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Country(Area) Pharma Report-US Orange Book in statistics
Country(Area) Pharma market report—US Market expressed in Orange Book
US Pharma market is the biggest one in the world. You may find more reports and analysis on US Innovative Medicines. Here we have tried to present you some sheets regarding Generics according to the Orange Book(42nd Edition) 202203. Where there is a list, there is a champion. Let's congratulate the different champions in different aspects.
Part 1 Statistics of the data on the whole
There are total 41311 products in the Orange Book(42nd Edition) 202203 under two major application types, ANDA and NDA. The champion goes to ANDA, about 3.17times of NDA.
Sheet 1 Total products in two application types-ANDA & NDA
NDA: New Drug Application
ANDA: Abbreviated New Drug Application
Partly because of age(a joke only, we donot know the exact reason), all products approved before 1982 were connected in the time period named “Approved Prior to Jan 1, 1982” . In 2019( the champion), total 1835 products were approved, about 8.95times of the figure in 1990(the lowest). The period from 1989-1995 should be further investigated because of obvious low approval records.
Sheet 2 Annual record of approvals
There are total 5118 APIs(including combined APIs because of 2 or more APIs were used in the same dosage form; to make it simple, the combined APIs were treated as a new API) used for the 41311 products. The special team “ACETAMINOPHEN; HYDROCODONE BITARTRATE” won the champion by covering 251 products.
Sheet 3 Top20 ingredients
Among the 1836 applicants, WATSON LABORATORIES INC is the champion holding the most products up to 1225. Mylan ranks the second with 1119 products and Sandoz the third with 775products. You can see many Indian pharma companies in the Top20 list.
Sheet 4 Top20 applicants
When DF-Route(Dosage forms and routes of administration) is concerned, TABLET;ORAL is leading the way as the champion with 17094 products, more than double of the silver medal winner- INJECTABLE;INJECTION, 6663products. For your info, there are total 293 categories mentioned for DF-Route(Dosage forms and routes of administration) in Orange Book Edition 42.
Sheet 5 Top20 DF-Routes
When the time period is tightened to 2012-2021(a decade), we will find some different ranks in terms of applicants and ingredients. Indian companies are dominating the major parts of the list.
Sheet 5 Top20 Applicants during 2012-2021
There are also changes in ingredient list during 2012-2021.METHYLPHENIDATE HYDROCHLORIDE won the champion
Sheet 6 Top20 Ingredients during 2012-2021
Part 2 NDA statistics
The total NDAs included in Orange Book Edition 42 are 9906. NOVARTIS PHARMACEUTICALS CORP takes the first place with 372 products.
Sheet 7 Top20 NDA applicants
For NDAs, the most popular ingredient goes to HEPARIN SODIUM with 161 products.
Sheet 8 Top20 NDA ingredients
As the same way, when the time period is limited from 2012-2021, the situation for NDAs also changes a lot. The applicant champion goes to TAKEDA PHARMACEUTICALS USA INC.
Sheet 9 Top20 NDA applicants during 2012-2021
Among the top20 NDA ingredients list during 2012-2021, we could see more anti-cancer agents. METHOTREXATE takes the lead with 33 products.
Sheet 10 Top20 NDA ingredients during 2012-2021
Part 3 Rx-OTC Statistics
If all the products are categorized as per Type, there would be three types, Rx(51.66%, OTC 1.86% and DISCN(Discontinued). It is a big surprise to note 46.68% of the total goes to DISCN(to be separately discussed in part 4).
Sheet 11 Total products in three Types-Rx, OTC and DISCN
Among the top 20 applicants for Rx and OTC, Aurobindo is standing at the very top with 669 products. And the whole list is corresponding to Sheet 5 Top20 Applicants during 2012-2021 bearing strong Indian advantages, partly because of the fast growing global business of the Indian pharma companies during the period.
Sheet 12 Top20 Applicants from Type Rx and OTC
It is almost the same case for Top 20 ingredient list from Type Rx and OTC which matches the Top 20 ingredient list from 2012-2021(Sheet 6 Top20 Ingredients during 2012-2021).
