Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
Newly Added Patents
About This List
- This screen lists the current month's NEW ADDITIONS or NEW CHANGES to the patents for drugs listed in the Orange Book.
- This list will be purged after the Cumulative Supplement to the Orange Book is published on the first day of the next month. All the information listed on this screen is also available by using the other Orange Book search methods, such as searching by Proprietary Name.
- Patents will remain available in the Orange Book even when they are no longer listed as NEW additions or NEW changes.
Additional Information about Patents
- Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
- Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or drug product claims that are not indicated in the listing.
- As of December 5, 2016, an NDA holder submitting information on a patent that claims both the drug substance and the drug product (and is eligible for listing on either basis) is required only to specify that it claims either the drug substance or the drug product. Orange Book users should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of patent claims that may be asserted by an NDA holder or patent owner.
80 records returned
| Appl No | Active Ingredient | Proprietary Name | Dosage Form | Route | Strength | Patent No | Patent Expire Date | Drug Substance | Drug Product | Patent Use Code | Delist Requested | Mkt. Status | Submission Date |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Appl No | Active Ingredient | Proprietary Name | Dosage Form | Route | Strength | Patent No | Patent Expire Date | Drug Substance | Drug Product | Patent Use Code | Delist Requested | Mkt. Status | Submission Date |
| N021829 | ROTIGOTINE | NEUPRO | FILM, EXTENDED RELEASE | TRANSDERMAL | 2MG/24HR | 10350174 | 12/22/2030 | DP | RX | 07/18/2019 | |||
| N021829 | ROTIGOTINE | NEUPRO | FILM, EXTENDED RELEASE | TRANSDERMAL | 4MG/24HR | 10350174 | 12/22/2030 | DP | RX | 07/18/2019 | |||
| N021829 | ROTIGOTINE | NEUPRO | FILM, EXTENDED RELEASE | TRANSDERMAL | 6MG/24HR | 10350174 | 12/22/2030 | DP | RX | 07/18/2019 | |||
| N021829 | ROTIGOTINE | NEUPRO | FILM, EXTENDED RELEASE | TRANSDERMAL | 1MG/24HR | 10350174 | 12/22/2030 | DP | RX | 07/18/2019 | |||
| N021829 | ROTIGOTINE | NEUPRO | FILM, EXTENDED RELEASE | TRANSDERMAL | 3MG/24HR | 10350174 | 12/22/2030 | DP | RX | 07/18/2019 | |||
| N021829 | ROTIGOTINE | NEUPRO | FILM, EXTENDED RELEASE | TRANSDERMAL | 8MG/24HR | 10350174 | 12/22/2030 | DP | RX | 07/18/2019 | |||
| N201688 | TOBRAMYCIN | TOBI PODHALER | POWDER | INHALATION | 28MG | 10207066 | 11/04/2030 | DP | U-909 | RX | 06/17/2019 | ||
| N201688 | TOBRAMYCIN | TOBI PODHALER | POWDER | INHALATION | 28MG | 8664187 | 06/20/2025 | U-909 | RX | 06/17/2019 | |||
| N201688 | TOBRAMYCIN | TOBI PODHALER | POWDER | INHALATION | 28MG | 8869794 | 09/12/2028 | DP | U-909 | RX | 06/17/2019 | ||
| N201688 | TOBRAMYCIN | TOBI PODHALER | POWDER | INHALATION | 28MG | 9421166 | 12/19/2022 | DP | U-909 | RX | 06/17/2019 | ||
| N202880 | HYDROCODONE BITARTRATE | ZOHYDRO ER | CAPSULE, EXTENDED RELEASE | ORAL | 10MG | 10322120 | 07/25/2033 | DP | RX | 07/17/2019 | |||
| N202880 | HYDROCODONE BITARTRATE | ZOHYDRO ER | CAPSULE, EXTENDED RELEASE | ORAL | 15MG | 10322120 | 07/25/2033 | DP | RX | 07/17/2019 | |||
| N202880 | HYDROCODONE BITARTRATE | ZOHYDRO ER | CAPSULE, EXTENDED RELEASE | ORAL | 20MG | 10322120 | 07/25/2033 | DP | RX | 07/17/2019 | |||
| N202880 | HYDROCODONE BITARTRATE | ZOHYDRO ER | CAPSULE, EXTENDED RELEASE | ORAL | 30MG | 10322120 | 07/25/2033 | DP | RX | 07/17/2019 | |||
| N202880 | HYDROCODONE BITARTRATE | ZOHYDRO ER | CAPSULE, EXTENDED RELEASE | ORAL | 40MG | 10322120 | 07/25/2033 | DP | RX | 07/17/2019 | |||
| N202880 | HYDROCODONE BITARTRATE | ZOHYDRO ER | CAPSULE, EXTENDED RELEASE | ORAL | 50MG | 10322120 | 07/25/2033 | DP | RX | 07/17/2019 | |||
| N203684 | SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES | LUMASON | FOR SUSPENSION | INTRAVENOUS | 60.7MG/25MG | 10335502 | 07/06/2038 | DP | RX | 07/16/2019 | |||
