KYNMOBI

210875 | Orange Book

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Filed May 21, 2020
Type New Drug Application
Case Type New Drug Application
Ingredients APOMORPHINE HYDROCHLORIDE
Dosage Form / Route SUBLINGUAL and FILM
PatentExpiration
10,888,4992 years, 11 months ago
11,077,0682 years, 11 months ago
9,855,2212 years, 11 months ago
9,931,3052 years, 11 months ago
8,663,6871 year, 11 months ago
8,765,16711 months, 1 week ago
8,603,5149 months, 4 weeks ago
10,821,0744 years, 6 months from now
10,420,7635 years, 4 months from now
9,044,4755 years, 4 months from now
9,283,2195 years, 4 months from now
9,326,9815 years, 4 months from now
9,669,0195 years, 4 months from now
9,669,0215 years, 4 months from now
8,414,9226 years, 10 months from now
8,846,0746 years, 10 months from now
10,449,14611 years, 2 months from now
10,959,94311 years, 2 months from now
Last Updated: 2 years, 5 months ago
Date Patent / Filing No. Patent and Drug Application Information
4/19/203610959943Expiration of Patent No 10,959,943: (U-2825).
4/19/203610449146Expiration of Patent No 10,449,146: (U-2825).
12/16/20318846074Expiration of Patent No 8,846,074: (U-2825). (drug product)
12/16/20318414922Expiration of Patent No 8,414,922: (U-2825). (drug product)
6/11/20309669021Expiration of Patent No 9,669,021: (U-2825).
6/11/20309669019Expiration of Patent No 9,669,019: (U-2825). (drug product)
6/11/20309326981Expiration of Patent No 9,326,981: (U-2825).
6/11/20309283219Expiration of Patent No 9,283,219: (U-2825). (drug product)
6/11/20309044475Expiration of Patent No 9,044,475: (drug product)
6/11/203010420763Expiration of Patent No 10,420,763: (U-2825). (drug product)
8/7/202910821074Expiration of Patent No 10,821,074: (drug product)
4/3/20248603514Expiration of Patent No 8,603,514: (drug product)
2/20/20248765167Expiration of Patent No 8,765,167: (drug product)
2/2/20238663687Expiration of Patent No 8,663,687: (drug product)
5/5/2022SUPPL-7Labeling-Package Insert, Labeling-Patient Package Insert:
2/14/20229931305Expiration of Patent No 9,931,305: (drug product)
2/14/20229855221Expiration of Patent No 9,855,221: (drug product)
2/14/202211077068Expiration of Patent No 11,077,068: (drug product)
2/14/202210888499Expiration of Patent No 10,888,499: (drug product)
5/21/2020
Approval for KYNMOBI, 30MG
  • Reference Drug
  • Active Ingredient: APOMORPHINE HYDROCHLORIDE
  • Dosage Form: FILM
  • Dosage Route: SUBLINGUAL
  • Therapeutic Equivalence:
5/21/2020
Approval for KYNMOBI, 25MG
  • Reference Drug
  • Active Ingredient: APOMORPHINE HYDROCHLORIDE
  • Dosage Form: FILM
  • Dosage Route: SUBLINGUAL
  • Therapeutic Equivalence:
5/21/2020
Approval for KYNMOBI, 20MG
  • Reference Drug
  • Active Ingredient: APOMORPHINE HYDROCHLORIDE
  • Dosage Form: FILM
  • Dosage Route: SUBLINGUAL
  • Therapeutic Equivalence:
5/21/2020
Approval for KYNMOBI, 15MG
  • Reference Drug
  • Active Ingredient: APOMORPHINE HYDROCHLORIDE
  • Dosage Form: FILM
  • Dosage Route: SUBLINGUAL
  • Therapeutic Equivalence:
5/21/2020
Approval for KYNMOBI, 10MG
  • Reference Drug
  • Active Ingredient: APOMORPHINE HYDROCHLORIDE
  • Dosage Form: FILM
  • Dosage Route: SUBLINGUAL
  • Therapeutic Equivalence:
5/21/2020ORIG-1Approval: