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Progesterone - Generic Drug Details
What are the generic sources for progesterone and what is the scope of progesterone patent protection?
Progesterone
is the generic ingredient in five branded drugs marketed by Amneal Pharms Ny, Bionpharma Inc, Dr Reddys Labs Inc, Eugia Pharma, Sandoz Inc, Sofgen Pharms, Teva Pharms, Virtus Pharms, Allergan Sales Llc, Actavis Labs Ut Inc, Fresenius Kabi Usa, Hikma Farmaceutica, Lilly, Luitpold, Alza, and Ferring, and is included in sixteen NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Progesterone has twelve patent family members in nine countries.
There are fifty-seven drug master file entries for progesterone. Twenty-four suppliers are listed for this compound.
Summary for progesterone
| International Patents: | 12 |
| US Patents: | 3 |
| Tradenames: | 5 |
| Applicants: | 16 |
| NDAs: | 16 |
| Drug Master File Entries: | 57 |
| Suppliers / Packagers: | 24 |
| Bulk Api Vendors: | 90 |
| Clinical Trials: | 812 |
| Patent Applications: | 7,255 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for progesterone |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for progesterone |
| DailyMed Link: | progesterone at DailyMed |
Pharmacology for progesterone
| Drug Class | Progesterone |
Medical Subject Heading (MeSH) Categories for progesterone
Synonyms for progesterone
| .beta.-Progesterone |
| .delta.-Pregnene-3,20-dione |
| .delta.(sup4)-Pregnene-3,20-dione |
| .delta.4-Pregnene-3,20-dione |
| (1S,10S,11S,14S,15S,2R)-14-acetyl-2,15-dimethyl-5-oxotetracyclo[8.7.0.0<2,7>.0 <11,15>]heptadec-6-ene |
| (1S,2R,10S,11S,14S,15S)-14-acetyl-2,15-dimethyltetracyclo[8.7.0.0;{2,7}.0;{11,15}]heptadec-6-en-5-one |
| (1S,2R,10S,11S,14S,15S)-14-ACETYL-2,15-DIMETHYLTETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]HEPTADEC-6-EN-5-ONE |
| (8S,9S,10R,13S,14S,17S)-17-acetyl-10,13-dimethyl-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-3H-cyclopenta[a]phenanthren-3-one |
| (8S,9S,10R,13S,14S,17S)-17-Acetyl-10,13-dimethyl-1,2,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-3-one |
| (8S,9S,10R,13S,14S,17S)-17-Acetyl-10,13-dimethyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-3(2H)-one |
| (S)-4-Pregnene-3,20-dione |
| (S)-Pregn-4-en-3,20-dione |
| (S)-Progesterone |
| 10324-EP2295503A1 |
| 10324-EP2301536A1 |
| 10324-EP2301538A1 |
| 10324-EP2311455A1 |
| 10324-EP2316452A1 |
| 17.alpha.-Hydroxy-6.alpha.-methylpregn-4-ene-3,20-dione |
| 17.alpha.-Progesterone |
| 17a-Progesterone |
| 17alpha-Hydroxy-6alpha-methylpregn-4-ene-3,20-dione |
| 17alpha-Progesterone |
| 1a28 |
| 1dbb |
| 1h60 |
| 257630-50-5 |
| 2aa6 |
| 3,20-Pregnene-4 |
| 32104FB6-BF81-4F6E-83C2-024DEEAEB272 |
| 4-Pregnen-3,20-dione |
| 4-Pregnene-3,20-dione |
| 4bb2 |
| 4G7DS2Q64Y |
| 57-83-0 |
| 6.alpha.-Methylpregn-4-en-17.alpha.-ol-3,20-dione |