Sheet 13 Top20 Ingredients from Type Rx and OTC
Part 4 DISCN Statistics
The total product count for 41311 is huge and the figure 19202 dominated by DISCN is a big surprise which indicates nearly half of the approvals are sleeping. What is more, the applicant at the foremost place of DISCN is the same one – the Grand Champion among 41311- WATSON LABORATORIES INC, so does the second player. There should be some stories behind the cold figures.
Sheet 13 Top20 applicants from Type DISCN
Associated with Top20 applicants from the DISCN type, there are Top20 ingredients related DISCN type listed as below. Either arranged or coincidentally placed in the list, the champion is the same as the Grand Champion as listed in Sheet 3 Top20 ingredients-- ACETAMINOPHEN; HYDROCODONE BITARTRATE. And HEPARIN SODIUM should have had a nightmare—161 products are all sleeping.
Sheet 15 Top20 Ingredients from Type DISCN
The market is just like the battlefields—the field is always there while the players are constantly changing. There should be many reasons for a company or an ingredient to be in a certain list. When looking deep into the list in Sheet 16, age could be one of the major causes.
Sheet 15 Top20 Years from Type DISCN
Part 5 Ingredient and DF-Route
It couldnot be technically useful but it might be interesting to name the champion of ingredients which has the most dosage forms. Just close your eyes and put your imagination into practice. Have you got some ideas? Yes, it is TRIAMCINOLONE ACETONIDE-covering 14 dosage forms. Among the list you will find more ingredients in the categories of Hormones and Antibiotics.
Sheet 16 Top20 ingredients against DF-Route
If you have further interests, you may find the list of all 14 dosage forms of TRIAMCINOLONE ACETONIDE as below:
Sheet 17 The 14 dosage forms of TRIAMCINOLONE ACETONIDE
The US market is one of the most attractive markets for pharmaceutical manufacturers and players worldwide. Are you already in the game or are you preparing for the entry? If you have more stories to share, please follow us or mail to sales@vcommend.com.
US Pharma market is the biggest one in the world. You may find more reports and analysis on US Innovative Medicines. Here we have tried to present you some sheets regarding Generics according to the Orange Book(42nd Edition) 202203. Where there is a list, there is a champion. Let's congratulate the different champions in different aspects.
Part 1 Statistics of the data on the whole
There are total 41311 products in the Orange Book(42nd Edition) 202203 under two major application types, ANDA and NDA. The champion goes to ANDA, about 3.17times of NDA.
| Applicant type | Product Count | Ratio |
| A(ANDA) | 31405 | 76.02% |
| N(NDA) | 9906 | 23.98% |
| Total | 41311 | 100.00% |
NDA: New Drug Application
ANDA: Abbreviated New Drug Application
Partly because of age(a joke only, we donot know the exact reason), all products approved before 1982 were connected in the time period named “Approved Prior to Jan 1, 1982” . In 2019( the champion), total 1835 products were approved, about 8.95times of the figure in 1990(the lowest). The period from 1989-1995 should be further investigated because of obvious low approval records.
| Rank | Year | Products |
| Before 1982 | 5872 | |
| 1 | 2019 | 1835 |
| 2 | 2017 | 1834 |
| 3 | 2018 | 1684 |
| 4 | 2020 | 1576 |
| 5 | 2021 | 1495 |
| 6 | 2016 | 1436 |
| 7 | 2015 | 1284 |
| 8 | 2012 | 1257 |
| 9 | 2008 | 1170 |
| 10 | 2007 | 1154 |
| 11 | 2009 | 1144 |
| 12 | 2011 | 1123 |
| 13 | 2013 | 1028 |
| 14 | 2010 | 1012 |
| 15 | 2014 | 987 |
| 16 | 1988 | 927 |
| 17 | 2006 | 891 |
| 18 | 2004 | 880 |
| 19 | 1986 | 852 |
| 20 | 1987 | 841 |
| 21 | 2002 | 809 |
| 22 | 2005 | 780 |
| 23 | 1985 | 688 |
| 24 | 1997 | 659 |
| 25 | 2003 | 653 |
| 26 | 1984 | 650 |
| 27 | 2000 | 650 |
| 28 | 1982 | 630 |
| 29 | 1996 | 603 |
| 30 | 1998 | 550 |
| 31 | 1983 | 538 |
| 32 | 2001 | 482 |
| 33 | 1995 | 460 |
| 34 | 1999 | 428 |
| 35 | 1989 | 428 |
| 36 | 2022 | 403 |
| 37 | 1992 | 391 |
| 38 | 1993 | 379 |
| 39 | 1994 | 336 |
| 40 | 1991 | 307 |
| 41 | 1990 | 205 |
| Total | 41311 | |
There are total 5118 APIs(including combined APIs because of 2 or more APIs were used in the same dosage form; to make it simple, the combined APIs were treated as a new API) used for the 41311 products. The special team “ACETAMINOPHEN; HYDROCODONE BITARTRATE” won the champion by covering 251 products.
