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SKYLA Drug Profile
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When do Skyla patents expire, and when can generic versions of Skyla launch?
This drug has seventy-seven patent family members in twenty-eight countries.
The generic ingredient in SKYLA is levonorgestrel. There are twenty drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.
Summary for SKYLA
| International Patents: | 77 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 74 |
| Patent Applications: | 3,418 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | SKYLA at DailyMed |
Pharmacology for SKYLA
| Ingredient-type | Progesterone Congeners |
| Drug Class | Progestin Progestin-containing Intrauterine Device |
| Physiological Effect | Inhibit Ovum Fertilization |
Medical Subject Heading (MeSH) Categories for SKYLA
Synonyms for SKYLA
| (-)-13-Ethyl-17-hydroxy-18,19-dinor-17alpha-pregn-4-en-20-yn-3-one |
| (-)-17alpha-Ethynyl-18-methyl-19-nortestosterone |
| (-)-18,19-Dinor-13beta-ethyl-17beta-hydroxy-4-pregnen-20-yn-3-one |
| (-)-Levonorgestrel |
| (-)-Norgestrel |
| (-)-Norgestrel, 98% |
| (+-)-13-Ethyl-17-hydroxy-18,19-dinor-17alpha-pregn-4-en-20-yn-3-one |
| (+-)-Norgestrel |
| (17?)-13-Ethyl-17-hydroxy-18,19-dinorpregn-4-en-yn-3-one |
| (1S,2R,10R,11S,14R,15S)-15-ethyl-14-ethynyl-14-hydroxytetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadec-6-en-5-one |
| (1S,2R,10R,11S,14R,15S)-15-ETHYL-14-ETHYNYL-14-HYDROXYTETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]HEPTADEC-6-EN-5-ONE |
| (8R,9S,10R,13S,14S,17R)-13-ethyl-17-ethynyl-17-hydroxy- 1,2,6,7,8,9,10,11,12,13,14,15,16, 17- tetradecahydrocyclopenta[a] phenanthren-3-one |
| (8R,9S,10R,13S,14S,17R)-13-ethyl-17-ethynyl-17-hydroxy-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-3H-cyclopenta[a]phenanthren-3-one |
| (8R,9S,10R,13S,14S,17R)-13-ethyl-17-ethynyl-17-hydroxy-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-3-one |
| (8R,9S,10R,13S,14S,17R)-13-ethyl-17-ethynyl-17-oxidanyl-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-3-one |
| [(-)-13-ethyl-17-hydroxy-18,19-dinor-17a-pregn-4-en-20-yn-3-one |
| [18,(17.alpha.)-(-)-] |
| 121714-72-5 |
| 13-BETA-ETHYL-17-ALPHA-ETHYNYL-17-BETA-HYDROXYGON-4-EN-3-ONE |
| 13-beta-Ethyl-17alpha-ethynyl-17beta-hydroxygon-4-en-3-one |
| 13-Ehyl-17alpha-ethynyl-17-hydroxygon-4-en-3-one |
| 13-Ethyl-17-alpha-ethynyl-17-beta-hydroxy-4-gonen-3-one |
| 13-Ethyl-17-alpha-ethynylgon-4-en-17-beta-ol-3-one |
| 13-Ethyl-17-hydroxy-18,19-dinor-17alpha-pregn-4-en-20-yn-3-one |
| 13-Ethyl-17alpha-ethynyl-17-hydroxygon-4-en-3-one |
| 13-ethyl-17alpha-ethynyl-17beta-hydroxygon-4-en-3-one |
| 13-Ethyl-17alpha-ethynylgon-4-en-17beta-ol-3-one |
| 13-ethyl-17alpha-hydroxy-18,19-dinorpregn-4-en-20-yn-3-one |
| 13beta-Ethyl-17alpha-ethynyl-17 beta-hydroxygon-4-en-3-one |
| 13beta-ethyl-17alpha-ethynyl-17-hydroxy-gon-4-en-3-one |
| 13beta-ethyl-17alpha-ethynyl-17beta-hydroxy-gon-4-en-3-one |
| 13beta-Ethyl-17alpha-ethynyl-17beta-hydroxygon-4-en-3-one |
| 17-alpha-Ethinyl-13-beta-ethyl-17-beta-hydroxy-4-estren-3-one |
| 17-alpha-Ethynyl-13-ethyl-19-nortestosterone |
| 17-beta-Hydroxy-18-methyl-19-nor-17-alpha-pregn-4-en-20-yn-3-one |
| 17-Ethynyl-18-methyl-19-nortestosterone |
| 17alpha-Ethynyl-13-ethyl-19-nortestosterone |
| 17alpha-Ethynyl-13beta-ethyl-3-oxo-4-estren-17beta-ol |
