Register entry
Vertex Pharmaceuticals Incorporated
Data as of · How to read this entry
- Registered sites
- 1
- Active NDC listings
- 21
- Live patents
- 601
- Exclusivities
- 6
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Analytical testing1Finished drug manufacture1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | 50 Northern Avenue, Boston, Massachusetts (MA) 02210, United States (USA) | Analytical testing, Finished drug manufacture | 1000513211602478257 |
Catalogue
Drug listings by form and route
2121 active NDC listings: 20 human prescription drug, 1 cellular therapy. By marketing category: NDA 20, BLA 1.
| Dosage form | NDCs |
|---|---|
| granule | 8 |
| kit | 6 |
| tablet, film coated | 6 |
| injection, suspension | 1 |
| Route | NDCs |
|---|---|
| oral | 14 |
| intravenous | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| vertex pharmaceuticals incorporated | 21 |
Exclusivity
Patents and exclusivities
601| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 7973038 | ORKAMBIivacaftor; lumacaftor | use | Nov 2026 |
| 8741933 | ORKAMBIivacaftor; lumacaftor | use | Nov 2026 |
| 9216969 | ORKAMBIivacaftor; lumacaftor | substance, product | Nov 2026 |
| 8410274 | ALYFTREK, KALYDECO, ORKAMBI, SYMDEKO (COPACKAGED), TRIKAFTA (COPACKAGED)deutivacaftor; tezacaftor; vanzacaftor calcium; elexacaftor, ivacaftor, tezacaftor; ivacaftor; ivacaftor; ivacaftor; ivacaftor, tezacaftor; ivacaftor; lumacaftor | product | Dec 2026 |
| 8754224 | ALYFTREK, KALYDECO, ORKAMBI, SYMDEKO (COPACKAGED), TRIKAFTA (COPACKAGED)deutivacaftor; tezacaftor; vanzacaftor calcium; elexacaftor, ivacaftor, tezacaftor; ivacaftor; ivacaftor; ivacaftor; ivacaftor, tezacaftor; ivacaftor; lumacaftor | substance, product | Dec 2026 |
| 9670163 | ALYFTREK, KALYDECO, ORKAMBI, SYMDEKO (COPACKAGED), TRIKAFTA (COPACKAGED)deutivacaftor; tezacaftor; vanzacaftor calcium; elexacaftor, ivacaftor, tezacaftor; ivacaftor; ivacaftor; ivacaftor; ivacaftor, tezacaftor; ivacaftor; lumacaftor | product | Dec 2026 |
| 9931334 | ALYFTREK, ORKAMBI, SYMDEKO (COPACKAGED), TRIKAFTA (COPACKAGED)deutivacaftor; tezacaftor; vanzacaftor calcium; elexacaftor, ivacaftor, tezacaftor; ivacaftor; ivacaftor; ivacaftor, tezacaftor; ivacaftor; lumacaftor | product | Dec 2026 |
| 8354427*PED | KALYDECOivacaftor | use | Jan 2027 |
| 10022352 | ALYFTREK, SYMDEKO (COPACKAGED), TRIKAFTA (COPACKAGED)deutivacaftor; tezacaftor; vanzacaftor calcium; elexacaftor, ivacaftor, tezacaftor; ivacaftor; ivacaftor; ivacaftor, tezacaftor | product | Apr 2027 |
| 10239867 | ALYFTREK, SYMDEKO (COPACKAGED), TRIKAFTA (COPACKAGED)deutivacaftor; tezacaftor; vanzacaftor calcium; elexacaftor, ivacaftor, tezacaftor; ivacaftor; ivacaftor; ivacaftor, tezacaftor | substance, product | Apr 2027 |
| 11639347 | ALYFTREK, SYMDEKO (COPACKAGED), TRIKAFTA (COPACKAGED)deutivacaftor; tezacaftor; vanzacaftor calcium; elexacaftor, ivacaftor, tezacaftor; ivacaftor; ivacaftor; ivacaftor, tezacaftor | substance, product | Apr 2027 |
