Register entry
- Registered sites
- 2
- Active NDC listings
- 4
- Live patents
- 48
- Exclusivities
- 3
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Analytical testing2Active ingredient (API) manufacture1Finished drug manufacture1
Sites
Registered establishments
2| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Alnylam Pharmaceuticals Inc.Registrant: Alnylam Pharmaceuticals, Inc. | 665 Concord Ave, Cambridge, Massachusetts (MA) 02138, United States (USA) | Analytical testing, Finished drug manufacture | 3013754451080889930 |
| Alnylam US Inc. | 20 Commerce Way, Norton, Massachusetts (MA) 02766, United States (USA) | Analytical testing, Active ingredient (API) manufacture | 3017995758118304944 |
Catalogue
Drug listings by form and route
44 active NDC listings: 4 human prescription drug. By marketing category: NDA 4.
| Dosage form | NDCs |
|---|---|
| injection, solution | 2 |
| injection | 1 |
| injection, lipid complex | 1 |
| Route | NDCs |
|---|---|
| subcutaneous | 3 |
| intravenous | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| alnylam pharmaceuticals, inc. | 4 |
Exclusivity
Patents and exclusivities
48| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 8642076 | ONPATTROpatisiran sodium | product | Oct 2027 |
| 10131907 | AMVUTTRA, GIVLAARI, OXLUMOgivosiran sodium; lumasiran sodium; vutrisiran sodium | substance, product | Aug 2028 |
| 10806791 | AMVUTTRAvutrisiran sodium | substance | Dec 2028 |
| 8828956 | AMVUTTRA, GIVLAARI, OXLUMOgivosiran sodium; lumasiran sodium; vutrisiran sodium | substance, product | Dec 2028 |
| 9370581 | AMVUTTRAvutrisiran sodium | substance, product | Dec 2028 |
| 11141378 | ONPATTROpatisiran sodium | product | Apr 2029 |
| 8058069 | ONPATTROpatisiran sodium | product | Apr 2029 |
| 8492359 | ONPATTROpatisiran sodium | product | Apr 2029 |
| 8822668 | ONPATTROpatisiran sodium | product | Apr 2029 |
| 9364435 | ONPATTROpatisiran sodium | product | Apr 2029 |
| 10240152 | ONPATTROpatisiran sodium | substance, product | Oct 2029 |
| 8741866 | ONPATTROpatisiran sodium | use | Oct 2029 |
| 9234196 | ONPATTROpatisiran sodium | product | Oct 2029 |
| 8106022 | AMVUTTRA, GIVLAARI, OXLUMOgivosiran sodium; lumasiran sodium; vutrisiran sodium | substance, product | Dec 2029 |
| 8802644 | ONPATTROpatisiran sodium | product | Oct 2030 |
| 8158601 | ONPATTROpatisiran sodium | product | Nov 2030 |
| 8168775 | ONPATTROpatisiran sodium | substance, product | Aug 2032 |
| 10570391 | AMVUTTRAvutrisiran sodium | substance, product | Nov 2032 |
| 9399775 | AMVUTTRAvutrisiran sodium | substance, product | Nov 2032 |
| 10125364 | GIVLAARIgivosiran sodium | substance, product | Mar 2033 |
| 9631193 | GIVLAARIgivosiran sodium | use | Mar 2033 |
| 9133461 | GIVLAARIgivosiran sodium | substance, product | Nov 2033 |
| 10119143 | GIVLAARIgivosiran sodium | substance, product | Oct 2034 |
| 11028392 | GIVLAARIgivosiran sodium | substance, product | Oct 2034 |
| 10435692 | OXLUMOlumasiran sodium | use | Dec 2034 |
| 10465195 | OXLUMOlumasiran sodium | substance, product | Dec 2034 |
| 10487330 | OXLUMOlumasiran sodium | substance, product | Dec 2034 |
| 11060093 | OXLUMOlumasiran sodium | substance, product | Dec 2034 |
| 9828606 | OXLUMOlumasiran sodium | substance, product | Dec 2034 |
| 10612024 | AMVUTTRA, OXLUMOlumasiran sodium; vutrisiran sodium | substance, product | Aug 2035 |
| 10612027 | OXLUMOlumasiran sodium | substance, product | Aug 2035 |
| 11401517 | AMVUTTRA, OXLUMOlumasiran sodium; vutrisiran sodium | substance, product | Aug 2035 |
| 11079379 | ONPATTROpatisiran sodium | substance, product | Aug 2035 |
| 10478500 | OXLUMOlumasiran sodium | substance, product | Oct 2035 |
| 11446380 | OXLUMOlumasiran sodium | substance, product | Oct 2035 |
| 10208307 | AMVUTTRAvutrisiran sodium | substance, product | Jul 2036 |
| 10683501 | AMVUTTRAvutrisiran sodium | substance, product | Jul 2036 |
| 11286486 | AMVUTTRAvutrisiran sodium | substance, product | Jul 2036 |
| 12049628 | AMVUTTRAvutrisiran sodium | substance, product | Jul 2036 |
| 11261447 | OXLUMOlumasiran sodium | substance, product | Nov 2038 |
| Product | Exclusivity | Until |
|---|---|---|
| AMVUTTRAVUTRISIRAN SODIUM | ODE-527 Orphan drug | Mar 2032 |
| GIVLAARIGIVOSIRAN SODIUM | ODE-273 Orphan drug | Nov 2026 |
| OXLUMOLUMASIRAN SODIUM | ODE-415 Orphan drug | Oct 2029 |
Catalogue
Marketed products
4| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| AMVUTTRA | VUTRISIRAN | injection, subcutaneous | 71336-1003NDA |
| GIVLAARI | givosiran sodium | injection, solution, subcutaneous | 71336-1001NDA |
| OXLUMO | lumasiran | injection, solution, subcutaneous | 71336-1002NDA |
| Onpattro | patisiran | injection, lipid complex, intravenous | 71336-1000NDA |
Neighbours
Registered in the same town
2- Shire Human Genetic Therapies, Inc.Cambridge, MA
- Vericel CorporationCambridge, MA
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Enquiry
Common questions
- Is Alnylam Pharmaceuticals, Inc. FDA approved?
- Alnylam Pharmaceuticals, Inc. holds 2 FDA-registered establishments 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 Alnylam Pharmaceuticals, Inc.'s drugs manufactured?
- The FDA register lists Cambridge, MA; Norton, MA. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.
- What drugs does Alnylam Pharmaceuticals, Inc. make?
- 4 products are listed under Alnylam Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as injection, solution; injection; injection, lipid complex. 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.