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MAKENA Drug Profile
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See Plans and PricingWhich patents cover Makena, and what generic alternatives are available?
Makena is a drug marketed by Amag Pharma Usa and is included in one NDA. There are nine patents protecting this drug.
The generic ingredient in MAKENA is hydroxyprogesterone caproate. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the hydroxyprogesterone caproate profile page.
US ANDA Litigation and Generic Entry Outlook for Makena
A generic version of MAKENA was approved as hydroxyprogesterone caproate by ASPEN GLOBAL INC on August 24th, 2015.
Summary for MAKENA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 60 |
| Clinical Trials: | 6 |
| Patent Applications: | 3,457 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for MAKENA |
| DailyMed Link: | MAKENA at DailyMed |
Recent Clinical Trials for MAKENA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| AMAG Pharmaceuticals, Inc. | Phase 1 |
| George Washington University | Phase 4 |
| Thomas Jefferson University | Phase 4 |
Pharmacology for MAKENA
| Drug Class | Progestin |
Synonyms for MAKENA
| (1S,11S,15S,2R,10R,14R)-14-acetyl-2,15-dimethyl-5-oxotetracyclo[8.7.0.0<2,7>.0 <11,15>]heptadec-6-en-14-yl hexanoate |
| (1S,2R,10R,11S,14R,15S)-14-acetyl-2,15-dimethyl-5-oxotetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadec-6-en-14-yl hexanoate |
| (8R,9S,10R,13S,14S,17R)-17-acetyl-10,13-dimethyl-3-oxo-2,3,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl hexanoate |
| [(8R,9S,10R,13S,14S,17R)-17-acetyl-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl] hexanoate |
| [(8R,9S,10R,13S,14S,17R)-17-ethanoyl-10,13-dimethyl-3-oxidanylidene-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl] hexanoate |
| 106111-89-1 |
| 17 -Hydroxyprogesterone Caproate |
| 17-.alpha.-Hexanoyloxypregn-4-ene-3,20-dione |
| 17-((1-Oxohexyl)oxy)pregn-4-ene-3,20-dione |
| 17-alpha-Hexanoyloxypregn-4-ene-3,20-dione |
| 17-alpha-Hydroxy progesterone n-caproate |
| 17-alpha-hydroxy-progesterone caproate |
| 17-alpha-Hydroxypregn-4-ene-3,20-dione hexanoate |
| 17-alpha-Hydroxyprogesterone caproate |
| 17-alpha-Hydroxyprogesterone hexanoate |
| 17-Caproxyprogesterone |
| 17-Caproyloxyprogesterone |
| 17-Hydroxypregn-4-ene-3,20-dione caproate |
| 17-Hydroxypregn-4-ene-3,20-dione hexanoate |
| 17-OHPC |
| 17.alpha.-Hydroxypregn-4-ene-3,20-dione caproate |
| 17.alpha.-Hydroxypregn-4-ene-3,20-dione hexanoate |
| 17.alpha.-Hydroxyprogesterone caproate |
| 17.alpha.-Hydroxyprogesterone hexanoate |
| 17.alpha.-Hydroxyprogesterone n-caproate |
| 17|A-Hydroxyprogesterone caproate |
| 17|A-Hydroxyprogesterone hexanoate |
| 17a-hydroxyprogesterone caproate |
| 17alpha-Caproyloxypregn-4-ene-3,20-dione |
| 17alpha-Caproyloxyprogesterone |
| 17alpha-hexanoyloxy-4pregnene-3,20-dione |
| 17alpha-Hydroxypregn-4-ene-3,20-diene Caproate |
| 17alpha-Hydroxyprogesteron-Caproat |
| 17alpha-Hydroxyprogesterone caproate |
| 17alpha-Hydroxyprogesterone caproate [Progestins] |
| 17alpha-Hydroxyprogesterone hexanoate, >=98% |
| 17alpha-Hydroxyprogesterone n-caproate |
| 17alpha-Hydroxyprogesterone-17alpha caproate |
| 2247-38-3 |
| 276F2O42F5 |
| 3,20-Dioxo-4-pregnen-17alpha-yl hexanoat |
| 3,20-Dioxopregn-4-en-17-yl hexanoate |
| 3,20-Dioxopregn-4-en-17.alpha.-yl caproate |
| 3,20-Dioxopregn-4-en-17.alpha.-yl hexanoate # |
| 3,20-Dioxopregn-4-en-17alpha-yl caproate |
| 630-56-8 |