| Rank | Ingredient | Products |
| 1 | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 251 |
| 2 | IBUPROFEN | 248 |
| 3 | METHYLPHENIDATE HYDROCHLORIDE | 240 |
| 4 | HEPARIN SODIUM | 229 |
| 5 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 225 |
| 6 | METFORMIN HYDROCHLORIDE | 215 |
| 7 | LAMOTRIGINE | 212 |
| 8 | MORPHINE SULFATE | 209 |
| 9 | LEVETIRACETAM | 209 |
| 10 | RISPERIDONE | 204 |
| 11 | POTASSIUM CHLORIDE | 203 |
| 12 | AMITRIPTYLINE HYDROCHLORIDE | 194 |
| 13 | LEVOTHYROXINE SODIUM | 191 |
| 14 | PREGABALIN | 189 |
| 15 | DILTIAZEM HYDROCHLORIDE | 186 |
| 16 | OLANZAPINE | 185 |
| 17 | PROPRANOLOL HYDROCHLORIDE | 179 |
| 18 | HYDROCORTISONE | 179 |
| 19 | PRAMIPEXOLE DIHYDROCHLORIDE | 175 |
| 20 | TRIAMCINOLONE ACETONIDE | 173 |
| Total top20 | 4096 | |
| Percentage from 41311 | 9.92% |
Among the 1836 applicants, WATSON LABORATORIES INC is the champion holding the most products up to 1225. Mylan ranks the second with 1119 products and Sandoz the third with 775products. You can see many Indian pharma companies in the Top20 list.
| Rank | Applicant Holder | Products |
| 1 | WATSON LABORATORIES INC | 1225 |
| 2 | MYLAN PHARMACEUTICALS INC | 1119 |
| 3 | SANDOZ INC | 775 |
| 4 | HOSPIRA INC | 762 |
| 5 | AUROBINDO PHARMA LTD | 739 |
| 6 | TEVA PHARMACEUTICALS USA INC | 682 |
| 7 | SUN PHARMACEUTICAL INDUSTRIES LTD | 617 |
| 8 | ZYDUS PHARMACEUTICALS USA INC | 546 |
| 9 | HIKMA PHARMACEUTICALS USA INC | 538 |
| 10 | FRESENIUS KABI USA LLC | 485 |
| 11 | TEVA PHARMACEUTICALS USA | 481 |
| 12 | APOTEX INC | 470 |
| 13 | SUN PHARMACEUTICAL INDUSTRIES INC | 463 |
| 14 | STRIDES PHARMA GLOBAL PTE LTD | 449 |
| 15 | DR REDDYS LABORATORIES LTD | 436 |
| 16 | BAXTER HEALTHCARE CORP | 429 |
| 17 | ANI PHARMACEUTICALS INC | 424 |
| 18 | NOVARTIS PHARMACEUTICALS CORP | 391 |
| 19 | LUPIN LTD | 352 |
| 20 | AKORN OPERATING CO LLC | 319 |
| Total top20 | 11702 | |
| Percentage from 41311 | 28.32% | |
When DF-Route(Dosage forms and routes of administration) is concerned, TABLET;ORAL is leading the way as the champion with 17094 products, more than double of the silver medal winner- INJECTABLE;INJECTION, 6663products. For your info, there are total 293 categories mentioned for DF-Route(Dosage forms and routes of administration) in Orange Book Edition 42.
