Details for New Drug Application (NDA): 204803
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NDA 204803 describes POSIMIR, which is a drug marketed by Innocoll and is included in one NDA. There are two patents protecting this drug. Additional details are available on the POSIMIR profile page.
The generic ingredient in POSIMIR is bupivacaine. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bupivacaine profile page.
The generic ingredient in POSIMIR is bupivacaine. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bupivacaine profile page.
Summary for 204803
| Tradename: | POSIMIR |
| Applicant: | Innocoll |
| Ingredient: | bupivacaine |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 204803
Generic Entry Date for 204803*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INFILTRATION |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Medical Subject Heading (MeSH) Categories for 204803
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INFILTRATION | Strength | 660MG/5ML (132MG/ML) | ||||
| Approval Date: | Feb 1, 2021 | TE: | RLD: | Yes | |||||
| Patent: | 11,400,019 | Patent Expiration: | Jan 12, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,771,624 | Patent Expiration: | Jan 12, 2041 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TO PRODUCE POST-SURGICAL ANALGESIA | ||||||||
Expired US Patents for NDA 204803
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Innocoll | POSIMIR | bupivacaine | SOLUTION;INFILTRATION | 204803-001 | Feb 1, 2021 | 8,846,072 | ⤷ Start Trial |
| Innocoll | POSIMIR | bupivacaine | SOLUTION;INFILTRATION | 204803-001 | Feb 1, 2021 | 8,153,149 | ⤷ Start Trial |
| Innocoll | POSIMIR | bupivacaine | SOLUTION;INFILTRATION | 204803-001 | Feb 1, 2021 | 8,753,665 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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