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ACTIVE PHARMA INGREDIENTS

68 API Suppliers, 29 USDMF, 1 JDMF, 7 EU WC, 21 KDMF, 25 NDC API, 53 Listed Suppliers, $ API Reference Price

68 API Suppliers
29 USDMF
1 JDMF
7 EU WC
21 KDMF
25 NDC API
53 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

34 Drugs in Development

34 Drugs in Development

INTERMEDIATES

58 Intermediates Suppliers

58 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

68 FDF Dossiers, 18 FDA Orange Book, 4 Europe, 9 Canada, 17 Australia, 1 South Africa, 19 Listed Dossiers

68 FDF Dossiers
18 FDA Orange Book
4 Europe
9 Canada
17 Australia
1 South Africa
19 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 3 SPI Pharma, 3 DKSH, 1 Jai Radhe Sales, 2 Boai NKY Pharmaceuticals Ltd, 10 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Alcedo Pharmachem, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 BASF, 5 DFE Pharma, 1 Finar, 4 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 1 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 17 Kerry, 10 Microlex e.U, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 3 Pluviaendo, 3 Prachin Chemical, 19 Roquette, 1 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

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52 Fillers, Diluents & Binders, 24 Direct Compression, 18 Film Formers & Plasticizers, 14 Disintegrants & Superdisintegrants, 12 Co-Processed Excipients, 12 Granulation, 11 Lubricants & Glidants, 11 Thickeners and Stabilizers, 11 Coating Systems & Additives, 8 Taste Masking, 5 Parenteral, 5 Controlled & Modified Release, 4 Chewable & Orodispersible Aids, 4 Solubilizers, 4 Topical, 3 Coloring Agents, 2 Emulsifying Agents, 2 Rheology Modifiers, 1 Soft Gelatin

DIGITAL CONTENT

8 DATA COMPILATION #PharmaFlow, 195 NEWS #PharmaBuzz

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8 DATA COMPILATION #PharmaFlow
195 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 2 Finished Drug Prices, 10 Annual Reports

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2 US Medicaid Prescriptions
2 Finished Drug Prices
10 Annual Reports

MARKET PLACE

21 APIs, 2 FDF Dossiers

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21 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

15 US Patents, 3 US Exclusivities, 3 Health Canada Patents

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15 US Patents
3 US Exclusivities
3 Health Canada Patents

REF. STANDARDS & IMPURITIES

24 Others

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24 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 16,069

MARKET PLACE

API

FDF

58INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

34DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

195

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

886,548,263

Annual Reports (USD Million)

15,156

Finished Drug Prices

120 RELATED EXCIPIENT COMPANIES

203EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 540737-29-9, Tasocitinib citrate, Xeljanz, Cp-690550 citrate, Tofacitinib (citrate), Tofacitinib (cp-690550) citrate

Molecular Formula

C₂₂H₂₈N₆O₈

Molecular Weight

504.5 g/mol

InChI Key

SYIKUFDOYJFGBQ-YLAFAASESA-N

FDA UNII

O1FF4DIV0D

1 2D Structure

Tofacitinib Citrate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2-hydroxypropane-1,2,3-tricarboxylic acid;3-[(3R,4R)-4-methyl-3-[methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino]piperidin-1-yl]-3-oxopropanenitrile

2.1.2 InChI

InChI=1S/C16H20N6O.C6H8O7/c1-11-5-8-22(14(23)3-6-17)9-13(11)21(2)16-12-4-7-18-15(12)19-10-20-16;7-3(8)1-6(13,5(11)12)2-4(9)10/h4,7,10-11,13H,3,5,8-9H2,1-2H3,(H,18,19,20);13H,1-2H2,(H,7,8)(H,9,10)(H,11,12)/t11-,13+;/m1./s1