| Rank | DF-Route | Products |
| 1 | TABLET;ORAL | 17094 |
| 2 | INJECTABLE;INJECTION | 6663 |
| 3 | CAPSULE;ORAL | 4376 |
| 4 | TABLET, EXTENDED RELEASE;ORAL | 2132 |
| 5 | CAPSULE, EXTENDED RELEASE;ORAL | 1027 |
| 6 | CREAM;TOPICAL | 555 |
| 7 | SOLUTION;ORAL | 543 |
| 8 | INJECTABLE;INTRAVENOUS | 495 |
| 9 | SOLUTION;INTRAVENOUS | 485 |
| 10 | SOLUTION/DROPS;OPHTHALMIC | 476 |
| 11 | FOR SUSPENSION;ORAL | 427 |
| 12 | TABLET, ORALLY DISINTEGRATING;ORAL | 390 |
| 13 | SYRUP;ORAL | 344 |
| 14 | OINTMENT;TOPICAL | 336 |
| 15 | TABLET, DELAYED RELEASE;ORAL | 309 |
| 16 | SUSPENSION;ORAL | 280 |
| 17 | CAPSULE, DELAYED REL PELLETS;ORAL | 243 |
| 18 | SOLUTION;TOPICAL | 231 |
| 19 | TABLET;ORAL-28 | 227 |
| 20 | TABLET, CHEWABLE;ORAL | 219 |
| Total top20 DF-Route | 36852 | |
| Percentage from 41311 | 89.20% |
When the time period is tightened to 2012-2021(a decade), we will find some different ranks in terms of applicants and ingredients. Indian companies are dominating the major parts of the list.
| Rank | Applicant | Total |
| 1 | AUROBINDO | 450 |
| 2 | ZYDUS PHARMS | 374 |
| 3 | MYLAN | 282 |
| 4 | ACCORD HLTHCARE | 257 |
| 5 | ALEMBIC | 241 |
| 6 | TEVA PHARMS | 235 |
| 7 | LUPIN LTD | 233 |
| 8 | SUN PHARM | 231 |
| 9 | ALKEM LABS LTD | 219 |
| 10 | MACLEODS | 192 |
| 11 | STRIDES PHARMA | 191 |
| 12 | AMNEAL PHARMS | 181 |
| 13 | HIKMA | 165 |
| 14 | RISING | 163 |
| 15 | FRESENIUS KABI | 161 |
| 16 | AMNEAL | 158 |
| 17 | EUGIA PHARMA | 157 |
| 18 | MYLAN LABS LTD | 145 |
| 19 | APOTEX | 136 |
| 20 | DR REDDYS | 134 |
Sheet 5 Top20 Applicants during 2012-2021
There are also changes in ingredient list during 2012-2021.METHYLPHENIDATE HYDROCHLORIDE won the champion
| Rank | Ingredient | Products |
| 1 | METHYLPHENIDATE HYDROCHLORIDE | 189 |
| 2 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 171 |
| 3 | PREGABALIN | 168 |
| 4 | QUETIAPINE FUMARATE | 154 |
| 5 | OLANZAPINE | 151 |
| 6 | ARIPIPRAZOLE | 133 |
| 7 | ROSUVASTATIN CALCIUM | 112 |
| 8 | MORPHINE SULFATE | 112 |
| 9 | POTASSIUM CHLORIDE | 108 |
| 10 | TADALAFIL | 103 |
| 11 | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 95 |
| 12 | PRAMIPEXOLE DIHYDROCHLORIDE | 94 |
| 13 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 94 |
| 14 | MEMANTINE HYDROCHLORIDE | 89 |
| 15 | CELECOXIB | 86 |
| 16 | TEMOZOLOMIDE | 83 |
| 17 | FENOFIBRATE | 82 |
| 18 | LAMOTRIGINE | 81 |
| 19 | DEFERASIROX | 80 |
| 20 | METFORMIN HYDROCHLORIDE | 78 |
Part 2 NDA statistics
The total NDAs included in Orange Book Edition 42 are 9906. NOVARTIS PHARMACEUTICALS CORP takes the first place with 372 products.
