
Issued: March 18, 2025
Inventor(s): Spargo; Peter Lionel et al.
Assignee(s): Verona Pharma PLC (Cardiff, GB)The disclosure relates to a particulate composition comprising ensifentrine, wherein the particulate composition further comprises: from greater than 0.00 wt % to 0.60 wt % of 1,3-bis(2-(2-(mesitylimino)-9,10-dimethoxy-4-oxo-6,7-dihydro-2H-pyrimido[6,1-a]isoquinolin-3(4H)-yl)ethyl)urea (BMIQU) relative to the total weight of ensifentrine; and from 0.00 wt % to 0.50 wt % of a biuret impurity of formula (A) relative to the total weight of ensifentrine. Further disclosed herein are liquid pharmaceutical compositions comprising the particulate composition, and a process for producing the particulate composition are also described.
Patent expiration dates:
- June 25, 2044✓
- June 25, 2044
-
Crystalline form of pyrimido[6,1-A] isoquinolin-4-one compound
Patent 9,062,047
Issued: June 23, 2015
Inventor(s): Walker Michael J. A. & Plouvier Bertrand M. C. & Northen Julian S. & Fernandes Philippe
Assignee(s): Verona Pharma plcThe current invention is directed towards a polymorph of N-{2-[(2E)-2-(mesitylimino)-9,10-dimethoxy-4-oxo-6,7-dihydro-2H-pyrimido[6,1-a]-isoquinolin-3(4H)-yl]ethyl}urea, in the form of a crystalline solid consisting of greater than 99% by weight of N-{2-[(2E)-2-(mesitylimino)-9,10-dimethoxy-4-oxo-6,7-dihydro-2H-pyrimido[6,1-a]-isoquinolin-3(4H)-yl]ethyl}urea, at least 95% in the polymorphic form of a thermodynamically stable polymorph (I) of N-{2-[(2E)-2-(mesitylimino)-9,10-dimethoxy-4-oxo-6,7-dihydro-2H-pyrimido[6,1-a]-isoquinolin-3(4H)-yl]ethyl}urea, wherein said polymorph is determined by single crystal X-ray structural analysis and X-ray powder diffraction pattern.
Patent expiration dates:
- August 21, 2031✓✓
- August 21, 2031
-
Liquid inhalation formulation comprising RPL554
Patent 9,956,171
Issued: May 1, 2018
Inventor(s): Spargo Peter Lionel & French Edward James & Haywood Phillip A.
Assignee(s): VERONA PHARMA PLCThe present invention relates to a liquid pharmaceutical composition suitable for administration by inhalation which comprises a diluent and a suspension of particles of 9,10-dimethoxy-2-(2,4,6-trimethylphenylimino)-3-(N-carbamoyl-2-aminoethyl)-3,4,6,7-tetrahydro-2H-pyrimido[6,1-a]isoquinolin-4-one (RPL554) or a pharmaceutically acceptable salt thereof. Also described is a liquid pharmaceutical composition according to the invention for use in the treatment of the human or animal body.
Patent expiration dates:
- September 15, 2035✓✓
- September 15, 2035
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- June 26, 2029 - NEW CHEMICAL ENTITY
More about Ohtuvayre (ensifentrine)
- Check interactions
- Compare alternatives
- Pricing & coupons
- Reviews (4)
- Drug images
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: miscellaneous respiratory agents
- En español
Patient resources
Professional resources
Related treatment guides
Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