2.1.3 InChI Key

SYIKUFDOYJFGBQ-YLAFAASESA-N

2.1.4 Canonical SMILES

CC1CCN(CC1N(C)C2=NC=NC3=C2C=CN3)C(=O)CC#N.C(C(=O)O)C(CC(=O)O)(C(=O)O)O

2.1.5 Isomeric SMILES

C[C@@H]1CCN(C[C@@H]1N(C)C2=NC=NC3=C2C=CN3)C(=O)CC#N.C(C(=O)O)C(CC(=O)O)(C(=O)O)O

2.2 Other Identifiers

2.2.1 UNII

O1FF4DIV0D

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Cp 690,550

2. Cp 690550

3. Cp-690,550

4. Cp-690550

5. Cp690550

6. Tasocitinib

7. Tofacitinib

8. Xeljanz

2.3.2 Depositor-Supplied Synonyms

1. 540737-29-9

2. Tasocitinib Citrate

3. Xeljanz

4. Cp-690550 Citrate

5. Tofacitinib (citrate)

6. Tofacitinib (cp-690550) Citrate

7. Xeljanz Xr

8. Tofacitinib Citrate [usan]

9. Cp-690,550-10

10. Tasocitinib Monocitrate

11. 540737-29-9 (citrate)

12. Cp-690550-10

13. Cp 690550 Citrate

14. O1ff4div0d

15. 3-((3r,4r)-4-methyl-3-(methyl(7h-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanenitrile 2-hydroxypropane-1,2,3-tricarboxylate

16. Chebi:71197

17. 1-piperidinepropanenitrile, 4-methyl-3-(methyl-7h-pyrrolo(2,3-d)pyrimidin-4-ylamino)- Beta-oxo-, (3r,4r)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

18. 2-hydroxypropane-1,2,3-tricarboxylic Acid; 3-[(3r,4r)-4-methyl-3-[methyl({7h-pyrrolo[2,3-d]pyrimidin-4-yl})amino]piperidin-1-yl]-3-oxopropanenitrile

19. 2-hydroxypropane-1,2,3-tricarboxylic Acid;3-[(3r,4r)-4-methyl-3-[methyl(7h-pyrrolo[2,3-d]pyrimidin-4-yl)amino]piperidin-1-yl]-3-oxopropanenitrile

20. Unii-o1ff4div0d

21. Mfcd11616529

22. 3-{(3r,4r)-4-methyl-3-[methyl(7h-pyrrolo[2,3-d]pyrimidin-4-yl)amino]piperidin-1-yl}-3-oxopropanenitrile 2-hydroxypropane-1,2,3-tricarboxylate

23. 3-{(3r,4r)-4-methyl-3-[methyl-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile Citrate Salt

24. 3-{(3r,4r)-4-methyl-3-[methyl-(7h-pyrrolo[2,3-d]pyrimidin-4-yl}-amino]-piperidin-1-yl)-3-oxo-propionitrile Citrate Salt

25. Xeljanz (tn)

26. Tofacitinib Monocitrate

27. Tasocitinib Citric Acid Salt

28. Cep-18770(delanzomib)

29. Mls006010058

30. Schembl1374185

31. Chembl2103743

32. Tofacitinib Citrate (jan/usan)

33. Amy4175

34. Dtxsid80202404

35. Ex-a204

36. Tofacitinib Citrate [jan]

37. C16h20n6o.c6h8o7

38. Tofacitinib Monocitrate [mi]

39. Hy-40354a

40. S5001

41. Tofacitinib Citrate [who-dd]

42. Akos022178222

43. Cp-690550 - Tofacitinib Citrate

44. Tofacitinib Citrate, >=98% (hplc)

45. Ccg-269730

46. Cs-0928

47. Tofacitinib Citrate [orange Book]

48. Ac-25004

49. As-19392

50. Bt163661

51. Smr004701220

52. Cp-690550 Citrate (tofacitinib Citrate)

53. Tofacitinib Citrate (cp-690550 Citrate)

54. Cp 690550-10

55. D09783

56. Q27139435

57. (3r,4r)-4-methyl-3-(methyl-7h-pyrro Lo[2,3-d]pyrimidin-4-ylamino)-beta-oxo-1-piperidinepro Panenitrile Citrate

58. (3r,4r)-4-methyl-3-(methyl-7h-pyrrolo[2,3-d]pyrimidin-4-ylamino)-?-oxo-1-piperidinepropanenitrile Citrate