| Rank | Company | Products |
| 1 | NOVARTIS PHARMACEUTICALS CORP | 372 |
| 2 | BAXTER HEALTHCARE CORP | 328 |
| 3 | B BRAUN MEDICAL INC | 277 |
| 4 | HOSPIRA INC | 264 |
| 5 | PFIZER INC | 236 |
| 6 | GLAXOSMITHKLINE | 180 |
| 7 | SANOFI AVENTIS US LLC | 158 |
| 8 | ELI LILLY AND CO | 157 |
| 9 | ABBVIE INC | 154 |
| 10 | JANSSEN PHARMACEUTICALS INC | 138 |
| 11 | FRESENIUS KABI USA LLC | 128 |
| 12 | ICU MEDICAL INC | 127 |
| 13 | ALLERGAN SALES LLC | 113 |
| 14 | HOFFMANN LA ROCHE INC | 110 |
| 15 | BAUSCH HEALTH US LLC | 105 |
| 16 | TAKEDA PHARMACEUTICALS USA INC | 103 |
| 17 | MERCK AND CO INC | 95 |
| 18 | SCHERING CORP SUB SCHERING PLOUGH CORP | 90 |
| 19 | BAYER HEALTHCARE PHARMACEUTICALS INC | 88 |
| 20 | ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV | 82 |
For NDAs, the most popular ingredient goes to HEPARIN SODIUM with 161 products.
| Rank | Ingredient | Products |
| 1 | HEPARIN SODIUM | 161 |
| 2 | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 135 |
| 3 | LEVOTHYROXINE SODIUM | 119 |
| 4 | MORPHINE SULFATE | 64 |
| 5 | SODIUM CHLORIDE | 52 |
| 6 | AMINO ACIDS | 48 |
| 7 | LIDOCAINE HYDROCHLORIDE | 47 |
| 8 | ESTRADIOL | 47 |
| 9 | METHYLPHENIDATE HYDROCHLORIDE | 46 |
| 10 | DEXTROSE; SODIUM CHLORIDE | 46 |
| 11 | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 45 |
| 12 | DEXTROSE | 43 |
| 13 | AMINO ACIDS; DEXTROSE | 41 |
| 14 | DILTIAZEM HYDROCHLORIDE | 39 |
| 15 | FUROSEMIDE | 39 |
| 16 | RESERPINE | 38 |
| 17 | MANNITOL | 38 |
| 18 | IBUPROFEN | 37 |
| 19 | DOCETAXEL | 37 |
| 20 | METRONIDAZOLE | 36 |
As the same way, when the time period is limited from 2012-2021, the situation for NDAs also changes a lot. The applicant champion goes to TAKEDA PHARMACEUTICALS USA INC.
| Rank | Applicant | Products |
| 1 | TAKEDA PHARMACEUTICALS USA INC | 51 |
| 2 | FRESENIUS KABI USA LLC | 46 |
| 3 | NOVARTIS PHARMACEUTICALS CORP | 43 |
| 4 | SUN PHARMACEUTICAL INDUSTRIES LTD | 37 |
| 5 | GILEAD SCIENCES INC | 34 |
| 6 | BOEHRINGER INGELHEIM PHARMACEUTICALS INC | 33 |
| 7 | MERCK SHARP AND DOHME CORP | 32 |
| 8 | JANSSEN PHARMACEUTICALS INC | 31 |
| 9 | ALLERGAN SALES LLC | 26 |
| 10 | PFIZER INC | 26 |
| 11 | OTSUKA PHARMACEUTICAL CO LTD | 22 |
| 12 | ABBVIE INC | 21 |
| 13 | BAYER HEALTHCARE PHARMACEUTICALS INC | 21 |
| 14 | EXELA PHARMA SCIENCES LLC | 20 |
| 15 | HOSPIRA INC | 20 |
| 16 | PURDUE PHARMA LP | 18 |
| 17 | ASTRAZENECA AB | 17 |
| 18 | INSTITUT BIOCHIMIQUE SA (IBSA) | 17 |
| 19 | ASTRAZENECA PHARMACEUTICALS LP | 17 |
| 20 | ACCORD HEALTHCARE INC | 15 |
Among the top20 NDA ingredients list during 2012-2021, we could see more anti-cancer agents. METHOTREXATE takes the lead with 33 products.