| 6370-EP1441224A2 |
| 6370-EP2269989A1 |
| 6370-EP2269990A1 |
| 6370-EP2275420A1 |
| 6370-EP2284149A1 |
| 6370-EP2289892A1 |
| 6370-EP2292088A1 |
| 6370-EP2292233A2 |
| 6370-EP2292592A1 |
| 6370-EP2295055A2 |
| 6370-EP2295416A2 |
| 6370-EP2298731A1 |
| 6370-EP2298748A2 |
| 6370-EP2298764A1 |
| 6370-EP2298765A1 |
| 6370-EP2298772A1 |
| 6370-EP2305636A1 |
| 6370-EP2305642A2 |
| 6370-EP2308839A1 |
| 6370-EP2308880A1 |
| 6370-EP2311453A1 |
| 6alpha-Methylpregn-4-en-17alpha-ol-3,20-dione |
| 753497-20-0 |
| 8012-32-6 |
| 8023-13-0 |
| AB2000233 |
| AC-700 |
| AC1L1LKF |
| Agolutin |
| AI3-51682 |
| AKOS015894908 |
| Akrolutin |
| AN-15619 |
| AS-12660 |
| BB_NC-0185 |
| BC200634 |
| BDBM8903 |
| beta-Progesterone |
| BHR-100 |
| BHR-310 |
| BIDD:ER0547 |
| BIDD:PXR0094 |
| Bio-luton |
| bmse000482 |
| BPBio1_000676 |
| BRD-K64994968-001-03-6 |
| BSPBio_000614 |
| BT000482 |
| C00410 |
| CAS-57-83-0 |
| CCG-100766 |
| CCRIS 533 |
| CHEBI:17026 |
| CHEMBL103 |
| CIDR |
| CMC_13406 |
| Colprosterone |
| component of Cyclogesterin |
| Corlutin |
| Corlutina |
| Corluvite |
| Corporin |
| Corpus luteum hormone |
| CPD000058345 |
| Crinone |
| Crinone (TN) |
| Crinone progesterone gel |
| Crinone, Endometrin |
| CS-1937 |
| CTK5A7509 |
| Curretab |
| Cyclogest |
| Cyclogesterin |
| Cyclogesterin (Salt/Mix) |
| D00066 |
| D07BSQ |
| D4-Pregnene-3,20-dione |
| DB00396 |
| Delta(4)-pregnene-3,20-dione |
| delta(sup 4)-Pregnene-3,20-dione |
| delta(Sup4)-pregnene-3,20-dione |
| Delta4-Pregnen-3,20-dione |
| delta4-Pregnene-3,20-dione |
| DR-2011 |
| DSSTox_CID_2370 |
| DSSTox_GSID_22370 |
| DSSTox_RID_76562 |
| DTXSID3022370 |
| Duraprogen |
| EBD2157912 |
| EC 200-350-6 |
| EINECS 200-350-6 |
| Endometrin |
| Epitope ID:116051 |
| Estima |
| ETI-411 |
| EU-0100895 |
| FE-999913 |
| Flavolutan |
| Fologenon |
| Gelbkoerperhormon |
| Gelbkorperhormon |
| Gesterol |
| Gesterol 100 |
| Gesterol 50 |
| Gestiron |
| Gestone |
| Gestormone |
| Gestron |
| Glanducorpin |
| GTPL2377 |
| Gynlutin |
| Gynoluton |
| Gynolutone |
| HMS1569O16 |
| HMS2051O05 |
| HMS2090J07 |
| HMS2096O16 |
| HMS2230F23 |
| HMS2233P11 |
| HMS3262D12 |
| Hormoflaveine |
| Hormoluton |
| HSDB 3389 |
| HY-N0437 |
| Hydroxyprogesterone Caproic acid |
| J10165 |
| KSC607K0T |
| Lingusorbs |
| Lipo-Lutin |
| Lipolutin |
| LMST02030159 |
| Lopac0_000895 |
| LP00895 |
| LPCN-1107 |
| LS-234 |
| Lucorteum |
| Lucorteum Sol |
| Lugesteron |
| lugesterone |
| Luteal hormone |
| Luteinique |
| Luteocrin normale |
| Luteodyn |
| Luteogan |
| Luteohormone |
| Luteol |
| Luteol (VAN) |
| Luteopur |
| Luteosan |
| Luteostab |
| Luteovis |
| Luteum |
| Lutex |
| Lutidon |
| Lutin |
| Lutinus |
| Lutociclina |
| Lutocuclin M |
| Lutocyclin |
| Lutocyclin M |
| Lutocylin |
| Lutoform |
| Lutogyl |
| Lutogynon |
| Lutren |
| Lutromone |
| Membrettes |
| Methylpregnone |
| MFCD00003658 |