| 9974781 | ALYFTREK, SYMDEKO (COPACKAGED), TRIKAFTA (COPACKAGED)deutivacaftor; tezacaftor; vanzacaftor calcium; elexacaftor, ivacaftor, tezacaftor; ivacaftor; ivacaftor; ivacaftor, tezacaftor | product | Apr 2027 |
| 7645789 | ALYFTREK, SYMDEKO (COPACKAGED), TRIKAFTA (COPACKAGED)deutivacaftor; tezacaftor; vanzacaftor calcium; elexacaftor, ivacaftor, tezacaftor; ivacaftor; ivacaftor; ivacaftor, tezacaftor | substance, product | May 2027 |
| 8598181 | ALYFTREK, SYMDEKO (COPACKAGED), TRIKAFTA (COPACKAGED)deutivacaftor; tezacaftor; vanzacaftor calcium; elexacaftor, ivacaftor, tezacaftor; ivacaftor; ivacaftor; ivacaftor, tezacaftor | use | May 2027 |
| 8623905 | ALYFTREK, SYMDEKO (COPACKAGED), TRIKAFTA (COPACKAGED)deutivacaftor; tezacaftor; vanzacaftor calcium; elexacaftor, ivacaftor, tezacaftor; ivacaftor; ivacaftor; ivacaftor, tezacaftor | substance, product | May 2027 |
| 7973038*PED | ORKAMBIivacaftor; lumacaftor | use | May 2027 |
| 8741933*PED | ORKAMBIivacaftor; lumacaftor | use | May 2027 |
| 9216969*PED | ORKAMBIivacaftor; lumacaftor | use | May 2027 |
| 7495103 | ALYFTREK, KALYDECO, ORKAMBI, SYMDEKO (COPACKAGED), TRIKAFTA (COPACKAGED)deutivacaftor; tezacaftor; vanzacaftor calcium; elexacaftor, ivacaftor, tezacaftor; ivacaftor; ivacaftor; ivacaftor; ivacaftor, tezacaftor; ivacaftor; lumacaftor | substance, product | May 2027 |
| 7776905 | ALYFTREK, SYMDEKO (COPACKAGED), TRIKAFTA (COPACKAGED)deutivacaftor; tezacaftor; vanzacaftor calcium; elexacaftor, ivacaftor, tezacaftor; ivacaftor; ivacaftor; ivacaftor, tezacaftor | substance, product | Jun 2027 |
| 8410274*PED | KALYDECO, ORKAMBIivacaftor; ivacaftor; lumacaftor | use | Jun 2027 |
| 8754224*PED | KALYDECO, ORKAMBIivacaftor; ivacaftor; lumacaftor | use | Jun 2027 |
| 9670163*PED | KALYDECO, ORKAMBIivacaftor; ivacaftor; lumacaftor | use | Jun 2027 |
| 9931334*PED | ORKAMBIivacaftor; lumacaftor | use | Jun 2027 |
| 8324242 | ALYFTREK, KALYDECO, ORKAMBI, SYMDEKO (COPACKAGED), TRIKAFTA (COPACKAGED)deutivacaftor; tezacaftor; vanzacaftor calcium; elexacaftor, ivacaftor, tezacaftor; ivacaftor; ivacaftor; ivacaftor; ivacaftor, tezacaftor; ivacaftor; lumacaftor | use | Aug 2027 |
| 8415387 | ALYFTREK, SYMDEKO (COPACKAGED), TRIKAFTA (COPACKAGED)deutivacaftor; tezacaftor; vanzacaftor calcium; elexacaftor, ivacaftor, tezacaftor; ivacaftor; ivacaftor; ivacaftor, tezacaftor | use | Nov 2027 |
| 7495103*PED | KALYDECO, ORKAMBIivacaftor; ivacaftor; lumacaftor | use | Nov 2027 |
| 8324242*PED | KALYDECO, ORKAMBIivacaftor; ivacaftor; lumacaftor | use | Feb 2028 |
| 8431615 | INCIVEKtelaprevir | use | May 2028 |
| 10076513 | ORKAMBIivacaftor; lumacaftor | product | Dec 2028 |
| 10597384 | ORKAMBIivacaftor; lumacaftor | substance, product | Dec 2028 |
| 11052075 | ORKAMBIivacaftor; lumacaftor | product | Dec 2028 |
| 12065432 | ORKAMBIivacaftor; lumacaftor | use | Dec 2028 |
