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TYVASO Drug Profile
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See Plans and PricingWhich patents cover Tyvaso, and when can generic versions of Tyvaso launch?
Tyvaso is a drug marketed by United Therap and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.
This drug has twenty-seven patent family members in seven countries.
The generic ingredient in TYVASO is treprostinil. There are nineteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the treprostinil profile page.
US ANDA Litigation and Generic Entry Outlook for Tyvaso
A generic version of TYVASO was approved as treprostinil by SANDOZ INC on November 30th, 2017.
Summary for TYVASO
| International Patents: | 27 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 55 |
| Clinical Trials: | 16 |
| Patent Applications: | 527 |
| Drug Prices: | Drug price information for TYVASO |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TYVASO |
| DailyMed Link: | TYVASO at DailyMed |
Recent Clinical Trials for TYVASO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| United Therapeutics | Phase 1 |
| Bastiaan Driehuys | Phase 2 |
| United Therapeutics | Phase 2/Phase 3 |
Recent Litigation for TYVASO
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Allergan Sales, LLC v. Teva Pharmaceuticals USA, Inc. | 2016-11-30 |
| UNITED THERAPEUTICS CORPORATION v. WATSON LABORATORIES, INC. | 2015-07-22 |
| UNITED THERAPEUTICS CORPORATION v. TEVA PHARMACEUTICALS USA, INC. | 2014-09-02 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| 2017-06-21 | |
| SteadyMed Ltd. | 2015-10-02 |
Pharmacology for TYVASO
| Drug Class | Prostacycline Vasodilator |
| Physiological Effect | Vasodilation |
Synonyms for TYVASO
| ((1R,2R,3aS,9aS)-2-hydroxy-1-((3S)-3-hydroxyoctyl)-2,3,3a,4,9,9a-hexahydro-1H-cylopent(b)naphthalen-5-yl)oxy)acetate |
| ({(1R,2R,3aS,9aS)-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[b]naphthalen-5-yl}oxy)acetic acid |
| (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy- 1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl] oxy]acetic acid |
| [[(1R,2R,3aS,9aS)-2-Hydroxy-1-[(3S)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[b]naphtalen-5-yl]oxy]acetic acid |
| [[(1R,2R,3aS,9aS)-2,3,3a,4,9,9a-Hexahydro-2-hydroxy-1-[(S)-3-hydroxyoctyl]-1H-benzo[f]indene-5-yl]oxy]acetic acid |
| [[(1R,2R,3aS,9aS)-2,3,4,9,9a-Hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid |
| [1R-[1|A(S*),2|A,3a|A,9a|A]]-[[2,3,3a,4,9,9a-| section signexahydro-2-hydroxy-1-(3-hydroxyoctyl)-1H-benz[f]inden-5-yl]oxy]acetic Acid |
| 15AU |
| 15AU81 |
| 2-(((1R,2R,3aS,9aS)-2-hydroxy-1-((S)-3-hydroxyoctyl)-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[b]naphthalen-5-yl)oxy)acetic acid |
| 2-((1r,2r,3as,9as)-2-hydroxy-1-((s)-3-hydroxyoctyl)-2,3,3a,4,9,9a-hexahydro-1h-cyclopenta[b]naphthalen-5-yloxy)acetic acid |
| 2-[[(1R,2R,3aS,9aS)-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[g]naphthalen-5-yl]oxy]acetic acid |
| 2-[[(1R,2R,3aS,9aS)-2,3,3a,4,9,9a-Hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic Acid |
| 2-[[(2R,3R,3aS,9aS)-2-hydroxy-3-[(3S)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[g]naphthalen-8-yl]oxy]acetic acid |
| 2-{[(1R,2R,3aS,9aS)-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H,2H,3H,3aH,4H,9H,9aH-cyclopenta[b]naphthalen-5-yl]oxy}acetic acid |
| 2025AH |
| 289480-64-4 |
| 289480-64-4 (Sodium salt) |
| 7JZ75N2NT6 |
| 81846-19-7 |
| 81846-19-7 (Parent) |
| AC-30205 |
| AC-30207 |
| AC1OCF2J |
| Acetic acid, (((1R,2R,3aS,9aS)-2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-((3S)-3-hydroxyoctyl)-1H-benz(f)inden-5-yl)oxy)- |
| Acetic acid, (((1R,2R,3aS,9aS)-2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-((3S)-3-hydroxyoctyl)-1H-benz(f)inden-5-yl)oxy)-, monosodium salt |
| Acetic acid, ((2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-(3-hydroxyoctyl)-1H-benz(f)inden-5-yl)oxy)-, (1R-(1alpha(S*),2beta,3aalpha,9aalpha))- |
| AKOS027470173 |
| AKOS030524396 |
| API0005768 |
| ARD-1550 |
| BCP10253 |
| BRD-K19706299-001-01-4 |
| BW 15AU |
| BW-15AU |
| C23H33O5.Na |
| CHEBI:50861 |
| CHEBI:50863 |
| CHEMBL1237119 |
| CS-6170 |
| CS-7872 |
| CTK8G3571 |
| D06213 |
| D08628 |
| DB00374 |
| EX-A1414 |
| EX-A1416 |
| GTPL5820 |
| HMS3648G07 |
| HY-100441 |
| HY-16504 |
| LRX 15 |
| LRX-15 |
| MolPort-027-720-928 |
| Orenitram |
| PAJMKGZZBBTTOY-ZFORQUDYSA-N |
| Remodulin |
| Remodulin (TN) |
| RP17714 |
| RUM6K67ESG |
| Rumodolin |
| SCHEMBL4349618 |
| SCHEMBL61996 |
| sodium ({(1R,2R,3aS,9aS)-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[b]naphthalen-5-yl}oxy)acetate |
| sodium 2-(((1R,2R,3aS,9aS)-2-hydroxy-1-((S)-3-hydroxyoctyl)-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[b]naphthalen-5-yl)oxy)acetate |
| SR-01000946210 |
| SR-01000946210-1 |
| Treprostinil |
| Treprostinil (JAN/USAN/INN) |
| Treprostinil (sodium) |
| Treprostinil [USAN:INN] |
| Treprostinil monosodium salt |
| Treprostinil pound>>UT-15 |
| Treprostinil sodium |
| treprostinilo |
| treprostinilum |
| Tresprostinil |
| Trevyent |
| U 62840 |
| U-62,840 |
| U-62840 |
| UNII-7JZ75N2NT6 |
| UNII-RUM6K67ESG |
| Uniprost |
| UT-15 |
| Viveta |
| Y0243 |
| ZINC3800475 |
Paragraph IV (Patent) Challenges for TYVASO
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| TYVASO | SOLUTION;INHALATION | treprostinil | 022387 | 2015-04-13 |
US Patents and Regulatory Information for TYVASO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for TYVASO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | Start Trial | Start Trial |
| United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | Start Trial | Start Trial |
| United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | Start Trial | Start Trial |
| United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TYVASO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 5797376 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2007134292 | Start Trial |
| Canada | 2710205 | Start Trial |
| Japan | 2014114269 | Start Trial |
| South Korea | 101898407 | Start Trial |
| South Korea | 20100105852 | Start Trial |
| South Korea | 20090007797 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