| Micronized Progesterone |
| MLS000028517 |
| MLS000758277 |
| MLS001074187 |
| MLS001423982 |
| MLS002222367 |
| MolPort-001-794-643 |
| Nalutron |
| Natural Progesterone |
| NC00016 |
| NCGC00015785-04 |
| NCGC00022185-03 |
| NCGC00022185-04 |
| NCGC00022185-05 |
| NCGC00022185-06 |
| NCGC00022185-07 |
| NCGC00022185-08 |
| NCGC00022185-09 |
| NCGC00022185-10 |
| NCGC00022185-11 |
| NCGC00022185-12 |
| NCGC00090798-01 |
| NCGC00090798-02 |
| NCGC00254120-01 |
| NCGC00259341-01 |
| NCGC00261580-01 |
| NCI60_042166 |
| NSC 64377 |
| NSC 9704 |
| NSC-64377 |
| NSC-9704 |
| NSC64377 |
| NSC9704 |
| Opera_ID_292 |
| P 0130 |
| P0130_SIGMA |
| P0478 |
| Percutacrine |
| Percutacrine Luteinique |
| Piaponon |
| PL000236 |
| Pregn-4-en-3,20-dione |
| Pregn-4-ene-3, 17.alpha.-hydroxy-6.alpha.-methyl- |
| Pregn-4-ene-3,20-dione |
| Pregn-4-ene-3,20-dione, 17.alpha.-hydroxy-6.alpha.-methyl- |
| Pregn-4-ene-3,20-dione, 17alpha-hydroxy-6alpha-methyl- |
| Pregnene-3,20-dione |
| Pregnene, 3,20-dione-delta^4- |
| Pregnenedione |
| Prestwick_411 |
| Prestwick0_000477 |
| Prestwick1_000477 |
| Prestwick2_000477 |
| Prestwick3_000477 |
| Primolut |
| Prochieve |
| PROG; |
| Progeffik |
| Progekan |
| Progestan |
| Progestasert |
| Progesterol |
| Progesteron |
| Progesterona |
| Progesterona [INN-Spanish] |
| Progesterone (JP17/USP/INN) |
| Progesterone (oral, preterm labor) |
| Progesterone (oral, preterm labor), Lipocine |
| Progesterone (Prometrium) |
| Progesterone [INN:BAN:JAN] |
| Progesterone [Progestins] |
| Progesterone [USP:INN:BAN:JAN] |
| Progesterone 1.0 mg/ml in Acetonitrile |
| Progesterone for peak identification, European Pharmacopoeia (EP) Reference Standard |
| Progesterone for system suitability, European Pharmacopoeia (EP) Reference Standard |
| Progesterone solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material |
| Progesterone-Water Soluble, powder, BioReagent, suitable for cell culture |
| Progesterone, >=99% |
| Progesterone, British Pharmacopoeia (BP) Reference Standard |
| Progesterone, European Pharmacopoeia (EP) Reference Standard |
| Progesterone, gamma-irradiated, BioXtra, suitable for cell culture |
| Progesterone, meets USP testing specifications |
| Progesterone, pharmaceutical secondary standard; traceable to USP, PhEur and BP |
| Progesterone, powder, BioReagent, suitable for cell culture |
| Progesterone, United States Pharmacopeia (USP) Reference Standard |
| Progesterone, Vetec(TM) reagent grade, 98% |
| Progesterone, VETRANAL(TM), analytical standard |
| Progesterone; 4-Pregnene-3,20-dione |
| Progesterone?? |
| Progesteronum |
| Progesteronum [INN-Latin] |
| Progestin |
| Progestogel |
| Progestol |
| Progeston |
| Progestone |
| Progestosol |
| Progestrel |
| Progestron |
| Progestronol |
| Projestaject |
| Prolets |
| Prolidon |
| Prolutin |
| Proluton |
| Prolutone |
| Prometrium |