| 8653103 | ORKAMBIivacaftor; lumacaftor | product | Dec 2028 |
| 9150552 | ORKAMBIivacaftor; lumacaftor | use | Dec 2028 |
| 10076513*PED | ORKAMBIivacaftor; lumacaftor | use | Jun 2029 |
| 10597384*PED | ORKAMBIivacaftor; lumacaftor | use | Jun 2029 |
| 11052075*PED | ORKAMBIivacaftor; lumacaftor | use | Jun 2029 |
| 12065432*PED | ORKAMBIivacaftor; lumacaftor | use | Jun 2029 |
| 8653103*PED | ORKAMBIivacaftor; lumacaftor | use | Jun 2029 |
| 9150552*PED | ORKAMBIivacaftor; lumacaftor | use | Jun 2029 |
| 8846718 | ORKAMBIivacaftor; lumacaftor | use | Jul 2029 |
| 10646481 | ALYFTREK, KALYDECO, ORKAMBI, SYMDEKO (COPACKAGED), TRIKAFTA (COPACKAGED)deutivacaftor; tezacaftor; vanzacaftor calcium; elexacaftor, ivacaftor, tezacaftor; ivacaftor; ivacaftor; ivacaftor; ivacaftor, tezacaftor; ivacaftor; lumacaftor | product | Aug 2029 |
| 11564916 | ALYFTREK, KALYDECO, ORKAMBI, SYMDEKO (COPACKAGED), TRIKAFTA (COPACKAGED)deutivacaftor; tezacaftor; vanzacaftor calcium; elexacaftor, ivacaftor, tezacaftor; ivacaftor; ivacaftor; ivacaftor; ivacaftor, tezacaftor; ivacaftor; lumacaftor | use | Aug 2029 |
| 12458635 | KALYDECO, ORKAMBI, SYMDEKO (COPACKAGED), TRIKAFTA (COPACKAGED)elexacaftor, ivacaftor, tezacaftor; ivacaftor; ivacaftor; ivacaftor; ivacaftor, tezacaftor; ivacaftor; lumacaftor | product | Aug 2029 |
| 9192606 | ORKAMBIivacaftor; lumacaftor | product | Sept 2029 |
| 8846718*PED | ORKAMBIivacaftor; lumacaftor | use | Jan 2030 |
| 10646481*PED | KALYDECO, ORKAMBIivacaftor; ivacaftor; lumacaftor | use | Feb 2030 |
| 11564916*PED | KALYDECO, ORKAMBIivacaftor; ivacaftor; lumacaftor | use | Feb 2030 |
| 12458635*PED | KALYDECO, ORKAMBIivacaftor; ivacaftor; lumacaftor | use | Feb 2030 |
| 9192606*PED | ORKAMBIivacaftor; lumacaftor | use | Mar 2030 |
| 8507534 | ORKAMBIivacaftor; lumacaftor | substance, product | Sept 2030 |
| 8716338 | ORKAMBIivacaftor; lumacaftor | product | Sept 2030 |
| 8993600 | ORKAMBIivacaftor; lumacaftor | product | Dec 2030 |
| 8507534*PED | ORKAMBIivacaftor; lumacaftor | use | Mar 2031 |
| 8716338*PED | ORKAMBIivacaftor; lumacaftor | use | Mar 2031 |
| 10081621 | ALYFTREK, SYMDEKO (COPACKAGED), TRIKAFTA (COPACKAGED)deutivacaftor; tezacaftor; vanzacaftor calcium; elexacaftor, ivacaftor, tezacaftor; ivacaftor; ivacaftor; ivacaftor, tezacaftor | product | Mar 2031 |
| 11578062 | ALYFTREK, SYMDEKO (COPACKAGED), TRIKAFTA (COPACKAGED)deutivacaftor; tezacaftor; vanzacaftor calcium; elexacaftor, ivacaftor, tezacaftor; ivacaftor; ivacaftor; ivacaftor, tezacaftor | product | Mar 2031 |
| 8993600*PED | ORKAMBIivacaftor; lumacaftor | use | Jun 2031 |
| RE50453 | ALYFTREK, SYMDEKO (COPACKAGED), TRIKAFTA (COPACKAGED)deutivacaftor; tezacaftor; vanzacaftor calcium; elexacaftor, ivacaftor, tezacaftor; ivacaftor; ivacaftor; ivacaftor, tezacaftor | substance, product | Jul 2031 |
| Product | Exclusivity | Until |
|---|---|---|
| ALYFTREKDEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM | ODE-536 Orphan drug | Mar 2033 |