| N205422 | BREXPIPRAZOLE | REXULTI | TABLET | ORAL | 0.25MG | 7888362 | 04/12/2026 | DS | RX | 07/17/2015 | |||
| N205422 | BREXPIPRAZOLE | REXULTI | TABLET | ORAL | 0.5MG | 7888362 | 04/12/2026 | DS | RX | 07/17/2015 | |||
| N205422 | BREXPIPRAZOLE | REXULTI | TABLET | ORAL | 1MG | 7888362 | 04/12/2026 | DS | RX | 07/23/2015 | |||
| N205422 | BREXPIPRAZOLE | REXULTI | TABLET | ORAL | 2MG | 7888362 | 04/12/2026 | DS | RX | 07/23/2015 | |||
| N205422 | BREXPIPRAZOLE | REXULTI | TABLET | ORAL | 3MG | 7888362 | 04/12/2026 | DS | RX | 07/23/2015 | |||
| N205422 | BREXPIPRAZOLE | REXULTI | TABLET | ORAL | 4MG | 7888362 | 04/12/2026 | DS | RX | 07/23/2015 | |||
| N207589 | BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE | ENSTILAR | AEROSOL, FOAM | TOPICAL | 0.064%;0.005% | 10130640 | 06/10/2031 | DP | RX | 12/06/2018 | |||
| N207589 | BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE | ENSTILAR | AEROSOL, FOAM | TOPICAL | 0.064%;0.005% | 10130640*PED | 12/10/2031 | RX | |||||
| N207589 | BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE | ENSTILAR | AEROSOL, FOAM | TOPICAL | 0.064%;0.005% | 9119781 | 06/10/2031 | DP | U-1761 | RX | 11/12/2015 | ||
| N207589 | BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE | ENSTILAR | AEROSOL, FOAM | TOPICAL | 0.064%;0.005% | 9119781*PED | 12/10/2031 | RX | |||||
| N208325 | ETELCALCETIDE | PARSABIV | SOLUTION | INTRAVENOUS | 2.5MG/0.5ML (2.5MG/0.5ML) | 10344765 | 06/27/2034 | DP | RX | 07/19/2019 | |||
| N208325 | ETELCALCETIDE | PARSABIV | SOLUTION | INTRAVENOUS | 5MG/ML (5MG/ML) | 10344765 | 06/27/2034 | DP | RX | 07/19/2019 | |||
| N208325 | ETELCALCETIDE | PARSABIV | SOLUTION | INTRAVENOUS | 10MG/2ML (5MG/ML) | 10344765 | 06/27/2034 | DP | RX | 07/19/2019 | |||
| N209091 | DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE | QTERN | TABLET | ORAL | 10MG;EQ 5MG BASE | 6414126 | 10/04/2020 | DS | DP | U-493 | RX | 03/22/2017 | |
| N209091 | DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE | QTERN | TABLET | ORAL | 10MG;EQ 5MG BASE | 6515117 | 10/04/2020 | DS | DP | U-493 | RX | 03/22/2017 | |
| N209091 | DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE | QTERN | TABLET | ORAL | 10MG;EQ 5MG BASE | RE44186 | 07/31/2023 | DS | DP | U-493 | RX | 03/22/2017 | |
| N209360 | ANGIOTENSIN II ACETATE | GIAPREZA | SOLUTION | INTRAVENOUS | EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) | 9572856 | 11/20/2030 | U-2221 | RX | 01/22/2018 | |||
| N209360 | ANGIOTENSIN II ACETATE | GIAPREZA | SOLUTION | INTRAVENOUS | EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML) | 9572856 | 11/20/2030 | U-2221 | DISCN | 01/22/2018 | |||
| N209449 | NITISINONE | NITYR | TABLET | ORAL | 2MG | 10328029 | 01/05/2035 | DP | U-1836 | RX | 07/17/2019 | ||
| N209449 | NITISINONE | NITYR | TABLET | ORAL | 5MG | 10328029 | 01/05/2035 | DP | U-1836 | RX | 07/17/2019 | ||
| N209449 | NITISINONE | NITYR | TABLET | ORAL | 10MG | 10328029 | 01/05/2035 | DP | U-1836 | RX | 07/17/2019 | ||
| N209589 | CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE | CLENPIQ | SOLUTION | ORAL | 12GM/BOT;3.5GM/BOT;10MG/BOT | 9827231 | 06/26/2034 | DP | U-2162 | RX | 12/06/2017 | ||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 150MG,N/A;150MG, 100MG | 10022352 | 04/09/2027 | DP | U-2343 | RX | 08/08/2018 | ||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 150MG,N/A;150MG, 100MG | 10022352 | 04/09/2027 | DP | U-2573 | RX | 08/08/2018 | ||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 10022352 | 04/09/2027 | DP | U-2343 | RX | 07/17/2019 | ||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 10022352 | 04/09/2027 | DP | U-2573 | RX | 07/17/2019 | ||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 150MG,N/A;150MG, 100MG | 10058546 | 07/15/2033 | U-2399 | RX | 09/21/2018 | |||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 150MG,N/A;150MG, 100MG | 10058546 | 07/15/2033 | U-2572 | RX | 09/21/2018 | |||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 10058546 | 07/15/2033 | U-2399 | RX | 07/17/2019 | |||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 10058546 | 07/15/2033 | U-2572 | RX | 07/17/2019 | |||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 150MG,N/A;150MG, 100MG | 10081621 | 03/25/2031 | DP | U-2420 | RX | 10/25/2018 | ||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 150MG,N/A;150MG, 100MG | 10081621 | 03/25/2031 | DP | U-2571 | RX | 10/25/2018 | ||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 10081621 | 03/25/2031 | DP | U-2420 | RX | 07/17/2019 | ||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 10081621 | 03/25/2031 | DP | U-2571 | RX | 07/17/2019 | ||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 150MG,N/A;150MG, 100MG | 10206877 | 04/14/2035 | DP | U-2498 | RX | 03/20/2019 | ||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 150MG,N/A;150MG, 100MG | 10206877 | 04/14/2035 | DP | U-2570 | RX | 03/20/2019 | ||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 10206877 | 04/14/2035 | DP | U-2498 | RX | 07/17/2019 | ||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 10206877 | 04/14/2035 | DP | U-2570 | RX | 07/17/2019 | ||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 150MG,N/A;150MG, 100MG | 10239867 | 04/09/2027 | DS | DP | U-2512 | RX | 04/19/2019 | |
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 150MG,N/A;150MG, 100MG | 10239867 | 04/09/2027 | DS | DP | U-2569 | RX | 04/19/2019 | |
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 10239867 | 04/09/2027 | DS | DP | U-2512 | RX | 07/17/2019 | |
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 10239867 | 04/09/2027 | DS | DP | U-2569 | RX | 07/17/2019 | |
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 7495103 | 05/20/2027 | DS | DP | RX | 07/17/2019 | ||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 7645789 | 05/01/2027 | DS | DP | RX | 07/17/2019 | ||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 7776905 | 06/03/2027 | DS | DP | RX | 07/17/2019 | ||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 8324242 | 08/05/2027 | U-2246 | RX | 07/17/2019 | |||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 8410274 | 12/28/2026 | DP | RX | 07/17/2019 | |||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 8415387 | 11/12/2027 | U-2246 | RX | 07/17/2019 | |||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 8598181 | 05/01/2027 | U-2246 | RX | 07/17/2019 | |||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 8623905 | 05/01/2027 | DS | DP | RX | 07/17/2019 | ||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 8629162 | 06/24/2025 | U-2247 | RX | 07/17/2019 | |||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 8754224 | 12/28/2026 | DS | DP | RX | 07/17/2019 | ||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 9012496 | 07/15/2033 | U-2248 | RX | 07/17/2019 | |||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 9670163 | 12/28/2026 | DP | U-2246 | RX | 07/17/2019 | ||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 150MG,N/A;150MG, 100MG | 9931334 | 12/28/2026 | DP | U-2275 | RX | 05/01/2018 | ||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 150MG,N/A;150MG, 100MG | 9931334 | 12/28/2026 | DP | U-2575 | RX | 05/01/2018 | ||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 9931334 | 12/28/2026 | DP | U-2275 | RX | 07/17/2019 | ||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 9931334 | 12/28/2026 | DP | U-2575 | RX | 07/17/2019 | ||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 150MG,N/A;150MG, 100MG | 9974781 | 04/09/2027 | DP | U-2318 | RX | 06/20/2018 | ||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 150MG,N/A;150MG, 100MG | 9974781 | 04/09/2027 | DP | U-2574 | RX | 06/20/2018 | ||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 9974781 | 04/09/2027 | DP | U-2318 | RX | 07/17/2019 | ||
| N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 9974781 | 04/09/2027 | DP | U-2574 | RX | 07/17/2019 | ||
| N210598 | REVEFENACIN | YUPELRI | SOLUTION | INHALATION | 175MCG/3ML | 10343995 | 03/10/2025 | U-2440 | RX | 07/15/2019 |
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Last Updated July 23, 2019.
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