| 17alpha-Ethynyl-17-hydroxy-18-methylestr-4-en-3-one |
| 17alpha-ethynyl-17beta-hydroxy-18a-homoestr-4-en-3-one |
| 17alpha-Ethynyl-18-homo-19-nor-testosterone |
| 17alpha-Ethynyl-18-homo-19-nortestosterone |
| 18-Methyl-17-alpha-ethynyl-19-nortestosterone |
| 18-Methylnorethindrone |
| 18-Methylnorethisterone |
| 18,19-Dinor-13beta-ethyl-17 beta hydroxy-4-pregnen-20-yn-3-one |
| 18,19-Dinor-13beta-ethyl-17beta-hydroxy-4-pregnen-20-yn-3-one |
| 18,19-Dinor-17-alpha-pregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy- |
| 18,19-Dinor-17-alpha-pregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (+-)- |
| 18,19-Dinor-17-alpha-pregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (+)- |
| 18,19-Dinor-4-pregnen-20-yn-3-one |
| 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17alpha)-(-)- |
| 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17alpha)-(+-)- |
| 19-Nortestosterone, 17-ethynyl-18-methyl- |
| 1lhv |
| 4222-79-1 |
| 5W7SIA7YZW |
| 6533-00-2 |
| 72-HOURS |
| 797-62-6 |
| 797-63-7 |
| 797L637 |
| A835065 |
| AB0012485 |
| AB2000252 |
| AC1L211U |
| AC1Q6OEV |
| AJ-45701 |
| AK161683 |
| AKOS015894913 |
| alpha-Norgestrel |
| BAY 86-5028 |
| BAY86-5028 |
| BCP9000852 |
| BDBM50410522 |
| BIDD:PXR0194 |
| Bio-0595 |
| BPBio1_000932 |
| BRD-K35189033-001-03-0 |
| BRN 2391114 |
| BSPBio_000846 |
| C08149 |
| C08153 |
| Capronor |
| CAS-797-63-7 |
| CCG-100853 |
| CCRIS 6525 |
| CCRIS 9033 |
| CHEBI:6443 |
| CHEMBL1389 |
| component of Lo/ovral |
| CS-2243 |
| D-(-)-Norgestrel |
| D-Norgestrel |
| d(-)-Norgestrel |
| D(-)-Norgestrel, analytical standard |
| D00950 |
| D00954 |
| D0A9MR |
| D0BA9U |
| D0G6CT |
| DB00367 |
| dl-13-beta-Ethyl-17-alpha-ethynyl-17-beta-hydroxygon-4-en-3-one |
| dl-13-beta-Ethyl-17-alpha-ethynyl-19-nortestosterone |
| dl-Norgestrel |
| DNorgestrel |
| DSSTox_CID_16496 |
| DSSTox_GSID_36496 |
| DSSTox_RID_79283 |
| DTXSID3036496 |
| E-Gen-C |
| EINECS 212-349-8 |
| EINECS 229-433-5 |
| EN300-122613 |
| Fallback Solo |
| FH 122-A |
| Follistrel |
| FT-0658692 |
| GTPL2881 |
| HMS1570K08 |
| HMS2051M08 |
| HMS2090O06 |
| HMS2097K08 |
| HMS2232H06 |
| HMS2232K12 |
| HMS3649J10 |
| HSDB 3595 |
| HSDB 6483 |
| HY-B0257 |
| Jadelle |
| Kyleena |
| Ld norgestrel |
| LD norgestrel [French] |
| Levlen |
| Levlen ED |
| Levogel |
| Levonelle |
| Levonelle, D-Norgestrel, Levonova, Levonorgestrel |
| Levonelle;D-Norgestrel;Levonova |
| Levonorgestrel |
| Levonorgestrel (JAN/USP/INN) |
| Levonorgestrel (Levonelle) |
| Levonorgestrel [USAN:INN:BAN] |
| Levonorgestrel [USAN:USP:INN:BAN] |
| Levonorgestrel for system suitability 2, European Pharmacopoeia (EP) Reference Standard |
| Levonorgestrel implants |
| Levonorgestrel, European Pharmacopoeia (EP) Reference Standard |
| Levonorgestrel, pharmaceutical secondary standard; traceable to USP, PhEur, BP |
| Levonorgestrel, United States Pharmacopeia (USP) Reference Standard |
| Levonorgestrel(Levonelle) |
| Levonorgestrelum |
| Levonorgestrelum [INN-Latin] |
| Levonova |
| Levora-21 |
| Levora-28 |
| Levosert |
| Liletta |
| LMST02030119 |
| LNG-IUS |
| LO/Ovral |
| Logynon ED |
| LS-62083 |
| LS-62084 |
| MCULE-1283162506 |
| Methylnorethindrone |
| MFCD00199013 |
| Microgest ED |
| Microgyn |
| Microgynon 21 |
| Microgynon 28 |
| Microgynon 30 ED |
| Microgynon CD |
| Microlut |
| Microlution |
| Microluton |
| Microval |
| Minivlar 30 |
