Generic Onpattro Availability

Last updated on Jan 11, 2023.

Onpattro is a brand name of patisiran, approved by the FDA in the following formulation(s):

ONPATTRO (patisiran sodium - solution;intravenous)

Manufacturer: ALNYLAM PHARMS INC
Approval date: August 10, 2018
Strength(s): EQ 10MG BASE/5ML (EQ 2MG BASE/ML) ^[RLD]

Has a generic version of Onpattro been approved?

No. There is currently no therapeutically equivalent version of Onpattro available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Onpattro. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

Compositions and methods for inhibiting expression of transthyretin
Patent 10,240,152
Issued: March 26, 2019
Assignee(s): Alnylam Pharmaceuticals, Inc.
The invention relates to a double-stranded ribonucleic acid (dsRNA) targeting a transthyretin (TTR) gene, and methods of using the dsRNA to inhibit expression of TTR.
Patent expiration dates:
- October 20, 2029
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  Patent use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
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  Drug substance
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Patent 11,079,379
Patent expiration dates:
- August 27, 2035
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  Patent use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
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Patent 11,141,378
Patent expiration dates:
- April 15, 2029
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  Drug product
Lipid formulations for nucleic acid delivery
Patent 8,058,069
Issued: November 15, 2011
Inventor(s): Yaworski; Edward & Lam; Kieu & Jeffs; Lloyd & Palmer; Lorne & MacLachlan; Ian
Assignee(s): Protiva Biotherapeutics, Inc.
The present invention provides novel, stable lipid particles comprising one or more active agents or therapeutic agents, methods of making the lipid particles, and methods of delivering and/or administering the lipid particles. More particularly, the present invention provides stable nucleic acid-lipid particles (SNALP) comprising a nucleic acid (such as one or more interfering RNA), methods of making the SNALP, and methods of delivering and/or administering the SNALP.
Patent expiration dates:
- April 15, 2029
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  Drug product
Lipid formulation
Patent 8,158,601
Issued: April 17, 2012
Inventor(s): Chen; Jianxin & Ansell; Steven & Akinc; Akin & Dorkin; Joseph Robert & Qin; Xiaojun & Cantley; William & Manoharan; Muthiah & Rajeev; Kallanthottathil G. & Narayanannair; Jayaprakash K. & Jayaraman; Muthusamy
Assignee(s): Alnylam Pharmaceuticals, Inc.
The invention features a cationic lipid of formula I, an improved lipid formulation comprising a cationic lipid of formula I and corresponding methods of use. Also disclosed are targeting lipids, and specific lipid formulations comprising such targeting lipids.
Patent expiration dates:
- November 10, 2030
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  Patent use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
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  Drug product
Compositions and methods for inhibiting expression of transthyretin
Patent 8,168,775
Issued: May 1, 2012
Inventor(s): Sah; Dinah Wen-Yee & Hinkle; Gregory & Alvarez; Rene & Milstein; Stuart & Chen; Qingmin
Assignee(s): Alnylam Pharmaceuticals, Inc.
The invention relates to a double-stranded ribonucleic acid (dsRNA) targeting a transthyretin (TTR) gene, and methods of using the dsRNA to inhibit expression of TTR.
Patent expiration dates:
- October 20, 2029
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  Patent use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
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  Drug substance
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  Drug product
Nuclease resistant double-stranded ribonucleic acid
Patent 8,334,373
Issued: December 18, 2012
Inventor(s): Vornlocher; Hans-Peter & Roehl; Ingo & Hadwiger; Philipp & Zimmermann; Tracy Stage & Manoharan; Muthiah & Rajeev; Kallanthottathil G. & Akinc; Akin
Assignee(s): Alnylam Pharmaceuticals, Inc.
This invention relates to modified double-stranded oligoribonucleic acid (dsRNA) having improved stability in cells and biological fluids, and methods of making and identifying dsRNA having improved stability, and of using the dsRNA to inhibit the expression or function of a target gene.
Patent expiration dates:
- May 27, 2025
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Lipid formulations for nucleic acid delivery
Patent 8,492,359
Issued: July 23, 2013
Assignee(s): Protiva Biotherapeutics, Inc.
The present invention provides novel, stable lipid particles comprising one or more active agents or therapeutic agents, methods of making the lipid particles, and methods of delivering and/or administering the lipid particles. More particularly, the present invention provides stable nucleic acid-lipid particles (SNALP) comprising a nucleic acid (such as one or more interfering RNA), methods of making the SNALP, and methods of delivering and/or administering the SNALP.
Patent expiration dates:
- April 15, 2029
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  Drug product
Lipid containing formulations
Patent 8,642,076
Issued: February 4, 2014
Assignee(s): Tekmira Pharmaceuticals Corporation
Compositions and methods useful in administering nucleic acid based therapies, for example association complexes such as liposomes and lipoplexes are described.
Patent expiration dates:
- October 3, 2027
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  Drug product
Compositions and methods for inhibiting expression of transthyretin
Patent 8,741,866