| Rank | Ingredient | Products |
| 1 | METHOTREXATE | 33 |
| 2 | DOCETAXEL | 24 |
| 3 | METHYLPHENIDATE HYDROCHLORIDE | 23 |
| 4 | LEVOTHYROXINE SODIUM | 22 |
| 5 | HYDROCODONE BITARTRATE | 18 |
| 6 | MORPHINE SULFATE | 17 |
| 7 | GEMCITABINE HYDROCHLORIDE | 14 |
| 8 | VANCOMYCIN HYDROCHLORIDE | 13 |
| 9 | BARIUM SULFATE | 13 |
| 10 | ISOTRETINOIN | 12 |
| 11 | PHENYLEPHRINE HYDROCHLORIDE | 12 |
| 12 | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | 12 |
| 13 | TOPIRAMATE | 10 |
| 14 | TESTOSTERONE | 10 |
| 15 | SEMAGLUTIDE | 10 |
| 16 | PONESIMOD | 10 |
| 17 | EPINEPHRINE | 10 |
| 18 | ARIPIPRAZOLE | 10 |
| 19 | MINOCYCLINE HYDROCHLORIDE | 9 |
| 20 | SELEXIPAG | 9 |
Part 3 Rx-OTC Statistics
If all the products are categorized as per Type, there would be three types, Rx(51.66%, OTC 1.86% and DISCN(Discontinued). It is a big surprise to note 46.68% of the total goes to DISCN(to be separately discussed in part 4).
| Type | Products | Ratio |
| Rx | 21341 | 51.66% |
| DISCN | 19202 | 46.48% |
| OTC | 768 | 1.86% |
| Total | 41311 | 100.00% |
Among the top 20 applicants for Rx and OTC, Aurobindo is standing at the very top with 669 products. And the whole list is corresponding to Sheet 5 Top20 Applicants during 2012-2021 bearing strong Indian advantages, partly because of the fast growing global business of the Indian pharma companies during the period.
| Rank | Applicant | Product |
| 1 | AUROBINDO PHARMA LTD | 669 |
| 2 | ZYDUS PHARMACEUTICALS USA INC | 488 |
| 3 | SANDOZ INC | 465 |
| 4 | SUN PHARMACEUTICAL INDUSTRIES LTD | 443 |
| 5 | MYLAN PHARMACEUTICALS INC | 376 |
| 6 | HIKMA PHARMACEUTICALS USA INC | 365 |
| 7 | FRESENIUS KABI USA LLC | 356 |
| 8 | DR REDDYS LABORATORIES LTD | 338 |
| 9 | HOSPIRA INC | 321 |
| 10 | LUPIN LTD | 312 |
| 11 | APOTEX INC | 306 |
| 12 | TEVA PHARMACEUTICALS USA INC | 291 |
| 13 | ACCORD HEALTHCARE INC | 291 |
| 14 | BAXTER HEALTHCARE CORP | 266 |
| 15 | ALEMBIC PHARMACEUTICALS LTD | 256 |
| 16 | TEVA PHARMACEUTICALS USA | 247 |
| 17 | ALKEM LABORATORIES LTD | 237 |
| 18 | AKORN OPERATING CO LLC | 225 |
| 19 | STRIDES PHARMA GLOBAL PTE LTD | 223 |
| 20 | SUN PHARMACEUTICAL INDUSTRIES INC | 182 |
It is almost the same case for Top 20 ingredient list from Type Rx and OTC which matches the Top 20 ingredient list from 2012-2021(Sheet 6 Top20 Ingredients during 2012-2021).