| Prometrium (TN) |
| Prometrium;Agolutin;Corlutin |
| Prontogest |
| Protormone |
| Q-201624 |
| RJKFOVLPORLFTN-LEKSSAKUSA-N |
| RL04181 |
| S00293 |
| s1705 |
| SBB012538 |
| SC-22719 |
| SCHEMBL7671 |
| SMR000058345 |
| SMR000653542 |
| SPBio_002553 |
| Spectrum5_002053 |
| SR-01000000088 |
| SR-01000000088-5 |
| SR-01000076054 |
| SR-01000076054-4 |
| ST069329 |
| Syngesterone |
| Syngestrets |
| Synovex S |
| Syntolutan |
| Tox21_113157 |
| Tox21_201792 |
| Tox21_300307 |
| Tox21_500895 |
| TR-031737 |
| U 3672 |
| UNII-4G7DS2Q64Y |
| Utrogest |
| Utrogestan |
| Vitarrine |
| WLN: L E5 B666 OV MUTJ A1 E1 FV1 |
| ZINC4428529 |
US Patents and Regulatory Information for progesterone
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dr Reddys Labs Inc | PROGESTERONE | progesterone | CAPSULE;ORAL | 208801-002 | Feb 28, 2017 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Lilly | PROGESTERONE | progesterone | INJECTABLE;INJECTION | 009238-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Amneal Pharms Ny | PROGESTERONE | progesterone | CAPSULE;ORAL | 207724-002 | Sep 7, 2017 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Ferring | ENDOMETRIN | progesterone | INSERT;VAGINAL | 022057-001 | Jun 21, 2007 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Sandoz Inc | PROGESTERONE | progesterone | CAPSULE;ORAL | 205229-001 | Oct 20, 2017 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Ferring | ENDOMETRIN | progesterone | INSERT;VAGINAL | 022057-001 | Jun 21, 2007 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| 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 progesterone
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Allergan Sales Llc | CRINONE | progesterone | GEL;VAGINAL | 020701-001 | Jul 31, 1997 | ➤ Sign Up | ➤ Sign Up |
| Allergan Sales Llc | CRINONE | progesterone | GEL;VAGINAL | 020701-002 | Jul 31, 1997 | ➤ Sign Up | ➤ Sign Up |
| Allergan Sales Llc | CRINONE | progesterone | GEL;VAGINAL | 020701-002 | Jul 31, 1997 | ➤ Sign Up | ➤ Sign Up |
| Allergan Sales Llc | CRINONE | progesterone | GEL;VAGINAL | 020701-001 | Jul 31, 1997 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for progesterone
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Canada | 2568823 | ➤ Sign Up |
| Spain | 2390959 | ➤ Sign Up |
| Japan | 2011026335 | ➤ Sign Up |
| Japan | 2002529494 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 0028970 | ➤ Sign Up |
| Australia | 1176200 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for progesterone
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C0037 | Belgium | ➤ Sign Up | PRODUCT NAME: OESTROGENES EQUINS CONJUGUES; ACETATE DE MEDROXYPROGESTERONE; NAT. REGISTRATION NO/DATE: NL 19569 19950301; FIRST REGISTRATION: CH - 52647 01 010 19940826 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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