59. (3r,4r)-4-methyl-3-(methyl-7h-pyrrolo[2,3-d]pyrimidin-4-ylamino)-beta-oxo-1-piperidine Propanenitrile 2-hydroxy-1,2,3-propanetricarboxylate

60. (3r,4r)-4-methyl-3-(methyl-7h-pyrrolo[2,3-d]pyrimidin-4-ylamino)-ss-oxo-1-piperidinepropanenitrile Citrate Salt

61. 1-piperidinepropanenitrile, 4-methyl-3-(methyl-7h-pyrrolo(2,3-d)pyrimidin-4-ylamino)-.beta.-oxo-, (3r,4r)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

62. 1-piperidinepropanenitrile,4-methyl-3-(methyl-7h-pyrrolo[2,3-d]pyrimidin-4-ylamino)-beta-oxo-,(3r,4r)-,2-hydroxy-1,2,3-propanetricarboxylate(1:1)

63. 3-((3r,4r)-4-methyl-3-(methyl(7h-pyrrolo(2,3-d)pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxo-propanenitrile2-hydroxypropane-1,2,3-tricarboxylate (1:1)

64. 3-((3r,4r)-4-methyl-3-(methyl(7h-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanenitrile Mono Citrate Salt

65. 3-{(3r,4r)-4-methyl-3-[methyl-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile Mono Citrate Salt

2.4 Create Date

2006-10-25

3 Chemical and Physical Properties

Molecular Formula	C₂₂H₂₈N₆O₈
Molecular Weight	504.5 g/mol
Hydrogen Bond Donor Count	5
Hydrogen Bond Acceptor Count	12
Rotatable Bond Count	8
Exact Mass	504.19686187 g/mol
Monoisotopic Mass	504.19686187 g/mol
Topological Polar Surface Area	221 Å²
Heavy Atom Count	36
Formal Charge	0
Complexity	716
Isotope Atom Count	0
Defined Atom Stereocenter Count	2
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Xeljanz
PubMed Health	Tofacitinib (By mouth)
Drug Classes	Antirheumatic, Musculoskeletal Agent
Drug Label	XELJANZ is the citrate salt of tofacitinib, a JAK inhibitor.Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)--oxo-1-piperidinepropanenitrile, 2-hy...
Active Ingredient	Tofacitinib citrate
Dosage Form	Tablet
Route	Oral
Strength	eq 5mg base
Market Status	Prescription
Company	Pf Prism Cv

2 of 2
Drug Name	Xeljanz
PubMed Health	Tofacitinib (By mouth)
Drug Classes	Antirheumatic, Musculoskeletal Agent
Drug Label	XELJANZ is the citrate salt of tofacitinib, a JAK inhibitor.Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)--oxo-1-piperidinepropanenitrile, 2-hy...
Active Ingredient	Tofacitinib citrate
Dosage Form	Tablet
Route	Oral
Strength	eq 5mg base
Market Status	Prescription
Company	Pf Prism Cv

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Janus Kinase Inhibitors

Agents that inhibit JANUS KINASES. (See all compounds classified as Janus Kinase Inhibitors.)

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API Reference Price

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DATA COMPILATION #PharmaFlow