Issued: June 3, 2014
Assignee(s): Alnylam Pharmaceuticals, Inc.
The invention relates to a double-stranded ribonucleic acid (dsRNA) targeting a transthyretin (TTR) gene, and methods of using the dsRNA to inhibit expression of TTR.
Patent expiration dates:
- October 20, 2029
  ✓
  Patent use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
Lipid formulation
Patent 8,802,644
Issued: August 12, 2014
Assignee(s): Tekmira Pharmaceuticals Corporation
The invention features a cationic lipid of formula I, an improved lipid formulation comprising a cationic lipid of formula I and corresponding methods of use. Also disclosed are targeting lipids, and specific lipid formulations comprising such targeting lipids.
Patent expiration dates:
- October 21, 2030
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  Patent use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
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  Drug product
Lipid formulations for nucleic acid delivery
Patent 8,822,668
Issued: September 2, 2014
Assignee(s): Protiva Biotherapeutics, Inc.
The present invention provides novel, stable lipid particles comprising one or more active agents or therapeutic agents, methods of making the lipid particles, and methods of delivering and/or administering the lipid particles. More particularly, the present invention provides stable nucleic acid-lipid particles (SNALP) comprising a nucleic acid (such as one or more interfering RNA), methods of making the SNALP, and methods of delivering and/or administering the SNALP.
Patent expiration dates:
- April 15, 2029
  ✓
  Patent use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
  ✓
  Drug product
Compositions and methods for inhibiting expression of transthyretin
Patent 9,234,196
Issued: January 12, 2016
Assignee(s): Alnylam Pharmaceuticals, Inc.
The invention relates to a double-stranded ribonucleic acid (dsRNA) targeting a transthyretin (TTR) gene, and methods of using the dsRNA to inhibit expression of TTR.
Patent expiration dates:
- October 20, 2029
  ✓
  Patent use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
  ✓
  Drug product
Lipid formulations for nucleic acid delivery
Patent 9,364,435
Issued: June 14, 2016
Assignee(s): PROTIVA BIOTHERAPEUTICS, INC.
The present invention provides novel, stable lipid particles comprising one or more active agents or therapeutic agents, methods of making the lipid particles, and methods of delivering and/or administering the lipid particles. More particularly, the present invention provides stable nucleic acid-lipid particles (SNALP) comprising a nucleic acid (such as one or more interfering RNA), methods of making the SNALP, and methods of delivering and/or administering the SNALP.
Patent expiration dates:
- April 15, 2029
  ✓
  Patent use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
  ✓
  Drug product
2′-methoxy substituted oligomeric compounds and compositions for use in gene modulations
Patent 9,943,538
Issued: April 17, 2018
Assignee(s): Ionis Pharmaceuticals, Inc.
Compositions comprising first and second oligomers are provided wherein at least a portion of the first oligomer is capable of hybridizing with at least a portion of the second oligomer, at least a portion of the first oligomer is complementary to and capable of hybridizing to a selected target nucleic acid, and at least one of the first or second oligomers includes a modified sugar and/or backbone modification. In some embodiments the modification is a 2′-OCH3 substituent group on a sugar moiety. Oligomer/protein compositions are also provided comprising an oligomer complementary to and capable of hybridizing to a selected target nucleic acid and at least one protein comprising at least a portion of an RNA-induced silencing complex (RISC), wherein at least one nucleotide of the oligomer has a modified sugar and/or backbone modification.
Patent expiration dates:
- November 4, 2023
  ✓
  Drug product
2′-methoxy substituted oligomeric compounds and compositions for use in gene modulations
Patent 9,943,539
Issued: April 17, 2018
Assignee(s): Ionis Pharmaceuticals, Inc.
Compositions comprising first and second oligomers are provided wherein at least a portion of the first oligomer is capable of hybridizing with at least a portion of the second oligomer, at least a portion of the first oligomer is complementary to and capable of hybridizing to a selected target nucleic acid, and at least one of the first or second oligomers includes a modified sugar and/or backbone modification. In some embodiments the modification is a 2′-OCH3 substituent group on a sugar moiety. Oligomer/protein compositions are also provided comprising an oligomer complementary to and capable of hybridizing to a selected target nucleic acid and at least one protein comprising at least a portion of an RNA-induced silencing complex (RISC), wherein at least one nucleotide of the oligomer has a modified sugar and/or backbone modification.
Patent expiration dates:
- November 4, 2023
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  Drug product

Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

Exclusivity expiration dates:
- August 10, 2023 - NEW CHEMICAL ENTITY
- August 10, 2025 - INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS

More about Onpattro (patisiran)

Glossary

Term	Definition
Drug Patent	A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity	Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD	A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

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Pill medicine is Onpattro 10 mg/5 mL (2 mg/mL) solution for intravenous infusion

Onpattro 10 mg/5 mL (2 mg/mL) solution for intravenous infusion (medicine)