| Rank | Ingredient | Products |
| 1 | METHYLPHENIDATE HYDROCHLORIDE | 188 |
| 2 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 179 |
| 3 | PREGABALIN | 175 |
| 4 | LEVOTHYROXINE SODIUM | 158 |
| 5 | LEVETIRACETAM | 156 |
| 6 | LAMOTRIGINE | 155 |
| 7 | METFORMIN HYDROCHLORIDE | 135 |
| 8 | QUETIAPINE FUMARATE | 134 |
| 9 | OLANZAPINE | 132 |
| 10 | RISPERIDONE | 125 |
| 11 | POTASSIUM CHLORIDE | 123 |
| 12 | ARIPIPRAZOLE | 121 |
| 13 | VENLAFAXINE HYDROCHLORIDE | 117 |
| 14 | DILTIAZEM HYDROCHLORIDE | 113 |
| 15 | IBUPROFEN | 108 |
| 16 | CETIRIZINE HYDROCHLORIDE | 108 |
| 17 | MORPHINE SULFATE | 103 |
| 18 | PRAMIPEXOLE DIHYDROCHLORIDE | 100 |
| 19 | FENOFIBRATE | 98 |
| 20 | TADALAFIL | 95 |
Part 4 DISCN Statistics
The total product count for 41311 is huge and the figure 19202 dominated by DISCN is a big surprise which indicates nearly half of the approvals are sleeping. What is more, the applicant at the foremost place of DISCN is the same one – the Grand Champion among 41311- WATSON LABORATORIES INC, so does the second player. There should be some stories behind the cold figures.
| Rank | Applicant | Products |
| 1 | WATSON LABORATORIES INC | 1051 |
| 2 | MYLAN PHARMACEUTICALS INC | 743 |
| 3 | HOSPIRA INC | 441 |
| 4 | TEVA PHARMACEUTICALS USA INC | 391 |
| 5 | SANDOZ INC | 310 |
| 6 | ANI PHARMACEUTICALS INC | 310 |
| 7 | SUN PHARMACEUTICAL INDUSTRIES INC | 281 |
| 8 | TEVA PHARMACEUTICALS USA | 234 |
| 9 | IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA | 233 |
| 10 | GLAXOSMITHKLINE | 227 |
| 11 | STRIDES PHARMA GLOBAL PTE LTD | 226 |
| 12 | NOVARTIS PHARMACEUTICALS CORP | 221 |
| 13 | APOTHECON INC DIV BRISTOL MYERS SQUIBB | 200 |
| 14 | CHARTWELL RX SCIENCES LLC | 185 |
| 15 | SUN PHARMACEUTICAL INDUSTRIES LTD | 174 |
| 16 | ELI LILLY AND CO | 173 |
| 17 | HIKMA PHARMACEUTICALS USA INC | 173 |
| 18 | ROXANE LABORATORIES INC | 166 |
| 19 | APOTEX INC | 164 |
| 20 | BAXTER HEALTHCARE CORP | 163 |
Associated with Top20 applicants from the DISCN type, there are Top20 ingredients related DISCN type listed as below. Either arranged or coincidentally placed in the list, the champion is the same as the Grand Champion as listed in Sheet 3 Top20 ingredients-- ACETAMINOPHEN; HYDROCODONE BITARTRATE. And HEPARIN SODIUM should have had a nightmare—161 products are all sleeping.
| Rank | Ingredient | Products |
| 1 | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 171 |
| 2 | HEPARIN SODIUM | 161 |
| 3 | AMITRIPTYLINE HYDROCHLORIDE | 146 |
| 4 | HYDROCORTISONE | 143 |
| 5 | IBUPROFEN | 140 |
| 6 | THEOPHYLLINE | 136 |
| 7 | PROPRANOLOL HYDROCHLORIDE | 115 |
| 8 | PREDNISONE | 113 |
| 9 | ACETAMINOPHEN; CODEINE PHOSPHATE | 110 |
| 10 | MORPHINE SULFATE | 106 |
| 11 | HYDROXYZINE HYDROCHLORIDE | 102 |
| 12 | DIPHENHYDRAMINE HYDROCHLORIDE | 99 |
| 13 | HYDROCHLOROTHIAZIDE | 96 |
| 14 | LIDOCAINE HYDROCHLORIDE | 93 |
| 15 | TRIAMCINOLONE ACETONIDE | 91 |
| 16 | PHENDIMETRAZINE TARTRATE | 91 |
| 17 | CHLORPROMAZINE HYDROCHLORIDE | 91 |
| 18 | PROMETHAZINE HYDROCHLORIDE | 90 |
| 19 | RANITIDINE HYDROCHLORIDE | 90 |
| 20 | THIORIDAZINE HYDROCHLORIDE | 90 |
The market is just like the battlefields—the field is always there while the players are constantly changing. There should be many reasons for a company or an ingredient to be in a certain list. When looking deep into the list in Sheet 16, age could be one of the major causes.