Company Tracker: Pfizer turns to acquisitions as Covid products’ sales nosedive

Over the last five years, a lot has changed for Pfizer Inc, one of the world’s leading pharmaceutical companies based on pharma sales revenue. From entering into an agreement with German biotechnology company BioNTech SE in August 2018 for joint research and development of mRNA-based influenza vaccines to merging its off-patent branded and generic drug business, known as Upjohn, with Mylan to form Viatris and launching Covid-19 vaccine Comirnaty and antiviral drug Paxlovid during the pandemic, the New York-headquartered pharma giant has witnessed substantial transformation in the recent past.The launch of Covid products was undoubtedly the biggest event for the 174-year-old drugmaker, propelling it to the number 1 slot in 2021 with a turnover of US$ 81.3 billion, surpassing competitors such as AbbVie, Johnson & Johnson, Novartis, Roche, Bristol Myers Squibb, Merck, and several others. In 2022, Pfizer further consolidated its position, with revenues exceeding US$ 100 billion, largely due to the success of its Covid products. This success of Covid products filled Pfizer’s coffers, allowing it to expand through the acquisition of smaller companies. Pfizer’s new brand identity and logo, unveiled in 2021, signaled the company's shift from "commerce to science".Pfizer commercially operates through two segments — Biopharma, or its innovative science-based biopharmaceutical business that posted revenues worth US$ 98.98 billion in 2022, and Pfizer CentreOne (PC1), a global contract development and manufacturing organization as well as a leading supplier of specialty active pharmaceutical ingredients (APIs) with US$ 1.3 billion in 2022 revenues.Pfizer’s core therapeutic areas are inflammation and immunology, internal medicine, oncology, rare diseases, vaccines and anti-infectives.View our Dashboard to know more about Pfizer's Drugs in Development (Free Excel)Pfizer in acquisition overdrive: Buys Seagen for US$ 43 bn, Biohaven for US$ 11.6 bnPfizer has been utilizing its war chest generated during the pandemic in acquiring companies that would help grow the business when Covid is behind us and its other best-selling drugs (such as Ibrance, Vyndaqel/Vyndamax, Xeljanz and Xtandi) face expiration of patents. In November 2021, Pfizer snapped up Trillium Therapeutics for US$ 2.22 billion. Trillium is a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer. In March 2022, Pfizer acquired Arena Pharmaceuticals for US$ 6.7 billion, a company that develops novel therapies to treat immune-inflammatory ailments. Then, in Oct 2022 it completed the US$ 11.6 billion buyout of migraine specialist Biohaven. This brought Biohaven’s leading oral migraine drug in the US – Nurtec ODT (rimegepant) – into Pfizer’s fold. In June 2022, Pfizer completed the acquisition of ReViral Limited, gaining access to its experimental drugs used to combat respiratory syncytial virus (RSV) infections. In October, Pfizer paid US$ 5.4 billion for blood disorder drugmaker Global Blood Therapeutics (GBT). Through this buyout, Pfizer has added GBT’s approved drug, Oxbryta, along with two other sickle cell medicines – GBT601 and inclacumab (both in mid- to late-stage testing) – to its portfolio.And this month, Pfizer announced it will acquire Seattle-based cancer specialist Seagen for US$ 43 billion, its biggest acquisition in the recent past. “We are not buying the golden eggs,” Albert Bourla, CEO of Pfizer, said post the announcement. “We are acquiring the goose that is laying the golden eggs.”The Pfizer-Seagen deal is also the largest biopharma acquisition since 2019, when BMS bought Celgene for US$ 74 billion. Seagen is a leader in antibody-drug conjugate (ADC) technology. This deal will bring four commercial medicines (Adcetris, Padcev, Tukysa and Tivdak) and a deep pipeline of ADC candidates to Pfizer’s fold.Seagen is likely to post US$ 2.2 billion in revenues this year, which is expected to grow to over US$ 10 billion (risk-adjusted) by 2030. Earlier this year, Bourla had said the company has planned to use its “extraordinary firepower” to buy products that will deliver US$ 25 billion in incremental revenue by 2030. While Seagen will bring in US$ 10 billion, another US$ 10.5 billion will come from Arena, Biohaven, GBT and ReViral.View our Dashboard to know more about Pfizer's Drugs in Development (Free Excel) Diminishing demand for Covid products, expiring patents to drag turnover downPfizer’s turnover has nearly doubled since 2018, when it was at US$ 53.6 billion. In July 2019, Pfizer had announced the plan to combine Upjohn with Mylan to form a new company — Viatris. With the separation of the Upjohn business and the formation of a consumer healthcare joint venture with GSK in 2019, Pfizer transformed into a more focused player in