| Mirena |
| Mirena (TN) |
| MLS000069491 |
| MLS000759484 |
| MLS001074069 |
| MLS001423967 |
| MolPort-002-510-453 |
| Monofeme 28 |
| Monovar |
| N0889 |
| NC00103 |
| NCGC00159349-02 |
| NCGC00159349-03 |
| NCGC00159349-05 |
| NCGC00257283-01 |
| NCGC00260418-01 |
| Neogest |
| Neogynon 21 |
| Next choice |
| Nordet |
| Nordette |
| Nordette 21 |
| Nordette 28 |
| Norgeston |
| norgestrel |
| Norgestrel (JP15/USP/INN) |
| Norgestrel (JP17/USP/INN) |
| Norgestrel [Progestins] |
| Norgestrel [USAN:BAN:INN:JAN] |
| Norgestrel [USAN:INN:BAN:JAN] |
| Norgestrel [USAN:USP:INN:BAN:JAN] |
| Norgestrel-(-)-D |
| Norgestrelum |
| Norgestrelum [INN-Latin] |
| NorLevo |
| NORPLANT |
| Norplant (TN) |
| Norplant 2 |
| Norplant II |
| Norplant System in Plastic Container |
| Norplant-2 |
| NSC-744007 |
| NSC744007 |
| Opera_ID_552 |
| Ovoplex 30-150 |
| Ovral |
| Ovral-Lo |
| Ovranette |
| Ovrette |
| Ovrette (TN) |
| PL000229 |
| Plan B |
| Plan B One Step |
| Plan B One-Step |
| Postinor |
| Postinor-2 |
| Prestwick_109 |
| Prestwick0_000773 |
| Prestwick1_000773 |
| Prestwick2_000773 |
| Prestwick3_000773 |
| Preven |
| Rigevidon 21+7 |
| s1727 |
| SCHEMBL27597 |
| SH 70850 |
| SH 850 |
| Skyla (TN) |
| SMR000059117 |
| SMR000653526 |
| SOH-075 |
| SPBio_002785 |
| SR-01000759218 |
| SR-01000759218-5 |
| SR-01000946725 |
| SR-01000946725-1 |
| Stediril 30 |
| Tetragynon |
| Tox21_111593 |
| Tox21_111593_1 |
| Tox21_202872 |
| Tox21_303658 |
| Tri-Levlen |
| Tri-Levlen 21 |
| Triagynon |
| Triciclor |
| Trifeme 28 |
| Trigoa |
| Trinordiol 21 |
| Trinordiol 28 |
| Triphasil 21 |
| Triphasil 28 |
| Triquilar ED |
| Trivora |
| UNII-3J8Q1747Z2 component WWYNJERNGUHSAO-XUDSTZEESA-N |
| UNII-5W7SIA7YZW |
| WWYNJERNGUHSAO-XUDSTZEESA-N |
| Wy 3707 |
| Wy-3707 |
| Wy-5104 |
| Z1551429747 |
| ZINC3814395 |
US Patents and Regulatory Information for SKYLA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | SKYLA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 203159-001 | Jan 9, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Bayer Hlthcare | SKYLA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 203159-001 | Jan 9, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Bayer Hlthcare | SKYLA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 203159-001 | Jan 9, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Expired US Patents for SKYLA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | SKYLA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 203159-001 | Jan 9, 2013 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Non-Orange Book US Patents for SKYLA
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
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International Patents for SKYLA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1400258 | ➤ Sign Up |
| South Korea | 101604507 | ➤ Sign Up |
| South Korea | 100827635 | ➤ Sign Up |
| China | 1681455 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for SKYLA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 0814 | Netherlands | ➤ Sign Up | PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
| 2016 00016 | Denmark | ➤ Sign Up | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
| 156 | Luxembourg | ➤ Sign Up | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
| /2015 | Austria | ➤ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