| JOURNAVXSUZETRIGINE | NCE New chemical entity | Jan 2030 |
| KALYDECOIVACAFTOR | PED Paediatric | Nov 2030 |
| ORKAMBIIVACAFTOR; LUMACAFTOR | PED Paediatric | Mar 2030 |
| SYMDEKO (COPACKAGED)IVACAFTOR; IVACAFTOR, TEZACAFTOR | ODE-335 Orphan drug | Dec 2027 |
| TRIKAFTA (COPACKAGED)ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | ODE-543 Orphan drug | Mar 2033 |
Catalogue
Marketed products
21| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| ALYFTREK | vanzacaftor, tezacaftor, and deutivacaftor | tablet, film coated, oral | 51167-121NDA |
| ALYFTREK | vanzacaftor, tezacaftor, and deutivacaftor | tablet, film coated, oral | 51167-135NDA |
| CASGEVY | exagamglogene autotemcel | injection, suspension, intravenous | 51167-290BLA |
| JOURNAVX | Suzetrigine | tablet, film coated, oral | 51167-548NDA |
| Kalydeco | ivacaftor | tablet, film coated, oral | 51167-200NDA |
| Kalydeco | ivacaftor | granule, oral | 51167-300NDA |
| Kalydeco | ivacaftor | granule, oral | 51167-400NDA |
| Kalydeco | ivacaftor | granule, oral | 51167-600NDA |
| Kalydeco | ivacaftor | granule, oral | 51167-770NDA |
| Kalydeco | ivacaftor | granule, oral | 51167-785NDA |
| ORKAMBI | lumacaftor and ivacaftor | granule, oral | 51167-122NDA |
| ORKAMBI | lumacaftor and ivacaftor | granule, oral | 51167-500NDA |
| ORKAMBI | lumacaftor and ivacaftor | tablet, film coated, oral | 51167-700NDA |
| ORKAMBI | lumacaftor and ivacaftor | tablet, film coated, oral | 51167-809NDA |
| ORKAMBI | lumacaftor and ivacaftor | granule, oral | 51167-900NDA |
| SYMDEKO | Tezacaftor and Ivacaftor | kit | 51167-113NDA |
| SYMDEKO | Tezacaftor and Ivacaftor | kit | 51167-661NDA |
| Trikafta | Elexacaftor, Tezacaftor, and Ivacaftor | kit | 51167-106NDA |
| Trikafta | Elexacaftor, Tezacaftor, and Ivacaftor | kit | 51167-331NDA |
| Trikafta | Elexacaftor, Tezacaftor, and Ivacaftor | kit | 51167-445NDA |
| Trikafta | Elexacaftor, Tezacaftor, and Ivacaftor | kit | 51167-446NDA |
Neighbours
Registered in the same town
6- EMD Serono, Inc.Boston, MA
- Spectrum Pharmaceuticals, Inc.Boston, MA
- MassBiologicsBoston, MA
- Zealand Pharma A/SBoston, MA
- BRIGHAM AND WOMEN`S HOSPITAL, INC., THEBoston, MA
- Massachusetts General Hospital, TheBoston, MA
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Enquiry
Common questions
- Is Vertex Pharmaceuticals Incorporated FDA approved?
- Vertex Pharmaceuticals Incorporated holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are Vertex Pharmaceuticals Incorporated's drugs manufactured?
- The FDA register lists Boston, MA. Registered operations: analytical testing, finished drug manufacture.
- What drugs does Vertex Pharmaceuticals Incorporated make?
- 21 products are listed under Vertex Pharmaceuticals Incorporated in the openFDA NDC Directory, most often as granule; kit; tablet, film coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.