| Rank | Year | DISCN | All Products |
| 1 | Before 1982 | 5143 | 5872 |
| 2 | 1986 | 699 | 852 |
| 3 | 1988 | 681 | 927 |
| 4 | 1987 | 677 | 841 |
| 5 | 1985 | 544 | 688 |
| 6 | 1984 | 533 | 650 |
| 7 | 1982 | 509 | 630 |
| 8 | 2007 | 478 | 1154 |
| 9 | 1983 | 444 | 538 |
| 10 | 2008 | 439 | 1170 |
| 11 | 2004 | 436 | 880 |
| 12 | 1997 | 404 | 336 |
| 13 | 2009 | 402 | 1144 |
| 14 | 1996 | 385 | 603 |
| 15 | 2000 | 359 | 650 |
| 16 | 2006 | 352 | 891 |
| 17 | 2010 | 348 | 1012 |
| 18 | 2002 | 341 | 809 |
| 19 | 2019 | 337 | 1835 |
| 20 | 1989 | 334 | 428 |
Part 5 Ingredient and DF-Route
It couldnot be technically useful but it might be interesting to name the champion of ingredients which has the most dosage forms. Just close your eyes and put your imagination into practice. Have you got some ideas? Yes, it is TRIAMCINOLONE ACETONIDE-covering 14 dosage forms. Among the list you will find more ingredients in the categories of Hormones and Antibiotics.
| Rank | Ingredient | DF-Route occupied |
| 1 | TRIAMCINOLONE ACETONIDE | 14 |
| 2 | HYDROCORTISONE | 12 |
| 3 | THEOPHYLLINE | 11 |
| 4 | ESTRADIOL | 11 |
| 5 | ERYTHROMYCIN | 11 |
| 6 | NYSTATIN | 10 |
| 7 | CLINDAMYCIN PHOSPHATE | 10 |
| 8 | DEXAMETHASONE | 10 |
| 9 | METHADONE HYDROCHLORIDE | 9 |
| 10 | HYDROCORTISONE ACETATE | 9 |
| 11 | NITROGLYCERIN | 9 |
| 12 | BETAMETHASONE DIPROPIONATE | 9 |
| 13 | MORPHINE SULFATE | 8 |
| 14 | TETRACYCLINE HYDROCHLORIDE | 8 |
| 15 | TESTOSTERONE | 8 |
| 16 | METRONIDAZOLE | 8 |
| 17 | MICONAZOLE NITRATE | 8 |
| 18 | MINOCYCLINE HYDROCHLORIDE | 8 |
| 19 | FLUOCINOLONE ACETONIDE | 8 |
| 20 | BUDESONIDE | 8 |
If you have further interests, you may find the list of all 14 dosage forms of TRIAMCINOLONE ACETONIDE as below:
| Ingredient | DF;Route |
| TRIAMCINOLONE ACETONIDE | AEROSOL, METERED;INHALATION |
| TRIAMCINOLONE ACETONIDE | AEROSOL, METERED;NASAL |
| TRIAMCINOLONE ACETONIDE | CREAM;TOPICAL |
| TRIAMCINOLONE ACETONIDE | FOR SUSPENSION, EXTENDED RELEASE;INTRA-ARTICULAR |
| TRIAMCINOLONE ACETONIDE | GEL;TOPICAL |
| TRIAMCINOLONE ACETONIDE | INJECTABLE;INJECTION |
| TRIAMCINOLONE ACETONIDE | INJECTABLE;INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL |
| TRIAMCINOLONE ACETONIDE | INJECTABLE;INTRAVITREAL |
| TRIAMCINOLONE ACETONIDE | LOTION;TOPICAL |
| TRIAMCINOLONE ACETONIDE | OINTMENT;TOPICAL |
| TRIAMCINOLONE ACETONIDE | PASTE;DENTAL |
| TRIAMCINOLONE ACETONIDE | SPRAY, METERED;NASAL |
| TRIAMCINOLONE ACETONIDE | SPRAY;TOPICAL |
| TRIAMCINOLONE ACETONIDE | SUSPENSION;INJECTION |
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