innovative medicines and vaccines. However, this restructuring measure also led to a drop in its turnover to US$ 51.8 billion in 2019 and to US$ 41.9 billion in 2020. From the number three slot in 2018 (behind J&J and Roche), Pfizer’s ranking fell to eight in 2020. However, Covid turned its fortunes yet again and its turnover increased to US$ 81.3 billion in 2021.When we split Pfizer’s 2022 revenues of US$ 100.3 billion, we notice that its portfolio has 10 products with sales greater than US$ 1 billion. These include the Covid-19 vaccine Comirnaty with US$ 37.8 billion in revenues, Paxlovid with US$ 18.9 billion, anticoagulant Eliquis with US$ 6.5 billion, and the Prevnar family of pneumococcal vaccines with US$ 6.3 billion in revenues. Pfizer's partner BMS recorded sales of US$ 11.8 billion for Eliquis in 2022.With a drop in Covid cases, demand for Comirnaty and Paxlovid has decreased significantly. In 2023, Comirnaty’s revenue is likely to drop 64 percent to around US$ 13.5 billion, and Paxlovid’s revenue is likely to plummet by around 58 percent to around US$ 8 billion.Pfizer expects its 2023 revenues to be between US$ 67 billion and US$ 71 billion, reflecting an operational decline of over 30 percent. However, when we exclude the revenues of Covid products, we are likely to see a growth in revenues of around 7 to 9 percent, coming primarily from new product launches, recently acquired products and Pfizer’s in-line portfolio.“Pfizer expects 2024 sales of Covid products to stabilize, then starting in 2025 and continuing in 2026 and beyond, it expects to see an increase in Covid-19 vaccination rates, assuming the successful development and approval of a Covid-flu combination product,” said Bourla. Last December, Pfizer and BioNTech received fast track designation from the US Food and Drug Administration (FDA) for their mRNA-based combination vaccine candidate for influenza and Covid-19, which aims to help prevent two respiratory diseases with a single injection.View our Dashboard to know more about Pfizer's Drugs in Development (Free Excel) Stars in Pfizer’s pipeline — RSV, pneumococcal and meningococcal vaccinesIn 2022, Pfizer spent US$ 11.4 billion in research and development, up 12 percent from its R&D spend in 2021. It has a power-packed pipeline with 110 programs, including 72 new molecular entities. Out of the 110 programs, 33 are in oncology, 23 in inflammation and immunology, 19 in vaccines, 15 in internal medicines, 12 in rare diseases and eight in anti-infectives.However, the stars in Pfizer’s pipeline are its vaccine candidates. Pfizer’s RSV vaccine candidate RSVpreF is being developed for pregnant women (to help protect their babies from RSV after birth) and individuals 60 years of age or older for the prevention of lower respiratory tract disease caused by RSV. The vaccine recently received support from the FDA's advisory committee, and a decision on its use for older adults is expected by May 2023.The agency has also granted priority review to the maternal RSV vaccine, with an action date of August 2023. If approved, it would be the first vaccine for pregnant women to help protect against the complications of RSV disease in infants from birth through six months.Recently, FDA also designated Prevnar 20 for priority review in children aged six weeks through 17 years. Six months ago, Merck’s Vaxneuvance had received pediatric approval. The Merck vaccine defends against 15 serotypes, as compared to 13 strains covered by Pfizer’s Prevnar. However, Merck’s edge could be short-lived as Prevnar’s next-generation vaccine protects against 20 serotypes. The US regulatory agency has also accepted the BLA (biologics license application) review of Pfizer’s pentavalent meningococcal vaccine candidate — MenABCWY — in adolescents with the PDUFA date of October 2023. Moreover, the company has announced positive top-line results from a phase 3 study of its hemophilia B gene therapy candidate, fidanacogene elaparvovec.Besides this vaccines and therapies, FDA is going to decide on several other Pfizer drugs in 2023, such as ritlecitinib for alopecia, elranatamab for multiple myeloma, etrasimod for ulcerative colitis, and Abrilada, a biosimilar of AbbVie’s blockbuster Humira (adalimumab).View our Dashboard to know more about Pfizer's Drugs in Development (Free Excel) Our viewAs of today, the sweet spot of US$ 100.3 billion in 2022 revenues posted by Pfizer surely looks like a one-off. Though the drug behemoth’s vaccine pipeline looks promising, its shopping list reflects a huge reliance on oncology for future growth.While only time can tell which of those bets will work and which won’t, it looks like Pfizer has capitalized on the lead the pandemic granted it to race ahead of competition.(All financial and drug pipeline-related information has been taken from the Pfizer website.)