| 630H568 |
| 91037-33-1 |
| A834188 |
| AC1L54KP |
| AC1Q6OC8 |
| ACN-037582 |
| AKOS005267159 |
| ARONIS24417 |
| BCP16081 |
| BDBM70293 |
| C-22216 |
| C08148 |
| Caproate d'hydroxyprogesterone |
| Caproate d'hydroxyprogesterone [INN-French] |
| Caproato de hidroxiprogesterona |
| Caproato de hidroxiprogesterona [INN-Spanish] |
| Caproic acid hydroxyprogesterone |
| CAS-630-56-8 |
| CC-29446 |
| CHEBI:5812 |
| CHEMBL1200848 |
| cid_169870 |
| Corlutin L.A. |
| CTK6D6716 |
| D00949 |
| DB06789 |
| Delalutin |
| Delalutin (TN) |
| Deluteval 2X (Salt/Mix) |
| Depo-Proluton |
| DOMWKUIIPQCAJU-LJHIYBGHSA-N |
| DSSTox_CID_23915 |
| DSSTox_GSID_43915 |
| DSSTox_RID_80089 |
| DTXSID6043915 |
| Duraluton |
| EINECS 211-138-8 |
| Estralutin |
| Gesterol LA 250 |
| Gestiva |
| GS-3233 |
| hexanoic acid [(8R,9S,10R,13S,14S,17R)-17-acetyl-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl] ester |
| Hexanoic acid, ester with 17-hydroxypregn-4-ene-3,20-dione |
| HMS2230L08 |
| Hormofort |
| HY-B0742 |
| HYDROXYPROGESTERONE CAPROATE |
| Hydroxyprogesterone caproate (JAN/USP/INN) |
| Hydroxyprogesterone caproate [USP:INN:JAN] |
| Hydroxyprogesterone caproate, United States Pharmacopeia (USP) Reference Standard |
| Hydroxyprogesterone hexanoate |
| Hydroxyprogesteroni caproas |
| Hydroxyprogesteroni caproas [INN-Latin] |
| Hylutin |
| Hylutin (TN) |
| Hyproval |
| Hyproval P.A. |
| Hyproval-PA |
| Hyroxon |
| Idrogestene |
| Idroprogesterone caproato |
| Idroprogesterone caproato [DCIT] |
| Kaprogest |
| Lewntogest |
| Lutate |
| Luteocrin |
| Luteocrin depot |
| Lutopron |
| Makena (TN) |
| MLS000028438 |
| MLS001148643 |
| MLS002207289 |
| MolPort-002-529-231 |
| NCGC00021268-03 |
| NCGC00021268-04 |
| NCGC00255784-01 |
| Neolutin |
| Neolutin forte |
| NSC-17592 |
| NSC17592 |
| Opera_ID_1479 |
| Oxiprogesterone Caproate |
| Pregn-4-ene-3, 17-[(1-oxohexyl)oxy]- |
| Pregn-4-ene-3, 17-hydroxy-, hexanoate |
| Pregn-4-ene-3,20-dione, 17-((1-oxohexyl)oxy)- |
| Pregn-4-ene-3,20-dione, 17-[(1-oxohexyl)oxy]- |
| Pregn-4-ene-3,20-dione, 17-hydroxy-, hexanoate |
| Primolut Depot |
| Proge |
| Progesterone caproate |
| Progesterone retard pharlon |
| Progesterone, 17-hydroxy-, hexanoate |
| Progesterone, hexanoate |
| Proluton Depot |
| Q-201222 |
| Relutin |
| RL04400 |
| s4674 |
| SBB080822 |
| SC-74381 |
| SCHEMBL5330 |
| SMR000058336 |
| SR-01000003075 |
| SR-01000003075-3 |
| ST075196 |
| Syngynon |
| Teralutil |
| TL8004370 |
| Tox21_113502 |
| Tox21_113502_1 |
| Tox21_302333 |
| UNII-276F2O42F5 |
| ZINC4083606 |
US Patents and Regulatory Information for MAKENA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amag Pharma Usa | MAKENA | hydroxyprogesterone caproate | SOLUTION;INTRAMUSCULAR | 021945-001 | Feb 3, 2011 | AP1 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Amag Pharma Usa | MAKENA (AUTOINJECTOR) | hydroxyprogesterone caproate | SOLUTION;SUBCUTANEOUS | 021945-004 | Feb 14, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Amag Pharma Usa | MAKENA (AUTOINJECTOR) | hydroxyprogesterone caproate | SOLUTION;SUBCUTANEOUS | 021945-004 | Feb 14, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Amag Pharma Usa | MAKENA (AUTOINJECTOR) | hydroxyprogesterone caproate | SOLUTION;SUBCUTANEOUS | 021945-004 | Feb 14, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Amag Pharma Usa | MAKENA (AUTOINJECTOR) | hydroxyprogesterone caproate | SOLUTION;SUBCUTANEOUS | 021945-004 | Feb 14, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
